Subchapter H—Medical Devices

SUBCHAPTER H—MEDICAL DEVICES

PART 800—GENERAL this chapter, this ruling is applicable to ophthalmic preparations that are Subpart A [Reserved] regulated as drugs. (3) The containers shall be sterile at Subpart B—Requirements for Specific the time of filling and closing, and the Medical Devices container or individual carton shall be Sec. so sealed that the contents cannot be 800.10 Contact lens solutions; sterility. used without destroying the seal. The 800.12 Contact lens solutions and tablets; packaging and labeling of these solu- tamper-resistant packaging. tions shall also comply with § 800.12 on 800.20 Patient examination gloves and sur- tamper-resistant packaging require- geons’ gloves; sample plans and test ments. method for leakage defects; adulteration. (b) Liquid ophthalmic preparations Subpart C—Administrative Practices and packed in multiple-dose containers Procedures should: (1) Contain one or more suitable and 800.55 Administrative detention. harmless substances that will inhibit AUTHORITY: 21 U.S.C. 321, 334, 351, 352, 355, the growth of microorganisms; or 360e, 360i, 360k, 361, 362, 371. (2) Be so packaged as to volume and type of container and so labeled as to Subpart A [Reserved] duration of use and with such necessary warnings as to afford adequate Subpart B—Requirements for protection and minimize the hazard of Specific Medical Devices injury resulting from contamination during use. § 800.10 Contact lens solutions; ste- (c) Eye cups, eye droppers, and other rility. dispensers intended for ophthalmic use (a)(1) Informed medical opinion is in should be sterile, and may be regarded agreement that all preparations offered as falling below their professed stand- or intended for ophthalmic use, includ- ard of purity or quality if they are not ing contact lens solutions, should be sterile. These articles, which are regu- sterile. It is further evident that such lated as medical devices unless pack- preparations purport to be of such pu- aged with the drugs with which they rity and quality as to be suitable for are to be used, should be packaged so safe use in the eye. as to maintain sterility until the pack- (2) The Food and Drug Administra- age is opened and be labeled, on or tion concludes that all such prepara- within the retail package, so as to af- tions, if they are not sterile, fall below ford adequate directions and necessary their professed standard of purity or warnings to minimize the hazard of in- quality and may be unsafe. In a state- jury resulting from contamination dur- ment of policy issued on September 1, ing use. 1964, the Food and Drug Administra- tion ruled that liquid preparations of- [47 FR 50455, Nov. 5, 1982] fered or intended for ophthalmic use that are not sterile may be regarded as § 800.12 Contact lens solutions and tablets; tamper-resistant packaging. adulterated within the meaning of section 501(c) of the Federal Food, Drug, (a) General. Unless contact lens solu- and Cosmetic Act (the act), and, fur- tions used, for example, to clean, dis- ther, may be deemed misbranded with- infect, wet, lubricate, rinse, soak, or in the meaning of section 502(j) of the store contact lenses and salt tablets or act. By this regulation, this ruling is other dosage forms to be used to make applicable to all preparations for oph- any such solutions are packaged in thalmic use that are regulated as med- tamper-resistant retail packages, there ical devices, i.e., contact lens solu- is the opportunity for the malicious tions. By the regulation in § 200.50 of adulteration of these products with

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risks both to individuals who unknow- a visual indication of package integ- ingly purchase adulterated products rity. The tamper-resistant feature and with loss of consumer confidence shall be designed to and shall remain in the security of the packages of over- intact when handled in a reasonable the-counter (OTC) health care prod- manner during manufacture, distribu- ucts. The Food and Drug Administra- tion, and retail display. tion has the authority and responsi- (c) Labeling. Each retail package of a bility under the Federal Food, Drug, product covered by this section is re- and Cosmetic Act (the act) to establish quired to bear a statement that is a uniform national standard for tam- prominently placed so that consumers per-resistant packaging of those OTC are alerted to the tamper-resistant fea- products vulnerable to malicious adul- ture of the package. The labeling state- teration that will improve the security ment is also required to be so placed of OTC packaging and help assure the that it will be unaffected if the tamper- safety and effectiveness of the products resistant feature of the package is contained therein. A contact lens solu- breached or missing. If the tamper-re- tion or tablet or other dosage form to sistant feature chosen to meet the re- be used to make such a solution for requirement in paragraph (b) of this sec- tail sale that is not packaged in a tam- tion is one that uses an identifying per-resistant package and labeled in characteristic, that characteristic is accordance with this section is adulter- required to be referred to in the label- ated under section 501 of the act or ing statement. For example, the label- misbranded under section 502 of the ing statement on a bottle with a shrink act, or both. band could say ‘‘For your protection, (b) Requirement for tamper-resistant this bottle has an imprinted seal package. Each manufacturer and pack- around the neck.’’ er who packages for retail sale a prod- (d) Requests for exemptions from pack- uct regulated as a medical device that aging and labeling requirements. A man- is a solution intended for use with con- ufacturer or packer may request an ex- tact lenses, e.g., for cleaning, dis- emption from the packaging and label- infecting, wetting, lubricating, rinsing, ing requirements of this section. A re- soaking, or storing contact lenses or quest for an exemption is required to tablets or other dosage forms to be be submitted in the form of a citizen used to make any such solution shall petition under § 10.30 of this chapter package the product in a tamper-resist- and should be clearly identified on the ant package, if this product is acces- envelope as a ‘‘Request for Exemption sible to the public while held for sale. from Tamper-resistant Rule.’’ A peti- A tamper-resistant package is one hav- tion for an exemption from a require- ing an indicator or barrier to entry ment of this section is required to con- which, if breached or missing, can rea- tain the same kind of information sonably be expected to provide visible about the product as is specified for evidence to consumers that tampering OTC drugs in § 211.132(d) of this chap- has occurred. To reduce the likelihood ter. of substitution of a tamper-resistant (e) Products subject to approved pre- feature after tampering, the indicator market approval applications. Holders of or barrier to entry is required to be disapproved premarket approval applica- tinctive by design or by the use of an tions for products subject to this sec- identifying characteristic (e.g., a pat- tion are required to submit supple- tern, name, registered trademark, logo, ments to provide for changes in pack- or picture). For purposes of this sec- aging to comply with the requirement tion, the term ‘‘distinctive by design’’ of paragraph (b) of this section unless means the package cannot be dupli- these changes do not affect the com- cated with commonly available mate- position of the container, the torque rial or through commonly available (tightness) of the container, or the processes. A tamper-resistant package composition of the closure component may involve an immediate-container in contact with the contents (cap liner and closure system or secondary-con- or innerseal) as these features are de- tainer or carton system or any com- scribed in the approved premarket ap- bination of systems intended to provide proval application. Any supplemental

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premarket approval application under ulations without regard to the retail this paragraph is required to include level effective date. data sufficient to show that these changes do not adversely affect the [47 FR 50455, Nov. 5, 1982; 48 FR 1706, Jan. 14, 1983, as amended at 48 FR 16666, Apr. 19, 1983; product. 48 FR 37625, Aug. 19, 1983; 53 FR 11252, Apr. 6, (f) Effective date. Each product sub- 1988; 73 FR 34859, June 19, 2008] ject to this section is required to comply with the requirements of this sec- EFFECTIVE DATE NOTE: A document published at 48 FR 41579, Sept. 16, 1983, stayed tion on the dates listed below except to the effective date of § 800.12(f)(3) until further the extent that a product’s manufac- notice. turer or packer has obtained an exemption from a packaging or labeling re- § 800.20 Patient examination gloves quirement: and surgeons’ gloves; sample plans (1) Initial effective date for packaging and test method for leakage defects; requirements. (i) The packaging require- adulteration. ment in paragraph (b) of this section is (a) Purpose. The prevalence of human effective on February 7, 1983 for each immunodeficiency virus (HIV), which contact lens solution packaged for re- causes acquired immune deficiency tail sale on or after that date, except syndrome (AIDS), and its risk of trans- for the requirement in paragraph (b) of mission in the health care context, this section for a distinctive indicator have caused the Food and Drug Admin- or barrier to entry. istration (FDA) to look more closely at (ii) The packaging requirement in the quality control of barrier devices, paragraph (b) of this section is effec- such as surgeons’ gloves and patient tive on May 5, 1983 for each tablet that examination gloves (collectively is to be used to make a contact lens so- known as medical gloves) to reduce the lution and that is packaged for retail risk of transmission of HIV and other sale on or after that date. blood-borne infectious diseases. The (2) Initial effective date for labeling re- Centers for Disease Control (CDC) rec- quirements. The requirement in para- ommend that health care workers wear graph (b) of this section that the indi- medical gloves to reduce the risk of cator or barrier to entry be distinctive transmission of HIV and other blood- by design and the requirement in para- borne infectious deseases. The CDC rec- graph (c) of this section for a labeling ommends that health care workers statement are effective on May 5, 1983 wear medical gloves when touching for each product subject to this section blood or other body fluids, mucous packaged for retail sale on or after membranes, or nonintact skin of all pa- that date, except that the requirement tients; when handling items or surfaces for a specific label reference to any soiled with blood or other body fluids; identifying characteristic is effective and when performing venipuncture and on February 6, 1984 for each affected other vascular access procedures. product subject to this section pack- Among other things, CDC’s rec- aged for retail sale on or after that ommendation that health care pro- date. viders wear medical gloves dem- (3) Retail level effective date. The tam- onstrates the proposition that devices per-resistant packaging requirement of labeled as medical gloves purport to be paragraph (b) of this section is effec- and are represented to be effective bar- tive on February 6, 1984 for each prod- riers against the transmission of blood- uct subject to this section that is held and fluid-borne pathogens. Therefore, for sale at retail level on or after that FDA, through this regulation, is defin- date that was packaged for retail sale ing adulteration for patient examina- before May 5, 1983. This does not in- tion and surgeons’ gloves as a means of clude the requirement in paragraph (b) assuring safe and effective devices. of this section that the indicator or (1) For a description of a patient ex- barrier to entry be distinctive by de- amination glove, see § 880.6250. Finger sign. Products packaged for retail sale cots, however, are excluded from the after May 5, 1983, are required to be in test method and sample plans in para- compliance with all aspects of the reg- graphs (b) and (c) of this section.

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(2) For a description of a surgeons’ tube. The horizontal support rod must glove, see § 878.4460 of this chapter. be capable of holding the weight of the (b)(1) General test method. For the pur- total number of gloves that will be sus- poses of this part, FDA’s analysis of pended at any one time, e.g., five gloves for leaks and visual defects will gloves suspended will weigh about 5 be conducted by a visual examination kilograms (kg); and by a water leak test method, using (v) Timer capable of measuring two 1,000 milliliters (ml) of water. minute intervals. (i) Units examined. Each medical (3) Visual defects and leak test proce- glove will be analyzed independently. dures. Examine the sample and identify When packaged as pairs, each glove is code/lot number, size, and brand as ap- considered separately, and both gloves propriate. Continue the visual exam- will be analyzed. ination using the following procedures: (ii) Identification of defects. For this (i) Visual defects examination. Inspect test, defects include leaks detected the gloves for visual defects by care- when tested in accordance with para- fully removing the glove from the graph (b)(3) of this section. A leak is wrapper, box, or package. Visually ex- defined as the appearance of water on amine each glove for defects. As noted the outside of the glove. This emer- in paragraph (b)(1)(iii) of this section, a gence of water from the glove con- visual defect observed in the top 40 mm stitutes a watertight barrier failure. of a glove will not be counted as a de- Other defects include tears, embedded fect for the purpose of this part. Vis- foreign objects, extrusions of glove ma- ually defective gloves do not require terial on the exterior or interior sur- further testing, although they must be face of the glove, gloves that are fused included in the total number of defec- together so that individual glove sepa- tive gloves counted for the sample. ration is impossible, gloves that adhere (ii) Leak test set-up. (A) During this to each other and tear when separated, procedure, ensure that the exterior of or other visual defects that are likely the glove remains dry. Attach the to affect the barrier integrity. glove to the plastic fill tube by bring- (iii) Factors for counting defects. One ing the cuff end to the 40 mm mark and defect in one glove is counted as one fastening with elastic strapping to defect. A defect in both gloves in a pair make a watertight seal. of gloves is counted as two defects. If (B) Add 1,000 ml of room temperature multiple defects, as defined in para- water (i.e., 20 (deg)C to 30 (deg)C) into graph (b)(1)(ii) of this section, are the open end of the fill tube. The water found in one glove, they are counted as should pass freely into the glove. (With one defect. Visual defects and leaks some larger sizes of long-cuffed sur- that are observed in the top 40 millime- geons’ gloves, the water level may ters (mm) of a glove will not be count- reach only the base of the thumb. With ed as a defect for the purposes of this some smaller gloves, the water level part. may extend several inches up the fill (2) Leak test materials. FDA considers tube.) the following to be the minimum mate- (iii) Leak test examination. Imme- rials required for this test : diately after adding the water, examine (i) A 60 mm by 380 mm (clear) plastic the glove for water leaks. Do not cylinder with a hook on one end and a squeeze the glove; use only minimum mark scored 40 mm from the other end manipulation to spread the fingers to (a cylinder of another size may be used check for leaks. Water drops may be if it accommodates both cuff diameter blotted to confirm leaking. and any water above the glove capac- (A) If the glove does not leak imme- ity); diately, keep the glove/filling tube as- (ii) Elastic strapping with velcro or sembly upright and hang the assembly other fastening material; vertically from the horizontal rod, (iii) Automatic water-dispensing ap- using the wire hook on the open end of paratus or manual device capable of de- the fill tube (do not support the filled livering 1,000 ml of water; glove while transferring). (iv) Stand with horizontal rod for (B) Make a second observation for hanging the hook end of the plastic leaks 2 minutes after the water is

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added to the glove. Use only minimum normal sampling for lots of 1,200 gloves manipulation of the fingers to check or less and multiple normal sampling for leaks. for all larger lots. FDA will use general (C) Record the number of defective inspection level II in determining the gloves. sample size for any lot size. As shown (c) Sampling, inspection, acceptance, in the tables following paragraph (c)(3) and adulteration. In performing the test of this section, FDA considers a 1.5 for leaks and other visual defects de- AQL to be the minimum level of qual- scribed in paragraph (b) of this section, ity acceptable for surgeons’ gloves and FDA will collect and inspect samples of a 2.5 AQL to be the minimum level of medical gloves, and determine when the gloves are acceptable as set out in quality acceptable for patient exam- paragraphs (c)(1) through (c)(3) of this ination gloves. section. (3) Adulteration levels and accept/reject (1) Sample plans. FDA will collect criteria. FDA considers a lot of medical samples from lots of medical gloves in gloves to be adulterated when the num- accordance with agency sampling ber of defective gloves found in the plans. These plans are based on sample tested sample meets or exceeds the ap- sizes, levels of sample inspection, and plicable rejection number at the 1.5 acceptable quality levels (AQLs) found AQL for surgeons’ gloves or the 2.5 in the International Standard Organi- AQL for patient examination gloves. zation’s standard ISO 2859, ‘‘Sampling These acceptance and rejection num- Procedures For Inspection By At- bers are identified in the tables fol- tributes.’’ lowing paragraph (c)(3) of this section (2) Sample sizes, inspection levels, and as follows: minimum AQLs. FDA will use single

ACCEPT/REJECT CRITERIA AT 1.5 AQL FOR SURGEONS’ GLOVES

Number Defective Lot Size Sample Sample Size Number Examined Accept Reject

8 to 90 Single sample 8 0 1

91 to 280 Single sample 32 1 2

281 to 500 Single sample 50 2 3

501 to 1,200 Single sample 80 3 4

1,201 to 3,200 First 32 32 — 4 Second 32 64 1 5 Third 32 96 2 6 Fourth 32 128 3 7 Fifth 32 160 5 8 Sixth 32 192 7 9 Seventh 32 224 9 10

3,201 to 10,000 First 50 50 0 4 Second 50 100 1 6 Third 50 150 3 8 Fourth 50 200 5 10 Fifth 50 250 7 11 Sixth 50 300 10 12 Seventh 50 350 13 14

10,001 to 35,000 First 80 80 0 5 Second 80 160 3 8 Third 80 240 6 10 Fourth 80 320 8 13 Fifth 80 400 11 15 Sixth 80 480 14 17 Seventh 80 560 18 19

35,000 First 125 125 1 7 Second 125 250 4 10 Third 125 375 8 13 Fourth 125 500 12 17 Fifth 125 625 17 20

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ACCEPT/REJECT CRITERIA AT 1.5 AQL FOR SURGEONS’ GLOVES—Continued

Number Defective Lot Size Sample Sample Size Number Examined Accept Reject

Sixth 125 750 21 23 Seventh 125 875 25 26

ACCEPT/REJECT CRITERIA AT 2.5 AQL FOR PATIENT EXAMINATION GLOVES

Number Defective Lot Size Sample Sample Size Number Examined Accept Reject

5 to 50 Single sample 5 0 1

51 to 150 Single sample 20 1 2

151 to 280 Single sample 32 2 3

281 to 500 Single sample 50 3 4

501 to 1,200 Single sample 80 5 6

1,201 to 3,200 First 32 32 0 4 Second 32 64 1 6 Third 32 96 3 8 Fourth 32 128 5 10 Fifth 32 160 7 11 Sixth 32 192 10 12 Seventh 32 224 13 14

3,201 to 10,000 First 50 50 0 5 Second 50 100 3 8 Third 50 150 6 10 Fourth 50 200 8 13 Fifth 50 250 11 15 Sixth 50 300 14 17 Seventh 50 350 18 19

10,001 to 35,000 First 80 80 1 7 Second 80 160 4 10 Third 80 240 8 13 Fourth 80 320 12 17 Fifth 80 400 17 20 Sixth 80 480 21 23 Seventh 80 560 25 26

35,000 and above First 125 125 2 9 Second 125 250 7 14 Third 125 375 13 19 Fourth 125 500 19 25 Fifth 125 625 25 29 Sixth 125 750 31 33 Seventh 125 875 37 38

(d) Compliance. Lots of gloves that (2) Reconditioning. FDA may author- are sampled, tested, and rejected using ize the owner of the product, or the procedures in paragraphs (b) and (c) of owner’s representative, to attempt to this section, are considered adulterated recondition, i.e., bring into compliance within the meaning of section 501(c) of with the act, a lot or part of a lot of the act. foreign gloves detained at importation, (1) Detention and seizure. Lots of or a lot or part of a lot of seized domes- gloves that are adulterated under sec- tic gloves. tion 501(c) of the act are subject to ad- (i) Modified sampling, inspection, and ministrative and judicial action, such acceptance. If FDA authorizes reconditioning of a lot or portion of a lot of as detention of imported products and adulterated gloves, testing to confirm seizure of domestic products. that the reconditioned gloves meet

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AQLs must be performed by an inde- accordance with paragraph (d)(2)(i) of pendent testing facility. The following this section, to be acceptable when the tightened sampling plan must be fol- number of defective gloves found in the lowed, as described in ISO 2859 ‘‘Sam- tested sample does not exceed the ac- pling Procedures for Inspection by At- ceptance number in the appropriate ta- tributes:’’ bles in paragraph (d)(2)(ii)(B) of this (A) General inspection level II, section for reconditioned surgeons’ (B) Single sampling plans for tight- gloves or patient examination gloves. ened inspection, (B) FDA considers a reconditioned lot (C) 1.5 AQL for surgeons’ gloves, and of medical gloves to be adulterated (D) 2.5 AQL for patient examination within the meaning of section 501(c) of gloves. the act when the number of defective (ii) Adulteration levels and acceptance gloves found in the tested sample criteria for reconditioned gloves. (A) FDA meets or exceeds the applicable rejec- considers a lot or part of a lot of adul- tion number in the tables following terated gloves, that is reconditioned in paragraph (d)(2)(ii)(B) of this section:

ACCEPT/REJECT CRITERIA AT 1.5 AQL FOR RECONDITIONED SURGEONS’ GLOVES

Number Defective Lot Size Sample Sample Size Accept Reject

13 to 90 Single sample 13 0 1

91 to 500 Single sample 50 1 2

501 to 1,200 Single sample 80 2 3

1,201 to 3,200 Single sample 125 3 4

3,201 to 10,000 Single sample 200 5 6

10,001 to 35,000 Single sample 315 8 9

35,000 and above Single sample 500 12 13

ACCEPT/REJECT CRITERIA AT 2.5 AQL FOR RECONDITIONED PATIENT EXAMINATION GLOVES

Number Defective Lot Size Sample Sample Size Accept Reject

8 to 50 Single sample 8 0 1

51 to 280 Single sample 32 1 2

281 to 500 Single sample 50 2 3

501 to 1,200 Single sample 80 3 4

1,201 to 3,200 Single sample 125 5 6

3,201 to 10,000 Single sample 200 8 9

10,001 to 35,000 Single sample 315 12 13

35,000 and above Single sample 500 18 19

[55 FR 51256, Dec. 12, 1990, as amended at 71 Subpart C—Administrative FR 75876, Dec. 19, 2006] Practices and Procedures § 800.55 Administrative detention. (a) General. This section sets forth the procedures for detention of medical devices intended for human use believed to be adulterated or misbranded.

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Administrative detention is intended misbranded, and issued to the owner, to protect the public by preventing dis- operator, or agent in charge of the tribution or use of devices encountered place where the devices are located. If during inspections that may be adul- the owner or the user of the devices is terated or misbranded, until the Food different from the owner, operator, or and Drug Administration (FDA) has agent in charge of the place where the had time to consider what action it devices are detained, a copy of the de- should take concerning the devices, tention order shall be provided to the and to initiate legal action, if appro- owner or user of the devices if the own- priate. Devices that FDA orders de- er’s or user’s identity can be readily tained may not be used, moved, al- determined. tered, or tampered with in any manner (2) If detention of devices in a vehicle by any person during the detention pe- or other carrier is ordered, a copy of riod, except as authorized under para- the detention order shall be provided to graph (h) of this section, until FDA the shipper of record and the owner of terminates the detention order under the vehicle or other carrier, if their paragraph (j) of this section, or the de- identities can be readily determined. tention period expires, whichever oc- (3) The detention order shall include curs first. the following information: (b) Criteria for ordering detention. Ad- (i) A statement that the devices iden- ministrative detention of devices may tified in the order are detained for the be ordered in accordance with this sec- period shown; tion when an authorized FDA rep- (ii) A brief, general statement of the resentative, during an inspection under reasons for the detention; section 704 of the Federal Food, Drug, (iii) The location of the devices; and Cosmetic Act (the act), has reason (iv) A statement that these devices to believe that a device, as defined in are not to be used, moved, altered, or section 201(h) of the act, is adulterated tampered with in any manner during or misbranded. that period, except as permitted under (c) Detention period. The detention is paragraph (h) of this section, without to be for a reasonable period that may the written permission of an author- not exceed 20 calendar days after the ized FDA representative; detention order is issued, unless the (v) Identification of the detained de- FDA District Director in whose district vices; the devices are located determines that a greater period is required to seize the (vi) The detention order number; devices, to institute injuction pro- (vii) The date and hour of the deten- ceedings, or to evaluate the need for tion order; legal action, in which case the District (viii) The period of the detention; Director may authorize detention for (ix) The text of section 304(g) of the 10 additional calendar days. The addi- act and paragraph (g) (1) and (2) of this tional 10-calendar-day detention period section; may be ordered at the time the deten- (x) A statement that any informal tion order is issued or at any time hearing on an appeal of a detention thereafter. The entire detention period order shall be conducted as a regu- may not exceed 30 calendar days, ex- latory hearing under part 16 of this cept when the detention period is ex- chapter, with certain exceptions de- tended under paragraph (g)(6) of this scribed in paragraph (g)(3) of this sec- section. An authorized FDA represent- tion; and ative may, in accordance with para- (xi) The location and telephone num- graph (j) of this section, terminate a ber of the FDA district office and the detention before the expiration of the name of the FDA District Director. detention period. (e) Approval of detention order. A de- (d) Issuance of detention order. (1) The tention order, before issuance, shall be detention order shall be issued in writ- approved by the FDA District Director ing, in the form of a detention notice, in whose district the devices are lo- signed by the authorized FDA rep- cated. If prior written approval is not resentative who has reason to believe feasible, prior oral approval shall be that the devices are adulterated or obtained and confirmed by written

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memorandum within FDA as soon as ducted as a regulatory hearing pursu- possible. ant to regulation in accordance with (f) Labeling or marking a detained depart 16 of this chapter, except that: vice. An FDA representative issuing a (i) The detention order under para- detention order under paragraph (d) of graph (d) of this section, rather than this section shall label or mark the de- the notice under § 16.22(a) of this chap- vices with official FDA tags that inter, provides notice of opportunity for clude the following information: a hearing under this section and is part (1) A statement that the devices are of the administrative record of the reg- detained by the United States Govern- ulatory hearing under § 16.80(a) of this ment in accordance with section 304(g) chapter. of the Federal Food, Drug, and Cos- (ii) A request for a hearing under this metic Act (21 U.S.C. 334(g)). section should be addressed to the FDA (2) A statement that the devices shall District Director. not be used, moved, altered, or tam- (iii) The last sentence of § 16.24(e) of pered with in any manner for the pe- this chapter, stating that a hearing riod shown, without the written per- may not be required to be held at a mission of an authorized FDA rep- time less than 2 working days after re- resentative, except as authorized in ceipt of the request for a hearing, does paragraph (h) of this section. not apply to a hearing under this sec- (3) A statement that the violation of tion. a detention order or the removal or al- (iv) Paragraph (g)(4) of this section, teration of the tag is punishable by fine or imprisonment or both (section rather than § 16.42(a) of this chapter, 303 of the act, 21 U.S.C. 333). describes the FDA employees, i.e., Of- (4) The detention order number, the fice of Regulatory Affairs Program Di- date and hour of the detention order, rectors or other FDA officials senior to the detention period, and the name of an FDA District Director, who preside the FDA representative who issued the at hearings under this section. detention order. (4) The presiding officer of a regu- (g) Appeal of a detention order. (1) A latory hearing on an appeal of a deten- person who would be entitled to claim tion order, who also shall decide the the devices, if seized, may appeal a de- appeal, shall be an Office of Regulatory tention order. Any appeal shall be sub- Affairs Program Director or another mitted in writing to the FDA District FDA official senior to an FDA District Director in whose district the devices Director who is permitted by § 16.42(a) are located within 5 working days of of this chapter to preside over the receipt of a detention order. If the ap- hearing. peal includes a request for an informal (5) If the appellant requests a regu- hearing, as defined in section 201(x) of latory hearing and requests that the the act, the appellant shall request ei- hearing be held within 5 working days ther that a hearing be held within 5 after the appeal is filed, the presiding working days after the appeal is filed officer shall, within 5 working days, or that the hearing be held at a later hold the hearing and render a decision date, which shall not be later than 20 affirming or revoking the detention. calendar days after receipt of a deten- (6) If the appellant requests a regu- tion order. latory hearing and requests that the (2) The appellant of a detention order hearing be held at a date later than shall state the ownership or propri- within 5 working days after the appeal etary interest the appellant has in the is filed, but not later than 20 calendar detained devices. If the detained de- days after receipt of a detention order, vices are located at a place other than the presiding officer shall hold the an establishment owned or operated by hearing at a date agreed upon by FDA the appellant, the appellant shall in- and the appellant. The presiding officer clude documents showing that the ap- shall decide whether to affirm or re- pellant would have legitimate author- voke the detention within 5 working ity to claim the devices if seized. days after the conclusion of the hear- (3) Any informal hearing on an ap- ing. The detention period extends to peal of a detention order shall be con- the date of the decision even if the 5-

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working-day period for making the de- (i) To prevent interference with an cision extends beyond the otherwise establishment’s operations or harm to applicable 20-calendar-day or 30-cal- the devices. endar-day detention period. (ii) To destroy the devices. (7) If the appellant appeals the deten- (iii) To bring the devices into compli- tion order but does not request a regu- ance. latory hearing, the presiding officer (iv) For any other purpose that the shall render a decision on the appeal FDA representative who issued the de- affirming or revoking the detention tention order, or other responsible dis- within 5 working days after the filing trict office official, believes is appro- of the appeal. priate in the case. (8) If the presiding officer affirms a (4) If an FDA representative approves detention order, the devices continue the movement of detained devices to be detained until FDA terminates under paragraph (h)(3) of this section, the detention under paragraph (j) of the detained devices shall remain seg- this section or the detention period ex- regated from other devices and the per- pires, whichever occurs first. son responsible for their movement (9) If the presiding officer revokes a shall immediately orally notify the of- detention order, FDA shall terminate ficial who approved the movement of the detention under paragraph (j) of the devices, or another responsible this section. FDA district office official, of the new (h)(1) Movement of detained devices. location of the detained devices. Except as provided in this paragraph, (5) Unless otherwise permitted by the no person shall move detained devices FDA representative who is notified of, within or from the place where they or who approves, the movement of de- have been ordered detained until FDA vices under this paragraph, the re- terminates the detention under para- quired tags shall accompany the de- graph (j) of this section or the deten- vices during and after movement and tion period expires, whichever occurs shall remain with the devices until first. FDA terminates the detention or the (2) If detained devices are not in final detention period expires, whichever oc- form for shipment, the manufacturer curs first. may move them within the establish- (i) Actions involving adulterated or mis- ment where they are detained to com- branded devices. If FDA determines that plete the work needed to put them in the detained devices, including any final form. As soon as the devices are that have been put in final form, are moved for this purpose, the individual adulterated or misbranded, or both, it responsible for their movement shall may initiate legal action against the orally notify the FDA representative devices or the responsible individuals, who issued the detention order, or an- or both, or request that the devices be other responsible district office offi- destroyed or otherwise brought into cial, of the movement of the devices. compliance with the act under FDA’s As soon as the devices are put in final supervision. form, they shall be segregated from (j) Detention termination. If FDA de- other devices, and the individual re- cides to terminate a detention or when sponsible for their movement shall the detention period expires, whichever orally notify the FDA representative occurs first, an FDA representative au- who issued the detention order, or an- thorized to terminate a detention will other responsible district office offi- issue a detention termination notice cial, of their new location. The devices releasing the devices to any person who put in final form shall not be moved received the original detention order or further without FDA approval. that person’s representative and will (3) The FDA representative who remove, or authorize in writing the re- issued the detention order, or another moval of, the required labels or tags. responsible district office official, may (k) Recordkeeping requirements. (1) approve, in writing, the movement of After issuance of a detention order detained devices for any of the fol- under paragraph (d) of this section, the lowing purposes: owner, operator, or agent in charge of

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any factory, warehouse, other estab- PART 801—LABELING lishment, or consulting laboratory where detained devices are manufac- Subpart A—General Labeling Provisions tured, processed, packed, or held shall have, or establish, and maintain ade- Sec. 801.1 Medical devices; name and place of quate records relating to how the de- business of manufacturer, packer or dis- tained devices may have become adul- tributor. terated or misbranded, records on any 801.3 Definitions. distribution of the devices before and 801.4 Meaning of intended uses. after the detention period, records on 801.5 Medical devices; adequate directions the correlation of any in-process de- for use. 801.6 Medical devices; misleading state- tained devices that are put in final ments. form under paragraph (h) of this sec- 801.15 Medical devices; prominence of re- tion to the completed devices, records quired label statements; use of symbols of any changes in, or processing of, the in labeling. devices permitted under the detention 801.16 Medical devices; Spanish-language order, and records of any other move- version of certain required statements. 801.18 Format of dates provided on a med- ment under paragraph (h) of this sec- ical device label. tion. Records required under this paragraph shall be provided to the FDA on Subpart B—Labeling Requirements for request for review and copying. Any Unique Device Identification FDA request for access to records re- 801.20 Label to bear a unique device identi- quired under this paragraph shall be fier. made at a reasonable time, shall state 801.30 General exceptions from the require- the reason or purpose for the request, ment for the label of a device to bear a and shall identify to the fullest extent unique device identifier. practicable the information or type of 801.35 Voluntary labeling of a device with a information sought in the records to unique device identifier. 801.40 Form of a unique device identifier. which access is requested. 801.45 Devices that must be directly marked (2) Records required under this para- with a unique device identifier. graph shall be maintained for a max- 801.50 Labeling requirements for stand- imum period of 2 years after the alone software. issuance of the detention order or for 801.55 Request for an exception from or al- such other shorter period as FDA di- ternative to a unique device identifier requirement. rects. When FDA terminates the deten- 801.57 Discontinuation of legacy FDA iden- tion or when the detention period ex- tification numbers assigned to devices. pires, whichever occurs first, FDA will advise all persons required under this Subpart C—Labeling Requirements for paragraph to keep records concerning Over-the-Counter Devices that detention whether further record- 801.60 Principal display panel. keeping is required for the remainder 801.61 Statement of identity. of the 2-year, or shorter, period. FDA 801.62 Declaration of net quantity of con- ordinarily will not require further rec- tents. ordkeeping if the agency determines 801.63 Medical devices; warning statements that the devices are not adulterated or for devices containing or manufactured with chlorofluorocarbons and other class misbranded or that recordkeeping is I ozone-depleting substances. not necessary to protect the public health, unless the records are required Subpart D—Exemptions From Adequate under other regulations in this chapter Directions for Use (e.g., the good manufacturing practice 801.109 Prescription devices. regulation in part 820 of this chapter). 801.110 Retail exemption for prescription de- [44 FR 13239, Mar. 9, 1979, as amended at 49 vices. FR 3174, Jan. 26, 1984; 69 FR 17292, Apr. 2, 801.116 Medical devices having commonly 2004; 79 FR 9412, Feb. 19, 2014; 82 FR 14147, known directions. 801.119 In vitro diagnostic products. Mar. 17, 2017] 801.122 Medical devices for processing, repacking, or manufacturing.

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801.125 Medical devices for use in teaching, be used and ‘‘The’’ may be omitted. In law enforcement, research, and analysis. the case of an individual, partnership, 801.127 Medical devices; expiration of ex- or association, the name under which emptions. the business is conducted shall be used. 801.128 Exceptions or alternatives to labeling requirements for medical devices (c) Where a device is not manufac- held by the Strategic National Stockpile. tured by the person whose name appears on the label, the name shall be Subpart E—Other Exemptions qualified by a phrase that reveals the 801.150 Medical devices; processing, label- connection such person has with such ing, or repacking. device; such as, ‘‘Manufactured for lll’’, ‘‘Distributed by lllll’’, or Subparts F–G [Reserved] any other wording that expresses the facts. Subpart H—Special Requirements for (d) The statement of the place of Specific Devices business shall include the street ad- 801.405 Labeling of articles intended for lay dress, city, State, and Zip Code; how- use in the repairing and/or refitting of ever, the street address may be omitted dentures. if it is shown in a current city direc- 801.410 Use of impact-resistant lenses in tory or telephone directory. The re- eyeglasses and sunglasses. quirement for inclusion of the ZIP 801.415 Maximum acceptable level of ozone. Code shall apply only to consumer 800.417 Chlorofluorocarbon propellants. commodity labels developed or revised 801.420 Hearing aid devices; professional and patient labeling. after the effective date of this section. 801.421 Hearing aid devices; conditions for In the case of nonconsumer packages, sale. the ZIP Code shall appear on either the 801.430 User labeling for menstrual tam- label or the labeling (including the in- pons. voice). 801.433 Warning statements for prescription (e) If a person manufactures, packs, and restricted device products containing or distributes a device at a place other or manufactured with than his principal place of business, the chlorofluorocarbons or other ozone-depleting substances. label may state the principal place of 801.435 User labeling for latex condoms. business in lieu of the actual place 801.437 User labeling for devices that con- where such device was manufactured or tain natural rubber. packed or is to be distributed, unless AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 360d, such statement would be misleading. 360i, 360j, 371, 374. § 801.3 Definitions. SOURCE: 41 FR 6896, Feb. 13, 1976, unless otherwise noted. As used in this part: Automatic identification and data cap- Subpart A—General Labeling ture (AIDC) means any technology that Provisions conveys the unique device identifier or the device identifier of a device in a § 801.1 Medical devices; name and form that can be entered into an elec- place of business of manufacturer, tronic patient record or other com- packer or distributor. puter system via an automated proc- (a) The label of a device in package ess. form shall specify conspicuously the Center Director means the Director of name and place of business of the man- the Center for Devices and Radio- ufacturer, packer, or distributor. logical Health or the Director of the (b) The requirement for declaration Center for Biologics Evaluation and of the name of the manufacturer, pack- Research, depending on which Center er, or distributor shall be deemed to be has been assigned lead responsibility satisfied, in the case of a corporation, for the device. only by the actual corporate name Combination product has the meaning which may be preceded or followed by set forth in § 3.2(e) of this chapter. the name of the particular division of Convenience kit means two or more the corporation. Abbreviations for different medical devices packaged to- ‘‘Company,’’ ‘‘Incorporated,’’ etc., may gether for the convenience of the user.

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Device package means a package that ware version that are manufactured contains a fixed quantity of a par- under essentially the same conditions ticular version or model of a device. and that are intended to have uniform Expiration date means the date by characteristics and quality within which the label of a device states the specified limits. device must or should be used. Shipping container means a container FDA, we, or us means the Food and used during the shipment or transpor- Drug Administration. tation of devices, and whose contents Finished device means any device or may vary from one shipment to an- accessory to any device that is suitable other. for use or capable of functioning. Specification means any requirement Global Unique Device Identification with which a device must conform. Database (GUDID) means the database that serves as a repository of informa- Unique device identifier (UDI) means tion to facilitate the identification of an identifier that adequately identifies medical devices through their distribu- a device through its distribution and tion and use. use by meeting the requirements of Human cells, tissues, or cellular or tis- § 830.20 of this chapter. A unique device sue-based product (HCT/P) regulated as a identifier is composed of: device means an HCT/P as defined in (1) A device identifier—a mandatory, § 1271.3(d) of this chapter that does not fixed portion of a UDI that identifies meet the criteria in § 1271.10(a) and that the specific version or model of a de- is also regulated as a device. vice and the labeler of that device; and Implantable device means a device (2) A production identifier—a condi- that is intended to be placed in a sur- tional, variable portion of a UDI that gically or naturally formed cavity of identifies one or more of the following the human body. A device is regarded when included on the label of the de- as an implantable device for the purpose vice: of this part only if it is intended to re- (i) The lot or batch within which a main implanted continuously for a pe- device was manufactured; riod of 30 days or more, unless the (ii) The serial number of a specific Commissioner of Food and Drugs deter- device; mines otherwise in order to protect (iii) The expiration date of a specific human health. device; Label has the meaning set forth in section 201(k) of the Federal Food, (iv) The date a specific device was Drug, and Cosmetic Act. manufactured; Labeler means: (v) For an HCT/P regulated as a de- (1) Any person who causes a label to vice, the distinct identification code be applied to a device with the intent required by § 1271.290(c) of this chapter. that the device will be commercially Universal product code (UPC) means distributed without any intended sub- the product identifier used to identify sequent replacement or modification of an item sold at retail in the United the label; and States. (2) Any person who causes the label Version or model means all devices of a device to be replaced or modified that have specifications, performance, with the intent that the device will be size, and composition, within limits set commercially distributed without any by the labeler. subsequent replacement or modification of the label, except that the addi- [78 FR 55817, Sept. 24, 2013] tion of the name of, and contact infor- § 801.4 Meaning of intended uses. mation for, a person who distributes the device, without making any other The words intended uses or words of changes to the label, is not a modifica- similar import in §§ 801.5, 801.119, and tion for the purposes of determining 801.122 refer to the objective intent of whether a person is a labeler. the persons legally responsible for the Lot or batch means one finished device labeling of devices. The intent is deter- or more that consist of a single type, mined by such persons’ expressions or model, class, size, composition, or soft- may be shown by the circumstances

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surrounding the distribution of the ar- those intended by the person from whom he ticle. This objective intent may, for ex- received the device, such packer, distributor, ample, be shown by labeling claims, ad- or seller is required to supply adequate label- vertising matter, or oral or written ing in accordance with the new intended statements by such persons or their uses. And if the totality of the evidence establishes that a manufacturer objectively in- representatives. It may be shown by tends that a device introduced into inter- the circumstances that the article is, state commerce by him is to be used for con- with the knowledge of such persons or ditions, purposes, or uses other than ones for their representatives, offered and used which it has been approved, cleared, granted for a purpose for which it is neither la- marketing authorization, or is exempt from beled nor advertised. The intended uses premarket notification requirements (if of an article may change after it has any), he is required, in accordance with sec- been introduced into interstate com- tion 502(f) of the Federal Food, Drug, and merce by its manufacturer. If, for ex- Cosmetic Act, or, as applicable, duly promulgated regulations exempting the device from ample, a packer, distributor, or seller the requirements of section 502(f)(1), to pro- intends an article for different uses vide for such device adequate labeling that than those intended by the person from accords with such other intended uses. whom he received the devices, such packer, distributor, or seller is re- § 801.5 Medical devices; adequate di- quired to supply adequate labeling in rections for use. accordance with the new intended uses. Adequate directions for use means di- But if a manufacturer knows, or has rections under which the layman can knowledge of facts that would give him use a device safely and for the purposes notice that a device introduced into for which it is intended. Section 801.4 interstate commerce by him is to be defines intended use. Directions for use used for conditions, purposes, or uses may be inadequate because, among other than the ones for which he offers other reasons, of omission, in whole or it, he is required to provide adequate in part, or incorrect specification of: labeling for such a device which ac- (a) Statements of all conditions, pur- cords with such other uses to which the poses, or uses for which such device is article is to be put. intended, including conditions, pur- EFFECTIVE DATE NOTE: At 82 FR 2217, Jan. poses, or uses for which it is prescribed, 9, 2017, § 801.4 was revised, eff. Feb. 8, 2017. At recommended, or suggested in its oral, 82 FR 9501, Feb. 7, 2017, the effective date was written, printed, or graphic adver- delayed to Mar. 21, 2017. At 82 FR 14319, Mar. tising, and conditions, purposes, or 20, 2017, the effective date was further delayed to Mar. 19, 2018. For the convenience of uses for which the device is commonly the user, the revised text is set forth as fol- used; except that such statements shall lows: not refer to conditions, uses, or purposes for which the device can be safely § 801.4 Meaning of intended uses. used only under the supervision of a The words intended uses or words of similar practitioner licensed by law and for import in §§ 801.5, 801.119, 801.122, and 1100.5 of which it is advertised solely to such this chapter refer to the objective intent of the persons legally responsible for the label- practitioner. ing of devices. The intent is determined by (b) Quantity of dose, including usual such persons’ expressions or may be shown quantities for each of the uses for by the circumstances surrounding the dis- which it is intended and usual quan- tribution of the article. This objective intent tities for persons of different ages and may, for example, be shown by labeling different physical conditions. claims, advertising matter, or oral or written statements by such persons or their rep- (c) Frequency of administration or resentatives. It may be shown, for example, application. by circumstances in which the article is, (d) Duration of administration or ap- with the knowledge of such persons or their plication. representatives, offered and used for a pur- (e) Time of administration or appli- pose for which it is neither labeled nor ad- cation, in relation to time of meals, vertised. The intended uses of an article may time of onset of symptoms, or other change after it has been introduced into interstate commerce by its manufacturer. If, time factors. for example, a packer, distributor, or seller (f) Route or method of administra- intends an article for different uses than tion or application.

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(g) Preparation for use, i.e., adjust- vignettes, or crowding with other writ- ment of temperature, or other manipu- ten, printed, or graphic matter. lation or process. (b) No exemption depending on insufficiency of label space, as prescribed in § 801.6 Medical devices; misleading regulations promulgated under section statements. 502(b) of the act, shall apply if such in- Among representations in the label- sufficiency is caused by: ing of a device which render such de- (1) The use of label space for any vice misbranded is a false or mis- word, statement, design, or device leading representation with respect to which is not required by or under au- another device or a drug or food or cos- thority of the act to appear on the metic. label; (2) The use of label space to give § 801.15 Medical devices; prominence greater conspicuousness to any word, of required label statements; use of symbols in labeling. statement, or other information than is required by section 502(c) of the act; (a) A word, statement, or other infor- or mation required by or under authority (3) The use of label space for any rep- of the act to appear on the label may resentation in a foreign language. lack that prominence and conspicuous- (c)(1)(i) All words, statements, and ness required by section 502(c) of the other information required by or under act by reason, among other reasons, of: authority of the act to appear on the (1) The failure of such word, state- label or labeling for a device shall ap- ment, or information to appear on the pear thereon in one or more of the fol- part or panel of the label which is pre- lowing formats: sented or displayed under customary conditions of purchase; (A) The English language; (2) The failure of such word, state- (B) In the case of articles distributed ment, or information to appear on two solely in Puerto Rico or in a Territory or more parts or panels of the label, where the predominant language is one each of which has sufficient space other than English, the predominant therefor, and each of which is so de- language may be substituted for signed as to render it likely to be, English; under customary conditions of pur- (C) A symbol accompanied by adja- chase, the part or panel displayed; cent explanatory English text, or text (3) The failure of the label to extend in the predominant language of the over the area of the container or pack- Territory, in the case of articles dis- age available for such extension, so as tributed solely in Puerto Rico or in a to provide sufficient label space for the Territory where the predominant lan- prominent placing of such word, state- guage is one other than English; ment, or information; (D) A symbol not accompanied by ad- (4) Insufficiency of label space for the jacent explanatory text that: prominent placing of such word, state- (1) Is contained in a standard that ment, or information, resulting from FDA recognizes under its authority in the use of label space for any word, section 514(c) of the act; statement, design, or device which is (2) Is used according to the specifica- not required by or under authority of tions for use of the symbol set forth in the act to appear on the label; FDA’s section 514(c) recognition; and (5) Insufficiency of label space for the (3) Is explained in a paper or elec- placing of such word, statement, or in- tronic symbols glossary that is information, resulting from the use of cluded in the labeling for the device label space to give materially greater and the labeling on or within the pack- conspicuousness to any other word, age containing the device bears a statement, or information, or to any prominent and conspicuous statement design or device; or identifying the location of the symbols (6) Smallness or style of type in glossary that is written in English or, which such word, statement, or infor- in the case of articles distributed sole- mation appears, insufficient back- ly in Puerto Rico or in a Territory ground contrast, obscuring designs or where the predominant language is one

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other than English, the predominant (B) The term ‘‘symbols glossary’’ language may be used; means a compiled listing of: (E) A symbol not accompanied by ad- (1) Each SDO-established symbol jacent explanatory text that: used in the labeling for the device; (1) Is established in a standard devel- (2) The title and designation number oped by a standards development orga- of the SDO-developed standard con- nization (SDO); taining the symbol; (2) Is not contained in a standard (3) The title of the symbol and its ref- that is recognized by FDA under its au- erence number, if any, in the standard; thority in section 514(c) of the act or is and contained in a standard that is recog- (4) The meaning or explanatory text nized by FDA but is not used according for the symbol as provided in the FDA to the specifications for use of the sym- recognition or, if FDA has not recog- bol set forth in FDA’s section 514(c) nized the standard or portion of the recognition; standard in which the symbol is lo- (3) Is determined by the manufac- cated or the symbol is not used accord- turer to be likely to be read and under- ing to the specifications for use of the stood by the ordinary individual under symbol set forth in FDA’s section customary conditions of purchase and 514(c) recognition, the explanatory text use in compliance with section 502(c) of as provided in the standard. the act; (2) If the label contains any represen- (4) Is used according to the specifica- tation in a foreign language, all words, tions for use of the symbol set forth in statements, and other information re- the SDO-developed standard; and quired by or under authority of the act (5) Is explained in a paper or elec- to appear on the label shall appear tronic symbols glossary that is in- thereon in the foreign language. cluded in the labeling for the device (3) If the labeling contains any rep- and the labeling on or within the pack- resentation in a foreign language, all age containing the device bears a words, statements, and other informa- prominent and conspicuous statement tion required by or under authority of identifying the location of the symbols the act to appear on the label or label- glossary that is written in English or, ing shall appear on the labeling in the in the case of articles distributed sole- foreign language. ly in Puerto Rico or in a Territory where the predominant language is one [41 FR 6896, Feb. 13, 1976, as amended at 81 other than English, the predominant FR 38930, June 15, 2016] language may be used; (F) The symbol statement ‘‘Rx only’’ § 801.16 Medical devices; Spanish-lan- or ‘‘) only’’ may be used as provided guage version of certain required statements. under § 801.109(b)(1). (ii) The use of symbols in device la- If devices restricted to prescription beling which do not meet the require- use only are labeled solely in Spanish ments of paragraph (c)(1)(i) of this sec- for distribution in the Commonwealth tion renders a device misbranded under of Puerto Rico where Spanish is the section 502(c) of the act. predominant language, such labeling is (iii) For purposes of paragraph authorized under § 801.15(c). (c)(1)(i) of this section: (A) An SDO is an organization that is § 801.18 Format of dates provided on a nationally or internationally recog- medical device label. nized and that follows a process for (a) In general. Whenever the label of a standard development that is trans- medical device includes a printed expi- parent, (i.e., open to public scrutiny), ration date, date of manufacture, or where the participation is balanced, any other date intended to be brought where an appeals process is included, to the attention of the user of the de- where the standard is not in conflict vice, the date must be presented in the with any statute, regulation, or policy following format: The year, using four under which FDA operates, and where digits; followed by the month, using the standard is national or inter- two digits; followed by the day, using national in scope. two digits; each separated by hyphens.

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For example, January 2, 2014, must be of part 820 of this chapter, exclusive of presented as 2014–01–02. any continuing requirement for record- (b) Exceptions. (1) A combination keeping under §§ 820.180 and 820.198. product that properly bears a National (3) Individual single-use devices, all Drug Code (NDC) number is not subject of a single version or model, that are to the requirements of paragraph (a) of distributed together in a single device this section. package, intended to be stored in that (2) If the device is an electronic prod- device package until removed for use, uct to which a standard is applicable and which are not intended for indi- under subchapter J of this chapter, Ra- vidual commercial distribution. This diological Health, the date of manufac- exception is not available for any ture shall be presented as required by implantable device. The device package § 1010.3(a)(2)(ii) of this chapter. containing these individual devices is not excepted from the requirement of [78 FR 58818, Sept. 24, 2013] § 801.20, and must bear a UDI. (4) A device used solely for research, Subpart B—Labeling Requirements teaching, or chemical analysis, and not for Unique Device Identification intended for any clinical use. (5) A custom device within the mean- § 801.20 Label to bear a unique device ing of § 812.3(b) of this chapter. identifier. (6) An investigational device within (a) In general. (1) The label of every the meaning of part 812 of this chapter. medical device shall bear a unique de- (7) A veterinary medical device not vice identifier (UDI) that meets the re- intended for use in the diagnosis of dis- quirements of this subpart and part 830 ease or other conditions in man, in the of this chapter. cure, mitigation, treatment, or preven- (2) Every device package shall bear a tion of disease in man, or intended to UDI that meets the requirements of affect the structure or any function of this subpart and part 830 of this chap- the body of man. ter. (8) A device intended for export from (b) Exceptions. Exceptions to the gen- the United States. eral rule of paragraph (a) of this sec- (9) A device held by the Strategic Na- tion are provided by §§ 801.30, 801.45, and tional Stockpile and granted an excep- 801.128(f)(2), and § 801.55 provides a tion or alternative under § 801.128(f)(2). means to request an exception or alter- (10) A device for which FDA has es- native not provided by those provi- tablished a performance standard sions. under section 514(b) of the Federal [78 FR 55818, Sept. 24, 2013] Food, Drug, and Cosmetic Act and has provided therein an exception from the § 801.30 General exceptions from the requirement of § 801.20, or for which requirement for the label of a de- FDA has recognized all or part of a per- vice to bear a unique device identi- formance standard under section 514(c) fier. of the Federal Food, Drug, and Cos- (a) In general. The following types of metic Act and has included an excep- devices are excepted from the require- tion from the requirement of § 801.20 ment of § 801.20; a device within one or within the scope of that recognition. more of the following exceptions is not (11) A device packaged within the im- required to bear a unique device identi- mediate container of a combination fier (UDI): product or convenience kit, provided (1) A finished device manufactured that the label of the combination prod- and labeled prior to the compliance uct or convenience kit bears a UDI. date established by FDA for § 801.20 re- (b) National Drug Code (NDC) Numbers. garding the device. This exception ex- If a combination product properly pires with regard to a particular device bears an NDC number on its label— 3 years after the compliance date es- (1) The combination product is not tablished by FDA for the device. subject to the requirements of § 801.20. (2) A class I device that FDA has by (2) A device constituent of such a regulation exempted from the good combination product whose compo- manufacturing practice requirements nents are physically, chemically, or

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otherwise combined or mixed and pro- vice package must disclose the pres- duced as a single entity as described by ence of AIDC technology. § 3.2(e)(1) of this chapter is not subject (d) A class I device that bears a Uni- to the requirements of § 801.20. versal Product Code (UPC) on its label (3) Each device constituent of such a and device packages is deemed to meet combination product, other than one all requirements of subpart B of this described by § 3.2(e)(1) of this chapter, part. The UPC will serve as the unique must bear a UDI on its label unless device identifier required by § 801.20. paragraph (a)(11) of this section ap- [78 FR 55818, Sept. 24, 2013] plies. (c) Exception for shipping containers. § 801.45 Devices that must be directly This rule does not require a UDI to be marked with a unique device iden- placed on any shipping container. tifier. (d) The UDI of a class I device is not (a) In general. A device that must required to include a production identi- bear a unique device identifier (UDI) on fier. its label must also bear a permanent marking providing the UDI on the de- [78 FR 55818, Sept. 24, 2013] vice itself if the device is intended to § 801.35 Voluntary labeling of a device be used more than once and intended to with a unique device identifier. be reprocessed before each use. (b) UDI for direct marking. The UDI (a) The labeler of a device that is not provided through a direct marking on a required to bear a unique device identi- device may be: fier (UDI) may voluntarily comply with (1) Identical to the UDI that appears § 801.20. If a labeler voluntarily includes on the label of the device, or a UDI for a device, the labeler may vol- (2) A different UDI used to distin- untarily provide information con- guish the unpackaged device from any cerning the device under subpart E of device package containing the device. part 830 of this chapter. (c) Form of a UDI when provided as a (b) A device may bear both a Uni- direct marking. When a device must bear versal Product Code (UPC) and a UDI a UDI as a direct marking, the UDI on its label and packages. may be provided through either or both [78 FR 55818, Sept. 24, 2013] of the following: (1) Easily readable plain-text; § 801.40 Form of a unique device iden- (2) Automatic identification and data tifier. capture (AIDC) technology, or any alternative technology, that will provide (a) Every unique device identifier the UDI of the device on demand. (UDI) must meet the technical require- (d) Exceptions. The requirement of ments of § 830.20 of this chapter. The paragraph (a) of this section shall not UDI must be presented in two forms: apply to any device that meets any of (1) Easily readable plain-text, and the following criteria: (2) Automatic identification and data (1) Any type of direct marking would capture (AIDC) technology. interfere with the safety or effective- (b) The UDI must include a device ness of the device; identifier segment. Whenever a device (2) The device cannot be directly label includes a lot or batch number, a marked because it is not techno- serial number, a manufacturing date, logically feasible; an expiration date, or for a human cell, (3) The device is a single-use device tissue, or cellular or tissue-based prod- and is subjected to additional proc- uct (HCT/P) regulated as a device, a essing and manufacturing for the pur- distinct identification code as required pose of an additional single use. by § 1271.290(c) of this chapter, the UDI (4) The device has been previously must include a production identifier marked under paragraph (a) of this sec- segment that conveys such information. tion. (e) Exception to be noted in design his- (c) If the AIDC technology is not evi- tory file. A labeler that decides to make dent upon visual examination of the use of an exception under paragraph (d label or device package, the label or de- of this section) must document the

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basis of that decision in the design his- it would provide for more accurate, tory file required by § 820.30(j) of this precise, or rapid device identification chapter. than the requirements of this subpart [78 FR 55818, Sept. 24, 2013] or how the alternative would better ensure the safety or effectiveness of the § 801.50 Labeling requirements for device that would be subject to the al- stand-alone software. ternative; (a) Stand-alone software that is not (5) Provide, if known, the number of distributed in packaged form (e.g., labelers and the number of devices that when downloaded from a Web site) is would be affected if we grant the re- deemed to meet the UDI labeling requested exception or alternative; and quirements of this subpart if it com- (6) Provide other requested informa- plies with the requirements of para- tion that the Center Director needs to graph (b) of this section and conveys clarify the scope and effects of the re- the version number in its production quested exception or alternative. identifier. (b) Regardless of whether it is or is (b) A written request for an exception not distributed in packaged form, or alternative must be submitted by stand-alone software regulated as a sending it: medical device must provide its unique (1) If the device is regulated by the device identifier through either or both Center for Biologics Evaluation and of the following: Research (CBER), by email to: (1) An easily readable plain-text [email protected] or by cor- statement displayed whenever the soft- respondence to: Food and Drug Admin- ware is started; istration, Center for Biologics Evalua- (2) An easily readable plain-text tion and Research, Document Control statement displayed through a menu Center, 10903 New Hampshire Ave., command (e.g., an ‘‘About * * *’’ com- Bldg. 71, Rm. G112, Silver Spring, MD mand). 20993. (c) Stand-alone software that is dis- (2) In all other cases, by email to: tributed in both packaged form and in [email protected], or by cor- a form that is not packaged (e.g., when respondence to: UDI Regulatory Policy downloaded from a Web site) may be identified with the same device identi- Support, Center for Devices and Radio- fier. logical Health, Food and Drug Admin- istration, 10903 New Hampshire Ave., [78 FR 55818, Sept. 24, 2013] Bldg. 66, Rm. 3303, Silver Spring, MD 20993–0002. § 801.55 Request for an exception from or alternative to a unique device (c) The Center Director may grant an identifier requirement. exception or alternative, either in re- (a) A labeler may submit a request sponse to a request or on his or her own for an exception from or alternative to initiative, if the Center Director deter- the requirement of § 801.20 or any other mines that an exception is appropriate requirement of this subpart for a speci- because the requirements of this sub- fied device or a specified type of device. part are not technologically feasible, A written request for an exception or or that an alternative would provide alternative must: for more accurate, precise, or rapid de- (1) Identify the device or devices that vice identification than the require- would be subject to the exception or al- ments of this subpart or would better ternative; ensure the safety or effectiveness of (2) Identify the provisions of this sub- the device that would be subject to the part that are the subject of the request alternative. If we grant an exception or for an exception or alternative; alternative, we may include any safe- (3) If requesting an exception, explain guards or conditions deemed appro- why you believe the requirements of priate to ensure the adequate identi- this subpart are not technologically feasible; fication of the device through its dis- (4) If requesting an alternative, de- tribution and use. Any labeler may scribe the alternative and explain why

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make use of an exception or alter- (2) No later than September 24, 2014, native granted under this section, pro- the labeler submits, and obtains FDA vided that such use satisfies all safe- approval of, a request for continued use guards or conditions that are part of of the assigned labeler code. A request the exception or alternative. for continued use of an assigned labeler (d) FDA may initiate and grant an code must be submitted by email to: exception or alternative if we deter- [email protected], or by cor- mine that the exception or alternative respondence to: UDI Regulatory Policy is in the best interest of the public Support, Center for Devices and Radio- health. Any such exception or alter- logical Health, Food and Drug Admin- native will remain in effect only so istration, 10903 New Hampshire Ave., long as there remains a public health Bldg. 66, Rm. 3303, Silver Spring, MD need for the exception or alternative. 20993–0002. (e) The Center Director may rescind (d) Each request for continued use of an exception or alternative granted an assigned labeler code must provide— under this section if, after providing an (1) The name, mailing address, email opportunity for an informal hearing as address, and phone number of the label- defined in section 201(x) of the Federal er who is currently using the labeler Food, Drug, and Cosmetic Act and code; under part 16 of this chapter, the Cen- (2) The owner/operator account iden- ter Director determines that the excep- tification used by the labeler to submit tion or alternative no longer satisfies registration and listing information the criteria described in this paragraph using FDA’s Unified Registration and (e) or that any safeguard or condition Listing System (FURLS). required under this paragraph (e) has (3) The FDA labeler code that the la- not been met. beler wants to continue using. [78 FR 58818, Sept. 24, 2013, as amended at 80 [78 FR 55820, Sept. 24, 2013, as amended at 81 FR 18093, Apr. 3, 2015; 81 FR 11428, Mar. 4, FR 11428, Mar. 4, 2016] 2016]

§ 801.57 Discontinuation of legacy FDA Subpart C—Labeling Require- identification numbers assigned to ments for Over-the-Counter devices. Devices (a) On the date your device must bear a unique device identifier (UDI) on its § 801.60 Principal display panel. label, any National Health-Related The term principal display panel, as it Item Code (NHRIC) or National Drug applies to over-the-counter devices in Code (NDC) number assigned to that package form and as used in this part, device is rescinded, and you may no means the part of a label that is most longer provide an NHRIC or NDC num- likely to be displayed, presented, ber on the label of your device or on shown, or examined under customary any device package. conditions of display for retail sale. (b) If your device is not required to The principal display panel shall be bear a UDI on its label, any NHRIC or large enough to accommodate all the NDC number assigned to that device is mandatory label information required rescinded as of September 24, 2018, and to be placed thereon by this part with beginning on that date, you may no clarity and conspicuousness and with- longer provide an NHRIC or NDC num- out obscuring designs, vignettes, or ber of the label of your device or on crowding. Where packages bear alter- any device package. nate principal display panels, informa- (c) A labeler who has been assigned tion required to be placed on the prin- an FDA labeler code to facilitate use of cipal display panel shall be duplicated NHRIC or NDC numbers may continue on each principal display panel. For to use that labeler code under a system the purpose of obtaining uniform type for the issuance of UDIs, provided that— size in declaring the quantity of con- (1) Such use is consistent with the tents for all packages of substantially framework of the issuing agency that the same size, the term area of the prin- operates that system; and cipal display panel means the area of

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the side or surface that bears the prin- shall be in lines generally parallel to cipal display panel, which area shall the base on which the package rests as be: it is designed to be displayed. (a) In the case of a rectangular package where one entire side properly can § 801.62 Declaration of net quantity of be considered to be the principal dis- contents. play panel side, the product of the (a) The label of an over-the-counter height times the width of that side; device in package form shall bear a (b) In the case of a cylindrical or declaration of the net quantity of con- nearly cylindrical container, 40 percent tents. This shall be expressed in the of the product of the height of the con- terms of weight, measure, numerical tainer times the circumference; and count, or a combination of numerical (c) In the case of any other shape of count and weight, measure, or size: container, 40 percent of the total sur- Provided, That: face of the container: Provided, how- (1) In the case of a firmly established ever, That where such container pre- general consumer usage and trade cus- sents an obvious ‘‘principal display tom of declaring the quantity of a de- panel’’ such as the top of a triangular vice in terms of linear measure or or circular package, the area shall con- measure of area, such respective term sist of the entire top surface. may be used. Such term shall be aug- In determining the area of the prin- mented when necessary for accuracy of cipal display panel, exclude tops, bot- information by a statement of the toms, flanges at the tops and bottoms weight, measure, or size of the indi- of cans, and shoulders and necks of bot- vidual units or of the entire device. tles or jars. In the case of cylindrical (2) If the declaration of contents for a or nearly cylindrical containers, infor- device by numerical count does not mation required by this part to appear give accurate information as to the on the principal display panel shall ap- quantity of the device in the package, pear within that 40 percent of the cir- it shall be augmented by such state- cumference which is most likely to be ment of weight, measure, or size of the displayed, presented, shown, or exam- individual units or of the total weight, ined under customary conditions of dis- measure, or size of the device as will play for retail sale. give such information; for example, ‘‘100 tongue depressors, adult size’’, ‘‘1 § 801.61 Statement of identity. rectal syringe, adult size’’, etc. When- (a) The principal display panel of an ever the Commissioner determines for over-the-counter device in package a specific packaged device that an ex- form shall bear as one of its principal isting practice of declaring net quan- features a statement of the identity of tity of contents by weight, measure, the commodity. numerical count, or a combination of (b) Such statement of identity shall these does not facilitate value be in terms of the common name of the comparisions by consumers, he shall by device followed by an accurate state- regulation designate the appropriate ment of the principal intended ac- term or terms to be used for such arti- tion(s) of the device. Such statement cle. shall be placed in direct conjunction (b) Statements of weight of the con- with the most prominent display of the tents shall be expressed in terms of av- name and shall employ terms descrip- oirdupois pound and ounce. A state- tive of the principal intended action(s). ment of liquid measure of the contents The indications for use shall be in- shall be expressed in terms of the U.S. cluded in the directions for use of the gallon of 231 cubic inches and quart, device, as required by section 502(f)(1) pint, and fluid-ounce subdivisions of the act and by the regulations in thereof, and shall express the volume this part. at 68 °F (20 °C). See also paragraph (p) (c) The statement of identity shall be of this section. presented in bold face type on the prin- (c) The declaration may contain com- cipal display panel, shall be in a size mon or decimal fractions. A common reasonably related to the most promi- fraction shall be in terms of halves, nent printed matter on such panel, and quarters, eighths, sixteenths, or thirty-

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seconds; except that if there exists a (3) The principal display panel of a firmly established, general consumer device marketed on a display card to usage and trade custom of employing which the immediate container is af- different common fractions in the net fixed may be considered to be the dis- quantity declaration of a particular play panel of the card, and the type commodity, they may be employed. A size of the net quantity of contents common fraction shall be reduced to statement is governed by the dimen- its lowest terms; a decimal fraction sions of the display card. shall not be carried out to more than (f) The declaration shall accurately two places. A statement that includes reveal the quantity of device in the small fractions of an ounce shall be package exclusive of wrappers and deemed to permit smaller variations other material packed therewith. than one which does not include such (g) The declaration shall appear in fractions. conspicuous and easily legible boldface (d) The declaration shall be located print or type in distinct contrast (by on the principal display panel of the typography, layout, color, embossing, label, and with respect to packages or molding) to other matter on the bearing alternate principal panels it package; except that a declaration of shall be duplicated on each principal net quantity blown, embossed, or mold- display panel. ed on a glass or plastic surface is per- (e) The declaration shall appear as a missible when all label information is distinct item on the principal display so formed on the surface. Requirements panel, shall be separated, by at least a of conspicuousness and legibility shall space equal to the height of the let- include the specifications that: tering used in the declaration, from (1) The ratio of height to width of the other printed label information appear- letter shall not exceed a differential of ing above or below the declaration and, 3 units to 1 unit, i.e., no more than 3 by at least a space equal to twice the times as high as it is wide. width of the letter ‘‘N’’ of the style of (2) Letter heights pertain to upper type used in the quantity of contents case or capital letters. When upper and statement, from other printed label in- lower case or all lower case letters are formation appearing to the left or right used, it is the lower case letter ‘‘o’’ or of the declaration. It shall not include its equivalent that shall meet the min- any term qualifying a unit of weight, imum standards. measure, or count, such as ‘‘giant pint’’ (3) When fractions are used, each and ‘‘full quart’’, that tends to exag- component numeral shall meet one- gerate. It shall be placed on the prin- half the minimum height standards. cipal display panel within the bottom (h) The declaration shall be in letters 30 percent of the area of the label panel and numerals in a type size established in lines generally parallel to the base in relationship to the area of the prin- on which the package rests as it is de- cipal display panel of the package and signed to be displayed: Provided, That: shall be uniform for all packages of (1) On packages having a principal substantially the same size by com- display panel of 5 square inches or less plying with the following type speci- the requirement for placement within fications: the bottom 30 percent of the area of the (1) Not less than one-sixteenth inch label panel shall not apply when the in height on packages the principal dis- declaration of net quantity of contents play panel of which has an area of 5 meets the other requirements of this square inches or less. part; and (2) Not less than one-eighth inch in (2) In the case of a device that is mar- height on packages the principal dis- keted with both outer and inner retail play panel of which has an area of more containers bearing the mandatory label than 5 but not more than 25 square information required by this part and inches. the inner container is not intended to (3) Not less than three-sixteenths be sold separately, the net quantity of inch in height on packages the prin- contents placement requirement of this cipal display panel of which has an section applicable to such inner con- area of more than 25 but not more than tainer is waived. 100 square inches.

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(4) Not less than one-fourth inch in the case of fluid measure, it shall be height on packages the principal dis- expressed in the largest whole unit, play panel of which has an area of more i.e., gallons, followed by common or than 100 square inches, except not less decimal fractions of a gallon or by the than one-half inch in height if the area next smaller whole unit or units is more than 400 square inches. (quarts or quarts and pints), with any Where the declaration is blown, em- remainder in terms of fluid ounces or bossed, or molded on a glass or plastic common or decimal fractions of the surface rather than by printing, typ- pint or quart; see paragraph (k)(5) of ing, or coloring, the lettering sizes this section. 1 specified in paragraphs (h)(1) through (k) Examples: (1) A declaration of 1 ⁄2 (4) of this section shall be increased by pounds weight shall be expressed as one-sixteenth of an inch. ‘‘net wt. 24 oz (1 lb 8 oz),’’ or ‘‘Net wt. (i) On packages containing less than 24 oz (11⁄2 lb)’’ or ‘‘Net wt. 24 oz (1.5 lb).’’ 4 pounds or 1 gallon and labeled in (2) A declaration of three-fourths terms of weight or fluid measure: pound avoirdupois weight shall be ex- (1) The declaration shall be expressed pressed as ‘‘Net wt. 12 oz.’’. both in ounces, with identification by (3) A declaration of 1 quart liquid weight or by liquid measure and, if ap- measure shall be expressed as ‘‘Net plicable (1 pound or 1 pint or more) fol- contents 32 fl oz (1 qt)’’ or ‘‘32 fl oz (1 lowed in parentheses by a declaration qt).’’ in pounds for weight units, with any re- (4) A declaration of 13⁄4 quarts liquid mainder in terms of ounces or common measure shall be expressed as, ‘‘Net or decimal fractions of the pound (see contents 56 fl oz (1 qt 1 pt 8 oz)’’ or examples set forth in paragraphs (k) (1) ‘‘Net contents 56 fl oz (1 qt 1.5 pt),’’ but and (2) of this section), or in the case of not in terms of quart and ounce such as liquid measure, in the largest whole ‘‘Net contents 56 fl oz (1 qt 24 oz).’’ units (quarts, quarts and pints, or (5) A declaration of 21⁄2 gallons liquid pints, as appropriate) with any remain- measure shall be expressed as ‘‘Net der in terms of fluid ounces or common contents 2 gal 2 qt’’, ‘‘Net contents 2.5 or decimal fractions of the pint or gallons,’’ or ‘‘Net contents 21⁄2 gal’’ but quart (see examples set forth in para- not as ‘‘2 gal 4 pt’’. graphs (k) (3) and (4) of this section). If (l) For quantities, the following ab- the net weight of the package is less breviations and none other may be em- than 1 ounce avoirdupois or the net ployed. Periods and plural forms are fluid measure is less than 1 fluid ounce, optional: the declaration shall be in terms of gallon gal liter l common or decimal fractions of the re- milliliter ml cubic centimeter cc quart qt yard yd spective ounce and not in terms of pint pt feet or foot ft drams. ounce oz inch in (2) The declaration may appear in pound lb meter m grain gr centimeter cm more than one line. The term ‘‘net kilogram kg millimeter mm weight’’ shall be used when stating the gram g fluid fl net quantity of contents in terms of milligram mg square sq weight. Use of the terms ‘‘net’’ or ‘‘net microgram mcg weight wt contents’’ in terms of fluid measure or (m) On packages labeled in terms of numerical count is optional. It is suffi- linear measure, the declaration shall cient to distinguish avoirdupois ounce be expressed both in terms of inches from fluid ounce through association of and, if applicable (1 foot or more), the terms; for example, ‘‘Net wt. 6 oz’’ or largest whole units (yards, yards and ‘‘6 oz net wt.,’’ and ‘‘6 fl oz’’ or ‘‘net feet, feet). The declaration in terms of contents 6 fl oz.’’ the largest whole units shall be in pa- (j) On packages containing 4 pounds rentheses following the declaration in or 1 gallon or more and labeled in terms of inches and any remainder terms of weight or fluid measure, the shall be in terms of inches or common declaration shall be expressed in or decimal fractions of the foot or pounds for weight units with any re- yard; if applicable, as in the case of ad- mainder in terms of ounces or common hesive tape, the initial declaration in or decimal fractions of the pound; in linear inches shall be preceded by a

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statement of the width. Examples of § 801.63 Medical devices; warning linear measure are ‘‘86 inches (2 yd 1 ft statements for devices containing 2 in)’’, ‘‘90 inches (21⁄2 yd)’’, ‘‘30 inches or manufactured with chlorofluorocarbons and other class (2.5 ft)’’, ‘‘3⁄4 inch by 36 in (1 yd)’’, etc. I ozone-depleting substances. (n) On packages labeled in terms of area measure, the declaration shall be (a) All over-the-counter devices con- expressed both in terms of square taining or manufactured with inches and, if applicable (1 square foot chlorofluorocarbons, halons, carbon or more), the largest whole square unit tetrachloride, methyl chloride, or any other class I substance designated by (square yards, square yards and square the Environmental Protection Agency feet, square feet). The declaration in (EPA) shall carry one of the following terms of the largest whole units shall warnings: be in parentheses following the dec- (1) The EPA warning statement: laration in terms of square inches and any remainder shall be in terms of WARNING: Contains [or Manufactured with, square inches or common or decimal if applicable] [insert name of substance], a substance which harms public health and envi- fractions of the square foot or square ronment by destroying ozone in the upper at- yard; for example, ‘‘158 sq inches (1 sq mosphere. ft 14 sq in)’’. (2) The alternative statement: (o) Nothing in this section shall prohibit supplemental statements at loca- NOTE: The indented statement below is re- tions other than the principal display quired by the Federal government’s Clean panel(s) describing in nondeceptive Air Act for all products containing or manufactured with chlorofluorocarbons (CFC’s) terms the net quantity of contents, [or other class I substance, if applicable]: provided that such supplemental state- WARNING: Contains [or Manufactured with, ments of net quantity of contents shall if applicable] [insert name of substance], a sub- not include any term qualifying a unit stance which harms public health and envi- of weight, measure, or count that tends ronment by destroying ozone in the upper at- to exaggerate the amount of the device mosphere. contained in the package; for example, CONSULT WITH YOUR PHYSICIAN, ‘‘giant pint’’ and ‘‘full quart’’. Dual or HEALTH PROFESSIONAL, OR SUPPLIER combination declarations of net quan- IF YOU HAVE ANY QUESTION ABOUT THE tity of contents as provided for in para- USE OF THIS PRODUCT. graphs (a) and (i) of this section are not (b) The warning statement shall be regarded as supplemental net quantity clearly legible and conspicuous on the statements and shall be located on the product, its immediate container, its principal display panel. outer packaging, or other labeling in (p) A separate statement of net quan- accordance with the requirements of 40 tity of contents in terms of the metric CFR part 82 and appear with such system of weight or measure is not re- prominence and conspicuousness as to garded as a supplemental statement render it likely to be read and under- and an accurate statement of the net stood by consumers under normal con- quantity of contents in terms of the ditions of purchase. This provision does metric system of weight or measure not replace or relieve a person from may also appear on the principal dis- any requirements imposed under 40 CFR part 82. play panel or on other panels. (q) The declaration of net quantity of [61 FR 20101, May 3, 1996] contents shall express an accurate statement of the quantity of contents Subpart D—Exemptions From of the package. Reasonable variations Adequate Directions for Use caused by loss or gain of moisture during the course of good distribution § 801.109 Prescription devices. practice or by unavoidable deviations A device which, because of any poten- in good manufacturing practice will be tiality for harmful effect, or the meth- recognized. Variations from stated od of its use, or the collateral measures quantity of contents shall not be unnecessary to its use is not safe except reasonably large. under the supervision of a practitioner

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licensed by law to direct the use of the dispensing package under this pro- such device, and hence for which ‘‘ade- viso. quate directions for use’’ cannot be (d) Any labeling, as defined in section prepared, shall be exempt from section 201(m) of the act, whether or not it is 502(f)(1) of the act if all the following on or within a package from which the conditions are met: device is to be dispensed, distributed by (a) The device is: or on behalf of the manufacturer, pack- (1)(i) In the possession of a person, or er, or distributor of the device, that his agents or employees, regularly and furnishes or purports to furnish infor- lawfully engaged in the manufacture, mation for use of the device contains transportation, storage, or wholesale adequate information for such use, in- or retail distribution of such device; or cluding indications, effects, routes, (ii) In the possession of a practi- methods, and frequency and duration tioner, such as physicians, dentists, of administration and any relevant and veterinarians, licensed by law to hazards, contraindications, side effects, use or order the use of such device; and and precautions, under which practi- (2) Is to be sold only to or on the pre- tioners licensed by law to employ the scription or other order of such practi- device can use the device safely and for tioner for use in the course of his pro- the purposes for which it is intended, fessional practice. including all purposes for which it is (b) The label of the device, other than advertised or represented. This infor- surgical instruments, bears: mation will not be required on so- (1) The symbol statement ‘‘Rx only’’ called reminder—piece labeling which or ‘‘) only’’ or the statement ‘‘Caution: Federal law restricts this device to sale calls attention to the name of the de- by or on the order of a lll’’, the vice but does not include indications or blank to be filled with the word ‘‘phy- other use information. sician’’, ‘‘dentist’’, ‘‘veterinarian’’, or (e) All labeling, except labels and with the descriptive designation of any cartons, bearing information for use of other practitioner licensed by the law the device also bears the date of the of the State in which the practitioner issuance or the date of the latest revi- practices to use or order the use of the sion of such labeling. device; and [41 FR 6896, Feb. 13, 1976, as amended at 81 (2) The method of its application or FR 38930, June 15, 2016] use. (c) Labeling on or within the package § 801.110 Retail exemption for pre- from which the device is to be dis- scription devices. pensed bears information for use, in- A device subject to § 801.109 shall be cluding indications, effects, routes, exempt at the time of delivery to the methods, and frequency and duration ultimate purchaser or user from sec- of administration, and any relevant tion 502(f)(1) of the act if it is delivered hazards, contraindications, side effects, by a licensed practitioner in the course and precautions under which practi- of his professional practice or upon a tioners licensed by law to administer the device can use the device safely prescription or other order lawfully and for the purpose for which it is in- issued in the course of his professional tended, including all purposes for practice, with labeling bearing the which it is advertised or represented: name and address of such licensed prac- Provided, however, That such informa- titioner and the directions for use and tion may be omitted from the dis- cautionary statements, if any, con- pensing package if, but only if, the ar- tained in such order. ticle is a device for which directions, hazards, warnings, and other informa- § 801.116 Medical devices having commonly known directions. tion are commonly known to practitioners licensed by law to use the de- A device shall be exempt from sec- vice. Upon written request, stating rea- tion 502(f)(1) of the act insofar as ade- sonable grounds therefor, the Commis- quate directions for common uses sioner will offer an opinion on a pro- thereof are known to the ordinary indi- posal to omit such information from vidual.

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§ 801.119 In vitro diagnostic products. tinue until the devices are used for the A product intended for use in the di- purposes for which they are exempted, agnosis of disease and which is an in or until they are relabeled to comply vitro diagnostic product as defined in with section 502(f)(1) of the act. If, how- § 809.3(a) of this chapter shall be ever, the device is converted, or manu- deemed to be in compliance with the factured into a form limited to pre- requirements of this part and section scription dispensing, no exemption 502(f)(1) of the Federal Food, Drug, and shall thereafter apply to the article un- Cosmetic Act if it meets the require- less the device is labeled as required by ments of subpart B of this part and the § 801.109. requirements of § 809.10 of this chapter. § 801.128 Exceptions or alternatives to [78 FR 55820, Sept. 24, 2013] labeling requirements for medical devices held by the Strategic Na- § 801.122 Medical devices for proc- tional Stockpile. essing, repacking, or manufac- (a) The appropriate FDA Center Di- turing. rector may grant an exception or alter- A device intended for processing, re- native to any provision listed in para- packing, or use in the manufacture of graph (f) of this section and not explic- another drug or device shall be exempt itly required by statute, for specified from section 502(f)(1) of the act if its lots, batches, or other units of a med- label bears the statement ‘‘Caution: ical device, if the Center Director de- For manufacturing, processing, or re- termines that compliance with such la- packing’’. beling requirement could adversely affect the safety, effectiveness, or avail- § 801.125 Medical devices for use in teaching, law enforcement, re- ability of such devices that are or will search, and analysis. be included in the Strategic National Stockpile. A device subject to § 801.109 shall be exempt from section 502(f)(1) of this act (b)(1)(i) A Strategic National Stock- if shipped or sold to, or in the posses- pile official or any entity that manu- sion of, persons regularly and lawfully factures (including labeling, packing, engaged in instruction in pharmacy, relabeling, or repackaging), distrib- chemistry, or medicine not involving utes, or stores devices that are or will clinical use, or engaged in law enforce- be included in the Strategic National ment, or in research not involving clin- Stockpile may submit, with written ical use, or in chemical analysis, or concurrence from a Strategic National physical testing, and is to be used only Stockpile official, a written request for for such instruction, law enforcement, an exception or alternative described research, analysis, or testing. in paragraph (a) of this section to the Center Director. § 801.127 Medical devices; expiration (ii) The Center Director may grant of exemptions. an exception or alternative described (a) If a shipment or delivery, or any in paragraph (a) of this section on his part thereof, of a device which is ex- or her own initiative. empt under the regulations in this sec- (2) A written request for an exception tion is made to a person in whose pos- or alternative described in paragraph session the article is not exempt, or is (a) of this section must: made for any purpose other than those (i) Identify the specified lots, specified, such exemption shall expire, batches, or other units of the medical with respect to such shipment or deliv- device that would be subject to the ex- ery or part thereof, at the beginning of ception or alternative; that shipment or delivery. The causing (ii) Identify the labeling provision(s) of an exemption to expire shall be con- listed in paragraph (f) of this section sidered an act which results in such de- that are the subject of the exception or vice being misbranded unless it is dis- alternative request; posed of under circumstances in which (iii) Explain why compliance with it ceases to be a drug or device. the labeling provision(s) could ad- (b) The exemptions conferred by versely affect the safety, effectiveness, §§ 801.119, 801.122, and 801.125 shall con- or availability of the specified lots,

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batches, or other units of a medical de- (1) § 801.1(d); vice that are or will be held in the (2) Subpart B of this part and part 830 Strategic National Stockpile; of this chapter in its entirety; (iv) Describe any proposed safeguards (3) § 801.60; or conditions that will be implemented (4) § 801.61; so that the labeling of the device in- (5) § 801.62; cludes appropriate information nec- (6) § 801.63; essary for the safe and effective use of (7) § 801.109; and the device, given the anticipated cir- (8) Part 801, subpart H. cumstances of use of the device; [72 FR 73601, Dec. 28, 2007, as amended at 78 (v) Provide a draft of the proposed la- FR 55820, Sept. 24, 2013] beling of the specified lots, batches, or other units of the medical device sub- Subpart E—Other Exemptions ject to the exception or alternative; and § 801.150 Medical devices; processing, (vi) Provide any other information labeling, or repacking. requested by the Center Director in (a) Except as provided by paragraphs support of the request. (b) and (c) of this section, a shipment (c) The Center Director must respond or other delivery of a device which is, in writing to all requests under this in accordance with the practice of the section. The Center Director may im- trade, to be processed, labeled, or re- pose appropriate conditions when packed, in substantial quantity at an granting such an exception or alter- establishment other than that where native under this section. originally processed or packed, shall be (d) A grant of an exception or alter- exempt, during the time of introduc- native under this section will include tion into and movement in interstate any safeguards or conditions deemed commerce and the time of holding in appropriate by the Center Director so such establishment, from compliance that the labeling of devices subject to with the labeling and packaging re- the exception or alternative includes quirements of section 502(b) and (f) of the information necessary for the safe the act if: and effective use of the device, given (1) The person who introduced such the anticipated circumstances of use. shipment or delivery into interstate (e) If the Center Director grants a re- commerce is the operator of the estab- quest for an exception or alternative to lishment where such device is to be the labeling requirements under this processed, labeled, or repacked; or section: (2) In case such person is not such op- (1) The Center Director may deter- erator, such shipment or delivery is mine that the submission and grant of made to such establishment under a a written request under this section written agreement, signed by and con- satisfies the provisions relating to pre- taining the post office addresses of market notification submissions under such person and such operator, and § 807.81(a)(3) of this chapter. containing such specifications for the (2)(i) For a Premarket Approval Ap- processing, labeling, or repacking, as plication (PMA)-approved device, the the case may be, of such device in such submission and grant of a written re- establishment as will insure, if such quest under this section satisfies the specifications are followed, that such provisions relating to submission of device will not be adulterated or mis- PMA supplements under § 814.39 of this branded within the meaning of the act chapter; however, upon completion of such processing, la- (ii) The grant of the request must be beling, or repacking. Such person and identified in a periodic report under such operator shall each keep a copy of § 814.84 of this chapter. such agreement until 2 years after the (f) The Center Director may grant an final shipment or delivery of such de- exception or alternative under this sec- vice from such establishment, and shall tion to the following provisions of this make such copies available for inspec- chapter, to the extent that the require- tion at any reasonable hour to any offi- ments in these provisions are not ex- cer or employee of the Department who plicitly required by statute: requests them.

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(b) An exemption of a shipment or (ii) Provides instructions for main- other delivery of a device under para- taining proper records or otherwise ac- graph (a)(1) of this section shall, at the counting for the number of units in beginning of the act of removing such each shipment to insure that the num- shipment or delivery, or any part ber of units shipped is the same as the thereof, from such establishment, be- number received and sterilized. come void ab initio if the device com- (iii) Acknowledges that the device is prising such shipment, delivery, or part nonsterile and is being shipped for fur- is adulterated or misbranded within ther processing, and the meaning of the act when so re- (iv) States in detail the sterilization moved. process, the gaseous mixture or other (c) An exemption of a shipment or media, the equipment, and the testing other delivery of a device under para- method or quality controls to be used graph (a)(2) of this section shall be- by the contract sterilizer to assure come void ab initio with respect to the that the device will be brought into person who introduced such shipment full compliance with the Federal Food, Drug, and Cosmetic Act. or delivery into interstate commerce (2) Each pallet, carton, or other des- upon refusal by such person to make ignated unit is conspicuously marked available for inspection a copy of the to show its nonsterile nature when it is agreement, as required by such para- introduced into and is moving in inter- graph (a)(2). state commerce, and while it is being (d) An exemption of a shipment or held prior to sterilization. Following other delivery of a device under para- sterilization, and until such time as it graph (a)(2) of this section shall expire: is established that the device is sterile (1) At the beginning of the act of re- and can be released from quarantine, moving such shipment or delivery, or each pallet, carton, or other designated any part thereof, from such establish- unit is conspicuously marked to show ment if the device comprising such that it has not been released from shipment, delivery, or part is adulter- quarantine, e.g., ‘‘sterilized—awaiting ated or misbranded within the meaning test results’’ or an equivalent designa- of the act when so removed; or tion. (2) Upon refusal by the operator of the establishment where such device is Subparts F–G [Reserved] to be processed, labeled, or repacked, to make available for inspection a copy Subpart H—Special Requirements of the agreement, as required by such for Specific Devices clause. (e) As it is a common industry prac- § 801.405 Labeling of articles intended tice to manufacture and/or assemble, for lay use in the repairing and/or package, and fully label a device as refitting of dentures. sterile at one establishment and then (a) The American Dental Association ship such device in interstate com- and leading dental authorities have ad- merce to another establishment or to a vised the Food and Drug Administra- contract sterilizer for sterilization, the tion of their concern regarding the Food and Drug Administration will ini- safety of denture reliners, repair kits, tiate no regulatory action against the pads, cushions, and other articles mar- device as misbranded or adulterated keted and labeled for lay use in the re- when the nonsterile device is labeled pairing, refitting, or cushioning of ill- sterile, provided all the following con- fitting, broken, or irritating dentures. ditions are met: It is the opinion of dental authorities (1) There is in effect a written agree- and the Food and Drug Administration ment which: that to properly repair and properly (i) Contains the names and post office refit dentures a person must have pro- addresses of the firms involved and is fessional knowledge and specialized signed by the person authorizing such technical skill. Laymen cannot be ex- shipment and the operator or person in pected to maintain the original charge of the establishment receiving vertical dimension of occlusion and the the devices for sterilization. centric relation essential in the proper

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repairing or refitting of dentures. The dentures to fit properly. Home-repaired continued wearing of improperly re- dentures may cause irritation to the paired or refitted dentures may cause gums and discomfort and tiredness acceleration of bone resorption, soft while eating. Long term use may lead tissue hyperplasia, and other irrep- to more troubles, even permanent arable damage to the oral cavity. Such changes in bones, teeth, and gums, articles designed for lay use should be which may make it impossible to wear limited to emergency or temporary sit- dentures in the future. For these rea- uations pending the services of a li- sons, dentures repaired with this kit censed dentist. should be used only in an emergency (b) The Food and Drug Administra- until a dentist can be seen. Dentures tion therefore regards such articles as that don’t fit properly cause irritation unsafe and misbranded under the Fed- and injury to the gums and faster bone eral Food, Drug, and Cosmetic Act, un- loss, which is permanent. Dentures less the labeling: that don’t fit properly cause gum (1)(i) Limits directions for use for changes that may require surgery for denture repair kits to emergency re- correction. Continuing irritation and pairing pending unavoidable delay in injury may lead to cancer in the obtaining professional reconstruction mouth. You must see your dentist as of the denture; soon as possible. (ii) Limits directions for use for den- (2) For denture reliners, pads, and ture reliners, pads, and cushions to cushions: Use of these preparations or temporary refitting pending unavoid- devices may temporarily decrease the able delay in obtaining professional re- discomfort; however, their use will not construction of the denture; make the denture fit properly. Special (2) Contains in a conspicuous manner training and tools are needed to repair the word ‘‘emergency’’ preceding and a denture to fit properly. Dentures that modifying each indication-for-use do not fit properly cause irritation and statement for denture repair kits and injury to the gums and faster bone the word ‘‘temporary’’ preceding and loss, which is permanent and may re- modifying each indication-for-use quire a completely new denture. statement for reliners, pads, and cush- Changes in the gums caused by den- ions; and tures that do not fit properly may re- (3) Includes a conspicuous warning quire surgery for correction. Con- statement to the effect: tinuing irritation and injury may lead (i) For denture repair kits: ‘‘Warn- to cancer in the mouth. You must see ing—For emergency repairs only. Long your dentist as soon as possible. term use of home-repaired dentures (3) If the denture relining or repair- may cause faster bone loss, continuing ing material forms a permanent bond irritation, sores, and tumors. This kit with the denture, a warning statement for emergency use only. See Dentist to the following effect should be in- Without Delay.’’ cluded: ‘‘This reliner becomes fixed to (ii) For denture reliners, pads, and the denture and a completely new den- cushions: ‘‘Warning—For temporary use ture may be required because of its only. Longterm use of this product may use.’’ lead to faster bone loss, continuing ir- (d) Labeling claims exaggerating the ritation, sores, and tumors. For Use usefulness or the safety of the material Only Until a Dentist Can Be Seen.’’ or failing to disclose all facts relevant (c) Adequate directions for use re- to the claims of usefulness will be require full information of the temporary garded as false and misleading under and emergency use recommended in sections 201(n) and 502(a) of the Federal order for the layman to understand the Food, Drug, and Cosmetic Act. limitations of usefulness, the reasons (e) Regulatory action may be initi- therefor, and the importance of adher- ated with respect to any article found ing to the warnings. Accordingly, the within the jurisdiction of the act con- labeling should contain substantially trary to the provisions of this policy the following information: statement after 90 days following the (1) For denture repair kits: Special date of publication of this section in training and tools are needed to repair the FEDERAL REGISTER.

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§ 801.410 Use of impact-resistant each production batch, and the lenses lenses in eyeglasses and sunglasses. so tested shall be representative of the (a) Examination of data available on finished forms as worn by the wearer, the frequency of eye injuries resulting including finished forms that are of from the shattering of ordinary crown minimal lens thickness and have been glass lenses indicates that the use of subjected to any treatment used to im- such lenses constitutes an avoidable part impact resistance. All non- hazard to the eye of the wearer. prescription lenses and plastic pre- (b) The consensus of the ophthalmic scription lenses tested on the basis of community is that the number of eye statistical significance shall be tested injuries would be substantially reduced in uncut-finished or finished form. by the use in eyeglasses and sunglasses (d)(1) For the purpose of this regula- of impact-resistant lenses. tion, the impact test described in para- (c)(1) To protect the public more ade- graph (d)(2) of this section shall be the quately from potential eye injury, eye- ‘‘referee test,’’ defined as ‘‘one which glasses and sunglasses must be fitted will be utilized to determine compli- with impact-resistant lenses, except in ance with a regulation.’’ The referee those cases where the physician or op- test provides the Food and Drug Ad- tometrist finds that such lenses will ministration with the means of exam- not fulfill the visual requirements of ining a medical device for performance the particular patient, directs in writ- and does not inhibit the manufacturer ing the use of other lenses, and gives from using equal or superior test meth- written notification thereof to the pa- ods. A lens manufacturer shall conduct tient. tests of lenses using the impact test de- (2) The physician or optometrist scribed in paragraph (d)(2) of this sec- shall have the option of ordering glass tion or any equal or superior test. lenses, plastic lenses, or laminated Whatever test is used, the lenses shall glass lenses made impact resistant by be capable of withstanding the impact any method; however, all such lenses test described in paragraph (d)(2) of shall be capable of withstanding the this section if the Food and Drug Ad- impact test described in paragraph ministration examines them for per- (d)(2) of this section. formance. (3) Each finished impact-resistant (2) In the impact test, a 5⁄8-inch steel glass lens for prescription use shall be ball weighing approximately 0.56 ounce individually tested for impact resist- is dropped from a height of 50 inches ance and shall be capable of with- upon the horizontal upper surface of standing the impact test described in the lens. The ball shall strike within a paragraph (d)(2) of this section. Raised 5⁄8-inch diameter circle located at the multifocal lenses shall be impact re- geometric center of the lens. The ball sistant but need not be tested beyond may be guided but not restricted in its initial design testing. Prism segment fall by being dropped through a tube multifocal, slab-off prism, lenticular extending to within approximately 4 cataract, iseikonic, depressed segment inches of the lens. To pass the test, the one-piece multifocal, bioconcave, lens must not fracture; for the purpose myodisc and minus lenticular, custom of this section, a lens will be consid- laminate and cemented assembly ered to have fractured if it cracks lenses shall be impact resistant but through its entire thickness, including need not be subjected to impact test- a laminar layer, if any, and across a ing. To demonstrate that all other complete diameter into two or more types of impact-resistant lenses, in- separate pieces, or if any lens material cluding impact-resistant laminated visible to the naked eyes becomes de- glass lenses (i.e., lenses other than tached from the ocular surface. The those described in the three preceding test shall be conducted with the lens sentences of this paragraph (c)(3)), are supported by a tube (1-inch inside di- capable of withstanding the impact ameter, 11⁄4-inch outside diameter, and test described in this regulation, the approximately 1-inch high) affixed to a manufacturer of these lenses shall sub- rigid iron or steel base plate. The total ject to an impact test a statistically weight of the base plate and its rigidly significant sampling of lenses from attached fixtures shall be not less than

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27 pounds. For lenses of small min- inventories of stock as he deems nec- imum diameter, a support tube having essary, and otherwise to check the cor- an outside diameter of less than 11⁄4 rectness of such inventories. inches may be used. The support tube (f) In addition, those persons con- shall be made of rigid acrylic plastic, ducting tests in accordance with para- steel, or other suitable substance and graph (d) of this section shall maintain shall have securely bonded on the top the results thereof and a description of edge a 1⁄8- by 1⁄8-inch neoprene gasket the test method and of the test appa- having a hardness of 40 ±5, as deter- ratus for a period of 3 years. These mined by ASTM Method D 1415–88, records shall be made available upon ‘‘Standard Test Method for Rubber request at any reasonable hour by any Property—International Hardness’’ a officer or employee acting on behalf of minimum tensile strength of 1,200 the Secretary of Health and Human pounds, as determined by ASTM Meth- Services. The persons conducting tests od D 412–98A, ‘‘Standard Test Methods shall permit the officer or employee to for Vulcanized Rubber and Thermo- inspect and copy the records, to make plastic Elastomers—Tension,’’ and a such inventories of stock as the officer minimum ultimate elongation of 400 or employee deems necessary, and oth- percent, as determined by ASTM Meth- erwise to check the correctness of the od D 412–68 (Both methods are incor- inventories. porated by reference and are available (g) For the purpose of this section, from the American Society for Testing the term ‘‘manufacturer’’ includes an Materials, 100 Barr Harbor Dr., West importer for resale. Such importer may Conshohocken, Philadelphia, PA 19428, have the tests required by paragraph or available for inspection at the Cen- (d) of this section conducted in the ter for Devices and Radiological country of origin but must make the Health’s Library, 9200 Corporate Blvd., results thereof available, upon request, Rockville, MD 20850, or at the National to the Food and Drug Administration, Archives and Records Administration as soon as practicable. (NARA). For information on the avail- (h) All lenses must be impact-resist- ability of this material at NARA, call ant except when the physician or op- 202–741–6030, or go to: http:// tometrist finds that impact-resistant www.archives.gov/federallregister/ lenses will not fulfill the visual re- codeloflfederallregulations/ quirements for a particular patient. ibrllocations.html. The diameter or (i) This statement of policy does not contour of the lens support may be apply to contact lenses. 1 modified as necessary so that the ⁄8- by [41 FR 6896, Feb. 13, 1976, as amended at 44 1 ⁄8-inch neoprene gasket supports the FR 20678, Apr. 6, 1979; 47 FR 9397, Mar. 5, 1982; lens at its periphery. 65 FR 3586, Jan. 24, 2000; 65 FR 44436, July 18, (e) Copies of invoice(s), shipping doc- 2000; 69 FR 18803, Apr. 9, 2004] ument(s), and records of sale or distribution of all impact resistant lenses, § 801.415 Maximum acceptable level of including finished eyeglasses and sun- ozone. glasses, shall be kept and maintained (a) Ozone is a toxic gas with no for a period of 3 years; however, the known useful medical application in names and addresses of individuals pur- specific, adjunctive, or preventive ther- chasing nonprescription eyeglasses and apy. In order for ozone to be effective sunglasses at the retail level need not as a germicide, it must be present in a be kept and maintained by the retailer. concentration far greater than that The records kept in compliance with which can be safely tolerated by man this paragraph shall be made available and animals. upon request at all reasonable hours by (b) Although undesirable physio- any officer or employee of the Food logical effects on the central nervous and Drug Administration or by any system, heart, and vision have been re- other officer or employee acting on be- ported, the predominant physiological half of the Secretary of Health and effect of ozone is primary irritation of Human Services and such officer or em- the mucous membranes. Inhalation of ployee shall be permitted to inspect ozone can cause sufficient irritation to and copy such records, to make such the lungs to result in pulmonary

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edema. The onset of pulmonary edema (d) This section does not affect the is usually delayed for some hours after present threshold limit value of 0.10 exposure; thus, symptomatic response part per million (0.2 milligram per is not a reliable warning of exposure to cubic meter) of ozone exposure for an 8- toxic concentrations of ozone. Since ol- hour-day exposure of industrial work- factory fatigue develops readily, the ers as recommended by the American odor of ozone is not a reliable index of Conference of Governmental Industrial atmospheric ozone concentration. Hygienists. (c) A number of devices currently on (e) The method and apparatus speci- the market generate ozone by design or fied in 40 CFR part 50, or any other as a byproduct. Since exposure to equally sensitive and accurate method, ozone above a certain concentration may be employed in measuring ozone can be injurious to health, any such de- pursuant to this section. vice will be considered adulterated and/ or misbranded within the meaning of § 801.417 Chlorofluorocarbon propel- sections 501 and 502 of the act if it is lants. used or intended for use under the fol- The use of chlorofluorocarbon in de- lowing conditions: vices as propellants in self-pressurized (1) In such a manner that it gen- containers is generally prohibited ex- erates ozone at a level in excess of 0.05 cept as provided in § 2.125 of this chap- part per million by volume of air circu- ter. lating through the device or causes an [43 FR 11318, Mar. 17, 1978] accumulation of ozone in excess of 0.05 part per million by volume of air (when § 801.420 Hearing aid devices; profes- measured under standard conditions at sional and patient labeling. ° ° 25 C (77 F) and 760 millimeters of mer- (a) Definitions for the purposes of this cury) in the atmosphere of enclosed section and § 801.421. (1) Hearing aid space intended to be occupied by people means any wearable instrument or de- for extended periods of time, e.g., vice designed for, offered for the pur- houses, apartments, hospitals, and of- pose of, or represented as aiding per- fices. This applies to any such device, sons with or compensating for, im- whether portable or permanent or part paired hearing. of any system, which generates ozone (2) Ear specialist means any licensed by design or as an inadvertent or inci- physician who specializes in diseases of dental product. the ear and is medically trained to (2) To generate ozone and release it identify the symptoms of deafness in into the atmosphere in hospitals or the context of the total health of the other establishments occupied by the patient, and is qualified by special ill or infirm. training to diagnose and treat hearing (3) To generate ozone and release it loss. Such physicians are also known as into the atmosphere and does not indi- otolaryngologists, otologists, and cate in its labeling the maximum ac- otorhinolaryngologists. ceptable concentration of ozone which (3) Dispenser means any person, part- may be generated (not to exceed 0.05 nership, corporation, or association en- part per million by volume of air circu- gaged in the sale, lease, or rental of lating through the device) as estab- hearing aids to any member of the con- lished herein and the smallest area in suming public or any employee, agent, which such device can be used so as not sales person, and/or representative of to produce an ozone accumulation in such a person, partnership, corpora- excess of 0.05 part per million. tion, or association. (4) In any medical condition for (4) Audiologist means any person which there is no proof of safety and ef- qualified by training and experience to fectiveness. specialize in the evaluation and reha- (5) To generate ozone at a level less bilitation of individuals whose commu- than 0.05 part per million by volume of nication disorders center in whole or in air circulating through the device and part in the hearing function. In some it is labeled for use as a germicide or states audiologists must satisfy spe- deodorizer. cific requirements for licensure.

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(5) Sale or purchase includes any lease (b) Maintenance and care of the hear- or rental of a hearing aid to a member ing aid, including the procedure to fol- of the consuming public who is a user low in washing the earmold, when re- or prospective user of a hearing aid. placing tubing on those hearing aids (6) Used hearing aid means any hear- that use tubing, and in storing the ing aid that has been worn for any pe- hearing aid when it will not be used for riod of time by a user. However, a hear- an extended period of time. ing aid shall not be considered ‘‘used’’ (c) Replacing or recharging the bat- merely because it has been worn by a teries, including a generic designation prospective user as a part of a bona fide of replacement batteries. hearing aid evaluation conducted to de- (v) Information on how and where to termine whether to select that par- obtain repair service, including at least ticular hearing aid for that prospective one specific address where the user can user, if such evaluation has been con- go, or send the hearing aid to, to ob- ducted in the presence of the dispenser tain such repair service. or a hearing aid health professional se- (vi) A description of commonly oc- lected by the dispenser to assist the curring avoidable conditions that could buyer in making such a determination. adversely affect or damage the hearing (b) Label requirements for hearing aids. aid, such as dropping, immersing, or Hearing aids shall be clearly and per- exposing the hearing aid to excessive manently marked with: heat. (1) The name of the manufacturer or (vii) Identification of any known side distributor, the model name or num- effects associated with the use of a ber, the serial number, and the year of hearing aid that may warrant con- manufacture. sultation with a physician, e.g., skin (2) A ‘‘ + ’’ symbol to indicate the irritation and accelerated accumula- positive connection for battery insertion of cerumen (ear wax). tion, unless it is physically impossible (viii) A statement that a hearing aid to insert the battery in the reversed will not restore normal hearing and position. will not prevent or improve a hearing (c) Labeling requirements for hearing impairment resulting from organic aids—(1) General. All labeling informa- conditions. tion required by this paragraph shall (ix) A statement that in most cases be included in a User Instructional infrequent use of a hearing aid does not Brochure that shall be developed by permit a user to attain full benefit the manufacturer or distributor, shall from it. accompany the hearing aid, and shall (x) A statement that the use of a be provided to the prospective user by hearing aid is only part of hearing ha- the dispenser of the hearing aid in ac- bilitation and may need to be supple- cordance with § 801.421(c). The User In- mented by auditory training and instructional Brochure accompanying struction in lipreading. each hearing aid shall contain the fol- (xi) The warning statement required lowing information and instructions by paragraph (c)(2) of this section. for use, to the extent applicable to the (xii) The notice for prospective hear- particular requirements and character- ing aid users required by paragraph istics of the hearing aid: (c)(3) of this section. (i) An illustration(s) of the hearing (xiii) The technical data required by aid, indicating operating controls, user paragraph (c)(4) of this section, unless adjustments, and battery compart- such data is provided in separate label- ment. ing accompanying the device. (ii) Information on the function of all (2) Warning statement. The User In- controls intended for user adjustment. structional Brochure shall contain the (iii) A description of any accessory following warning statement: that may accompany the hearing aid, WARNING TO HEARING AID DISPENSERS e.g., accessories for use with a tele- A hearing aid dispenser should advise a vision or telephone. prospective hearing aid user to consult (iv) Specific instructions for: promptly with a licensed physician (pref- (a) Use of the hearing aid. erably an ear specialist) before dispensing a

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hearing aid if the hearing aid dispenser de- If you have reservations about your ability termines through inquiry, actual observa- to adapt to amplification, you should inquire tion, or review of any other available infor- about the availability of a trial-rental or mation concerning the prospective user, that purchase-option program. Many hearing aid the prospective user has any of the following dispensers now offer programs that permit conditions: you to wear a hearing aid for a period of (i) Visible congenital or traumatic deform- time for a nominal fee after which you may ity of the ear. decide if you want to purchase the hearing (ii) History of active drainage from the ear aid. within the previous 90 days. Federal law restricts the sale of hearing (iii) History of sudden or rapidly progres- aids to those individuals who have obtained sive hearing loss within the previous 90 days. a medical evaluation from a licensed physi- (iv) Acute or chronic dizziness. cian. Federal law permits a fully informed (v) Unilateral hearing loss of sudden or re- adult to sign a waiver statement declining cent onset within the previous 90 days. the medical evaluation for religious or per- (vi) Audiometric air-bone gap equal to or sonal beliefs that preclude consultation with greater than 15 decibels at 500 hertz (Hz), a physician. The exercise of such a waiver is 1,000 Hz, and 2,000 Hz. not in your best health interest and its use (vii) Visible evidence of significant ceru- is strongly discouraged. men accumulation or a foreign body in the CHILDREN WITH HEARING LOSS ear canal. (viii) Pain or discomfort in the ear. In addition to seeing a physician for a med- Special care should be exercised in select- ical evaluation, a child with a hearing loss ing and fitting a hearing aid whose max- should be directed to an audiologist for eval- imum sound pressure level exceeds 132 deci- uation and rehabilitation since hearing loss bels because there may be risk of impairing may cause problems in language develop- the remaining hearing of the hearing aid ment and the educational and social growth user. (This provision is required only for of a child. An audiologist is qualified by those hearing aids with a maximum sound training and experience to assist in the eval- pressure capability greater than 132 decibels uation and rehabilitation of a child with a (dB).) hearing loss. (3) Notice for prospective hearing aid (4) Technical data. Technical data users. The User Instructional Brochure useful in selecting, fitting, and check- shall contain the following notice: ing the performance of a hearing aid shall be provided in the User Instruc- IMPORTANT NOTICE FOR PROSPECTIVE HEARING tional Brochure or in separate labeling AID USERS that accompanies the device. The de- Good health practice requires that a per- termination of technical data values son with a hearing loss have a medical eval- for the hearing aid labeling shall be uation by a licensed physician (preferably a conducted in accordance with the test physician who specializes in diseases of the procedures of the American National ear) before purchasing a hearing aid. Li- Standard ‘‘Specification of Hearing Aid censed physicians who specialize in diseases of the ear are often referred to as Characteristics,’’ ANSI S3.22–2003 (Re- otolaryngologists, otologists or vision of ANSI S3.22–1996) (Includes otorhinolaryngologists. The purpose of med- April 2007 Erratum). The Director of ical evaluation is to assure that all medi- the Office of the Federal Register ap- cally treatable conditions that may affect proves this incorporation by reference hearing are identified and treated before the in accordance with 5 U.S.C. 552(a) and 1 hearing aid is purchased. CFR part 51. Copies are available from Following the medical evaluation, the phy- the Standards Secretariat of the sician will give you a written statement that states that your hearing loss has been medi- Acoustical Society of America, 120 cally evaluated and that you may be consid- Wall St., New York, NY 10005–3993, or ered a candidate for a hearing aid. The physi- are available for inspection at the Reg- cian will refer you to an audiologist or a ulations Staff, CDRH (HFZ–215), FDA, hearing aid dispenser, as appropriate, for a 1350 Piccard Dr., rm. 150, Rockville, MD hearing aid evaluation. 20850, or at the National Archives and The audiologist or hearing aid dispenser Records Administration (NARA). For will conduct a hearing aid evaluation to as- information on the availability of this sess your ability to hear with and without a hearing aid. The hearing aid evaluation will material at NARA, call 202–741–6030, or enable the audiologist or dispenser to select go to: http://www.archives.gov/ and fit a hearing aid to your individual federallregister/ needs. codeloflfederallregulations/

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ibrllocations.html. As a minimum, the sented to the hearing aid dispenser a User Instructional Brochure or such written statement signed by a licensed other labeling shall include the appro- physician that states that the patient’s priate values or information for the hearing loss has been medically evalu- following technical data elements as ated and the patient may be considered these elements are defined or used in a candidate for a hearing aid. The med- such standard: ical evaluation must have taken place (i) Saturation output curve (SSPL 90 within the preceding 6 months. curve). (2) Waiver to the medical evaluation re- (ii) Frequency response curve. quirements. If the prospective hearing (iii) Average saturation output (HF- aid user is 18 years of age or older, the Average SSPL 90). hearing aid dispenser may afford the (iv) Average full-on gain (HF-Average prospective user an opportunity to full-on gain). waive the medical evaluation require- (v) Reference test gain. ment of paragraph (a)(1) of this section (vi) Frequency range. provided that the hearing aid dis- (vii) Total harmonic distortion. penser: (viii) Equivalent input noise. (i) Informs the prospective user that (ix) Battery current drain. the exercise of the waiver is not in the (x) Induction coil sensitivity (tele- user’s best health interest; phone coil aids only). (ii) Does not in any way actively en- (xi) Input-output curve (ACG aids courage the prospective user to waive only). such a medical evaluation; and (xii) Attack and release times (ACG aids only). (iii) Affords the prospective user the (5) Statement if hearing aid is used or opportunity to sign the following rebuilt. If a hearing aid has been used or statement: rebuilt, this fact shall be declared on I have been advised by llll llll the container in which the hearing aid (Hearing aid dispenser’s name) that the Food is packaged and on a tag that is phys- and Drug Administration has determined ically attached to such hearing aid. that my best health interest would be served Such fact may also be stated in the if I had a medical evaluation by a licensed User Instructional Brochure. physician (preferably a physician who specializes in diseases of the ear) before pur- (6) Statements in User Instructional chasing a hearing aid. I do not wish a med- Brochure other than those required. A ical evaluation before purchasing a hearing User Instructional Brochure may con- aid. tain statements or illustrations in addition to those required by paragraph (b) Opportunity to review User Instruc- (c) of this section if the additional tional Brochure. Before signing any statements: statement under paragraph (a)(2)(iii) of (i) Are not false or misleading in any this section and before the sale of a particular, e.g., diminishing the impact hearing aid to a prospective user, the of the required statements; and hearing aid dispenser shall: (ii) Are not prohibited by this chap- (1) Provide the prospective user a ter or by regulations of the Federal copy of the User Instructional Bro- Trade Commission. chure for a hearing aid that has been, or may be selected for the prospective [42 FR 9294, Feb. 15, 1977, as amended at 47 user; FR 9398, Mar. 5, 1982; 50 FR 30154, July 24, 1985; 54 FR 52396, Dec. 21, 1989; 64 FR 59620, (2) Review the content of the User In- Nov. 3, 1999; 69 FR 18803, Apr. 9, 2004; 73 FR structional Brochure with the prospec- 31360, June 2, 2008] tive user orally, or in the predominate method of communication used during § 801.421 Hearing aid devices; condi- the sale; tions for sale. (3) Afford the prospective user an op- (a) Medical evaluation requirements— portunity to read the User Instruc- (1) General. Except as provided in para- tional Brochure. graph (a)(2) of this section, a hearing (c) Availability of User Instructional aid dispenser shall not sell a hearing Brochure. (1) Upon request by an indi- aid unless the prospective user has pre- vidual who is considering purchase of a

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hearing aid, a dispenser shall, with re- (c) If the information specified in spect to any hearing aid that he dis- paragraph (d) of this section is to be in- penses, provide a copy of the User In- cluded as a package insert, the fol- structional Brochure for the hearing lowing alert statement shall appear aid or the name and address of the prominently and legibly on the pack- manufacturer or distributor from age label: whom a User Instructional Brochure for the hearing aid may be obtained. ATTENTION: Tampons are associated with Toxic Shock Syndrome (TSS). TSS is a rare (2) In addition to assuring that a User but serious disease that may cause death. Instructional Brochure accompanies Read and save the enclosed information. each hearing aid, a manufacturer or distributor shall with respect to any (d) The labeling of menstrual tam- hearing aid that he manufactures or pons shall contain the following con- distributes: sumer information prominently and (i) Provide sufficient copies of the legibly, in such terms as to render the User Instructional Brochure to sellers information likely to be read and un- for distribution to users and prospec- derstood by the ordinary individual tive users; under customary conditions of pur- (ii) Provide a copy of the User In- chase and use: structional Brochure to any hearing (1)(i) Warning signs of TSS, e.g., sud- aid professional, user, or prospective den fever (usually 102° or more) and user who requests a copy in writing. vomiting, diarrhea, fainting or near (d) Recordkeeping. The dispenser shall fainting when standing up, dizziness, or retain for 3 years after the dispensing a rash that looks like a sunburn; of a hearing aid a copy of any written (ii) What to do if these or other signs statement from a physician required of TSS appear, including the need to under paragraph (a)(1) of this section remove the tampon at once and seek or any written statement waiving med- medical attention immediately; ical evaluation required under para- (2) The risk of TSS to all women graph (a)(2)(iii) of this section. using tampons during their menstrual (e) Exemption for group auditory train- period, especially the reported higher ers. Group auditory trainers, defined as risks to women under 30 years of age a group amplification system pur- and teenage girls, the estimated inci- chased by a qualified school or institu- dence of TSS of 1 to 17 per 100,000 men- tion for the purpose of communicating struating women and girls per year, with and educating individuals with and the risk of death from contracting hearing impairments, are exempt from TSS; the requirements of this section. (3) The advisability of using tampons [42 FR 9296, Feb. 15, 1977] with the minimum absorbency needed to control menstrual flow in order to § 801.430 User labeling for menstrual reduce the risk of contracting TSS; tampons. (4) Avoiding the risk of getting tam- (a) This section applies to scented or pon-associated TSS by not using tam- scented deodorized menstrual tampons pons, and reducing the risk of getting as identified in § 884.5460 and unscented TSS by alternating tampon use with menstrual tampons as identified in sanitary napkin use during menstrual § 884.5470 of this chapter. periods; and (b) Data show that toxic shock syn- (5) The need to seek medical atten- drome (TSS), a rare but serious and tion before again using tampons if TSS sometimes fatal disease, is associated warning signs have occurred in the with the use of menstrual tampons. To past, or if women have any questions protect the public and to minimize the about TSS or tampon use. serious adverse effects of TSS, men- (e) The statements required by para- strual tampons shall be labeled as set graph (e) of this section shall be promi- forth in paragraphs (c), (d), and (e) of nently and legibly placed on the pack- this section and tested for absorbency age label of menstrual tampons in con- as set forth in paragraph (f) of this sec- formance with section 502(c) of the tion. Federal Food, Drug, and Cosmetic Act

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(the act) (unless the menstrual tam- (ASTM) D 3492–97, ‘‘Standard Specifica- pons are exempt under paragraph (g) of tion for Rubber Contraceptives (Male this section). Condoms)’’ 1 for determining tensile (1) Menstrual tampon package labels strength, which is incorporated by ref- shall bear one of the following absorb- erence in accordance with 5 U.S.C. ency terms representing the absorb- 552(a), is attached to the large end of a ency of the production run, lot, or glass chamber (or a chamber made batch as measured by the test de- from hard transparent plastic) with a scribed in paragraph (f)(2) of this sec- rubber band (see figure 1) and pushed tion; through the small end of the chamber using a smooth, finished rod. The Ranges of absorbency in Corresponding term of ab- grams 1 sorbency condom is pulled through until all slack is removed. The tip of the 6 and under Light absorbency condom is cut off and the remaining 6 to 9 Regular absorbency end of the condom is stretched over the end of the tube and secured with a rub- 9 to 12 Super absorbency ber band. A preweighed (to the nearest 12 to 15 Super plus absorbency 0.01 gram) tampon is placed within the condom membrane so that the center 15 to 18 Ultra absorbency of gravity of the tampon is at the cen- Above 18 No term ter of the chamber. An infusion needle (14 gauge) is inserted through the sep- 1These ranges are defined, respectively, as follows: Less than or equal to 6 grams (g); greater than 6 g up to and in- tum created by the condom tip until it cluding 9 g; greater than 9 g up to and including 12 g; greater contacts the end of the tampon. The than 12 g up to and including 15 g; greater than 15 g up to and including 18 g; and greater than 18 g. outer chamber is filled with water pumped from a temperature-controlled (2) The package label shall include an waterbath to maintain the average explanation of the ranges of absorb- temperature at 27±1 °C. The water re- ency and a description of how con- turns to the waterbath as shown in fig- sumers can use a range of absorbency, ure 2. Syngyna fluid (10 grams sodium and its corresponding absorbency term, chloride, 0.5 gram Certified Reagent to make comparisons of absorbency of Acid Fushsin, 1,000 milliliters distilled tampons to allow selection of the tam- water) is then pumped through the in- pons with the minimum absorbency fusion needle at a rate of 50 milliliters needed to control menstrual flow in per hour. The test shall be terminated order to reduce the risk of contracting when the tampon is saturated and the TSS. first drop of fluid exits the apparatus. (f) A manufacturer shall measure the (The test result shall be discarded if absorbency of individual tampons using fluid is detected in the folds of the the test method specified in paragraph condom before the tampon is satu- (f)(2) of this section and calculate the rated). The water is then drained and mean absorbency of a production run, the tampon is removed and imme- lot, or batch by rounding to the nearest 0.1 gram. diately weighed to the nearest 0.01 (1) A manufacturer shall design and implement a sampling plan that in- 1The Director of the Federal Register ap- cludes collection of probability sam- proves this incorporation by reference in ac- ples of adequate size to yield consistent cordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain a copy from the Amer- tolerance intervals such that the prob- ican Society for Testing and Materials Inter- ability is 90 percent that at least 90 national, 100 Barr Harbor Dr., P.O. Box C700, percent of the absorbencies of indi- West Conshohocken, PA 19428–2959, 610–832– vidual tampons within a brand and 9578, www.astm.org. You may inspect a copy type are within the range of absorb- at the FDA Main Library, 10903 New Hamp- ency stated on the package label. shire Ave., Bldg. 2, 3d floor, Silver Spring, (2) In the absorbency test, an MD 20993–0002, 301–796–2039, or at the Na- unlubricated condom, with tensile tional Archives and Records Administration strength between 17 Mega Pascals (NARA). For information on the availability of this material at NARA, call 202–741–2139, (MPa) and 30 MPa, as measured accord- or go to: http://www.archives.gov/ ing to the procedure in the American federallregister/codeloflfederallregulations/ Society for Testing and Materials ibrllocations.html.

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gram. The absorbency of the tampon is end of the day during which the determined by subtracting its dry condom is used in testing, whichever weight from this value. The condom occurs first. shall be replaced after 10 tests or at the

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(3) The Food and Drug Administra- test method specified in this section if tion may permit the use of an absorb- each of the following conditions is met: ency test method different from the (i) The manufacturer presents evidence, in the form of a citizen petition

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submitted in accordance with the re- prominence and conspicuousness as to quirements of § 10.30 of this chapter, render it likely to be read and under- demonstrating that the alternative stood by consumers under normal con- test method will yield results that are ditions of purchase. equivalent to the results yielded by the (b)(1) For prescription and restricted test method specified in this section; device products, the following alter- and native warning statement may be used: (ii) FDA approves the method and has published notice of its approval of NOTE: The indented statement below is required by the Federal government’s Clean the alternative test method in the FED- Air Act for all products containing or manu- ERAL REGISTER. factured with chlorofluorocarbons (CFC’s) (g) Any menstrual tampon intended [or name of other class I substance, if appli- to be dispensed by a vending machine cable]: is exempt from the requirements of This product contains [or is manufactured this section. with, if applicable] [insert name of substance], (h) Any menstrual tampon that is not a substance which harms the environment by labeled as required by paragraphs (c), destroying ozone in the upper atmosphere. (d), and (e) of this section and that is Your physician has determined that this initially introduced or initially deliv- product is likely to help your personal ered for introduction into commerce health. USE THIS PRODUCT AS DIRECTED, after March 1, 1990, is misbranded UNLESS INSTRUCTED TO DO OTHERWISE under sections 201(n), 502 (a) and (f) of BY YOUR PHYSICIAN. If you have any ques- the act. tions about alternatives, consult with your physician. (Information collection requirements con- (2) The warning statement shall be tained in paragraphs (e) and (f) were ap- clearly legible and conspicuous on the proved by the Office of Management and product, its immediate container, its Budget under control number 0910–0257) outer packaging, or other labeling in [47 FR 26989, June 22, 1982, as amended at 54 accordance with the requirements of 40 FR 43771, Oct. 26, 1989; 55 FR 17600, Apr. 26, CFR part 82 and appear with such 1990; 65 FR 3586, Jan. 24, 2000; 65 FR 44436, prominence and conspicuousness as to July 18, 2000; 65 FR 62284, Oct. 18, 2000; 69 FR render it likely to be read and under- 18803, Apr. 9, 2004; 69 FR 52171, Aug. 25, 2004; 75 FR 20914, Apr. 22, 2010] stood by consumers under normal conditions of purchase. § 801.433 Warning statements for pre- (3) If the warning statement in para- scription and restricted device graph (b)(1) of this section is used, the products containing or manufac- following warning statement must be tured with chlorofluorocarbons or placed on the package labeling in- other ozone-depleting substances. tended to be read by the physician (a)(1) All prescription and restricted (physician package insert) after the device products containing or manufac- ‘‘How supplied’’ section, which de- tured with chlorofluorocarbons, halons, scribes special handling and storage carbon tetrachloride, methyl chloride, conditions on the physician labeling: or any other class I substance des- NOTE: The indented statement below is re- ignated by the Environmental Protec- quired by the Federal government’s Clean tion Agency (EPA) shall, except as pro- Air Act for all products containing or manu- vided in paragraph (b) of this section, factured with chlorofluorocarbons (CFC’s) bear the following warning statement: [or name of other class I substance, if applicable]: WARNING: Contains [or Manufactured with, if applicable] [insert name of substance], a sub- WARNING: Contains [or Manufactured with, stance which harms public health and envi- if applicable] [insert name of substance], a sub- ronment by destroying ozone in the upper at- stance which harms public health and envi- mosphere. ronment by destroying ozone in the upper atmosphere. (2) The warning statement shall be clearly legible and conspicuous on the A notice similar to the above WARNING has been placed in the information for the product, its immediate container, its patient [or patient information leaflet, if ap- outer packaging, or other labeling in plicable] of this product under Environ- accordance with the requirements of 40 mental Protection Agency (EPA) regula- CFR part 82 and appear with such tions. The patient’s warning states that the

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patient should consult his or her physician if tween 15 and 30 °C for the lifetime of there are questions about alternatives. the product (real time storage). (c) This section does not replace or (e) If a product fails the physical and relieve a person from any requirements mechanical integrity tests commonly imposed under 40 CFR part 82. used by industry after the completion of the accelerated storage tests de- [61 FR 20101, May 3, 1996] scribed in paragraphs (d)(1) and (d)(2) of § 801.435 User labeling for latex this section, the product expiration condoms. date must be demonstrated by real (a) This section applies to the subset time storage conditions described in of condoms as identified in § 884.5300 of paragraph (d)(3) of this section. If all of this chapter, and condoms with the products tested after storage at spermicidal lubricant as identified in temperatures as described in para- § 884.5310 of this chapter, which prod- graphs (d)(1) and (d)(2) of this section ucts are formed from latex films. pass the manufacturer’s physical and (b) Data show that the material in- mechanical integrity tests, the manu- tegrity of latex condoms degrade over facturer may label the product with an time. To protect the public health and expiration date of up to 5 years from minimize the risk of device failure, the date of product packaging. If the latex condoms must bear an expiration extrapolated expiration date under date which is supported by testing as paragraphs (d)(1) and (d)(2) of this sec- described in paragraphs (d) and (h) of tion is used, the labeled expiration date this section. must be confirmed by physical and me- (c) The expiration date, as dem- chanical integrity tests performed at onstrated by testing procedures re- the end of the stated expiration period quired by paragraphs (d) and (h) of this as described in paragraph (d)(3) of this section, must be displayed prominently section. If the data from tests fol- and legibly on the primary packaging lowing real time storage described in (i.e., individual package), and higher paragraph (d)(3) of this section fails to levels of packaging (e.g., boxes of confirm the extrapolated expiration condoms), in order to ensure visibility date, the manufacturer must, at that of the expiration date by consumers. time, relabel the product to reflect the (d) Except as provided under para- actual shelf life. graph (f) of this section, the expiration (f) Products that already have estab- date must be supported by data dem- lished shelf life data based upon real onstrating physical and mechanical in- time storage and testing and have such tegrity of the product after three discrete and representative lots of the storage and testing data available for product have been subjected to each of inspection are not required to confirm the following conditions: such data using accelerated and inter- (1) Storage of unpackaged bulk prod- mediate aging data described in para- uct for the maximum amount of time graphs (d)(1) and (d)(2) of this section. the manufacturer allows the product to If, however, such real time expiration remain unpackaged, followed by stor- dates were based upon testing of prod- age of the packaged product at 70 °C ucts that were not first left (plus or minus 2 °C) for 7 days; unpackaged for the maximum amount (2) Storage of unpackaged bulk prod- of time as described in paragraph (d)(3) uct for the maximum amount of time of this section, the real time testing the manufacturer allows the product to must be confirmed by testing products remain unpackaged, followed by stor- consistent with the requirements of age of the packaged product at a se- paragraph (d)(3) of this section. This lected temperature between 40 and 50 testing shall be initiated no later than °C (plus or minus 2 °C) for 90 days; and the effective date of this regulation. (3) Storage of unpackaged bulk prod- Until the confirmation testing in ac- uct for the maximum amount of time cordance with paragraph (d)(3) of this the manufacturer allows the product to section is completed, the product may remain unpackaged, followed by stor- remain on the market labeled with the age of the packaged product at a mon- expiration date based upon previous itored or controlled temperature be- real time testing.

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(g) If a manufacturer uses testing volves the use of natural latex in a con- data from one product to support expi- centrated colloidal suspension. Prod- ration dating on any variation of that ucts are formed from natural rubber product, the manufacturer must docu- latex by dipping, extruding, or coating. ment and provide, upon request, an ap- (2) The term ‘‘dry natural rubber’’ propriate justification for the applica- means rubber that is produced by the tion of the testing data to the vari- dry natural rubber process that ination of the tested product. volves the use of coagulated natural (h) If a latex condom contains a latex in the form of dried or milled spermicide, and the expiration date sheets. Products are formed from dry based on spermicidal stability testing natural rubber by compression mold- is different from the expiration date ing, extrusion, or by converting the based upon latex integrity testing, the sheets into a solution for dipping. product shall bear only the earlier ex- (3) The term ‘‘contacts humans’’ piration date. means that the natural rubber con- (i) The time period upon which the tained in a device is intended to con- expiration date is based shall start tact or is likely to contact the user or with the date of packaging. patient. This includes contact when (j) As provided in part 820 of this the device that contains natural rubber chapter, all testing data must be re- is connected to the patient by a liquid tained in each company’s files, and path or an enclosed gas path; or the de- shall be made available upon request vice containing the natural rubber is for inspection by the Food and Drug fully or partially coated with a powder, Administration. and such powder may carry natural (k) Any latex condom not labeled with an expiration date as required by rubber proteins that may contaminate paragraph (c) of this section, and ini- the environment of the user or patient. tially delivered for introduction into (c) Devices containing natural rubber interstate commerce after the effective shall be labeled as set forth in para- date of this regulation is misbranded graphs (d) through (h) of this section. under sections 201(n) and 502(a) and (f) Each required labeling statement shall of Federal Food, Drug, and Cosmetic be prominently and legibly displayed Act (21 U.S.C. 321(n) and 352(a) and (f)). in conformance with section 502(c) of the Federal Food, Drug, and Cosmetic [62 FR 50501, Sept. 26, 1997] Act (the act) (21 U.S.C. 352(c)). (d) Devices containing natural rubber § 801.437 User labeling for devices that contain natural rubber. latex that contacts humans, as described in paragraph (b) of this section, (a) Data in the Medical Device Re- shall bear the following statement in porting System and the scientific lit- bold print on the device labeling: erature indicate that some individuals ‘‘Caution: This Product Contains are at risk of severe anaphylactic reac- Natural Rubber Latex Which May tions to natural latex proteins. This la- Cause Allergic Reactions.’’ beling regulation is intended to minimize the risk to individuals sensitive This statement shall appear on all de- to natural latex proteins and protect vice labels, and other labeling, and the public health. shall appear on the principal display (b) This section applies to all devices panel of the device packaging, the out- composed of or containing, or having side package, container or wrapper, packaging or components that are and the immediate device package, composed of, or contain, natural rubber container, or wrapper. that contacts humans. The term ‘‘nat- (e) Devices containing dry natural ural rubber’’ includes natural rubber rubber that contacts humans, as de- latex, dry natural rubber, and syn- scribed in paragraph (b) of this section, thetic latex or synthetic rubber that that are not already subject to para- contains natural rubber in its formula- graph (d) of this section, shall bear the tion. following statement in bold print on (1) The term ‘‘natural rubber latex’’ the device labeling: means rubber that is produced by the ‘‘This Product Contains Dry Natural natural rubber latex process that in- Rubber.’’

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This statement shall appear on all de- tions relate to device packaging that uses vice labels, and other labeling, and ‘‘cold seal’’ adhesives. shall appear on the principal display [62 FR 51029, Sept. 30, 1997, as amended at 63 panel of the device packaging, the out- FR 46175, Aug. 31, 1998] side package, container or wrapper, and the immediate device package, PART 803—MEDICAL DEVICE container, or wrapper. REPORTING (f) Devices that have packaging containing natural rubber latex that con- Subpart A—General Provisions tacts humans, as described in para- Sec. graph (b) of this section, shall bear the 803.1 What does this part cover? following statement in bold print on 803.3 How does FDA define the terms used the device labeling: in this part? ‘‘Caution: The Packaging of This 803.9 What information from the reports do we disclose to the public? Product Contains Natural Rubber 803.10 Generally, what are the reporting re- Latex Which May Cause Allergic Reac- quirements that apply to me? tions.’’ 803.11 What form should I use to submit reports of individual adverse events and This statement shall appear on the where do I obtain these forms? packaging that contains the natural 803.12 How do I submit initial and supple- rubber, and the outside package, con- mental or followup reports? tainer, or wrapper. 803.13 Do I need to submit reports in (g) Devices that have packaging con- English? 803.15 How will I know if you require more taining dry natural rubber that con- information about my medical device re- tacts humans, as described in para- port? graph (b) of this section, shall bear the 803.16 When I submit a report, does the in- following statement in bold print on formation in my report constitute an ad- the device labeling: mission that the device caused or contributed to the reportable event? ‘‘The Packaging of This Product Con- 803.17 What are the requirements for devel- tains Dry Natural Rubber.’’ oping, maintaining, and implementing This statement shall appear on the written MDR procedures that apply to packaging that contains the natural me? 803.18 What are the requirements for estab- rubber, and the outside package, con- lishing and maintaining MDR files or tainer, or wrapper. records that apply to me? (h) Devices that contain natural rub- 803.19 Are there exemptions, variances, or ber that contacts humans, as described alternative forms of adverse event rein paragraph (b) of this section, shall porting requirements? not contain the term ‘‘hypoallergenic’’ Subpart B—Generally Applicable Require- on their labeling. ments for Individual Adverse Event Re- (i) Any affected person may request ports an exemption or variance from the requirements of this section by submit- 803.20 How do I complete and submit an individual adverse event report? ting a citizen petition in accordance 803.21 Where can I find the reporting codes with § 10.30 of this chapter. for adverse events that I use with med- (j) Any device subject to this section ical device reports? that is not labeled in accordance with 803.22 What are the circumstances in which paragraphs (d) through (h) of this sec- I am not required to file a report? 803.23 Where can I find information on how tion and that is initially introduced or to prepare and submit an MDR in elec- initially delivered for introduction into tronic format? interstate commerce after the effective date of this regulation is misbranded Subpart C—User Facility Reporting under sections 201(n) and 502(a), (c), and Requirements (f) of the act (21 U.S.C. 321(n) and 803.30 If I am a user facility, what reporting 352(a), (c), and (f)). requirements apply to me? 803.32 If I am a user facility, what informa- NOTE TO § 801.437: Paragraphs (f) and (g) are tion must I submit in my individual ad- stayed until June 27, 1999, as those regula- verse event reports?

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803.33 If I am a user facility, what must I in- (b) This part supplements and does clude when I submit an annual report? not supersede other provisions of this chapter, including the provisions of Subpart D—Importer Reporting part 820 of this chapter. Requirements (c) References in this part to regu- 803.40 If I am an importer, what reporting latory sections of the Code of Federal requirements apply to me? Regulations are to chapter I of title 21, 803.42 If I am an importer, what informa- unless otherwise noted. tion must I submit in my individual adverse event reports? § 803.3 How does FDA define the terms used in this part? Subpart E—Manufacturer Reporting Requirements Some of the terms we use in this part are specific to medical device reporting 803.50 If I am a manufacturer, what report- and reflect the language used in the ing requirements apply to me? statute (law). Other terms are more 803.52 If I am a manufacturer, what infor- general and reflect our interpretation mation must I submit in my individual adverse event reports? of the law. This section defines the fol- 803.53 If I am a manufacturer, in which cir- lowing terms as used in this part: cumstances must I submit a 5-day re- (a) Ambulatory surgical facility (ASF) port? means a distinct entity that operates 803.56 If I am a manufacturer, in what cir- for the primary purpose of furnishing cumstances must I submit a supple- same day outpatient surgical services mental or followup report and what are to patients. An ASF may be either an the requirements for such reports? 803.58 Foreign manufacturers. independent entity (i.e., not a part of a provider of services or any other facil- AUTHORITY: 21 U.S.C. 352, 360, 360i, 360j, 371, ity) or operated by another medical en- 374. tity (e.g., under the common owner- SOURCE: 79 FR 8846, Feb. 14, 2014, unless ship, licensure, or control of an entity). otherwise noted. An ASF is subject to this regulation regardless of whether it is licensed by a Subpart A—General Provisions Federal, State, municipal, or local government or regardless of whether it is § 803.1 What does this part cover? accredited by a recognized accredita- (a) This part establishes the require- tion organization. If an adverse event ments for medical device reporting for meets the criteria for reporting, the device user facilities, manufacturers, ASF must report that event regardless importers, and distributors. If you are of the nature or location of the medical a device user facility, you must report service provided by the ASF. deaths and serious injuries that a de- (b) Become aware means that an em- vice has or may have caused or contrib- ployee of the entity required to report uted to, establish and maintain adverse has acquired information that reason- event files, and submit summary an- ably suggests a reportable adverse nual reports. If you are a manufacturer event has occurred. or importer, you must report deaths (1) If you are a device user facility, and serious injuries that your device you are considered to have ‘‘become has or may have caused or contributed aware’’ when medical personnel, as de- to, you must report certain device mal- fined in this section, who are employed functions, and you must establish and by or otherwise formally affiliated maintain adverse event files. If you are with your facility, obtain information a manufacturer, you must also submit about a reportable event. specified followup. These reports help (2) If you are a manufacturer, you are us to protect the public health by help- considered to have become aware of an ing to ensure that devices are not adul- event when any of your employees be- terated or misbranded and are safe and comes aware of a reportable event that effective for their intended use. If you is required to be reported within 30 cal- are a medical device distributor, you endar days or that is required to be re- must maintain records (files) of inci- ported within 5 work days because we dents, but you are not required to re- had requested reports in accordance port these incidents. with § 803.53(b). You are also considered

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to have become aware of an event when Other devices are not labeled as to any of your employees with manage- their respective EOL, but are expected ment or supervisory responsibilities to remain operational through activi- over persons with regulatory, sci- ties such as maintenance, repairs, or entific, or technical responsibilities, or upgrades, for an estimated period of whose duties relate to the collection time. and reporting of adverse events, be- (g) FDA, we, us, or Agency means the comes aware, from any information, in- Food and Drug Administration. cluding any trend analysis, that a re- (h) Five-day report means a medical portable MDR event or events neces- device report that must be submitted sitates remedial action to prevent an by a manufacturer to us under § 803.53 unreasonable risk of substantial harm within 5 work days. to the public health. (i) Hospital means a distinct entity (3) If you are an importer, you are that operates for the primary purpose considered to have become aware of an of providing diagnostic, therapeutic event when any of your employees be- (such as medical, occupational, speech, comes aware of a reportable event that physical), surgical, and other patient is required to be reported by you with- services for specific and general med- in 30 days. ical conditions. Hospitals include gen- (c) Caused or contributed means that a eral, chronic disease, rehabilitative, death or serious injury was or may psychiatric, and other special-purpose have been attributed to a medical de- facilities. A hospital may be either vice, or that a medical device was or independent (e.g., not a part of a pro- may have been a factor in a death or vider of services or any other facility) serious injury, including events occur- or may be operated by another medical ring as a result of: entity (e.g., under the common owner- (1) Failure, ship, licensure, or control of another (2) Malfunction, entity). A hospital is covered by this (3) Improper or inadequate design, regulation regardless of whether it is (4) Manufacture, licensed by a Federal, State, municipal (5) Labeling, or or local government or whether it is (6) User error. accredited by a recognized accredita- (d) Device user facility means a hos- tion organization. If an adverse event pital, ambulatory surgical facility, meets the criteria for reporting, the nursing home, outpatient diagnostic hospital must report that event regard- facility, or outpatient treatment facil- less of the nature or location of the ity as defined in this section, which is medical service provided by the hos- not a physician’s office, as defined in pital. this section. School nurse offices and (j) Importer means any person who employee health units are not device imports a device into the United States user facilities. and who furthers the marketing of a (e) Distributor means any person device from the original place of manu- (other than the manufacturer or im- facture to the person who makes final porter) who furthers the marketing of delivery or sale to the ultimate user, a device from the original place of but who does not repackage or other- manufacture to the person who makes wise change the container, wrapper, or final delivery or sale to the ultimate labeling of the device or device pack- user, but who does not repackage or age. If you repackage or otherwise otherwise change the container, wrap- change the container, wrapper, or la- per, or labeling of the device or device beling, you are considered a manufac- package. If you repackage or otherwise turer as defined in this section. change the container, wrapper, or la- (k) Malfunction means the failure of a beling, you are considered a manufac- device to meet its performance speci- turer as defined in this section. fications or otherwise perform as in- (f) Expected life of a device means the tended. Performance specifications in- time that a device is expected to re- clude all claims made in the labeling main functional after it is placed into for the device. The intended perform- use. Certain implanted devices have ance of a device refers to the intended specified ‘‘end of life’’ (EOL) dates. use for which the device is labeled or

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marketed, as defined in § 801.4 of this gests that a device has or may have chapter. caused or contributed to a death or se- (l) Manufacturer means any person rious injury or who manufactures, prepares, propa- (2) An event that manufacturers or gates, compounds, assembles, or proc- importers become aware of that rea- esses a device by chemical, physical, sonably suggests that one of their mar- biological, or other procedure. The keted devices: term includes any person who either: (i) May have caused or contributed to (1) Repackages or otherwise changes a death or serious injury, or the container, wrapper, or labeling of a (ii) Has malfunctioned and that the device in furtherance of the distribu- device or a similar device marketed by tion of the device from the original the manufacturer or importer would be place of manufacture; likely to cause or contribute to a death (2) Initiates specifications for devices or serious injury if the malfunction that are manufactured by a second were to recur. party for subsequent distribution by (p) Medical personnel means an indi- the person initiating the specifica- vidual who: tions; (1) Is licensed, registered, or certified (3) Manufactures components or ac- by a State, territory, or other gov- cessories that are devices that are erning body, to administer health care; ready to be used and are intended to be (2) Has received a diploma or a degree commercially distributed and intended in a professional or scientific dis- to be used as is, or are processed by a cipline; licensed practitioner or other qualified (3) Is an employee responsible for re- person to meet the needs of a par- ceiving medical complaints or adverse ticular patient; or event reports; or (4) Is the U.S. agent of a foreign man- (4) Is a supervisor of these persons. ufacturer. (q) Nursing home means: (m) Manufacturer or importer report (1) An independent entity (i.e., not a number. This number uniquely identi- part of a provider of services or any fies each individual adverse event re- other facility) or one operated by an- port submitted by a manufacturer or other medical entity (e.g., under the importer. This number consists of the common ownership, licensure, or con- following three parts: trol of an entity) that operates for the (1) The FDA registration number for primary purpose of providing: the manufacturing site of the reported (i) Skilled nursing care and related device, or the registration number for services for persons who require med- the importer. If the manufacturing site ical or nursing care; or the importer does not have an estab- (ii) Hospice care to the terminally ill; lishment registration number, we will or assign a temporary MDR reporting (iii) Services for the rehabilitation of number until the site is registered in the injured, disabled, or sick. accordance with part 807 of this chap- (2) A nursing home is subject to this ter. We will inform the manufacturer regulation regardless of whether it is or importer of the temporary MDR re- licensed by a Federal, State, munic- porting number; ipal, or local government or whether it (2) The four-digit calendar year in is accredited by a recognized accredita- which the report is submitted; and tion organization. If an adverse event (3) The five-digit sequence number of meets the criteria for reporting, the the reports submitted during the year, nursing home must report that event starting with 00001. (For example, the regardless of the nature or location of complete number will appear as fol- the medical service provided by the lows: 1234567–2011–00001.) nursing home. (n) MDR means medical device re- (r) Outpatient diagnostic facility port. means: (o) MDR reportable event (or reportable (1) A distinct entity that: event) means: (i) Operates for the primary purpose (1) An event that user facilities be- of conducting medical diagnostic tests come aware of that reasonably sug- on patients,

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(ii) Does not assume ongoing respon- less of the nature or location of the sibility for patient care, and medical service provided by the out- (iii) Provides its services for use by patient treatment facility. other medical personnel. (t) Patient of the facility means any (2) Outpatient diagnostic facilities individual who is being diagnosed or include outpatient facilities providing treated and/or receiving medical care radiography, mammography, at or under the control or authority of ultrasonography, electrocardiography, the facility. This includes employees of magnetic resonance imaging, comput- the facility or individuals affiliated erized axial tomography, and in vitro with the facility who, in the course of testing. An outpatient diagnostic facil- their duties, suffer a device-related ity may be either independent (i.e., not death or serious injury that has or may a part of a provider of services or any have been caused or contributed to by other facility) or operated by another a device used at the facility. medical entity (e.g., under the common (u) Physician’s office means a facility ownership, licensure, or control of an that operates as the office of a physi- entity). An outpatient diagnostic facil- cian or other health care professional ity is covered by this regulation re- for the primary purpose of examina- gardless of whether it is licensed by a tion, evaluation, and treatment or re- Federal, State, municipal, or local gov- ferral of patients. Examples of physi- ernment or whether it is accredited by cian offices include: Dentist offices, a recognized accreditation organiza- chiropractor offices, optometrist of- tion. If an adverse event meets the cri- fices, nurse practitioner offices, school teria for reporting, the outpatient di- nurse offices, school clinics, employee agnostic facility must report that health clinics, or freestanding care event regardless of the nature or loca- units. A physician’s office may be inde- tion of the medical service provided by pendent, a group practice, or part of a the outpatient diagnostic facility. Health Maintenance Organization. (s) Outpatient treatment facility means (v) Remedial action means any action a distinct entity that operates for the other than routine maintenance or primary purpose of providing nonsur- servicing of a device where such action gical therapeutic (medical, occupa- is necessary to prevent recurrence of a tional, or physical) care on an out- reportable event. patient basis or in a home health care setting. Outpatient treatment facili- (w) Serious injury means an injury or ties include ambulance providers, res- illness that: cue services, and home health care (1) Is life-threatening, groups. Examples of services provided (2) Results in permanent impairment by outpatient treatment facilities in- of a body function or permanent dam- clude the following: Cardiac age to a body structure, or defibrillation, chemotherapy, radio- (3) Necessitates medical or surgical therapy, pain control, dialysis, speech intervention to preclude permanent or physical therapy, and treatment for impairment of a body function or per- substance abuse. An outpatient treat- manent damage to a body structure. ment facility may be either inde- Permanent means irreversible impair- pendent (i.e., not a part of a provider of ment or damage to a body structure or services or any other facility) or oper- function, excluding trivial impairment ated by another medical entity (e.g., or damage. under the common ownership, licen- (x) User facility report number means sure, or control of an entity). An out- the number that uniquely identifies patient treatment facility is covered each report submitted by a user facil- by this regulation regardless of wheth- ity to manufacturers and to us. This er it is licensed by a Federal, State, number consists of the following three municipal, or local government or parts: whether it is accredited by a recog- (1) The user facility’s 10-digit Centers nized accreditation organization. If an for Medicare and Medicaid Services adverse event meets the criteria for re- (CMS) number (if the CMS number has porting, the outpatient treatment fa- fewer than 10 digits, fill the remaining cility must report that event regard- spaces with zeros);

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(2) The four-digit calendar year in (v) For an HCT/P regulated as a de- which the report is submitted; and vice, the distinct identification code (3) The four-digit sequence number of required by § 1271.290(c) of this chapter. the reports submitted for the year, [79 FR 8846, Feb. 14, 2014, as amended at 80 starting with 0001. (For example, a FR 10587, Feb. 27, 2015] complete user facility report number will appear as follows: 1234560000–2011– § 803.9 What information from the re- 0001. If a user facility has more than ports do we disclose to the public? one CMS number, it must select one (a) We may disclose to the public any that will be used for all of its MDR re- report, including any FDA record of a ports. If a user facility has no CMS telephone report, submitted under this number, it should use all zeros in the part. Our disclosures are governed by appropriate space in its initial report (e.g., 0000000000–2011–0001). We will as- part 20 of this chapter. sign a number for future use and send (b) Before we disclose a report to the that number to the user facility. This public, we will delete the following: number is used in our record of the ini- (1) Any information that constitutes tial report, in subsequent reports, and trade secret or confidential commer- in any correspondence with the user facial or financial information under cility. If a facility has multiple sites, § 20.61 of this chapter; the primary site may submit reports (2) Any personal, medical, and simi- for all sites and use one reporting num- lar information, including the serial ber for all sites if the primary site pro- number of implanted devices, which vides the name, address, and CMS num- would constitute an invasion of per- ber for each respective site.) sonal privacy under § 20.63 of this chap- (y) Work day means Monday through ter. However, if a patient requests a re- Friday, except Federal holidays. port, we will disclose to that patient (z) [Reserved] all the information in the report con- (aa) Human cell, tissue, or cellular or cerning that patient, as provided in tissue-based product (HCT/P) regulated as § 20.61 of this chapter; and a device means an HCT/P as defined in (3) Any names and other identifying § 1271.3(d) of this chapter that does not information of a third party that vol- meet the criteria in § 1271.10(a) and that untarily submitted an adverse event is also regulated as a device. report. (bb) Unique device identifier (UDI) (c) We may not disclose the identity means an identifier that adequately of a device user facility that makes a identifies a device through its distribu- report under this part except in con- tion and use by meeting the require- nection with: ments of § 830.20 of this chapter. A (1) An action brought to enforce sec- unique device identifier is composed of: tion 301(q) of the Federal Food, Drug, (1) A device identifier—a mandatory, and Cosmetic Act (21 U.S.C. 331(q)), in- fixed portion of a UDI that identifies cluding the failure or refusal to furnish the specific version or model of a de- material or information required by vice and the labeler of that device; and section 519 of the Federal Food, Drug, (2) A production identifier—a condi- and Cosmetic Act (21 U.S.C. 360i)); tional, variable portion of a UDI that (2) A communication to a manufac- identifies one or more of the following turer of a device that is the subject of when included on the label of the de- a report required to be submitted by a vice: user facility under § 803.30; or (i) The lot or batch within which a (3) A disclosure to employees of the device was manufactured; Department of Health and Human (ii) The serial number of a specific Services, to the Department of Justice, device; or to the duly authorized committees (iii) The expiration date of a specific and subcommittees of the Congress. device; (iv) The date a specific device was manufactured.

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§ 803.10 Generally, what are the re- § 803.11 What form should I use to sub- porting requirements that apply to mit reports of individual adverse me? events and where do I obtain these forms? (a) If you are a device user facility, you must submit reports (described in (a) If you are a manufacturer or im- subpart C of this part), as follows: porter, you must submit reports of in- (1) Submit reports of individual ad- dividual adverse events to FDA in an verse events no later than 10 work days electronic format in accordance with after the day that you become aware of § 803.12(a) and § 803.20, unless granted an a reportable event: exemption under § 803.19. (i) Submit reports of device-related (b) Importer reports submitted to de- deaths to us and to the manufacturer, vice manufacturers may be in paper if known, or format or an electronic format that includes all required data fields to ensure (ii) Submit reports of device-related that the manufacturer has all required serious injuries to the manufacturers information. or, if the manufacturer is unknown, (c) If you are a user facility, you submit reports to us. must submit reports of individual ad- (2) Submit annual reports (described verse events in accordance with in § 803.33) to us. § 803.12(b) and § 803.20. (b) If you are an importer, you must (d) Form FDA 3500A is available on submit reports (described in subpart D the Internet at http://www.fda.gov/ of this part), as follows: medwatch/getforms.htm or from Division (1) Submit reports of individual ad- of International and Consumer Edu- verse events no later than 30 calendar cation, Center for Devices and Radio- days after the day that you become logical Health, Food and Drug Admin- aware of a reportable event: istration, 10903 New Hampshire Ave., (i) Submit reports of device-related Bldg. 66, Rm. 4621, Silver Spring, MD deaths or serious injuries to us and to 20993–0002, by email: [email protected], the manufacturer or FAX: 301–847–8149, or telephone: 800– (ii) Submit reports of device-related 638–2041. malfunctions to the manufacturer. [79 FR 8846, Feb. 14, 2014, as amended at 80 (2) [Reserved] FR 10587, Feb. 27, 2015] (c) If you are a manufacturer, you must submit reports (described in sub- § 803.12 How do I submit initial and part E of this part) to us, as follows: supplemental or followup reports? (1) Submit reports of individual ad- (a) Manufacturers and importers verse events no later than 30 calendar must submit initial and supplemental days after the day that you become or followup reports to FDA in an elec- aware of a reportable death, serious in- tronic format that FDA can process, jury, or malfunction. review, and archive. (2) Submit reports of individual ad- (b) User facilities that submit their verse events no later than 5 work days reports and additional information to after the day that you become aware FDA electronically must use an elec- of: tronic format that FDA can process, (i) A reportable event that requires review, and archive. User facilities that remedial action to prevent an unrea- submit their reports to FDA on paper sonable risk of substantial harm to the must submit any written report or ad- public health or ditional information required under (ii) A reportable event for which we this part to FDA, CDRH, Medical De- made a written request. vice Reporting, P.O. Box 3002, Rock- (3) Submit supplemental reports if ville, MD 20847–3002, using Form FDA you obtain information that you did 3500A. Each report must be identified not submit in an initial report. (e.g., ‘‘User Facility Report’’ or ‘‘An- nual Report’’). (c) If you are confronted with a public health emergency, this can be

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brought to FDA’s attention by con- You do not have to admit and may tacting FDA’s Office of Crisis Manage- deny that the report or information ment, Emergency Operations Center by submitted under this part constitutes telephone, 24-hours a day, at 301–796– an admission that the device, you, or 8240 or toll free at 866–300–4374, followed your employees, caused or contributed by the submission of an email to: emer- to a reportable event. [email protected]. NOTE: This action does not satisfy your ob- § 803.17 What are the requirements for ligation to report under part 803. developing, maintaining, and imple- (d) You may submit a voluntary tele- menting written MDR procedures phone report to the MedWatch office at that apply to me? 800–FDA–1088. You may also obtain in- If you are a user facility, importer, formation regarding voluntary report- or manufacturer, you must develop, ing from the MedWatch office at 800– maintain, and implement written MDR FDA–1088. You may also find the vol- procedures for the following: untary Form FDA 3500 and instructions (a) Internal systems that provide for: to complete it at: http://www.fda.gov/ (1) Timely and effective identifica- Safety/MedWatch/HowToReport/ tion, communication, and evaluation of DownloadForms/default.htm. events that may be subject to MDR requirements; § 803.13 Do I need to submit reports in (2) A standardized review process or English? procedure for determining when an Yes. You must submit all reports re- event meets the criteria for reporting quired by this part in English. under this part; and (3) Timely transmission of complete § 803.15 How will I know if you require medical device reports to manufactur- more information about my medical ers or to us, or to both if required. device report? (b) Documentation and record- (a) We will notify you in writing if we keeping requirements for: require additional information and will (1) Information that was evaluated to tell you what information we need. We determine if an event was reportable; will require additional information if (2) All medical device reports and in- we determine that protection of the formation submitted to manufacturers public health requires additional or and/or us; clarifying information for medical de- (3) Any information that was evalu- vice reports submitted to us and in ated for the purpose of preparing the cases when the additional information submission of annual reports; and is beyond the scope of FDA reporting (4) Systems that ensure access to informs or is not readily accessible to us. formation that facilitates timely fol- (b) In any request under this section, lowup and inspection by us. we will state the reason or purpose for the information request, specify the § 803.18 What are the requirements for establishing and maintaining MDR due date for submitting the informa- files or records that apply to me? tion, and clearly identify the reported event(s) related to our request. If we (a) If you are a user facility, im- verbally request additional informa- porter, or manufacturer, you must es- tion, we will confirm the request in tablish and maintain MDR event files. writing. You must clearly identify all MDR event files and maintain them to facili- § 803.16 When I submit a report, does tate timely access. the information in my report con- (b)(1) For purposes of this part, stitute an admission that the device ‘‘MDR event files’’ are written or elec- caused or contributed to the report- tronic files maintained by user facili- able event? ties, importers, and manufacturers. No. A report or other information MDR event files may incorporate ref- submitted by you, and our release of erences to other information (e.g., that report or information, is not nec- medical records, patient files, engi- essarily an admission that the device, neering reports), in lieu of copying and or you or your employees, caused or maintaining duplicates in this file. contributed to the reportable event. Your MDR event files must contain:

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(i) Information in your possession or (2) You must retain copies of the re- references to information related to quired device incident records for a pe- the adverse event, including all docu- riod of 2 years from the date of inclu- mentation of your deliberations and sion of the record in the file or for a pe- decision making processes used to de- riod of time equivalent to the expected termine if a device-related death, seri- life of the device, whichever is greater. ous injury, or malfunction was or was You must maintain copies of these not reportable under this part; records for this period even if you no (ii) Copies of all reports submitted longer distribute the device. under this part (whether paper or elec- (3) You must maintain the device tronic), and of all other information re- complaint files established under this lated to the event that you submitted section at your principal business es- to us or other entities such as an im- tablishment. If you are also a manufac- porter, distributor, or manufacturer; turer, you may maintain the file at the and same location as you maintain your (iii) Copies of all electronic acknowl- complaint file under part 820 of this edgments FDA sends you in response to chapter. You must permit any author- electronic MDR submissions. ized FDA employee, at all reasonable (2) If you are a user facility, im- times, to access, to copy, and to verify porter, or manufacturer, you must per- the records required by this part. mit any authorized FDA employee, at (e) If you are a manufacturer, you all reasonable times, to access, to copy, may maintain MDR event files as part and to verify the records required by of your complaint file, under part 820 of this part. this chapter, if you prominently identify these records as MDR reportable (c) If you are a user facility, you events. We will not consider your sub- must retain an MDR event file relating mitted MDR report to comply with this to an adverse event for a period of 2 part unless you evaluate an event in years from the date of the event. If you accordance with the quality system re- are a manufacturer or importer, you quirements described in part 820 of this must retain an MDR event file relating chapter. You must document and main- to an adverse event for a period of 2 tain in your MDR event files an expla- years from the date of the event or a nation of why you did not submit or period of time equivalent to the ex- could not obtain any information re- pected life of the device, whichever is quired by this part, as well as the re- greater. If the device is no longer dis- sults of your evaluation of each event. tributed, you still must maintain MDR event files for the time periods de- § 803.19 Are there exemptions, scribed in this paragraph (c). variances, or alternative forms of (d)(1) If you are a device distributor, adverse event reporting require- you must establish and maintain de- ments? vice complaint records (files). Your (a) We exempt the following persons records must contain any incident in- from the adverse event reporting re- formation, including any written, elec- quirements in this part: tronic, or oral communication, either (1) A licensed practitioner who pre- received or generated by you, that al- scribes or administers devices intended leges deficiencies related to the iden- for use in humans and manufactures or tity (e.g., labeling), quality, durability, imports devices solely for use in diag- reliability, safety, effectiveness, or per- nosing and treating persons with whom formance of a device. You must also the practitioner has a ‘‘physician-pa- maintain information about your eval- tient’’ relationship; uation of the allegations, if any, in the (2) An individual who manufactures incident record. You must clearly iden- devices intended for use in humans tify the records as device incident solely for this person’s use in research records and file these records by device or teaching and not for sale. This in- name. You may maintain these records cludes any person who is subject to al- in written or electronic format. You ternative reporting requirements under must back up any file maintained in the investigational device exemption electronic format. regulations (described in part 812 of

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this chapter), which require reporting section or until the date specified in of all adverse device effects; and our response granting your variance, at (3) Dental laboratories or optical lab- which time the provisions of this part oratories. will again apply. (b) If you are a manufacturer, importer, or user facility, you may re- Subpart B—Generally Applicable quest an exemption or variance from Requirements for Individual any or all of the reporting requirements in this part, including the re- Adverse Event Reports quirements of § 803.12. You must submit § 803.20 How do I complete and submit the request to us in writing at the fol- an individual adverse event report? lowing address: MDR Exemption Re- quests, Office of Surveillance and Bio- (a) What form must I complete and sub- metrics, 10903 New Hampshire Ave., mit? Bldg. 66, Rm. 3217, Silver Spring, MD (1) If you are a health professional or 20993–0002. Your request must include consumer or other entity, you may information necessary to identify you submit voluntary reports to FDA re- and the device; a complete statement garding devices or other FDA-regulated of the request for exemption, variance, products using the Form FDA 3500. or alternative reporting; and an expla- (2) To submit a mandatory report in nation why your request is justified. If written form, a user facility must use you are requesting an exemption from Form FDA 3500A. the requirement to submit reports to (3) An electronic submission of a FDA in electronic format under mandatory report from a user facility, § 803.12(a), your request should indicate importer, or manufacturer must con- for how long you will require this ex- tain the information from the applica- emption. ble blocks of Form FDA 3500A. All elec- (c) If you are a manufacturer, im- tronic submissions must include infor- porter, or user facility, we may grant mation about the patient, the event, in writing an exemption or variance the device, and the ‘‘initial reporter.’’ from, or alternative to, any or all of An electronic submission from a user the reporting requirements in this facility or importer must include the part, and may change the frequency of information from block F. An elec- reporting to quarterly, semiannually, tronic submission from a manufacturer annually or other appropriate time pe- must include the information from riod. We may grant these modifications blocks G and H. If you are a manufac- in response to your request, as de- turer and you receive a report from a scribed in paragraph (b) of this section, user facility or importer, you must in- or at our discretion. When we grant corporate that information in your modifications to the reporting require- electronic submission and include any ments, we may impose other reporting corrected or missing information. requirements to ensure the protection (b) To whom must I submit reports and of public health. when? (d) We may revoke or modify in writ- (1) If you are a user facility, you ing an exemption, variance, or alter- must submit MDR reports to: native reporting requirement if we de- (i) The manufacturer and to us no termine that revocation or modifica- later than 10 work days after the day tion is necessary to protect the public that you become aware of information health. that reasonably suggests that a device (e) If we grant your request for a re- has or may have caused or contributed porting modification, you must submit to a death or any reports or information required in (ii) The manufacturer no later than our approval of the modification. The 10 work days after the day that you be- conditions of the approval will replace come aware of information that rea- and supersede the regular reporting re- sonably suggests that a device has or quirement specified in this part until may have caused or contributed to a such time that we revoke or modify the serious injury. If the manufacturer is alternative reporting requirements in not known, you must submit this re- accordance with paragraph (d) of this port to us.

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(2) If you are an importer, you must qualified to make a medical judgment submit MDR reports to: include physicians, nurses, risk man- (i) The manufacturer and to us, no agers, and biomedical engineers. You later than 30 calendar days after the must keep in your MDR event files (de- day that you become aware of informa- scribed in § 803.18) the information that tion that reasonably suggests that a the qualified person used to determine device has or may have caused or con- whether or not a device-related event tributed to a death or serious injury or was reportable. (ii) The manufacturer, no later than 30 calendar days after receiving infor- § 803.21 Where can I find the reporting mation that a device you market has codes for adverse events that I use malfunctioned and that this device or a with medical device reports? similar device that you market would (a) The MedWatch Medical Device be likely to cause or contribute to a Reporting Code Instruction Manual death or serious injury if the malfunc- contains adverse event codes for use tion were to recur. (3) If you are a manufacturer, you with Form FDA 3500A. You may obtain must submit MDR reports to us: the coding manual from FDA’s Web (i) No later than 30 calendar days site at: http://www.fda.gov/ after the day that you become aware of MedicalDevices/Safety/ReportaProblem/ information that reasonably suggests FormsandInstructions/default.htm; and that a device may have caused or con- from the Division of Small Manufac- tributed to a death or serious injury or turers, International and Consumer As- (ii) No later than 30 calendar days sistance, Center for Devices and Radio- after the day that you become aware of logical Health, 10903 New Hampshire information that reasonably suggests a Ave., Bldg. 66, Rm. 4621, Silver Spring, device has malfunctioned and that this MD 20993–0002, FAX: 301–847–8149, or device or a similar device that you email to [email protected]. market would be likely to cause or (b) We may sometimes use additional contribute to a death or serious injury coding of information on the reporting if the malfunction were to recur; or forms or modify the existing codes. If (iii) Within 5 work days if required by we do make modifications, we will en- § 803.53. sure that we make the new coding in- (c) What kind of information reason- formation available to all reporters. ably suggests that a reportable event has occurred? § 803.22 What are the circumstances in (1) Any information, including pro- which I am not required to file a re- fessional, scientific, or medical facts, port? observations, or opinions, may reason- (a) If you become aware of informa- ably suggest that a device has caused or may have caused or contributed to tion from multiple sources regarding an MDR reportable event. An MDR re- the same patient and same reportable portable event is a death, a serious in- event, you may submit one medical de- jury, or, if you are a manufacturer or vice report. importer, a malfunction that would be (b) You are not required to submit a likely to cause or contribute to a death medical device report if: or serious injury if the malfunction (1) You are a user facility, importer, were to recur. or manufacturer, and you determine (2) If you are a user facility, im- that the information received is erro- porter, or manufacturer, you do not neous in that a device-related adverse have to report an adverse event if you event did not occur. You must retain have information that would lead a documentation of these reports in your person who is qualified to make a med- MDR files for the time periods speci- ical judgment reasonably to conclude fied in § 803.18. that a device did not cause or con- (2) You are a manufacturer or im- tribute to a death or serious injury, or porter and you did not manufacture or that a malfunction would not be likely import the device about which you to cause or contribute to a death or se- have adverse event information. When rious injury if it were to recur. Persons

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you receive reportable event informa- ance with the requirements of § 803.12 tion in error, you must forward this in- (b). formation to us with a cover letter ex- (b) What information does FDA con- plaining that you did not manufacture sider ‘‘reasonably known’’ to me? You or import the device in question. must submit all information required in this subpart C that is reasonably § 803.23 Where can I find information known to you. This information in- on how to prepare and submit an MDR in electronic format? cludes information found in documents that you possess and any information (a) You may obtain information on that becomes available as a result of how to prepare and submit reports in reasonable followup within your facil- an electronic format that FDA can ity. You are not required to evaluate or process, review, and archive at: http:// investigate the event by obtaining or www.fda.gov/ForIndustry/FDAeSubmitter/ evaluating information that you do not ucm107903.htm. reasonably know. (b) We may sometimes update information on how to prepare and submit § 803.32 If I am a user facility, what in- reports electronically. If we do make formation must I submit in my indi- modifications, we will ensure that we vidual adverse event reports? alert reporters by updating the eMDR Web page. You must include the following information in your report, if reasonably known to you, as described in Subpart C—User Facility Reporting § 803.30(b). These types of information Requirements correspond generally to the elements of Form FDA 3500A: § 803.30 If I am a user facility, what reporting requirements apply to me? (a) Patient information (Form FDA 3500A, Block A). You must submit the (a) You must submit reports to the following: manufacturer or to us, or both, as spec- (1) Patient name or other identifier; ified in paragraphs (a)(1) and (a)(2) of this section as follows: (2) Patient age at the time of event, or date of birth; (1) Reports of death. You must submit a report to us as soon as practicable (3) Patient gender; and but no more than 10 work days after (4) Patient weight. the day that you become aware of in- (b) Adverse event or product problem formation, from any source, that rea- (Form FDA 3500A, Block B). You must sonably suggests that a device has or submit the following: may have caused or contributed to the (1) Identification of adverse event or death of a patient of your facility. You product problem; must also submit the report to the de- (2) Outcomes attributed to the advice manufacturer, if known. You must verse event (e.g., death or serious in- submit the information required by jury). An outcome is considered a seri- § 803.32. Reports sent to the Agency ous injury if it is: must be submitted in accordance with (i) A life-threatening injury or ill- the requirements of § 803.12(b). ness; (2) Reports of serious injury. You must (ii) A disability resulting in perma- submit a report to the manufacturer of nent impairment of a body function or the device no later than 10 work days permanent damage to a body structure; after the day that you become aware of or information, from any source, that reasonably suggests that a device has or (iii) An injury or illness that requires may have caused or contributed to a intervention to prevent permanent im- serious injury to a patient of your fa- pairment of a body structure or func- cility. If the manufacturer is not tion; known, you must submit the report to (3) Date of event; us. You must report information re- (4) Date of this report; quired by § 803.32. Reports sent to the Agency must be submitted in accord-

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(5) Description of event or problem, (4) Whether the initial reporter also including a discussion of how the de- sent a copy of the report to us, if vice was involved, nature of the prob- known. lem, patient followup or required treat- (e) User facility information (Form ment, and any environmental condi- FDA 3500A, Block F). You must submit tions that may have influenced the the following: event; (1) An indication that this is a user (6) Description of relevant tests, in- facility report (by marking the user fa- cluding dates and laboratory data; and cility box on the form); (7) Description of other relevant his- (2) Your user facility number; tory, including preexisting medical (3) Your address; conditions. (4) Your contact person; (c) Device information (Form FDA (5) Your contact person’s telephone 3500A, Block D). You must submit the number; following: (6) Date that you became aware of (1) Brand name; the event (month, day, year); (2) Product Code, if known, and Com- (7) Type of report (initial or fol- mon Device Name; lowup); if it is a followup, you must in- (3) Manufacturer name, city, and clude the report number of the initial state; report; (4) Model number, catalog number, (8) Date of your report (month, day, serial number, lot number, or other year); identifying number; expiration date; (9) Approximate age of device; and unique device identifier (UDI) that (10) Event problem codes—patient appears on the device label or on the code and device code (refer to the device package; ‘‘MedWatch Medical Device Reporting (5) Operator of the device (health pro- Code Instructions’’); fessional, lay user/patient, other); (11) Whether a report was sent to us (6) Date of device implantation and the date it was sent (month, day, (month, day, year), if applicable; year); (7) Date of device explantation (12) Location where the event oc- (month, day, year), if applicable; curred; (8) Whether the device is a single-use (13) Whether the report was sent to device that was reprocessed and reused the manufacturer and the date it was on a patient (Yes, No)? sent (month, day, year); and (9) If the device is a single-use device (14) Manufacturer name and address, that was reprocessed and reused on a if available. patient (yes to paragraph (c)(8) of this [79 FR 8846, Feb. 14, 2014, as amended at 80 section), the name and address of the FR 10587, Feb. 27, 2015] reprocessor; (10) Whether the device was available § 803.33 If I am a user facility, what for evaluation and whether the device must I include when I submit an an- was returned to the manufacturer; if nual report? so, the date it was returned to the (a) You must submit to us an annual manufacturer; and report on Form FDA 3419. You must (11) Concomitant medical products submit an annual report by January 1, and therapy dates. (Do not report prod- of each year. You may obtain this form ucts that were used to treat the event.) from the following sources: (d) Initial reporter information (1) On the Internet at: http:// (Form FDA 3500A, Block E). You must www.fda.gov/downloads/AboutFDA/ submit the following: ReportsManualsForms/Forms/ (1) Name, address, and telephone UCM080796.pdf or number of the reporter who initially (2) Division of International and Con- provided information to you, or to the sumer Education, Center for Devices manufacturer or distributor; and Radiological Health, Food and (2) Whether the initial reporter is a Drug Administration, 10903 New Hamp- health professional; shire Ave., Bldg. 66, Rm. 4621, Silver (3) Occupation; and Spring, MD 20993–0002, by email:

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[email protected], FAX: 301–847–8149, or Subpart D—Importer Reporting telephone: 800–638–2041. Requirements (b) You must clearly identify your annual report as such. You must sub- § 803.40 If I am an importer, what re- mit your annual report to FDA, CDRH, porting requirements apply to me? Medical Device Reporting, P.O. Box (a) Reports of deaths or serious injuries. 3002, Rockville, MD 20847–3002. Your an- You must submit a report to us, and a nual report must include: copy of this report to the manufac- (1) Your CMS provider number used turer, as soon as practicable, but no for medical device reports, or the num- later than 30 calendar days after the ber assigned by us for reporting pur- day that you receive or otherwise be- poses in accordance with § 803.3; come aware of information from any (2) Reporting year; source, including user facilities, indi- (3) Your name and complete address; viduals, or medical or scientific lit- (4) Total number of reports attached erature, whether published or unpub- or summarized; lished, that reasonably suggests that (5) Date of the annual report and re- one of your marketed devices may have port numbers identifying the range of caused or contributed to a death or se- medical device reports that you sub- rious injury. You must submit the in- mitted during the report period (e.g., formation required by § 803.42. Reports sent to the Agency must be submitted 1234567890–2011–0001 through 1000); in accordance with the requirements of (6) Name, position title, and com- § 803.12(a). plete address of the individual des- (b) Reports of malfunctions. You must ignated as your contact person respon- submit a report to the manufacturer as sible for reporting to us and whether soon as practicable but no later than 30 that person is a new contact for you; calendar days after the day that you and receive or otherwise become aware of (7) Information for each reportable information from any source, including event that occurred during the annual user facilities, individuals, or through reporting period including: your own research, testing, evaluation, (i) Report number; servicing, or maintenance of one of (ii) Name and address of the device your devices, that reasonably suggests manufacturer; that one of your devices has malfunc- (iii) Device brand name and common tioned and that this device or a similar name; device that you market would be likely (iv) Product model, catalog, serial, to cause or contribute to a death or se- and lot number and unique device iden- rious injury if the malfunction were to tifier (UDI) that appears on the device recur. You must submit the informa- label or on the device package; tion required by § 803.42. Reports to (v) A brief description of the event manufacturers may be made in accord- reported to the manufacturer and/or ance with § 803.11(b). us; and (vi) Where the report was submitted, § 803.42 If I am an importer, what information must I submit in my indi- i.e., to the manufacturer, importer, or vidual adverse event reports? us. (c) In lieu of submitting the informa- You must include the following infor- tion in paragraph (b)(7) of this section, mation in your report, if the informa- you may submit a copy of each medical tion is known or should be known to device report that you submitted to you, as described in § 803.40. These the manufacturers and/or to us during types of information correspond gen- the reporting period. erally to the format of Form FDA 3500A: (d) If you did not submit any medical (a) Patient information (Form FDA device reports to manufacturers or us 3500A, Block A). You must submit the during the time period, you do not need following: to submit an annual report. (1) Patient name or other identifier; [79 FR 8846, Feb. 14, 2014, as amended at 80 (2) Patient age at the time of event, FR 10587, Feb. 27, 2015] or date of birth;

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(3) Patient gender; and (9) If the device is a single-use device (4) Patient weight. that was reprocessed and reused on a (b) Adverse event or product problem patient (yes to paragraph (c)(8) of this (Form FDA 3500A, Block B). You must section), the name and address of the submit the following: reprocessor; (1) Identification of adverse event or (10) Whether the device was available product problem; for evaluation, and whether the device (2) Outcomes attributed to the ad- was returned to the manufacturer, and verse event (e.g., death or serious in- if so, the date it was returned to the jury). An outcome is considered a seri- manufacturer; and ous injury if it is: (11) Concomitant medical products (i) A life-threatening injury or ill- and therapy dates. (Do not report prod- ness; ucts that were used to treat the event.) (ii) A disability resulting in perma- (d) Initial reporter information nent impairment of a body function or (Form FDA 3500A, Block E). You must permanent damage to a body structure; submit the following: or (1) Name, address, and telephone (iii) An injury or illness that requires number of the reporter who initially intervention to prevent permanent im- provided information to the manufac- pairment of a body structure or func- turer, user facility, or distributor; tion; (2) Whether the initial reporter is a (3) Date of event; health professional; (4) Date of this report; (3) Occupation; and (5) Description of the event or prob- (4) Whether the initial reporter also lem, including a discussion of how the sent a copy of the report to us, if device was involved, nature of the known. problem, patient followup or required (e) Importer information (Form FDA treatment, and any environmental con- 3500A, Block F). You must submit the ditions that may have influenced the following: event; (1) An indication that this is an im- (6) Description of relevant tests, in- porter report (by marking the importer cluding dates and laboratory data; and box on the form); (7) Description of other relevant pa- (2) Your importer report number; tient history, including preexisting (3) Your address; medical conditions. (c) Device information (Form FDA (4) Your contact person; 3500A, Block D). You must submit the (5) Your contact person’s telephone following: number; (1) Brand name; (6) Date that you became aware of (2) Product Code, if known, and Com- the event (month, day, year); mon Device Name; (7) Type of report (initial or fol- (3) Manufacturer name, city, and lowup). If it is a followup report, you state; must include the report number of (4) Model number, catalog number, your initial report; serial number, lot number, or other (8) Date of your report (month, day, identifying number; expiration date; year); and unique device identifier (UDI) that (9) Approximate age of device; appears on the device label or on the (10) Event problem codes—patient device package; code and device code (refer to FDA (5) Operator of the device (health pro- MedWatch Medical Device Reporting fessional, lay user/patient, other); Code Instructions); (6) Date of device implantation (11) Whether a report was sent to us (month, day, year), if applicable; and the date it was sent (month, day, (7) Date of device explanation year); (month, day, year), if applicable; (12) Location where event occurred; (8) Whether the device is a single-use (13) Whether a report was sent to the device that was reprocessed and reused manufacturer and the date it was sent on a patient (Yes, No)? (month, day, year); and

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(14) Manufacturer name and address, mental report under § 803.56 in accord- if available. ance with the requirements of § 803.12(a). [79 FR 8846, Feb. 14, 2014, as amended at 80 FR 10587, Feb. 27, 2015] § 803.52 If I am a manufacturer, what information must I submit in my in- Subpart E—Manufacturer dividual adverse event reports? Reporting Requirements You must include the following information in your reports, if known or § 803.50 If I am a manufacturer, what reporting requirements apply to reasonably known to you, as described me? in § 803.50(b). These types of information correspond generally to the for- (a) If you are a manufacturer, you mat of Form FDA 3500A: must report to us the information re- (a) Patient information (Form FDA quired by § 803.52 in accordance with 3500A, Block A). You must submit the the requirements of § 803.12(a), no later following: than 30 calendar days after the day that you receive or otherwise become (1) Patient name or other identifier; aware of information, from any source, (2) Patient age at the time of event, that reasonably suggests that a device or date of birth; that you market: (3) Patient gender; and (1) May have caused or contributed to (4) Patient weight. a death or serious injury or (b) Adverse event or product problem (2) Has malfunctioned and this device (Form FDA 3500A, Block B). You must or a similar device that you market submit the following: would be likely to cause or contribute (1) Identification of adverse event or to a death or serious injury, if the mal- product problem; function were to recur. (2) Outcomes attributed to the ad- (b) What information does FDA con- verse event (e.g., death or serious in- sider ‘‘reasonably known’’ to me? jury). An outcome is considered a seri- (1) You must submit all information ous injury if it is: required in this subpart E that is rea- (i) A life-threatening injury or ill- sonably known to you. We consider the ness; following information to be reasonably (ii) A disability resulting in perma- known to you: nent impairment of a body function or (i) Any information that you can ob- permanent damage to a body structure; tain by contacting a user facility, im- or porter, or other initial reporter; (iii) An injury or illness that requires (ii) Any information in your posses- intervention to prevent permanent im- sion; or pairment of a body structure or func- (iii) Any information that you can tion; obtain by analysis, testing, or other (3) Date of event; evaluation of the device. (4) Date of this report; (2) You are responsible for obtaining (5) Description of the event or prob- and submitting to us information that lem, including a discussion of how the is incomplete or missing from reports device was involved, nature of the submitted by user facilities, importers, problem, patient followup or required and other initial reporters. treatment, and any environmental con- (3) You are also responsible for conditions that may have influenced the ducting an investigation of each event event; and evaluating the cause of the event. (6) Description of relevant tests, in- If you cannot submit complete infor- cluding dates and laboratory data; and mation on a report, you must provide a (7) Other relevant patient history in- statement explaining why this infor- cluding preexisting medical conditions. mation was incomplete and the steps (c) Device information (Form FDA you took to obtain the information. If 3500A, Block D). You must submit the you later obtain any required informa- following: tion that was not available at the time (1) Brand name; you filed your initial report, you must (2) Product Code, if known, and Com- submit this information in a supple- mon Device Name;

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(3) Manufacturer name, city, and (6) Type of report being submitted state; (e.g., 5-day, initial, followup); and (4) Model number, catalog number, (7) Your report number. serial number, lot number, or other (f) Device manufacturer information identifying number; expiration date; (Form FDA 3500A, Block H). You must and unique device identifier (UDI) that submit the following: appears on the device label or on the (1) Type of reportable event (death, device package; serious injury, malfunction, etc.); (5) Operator of the device (health pro- (2) Type of followup report, if appli- fessional, lay user/patient, other); cable (e.g., correction, response to FDA (6) Date of device implantation request, etc); (month, day, year), if applicable; (3) If the device was returned to you (7) Date of device explantation and evaluated by you, you must in- (month, day, year), if applicable; clude a summary of the evaluation. If (8) Whether the device is a single-use you did not perform an evaluation, you device that was reprocessed and reused must explain why you did not perform on a patient (Yes, No)? an evaluation; (9) If the device is a single-use device (4) Device manufacture date (month, that was reprocessed and reused on a day, year); patient (yes to paragraph (c)(8) of this (5) Whether the device was labeled section), the name and address of the for single use; reprocessor; (6) Evaluation codes (including event (10) Whether the device was available codes, method of evaluation, result, for evaluation, and whether the device and conclusion codes) (refer to FDA was returned to the manufacturer, and MedWatch Medical Device Reporting if so, the date it was returned to the Code Instructions); manufacturer; and (7) Whether remedial action was (11) Concomitant medical products taken and the type of action; and therapy dates. (Do not report products that were used to treat the event.) (8) Whether the use of the device was initial, reuse, or unknown; (d) Initial reporter information (Form FDA 3500A, Block E). You must (9) Whether remedial action was resubmit the following: ported as a removal or correction (1) Name, address, and telephone under section 519(f) of the Federal number of the reporter who initially Food, Drug, and Cosmetic Act, and if it provided information to you, or to the was, provide the correction/removal re- user facility or importer; port number; and (2) Whether the initial reporter is a (10) Your additional narrative; and/or health professional; (11) Corrected data, including: (3) Occupation; and (i) Any information missing on the (4) Whether the initial reporter also user facility report or importer report, sent a copy of the report to us, if including any event codes that were known. not reported, or information corrected (e) Reporting information for all on these forms after your verification; manufacturers (Form FDA 3500A, (ii) For each event code provided by Block G). You must submit the fol- the user facility under § 803.32(e)(10) or lowing: the importer under § 803.42(e)(10), you (1) Your reporting office’s contact must include a statement of whether name and address and device manufac- the type of the event represented by turing site; the code is addressed in the device la- (2) Your contact person’s telephone beling; and number; (iii) If your report omits any required (3) Your report sources; information, you must explain why (4) Date received by you (month, day, this information was not provided and year); the steps taken to obtain this informa- (5) PMA/510k Number and whether or tion. not the product is a combination prod- [79 FR 8846, Feb. 14, 2014, as amended at 80 uct; FR 10587, Feb. 27, 2015]

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§ 803.53 If I am a manufacturer, in (c) Include only the new, changed, or which circumstances must I submit corrected information. a 5-day report? § 803.58 Foreign manufacturers. You must submit a 5-day report to us with the information required by (a) Every foreign manufacturer § 803.52 in accordance with the require- whose devices are distributed in the ments of § 803.12(a) no later than 5 work United States shall designate a U.S. days after the day that you become agent to be responsible for reporting in aware that: accordance with § 807.40 of this chapter. (a) An MDR reportable event neces- The U.S. designated agent accepts re- sitates remedial action to prevent an sponsibility for the duties that such unreasonable risk of substantial harm designation entails. Upon the effective to the public health. You may become date of this regulation, foreign manu- aware of the need for remedial action facturers shall inform FDA, by letter, from any information, including any of the name and address of the U.S. trend analysis or agent designated under this section and § 807.40 of this chapter, and shall (b) We have made a written request update this information as necessary. for the submission of a 5-day report. If Such updated information shall be sub- you receive such a written request mitted to FDA, within 5 days of a from us, you must submit, without fur- change in the designated agent infor- ther requests, a 5-day report for all mation. subsequent events of the same nature (b) U.S.-designated agents of foreign that involve substantially similar de- manufacturers are required to: vices for the time period specified in (1) Report to FDA in accordance with the written request. We may extend §§ 803.50, 803.52, 803.53, and 803.56; the time period stated in the original (2) Conduct, or obtain from the for- written request if we determine it is in eign manufacturer the necessary infor- the interest of the public health. mation regarding, the investigation and evaluation of the event to comport § 803.56 If I am a manufacturer, in with the requirements of § 803.50; what circumstances must I submit a supplemental or followup report (3) Forward MDR complaints to the and what are the requirements for foreign manufacturer and maintain such reports? documentation of this requirement; (4) Maintain complaint files in ac- If you are a manufacturer, when you cordance with § 803.18; and obtain information required under this (5) Register, list, and submit pre- part that you did not provide because market notifications in accordance it was not known or was not available with part 807 of this chapter. when you submitted the initial report, you must submit the supplemental in- EFFECTIVE DATE NOTE: At 79 FR 8846, Feb. formation to us within 30 calendar days 14, 2014, part 803 was revised. At 79 FR 8855, of the day that you receive this infor- Feb. 14, 2014, § 803.58 was stayed indefinitely. mation. You must submit the supplemental or followup report in accord- PART 806—MEDICAL DEVICES; RE- ance with the requirements of PORTS OF CORRECTIONS AND § 803.12(a). On a supplemental or fol- REMOVALS lowup report, you must: (a) Indicate that the report being Subpart A—General Provisions submitted is a supplemental or fol- Sec. lowup report; 806.1 Scope. (b) Submit the appropriate identi- 806.2 Definitions. fication numbers of the report that you are updating with the supplemental in- Subpart B—Reports and Records formation (e.g., your original manufac- 806.10 Reports of corrections and removals. turer report number and the user facil- 806.20 Records of corrections and removals ity or importer report number of any not required to be reported. report on which your report was based), 806.30 FDA access to records. if applicable; and 806.40 Public availability of reports.

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AUTHORITY: 21 U.S.C. 352, 360, 360i, 360j, 371, device means an HCT/P as defined in 374. § 1271.3(d) of this chapter that does not SOURCE: 62 FR 27191, May 19, 1997, unless meet the criteria in § 1271.10(a) and that otherwise noted. is also regulated as a device. (g) Importer means, for the purposes Subpart A—General Provisions of this part, any person who imports a device into the United States. § 806.1 Scope. (h) Manufacturer means any person (a) This part implements the provi- who manufactures, prepares, propa- sions of section 519(g) of the Federal gates, compounds, assembles, or proc- Food, Drug, and Cosmetic Act (the act) esses a device by chemical, physical, requiring device manufacturers and biological, or other procedures. The importers to report promptly to the term includes any person who: Food and Drug Administration (FDA) (1) Repackages or otherwise changes certain actions concerning device cor- the container, wrapper, or labeling of a rections and removals, and to maintain device in furtherance of the distribu- records of all corrections and removals tion of the device from the original regardless of whether such corrections place of manufacture to the person who and removals are required to be re- makes final delivery or sale to the ulti- ported to FDA. mate user or consumer; (b) The following actions are exempt (2) Initiates specifications for devices from the reporting requirements of this that are manufactured by a second part: party for subsequent distribution by (1) Actions taken by device manufac- the person initiating the specifica- turers or importers to improve the per- tions; or formance or quality of a device but (3) Manufactures components or ac- that do not reduce a risk to health cessories which are devices that are posed by the device or remedy a viola- ready to be used and are intended to be tion of the act caused by the device. commercially distributed and are in- (2) Market withdrawals as defined in tended to be used as is, or are processed § 806.2(h). by a licensed practitioner or other (3) Routine servicing as defined in qualified person to meet the needs of a § 806.2(k). particular patient. (4) Stock recoveries as defined in (i) Market withdrawal means a correc- § 806.2(l). tion or removal of a distributed device [62 FR 27191, May 19, 1997, as amended at 63 that involves a minor violation of the FR 42232, Aug. 7, 1998] act that would not be subject to legal action by FDA or that involves no vio- § 806.2 Definitions. lation of the act, e.g., normal stock ro- As used in this part: tation practices. (a) Act means the Federal Food, (j) Removal means the physical re- Drug, and Cosmetic Act. moval of a device from its point of use (b) Agency or FDA means the Food to some other location for repair, and Drug Administration. modification, adjustment, relabeling, (c) Consignee means any person or destruction, or inspection. firm that has received, purchased, or (k) Risk to health means used a device subject to correction or (1) A reasonable probability that use removal. of, or exposure to, the product will (d) Correction means the repair, modi- cause serious adverse health con- fication, adjustment, relabeling, de- sequences or death; or struction, or inspection (including pa- (2) That use of, or exposure to, the tient monitoring) of a device without product may cause temporary or medi- its physical removal from its point of cally reversible adverse health con- use to some other location. sequences, or an outcome where the (e) Correction or removal report number probability of serious adverse health means the number that uniquely iden- consequences is remote. tifies each report submitted. (l) Routine servicing means any regu- (f) Human cell, tissue, or cellular or tis- larly scheduled maintenance of a de- sue-based product (HCT/P) regulated as a vice, including the replacement of

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parts at the end of their normal life ex- (1) To reduce a risk to health posed pectancy, e.g., calibration, replace- by the device; or ment of batteries, and responses to (2) To remedy a violation of the act normal wear and tear. Repairs of an caused by the device which may unexpected nature, replacement of present a risk to health unless the in- parts earlier than their normal life ex- formation has already been provided as pectancy, or identical repairs or re- set forth in paragraph (f) of this sec- placements of multiple units of a de- tion or the corrective or removal ac- vice are not routine servicing. tion is exempt from the reporting re- (m) Stock recovery means the correc- quirements under § 806.1(b). tion or removal of a device that has (b) The manufacturer or importer not been marketed or that has not left shall submit any report required by the direct control of the manufacturer, paragraph (a) of this section within 10- i.e., the device is located on the prem- working days of initiating such correc- ises owned, or under the control of, the tion or removal. manufacturer, and no portion of the lot, model, code, or other relevant unit (c) The manufacturer or importer involved in the corrective or removal shall include the following information action has been released for sale or use. in the report: (n) Unique device identifier (UDI) (1) The seven digit registration num- means an identifier that adequately ber of the entity responsible for sub- identifies a device through its distribu- mission of the report of corrective or tion and use by meeting the require- removal action (if applicable), the ments of § 830.20 of this chapter. A UDI month, day, and year that the report is is composed of: made, and a sequence number (i.e., 001 (1) A device identifier—a mandatory, for the first report, 002 for the second fixed portion of a UDI that identifies report, 003 etc.), and the report type the specific version or model of a de- designation ‘‘C’’ or ‘‘R’’. For example, vice and the labeler of that device; and the complete number for the first cor- (2) A production identifier—a condi- rection report submitted on June 1, tional, variable portion of a UDI that 1997, will appear as follows for a firm identifies one or more of the following with the registration number 1234567: when included on the label of the de- 1234567–6/1/97–001–C. The second correc- vice: tion report number submitted by the (i) The lot or batch within which a same firm on July 1, 1997, would be device was manufactured; 1234567–7/1/97–002–C etc. For removals, (ii) The serial number of a specific the number will appear as follows: device; 1234567–6/1/97–001–R and 1234567–7/1/97– (iii) The expiration date of a specific 002–R, etc. Firms that do not have a device; seven digit registration number may (iv) The date a specific device was use seven zeros followed by the month, manufactured. date, year, and sequence number (i.e. (v) For an HCT/P regulated as a de- 0000000–6/1/97–001–C for corrections and vice, the distinct identification code 0000000–7/1/97–001–R for removals). Re- required by § 1271.290(c) of this chapter. ports received without a seven digit [62 FR 27191, May 19, 1997, as amended at 63 registration number will be assigned a FR 42232, Aug. 7, 1998; 78 FR 55821, Sept. 24, seven digit central file number by the 2013] district office reviewing the reports. (2) The name, address, and telephone Subpart B—Reports and Records number of the manufacturer or importer, and the name, title, address, § 806.10 Reports of corrections and re- and telephone number of the manufac- movals. turer or importer representative re- (a) Each device manufacturer or im- sponsible for conducting the device porter shall submit a written report to correction or removal. FDA of any correction or removal of a (3) The brand name and the common device initiated by such manufacturer name, classification name, or usual or importer if the correction or re- name of the device and the intended moval was initiated: use of the device.

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(4) Marketing status of the device, tional lots or batches of the same de- i.e., any applicable premarket notifica- vice, the manufacturer or importer tion number, premarket approval num- shall within 10-working days of initi- ber, or indication that the device is a ating the extension of the correction or preamendments device, and the device removal, amend the report by submit- listing number. A manufacturer or im- ting an amendment citing the original porter that does not have an FDA es- report number assigned according to tablishment registration number shall paragraph (c)(1) of this section, all of indicate in the report whether it has the information required by paragraph ever registered with FDA. (c)(2), and any information required by (5) The unique device identifier (UDI) paragraphs (c)(3) through (c)(12) of this that appears on the device label or on section that is different from the infor- the device package, or the device iden- mation submitted in the original re- tifier, universal product code (UPC), port. The manufacturer or importer model, catalog, or code number of the shall also provide a statement in ac- device and the manufacturing lot or se- cordance with paragraph (c)(13) of this rial number of the device or other iden- section for any required information tification number. that is not readily available. (6) The manufacturer’s name, ad- (e) A report submitted by a manufac- dress, telephone number, and contact turer or importer under this section person if different from that of the per- (and any release by FDA of that report son submitting the report. or information) does not necessarily re- (7) A description of the event(s) giv- flect a conclusion by the manufacturer, ing rise to the information reported importer, or FDA that the report or in- and the corrective or removal actions formation constitutes an admission that have been, and are expected to be that the device caused or contributed taken. to a death or serious injury. A manu- (8) Any illness or injuries that have facturer or importer need not admit, occurred with use of the device. If ap- and may deny, that the report or infor- plicable, include the medical device re- mation submitted under this section port numbers. constitutes an admission that the de- (9) The total number of devices man- vice caused or contributed to a death ufactured or distributed subject to the or serious injury. correction or removal and the number (f) No report of correction or removal in the same batch, lot, or equivalent is required under this part, if a report unit of production subject to the cor- of the correction or removal is required rection or removal. and has been submitted under parts 803 (10) The date of manufacture or dis- or 1004 of this chapter. tribution and the device’s expiration date or expected life. [62 FR 27191, May 19, 1997, as amended at 63 (11) The names, addresses, and tele- FR 42232, Aug. 7, 1998; 69 FR 11311, Mar. 10, phone numbers of all domestic and for- 2004; 78 FR 55821, Sept. 24, 2013] eign consignees of the device and the dates and number of devices distrib- § 806.20 Records of corrections and removals not required to be reported. uted to each such consignee. (12) A copy of all communications re- (a) Each device manufacturer or im- garding the correction or removal and porter who initiates a correction or re- the names and addresses of all recipi- moval of a device that is not required ents of the communications not pro- to be reported to FDA under § 806.10 vided in accordance with paragraph shall keep a record of such correction (c)(11) of this section. or removal. (13) If any required information is (b) Records of corrections and remov- not immediately available, a state- als not required to be reported to FDA ment as to why it is not available and under § 806.10 shall contain the fol- when it will be submitted. lowing information: (d) If, after submitting a report under (1) The brand name, common or usual this part, a manufacturer or importer name, classification, name and product determines that the same correction or code if known, and the intended use of removal should be extended to addi- the device.

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(2) The unique device identifier (UDI) cial or financial information under of the device, or the device identifier, § 20.61 of this chapter; and universal product code (UPC), model, (2) Any personnel, medical, or similar catalog, or code number of the device information, including the serial num- and the manufacturing lot or serial bers of implanted devices, which would number of the device or other identi- constitute a clearly unwarranted inva- fication number. sion of personal privacy under § 20.63 of (3) A description of the event(s) giv- this chapter or 5 U.S.C. 552(b)(6); pro- ing rise to the information reported vided, that except for the information and the corrective or removal action under § 20.61 of this chapter or 5 U.S.C. that has been, and is expected to be 552(b)(4), FDA will disclose to a patient taken. who requests a report all the informa- (4) Justification for not reporting the tion in the report concerning that pa- correction or removal action to FDA, tient. which shall contain conclusions and any followups, and be reviewed and evaluated by a designated person. PART 807—ESTABLISHMENT REG- (5) A copy of all communications re- ISTRATION AND DEVICE LISTING garding the correction or removal. FOR MANUFACTURERS AND INI- (c) The manufacturer or importer TIAL IMPORTERS OF DEVICES shall retain records required under this section for a period of 2 years beyond Subpart A—General Provisions the expected life of the device, even if the manufacturer or importer has Sec. ceased to manufacture or import the 807.3 Definitions. device. Records required to be maintained under paragraph (b) of this sec- Subpart B—Procedures for Device tion must be transferred to the new Establishments manufacturer or importer of the device 807.20 Who must register and submit a de- and maintained for the required period vice list? of time. 807.21 How to register establishments and list devices. [62 FR 27191, May 19, 1997, as amended at 63 FR 42233, Aug. 7, 1998; 78 FR 55821, Sept. 24, 807.22 Times for establishment registration 2013] and device listing. 807.25 Information required for device es- § 806.30 FDA access to records. tablishment registration and device listing. Each device manufacturer or im- 807.26 Additional listing information. porter required under this part to 807.28 Updating device listing information. maintain records and every person who 807.34 Summary of requirements for owners is in charge or custody of such records or operators granted a waiver from sub- shall, upon request of an officer or em- mitting required information electroni- ployee designated by FDA and under cally. section 704(e) of the act, permit such 807.35 Notification of registrant. officer or employee at all reasonable 807.37 Public availability of establishment times to have access to, and to copy registration and device listing informa- and verify, such records and reports. tion. 807.39 Misbranding by reference to estab- [63 FR 42233, Aug. 7, 1998] lishment registration or to registration number. § 806.40 Public availability of reports. (a) Any report submitted under this Subpart C—Procedures for Foreign Device part is available for public disclosure Establishments in accordance with part 20 of this chap- 807.40 Establishment registration and deter. vice listing for foreign establishments (b) Before public disclosure of a re- importing or offering for import devices port, FDA will delete from the report: into the United States. (1) Any information that constitutes 807.41 Identification of importers and per- trade secret or confidential commer- sons who import or offer for import.

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Subpart D—Exemptions market approval application as provided in section 515 of the act; or 807.65 Exemptions for device establish- (4) For foreign establishments, the ments. distribution of any device that is nei- Subpart E—Premarket Notification ther imported nor offered for import Procedures into the United States. (c) Establishment means a place of 807.81 When a premarket notification sub- business under one management at one mission is required. general physical location at which a 807.85 Exemption from premarket notification. device is manufactured, assembled, or 807.87 Information required in a premarket otherwise processed. notification submission. (d) Manufacture, preparation, propaga- 807.90 Format of a premarket notification tion, compounding, assembly, or proc- submission. essing of a device means the making by 807.92 Content and format of a 510(k) sum- chemical, physical, biological, or other mary. procedures of any article that meets 807.93 Content and format of a 510(k) statement. the definition of device in section 807.94 Format of class III certification. 201(h) of the act. These terms include 807.95 Confidentiality of information. the following activities: 807.97 Misbranding by reference to pre- (1) Repackaging or otherwise chang- market notification. ing the container, wrapper, or labeling 807.100 FDA action on a premarket notifica- of any device package in furtherance of tion. the distribution of the device from the AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 360, original place of manufacture to the 360c, 360e, 360i, 360j, 371, 374, 381, 393; 42 U.S.C. person who makes final delivery or sale 264, 271. to the ultimate consumer; SOURCE: 42 FR 42526, Aug. 23, 1977, unless (2) Initial importation of devices otherwise noted. manufactured in foreign establishments; or Subpart A—General Provisions (3) Initiation of specifications for devices that are manufactured by a sec- § 807.3 Definitions. ond party for subsequent commercial (a) Act means the Federal Food, distribution by the person initiating Drug, and Cosmetic Act. specifications. (b) Commercial distribution means any (e) Official correspondent means the distribution of a device intended for person designated by the owner or op- human use which is held or offered for erator of an establishment as respon- sale but does not include the following: sible for the following: (1) Internal or interplant transfer of (1) The annual registration of the es- a device between establishments within tablishment; the same parent, subsidiary, and/or af- (2) Contact with the Food and Drug filiate company; Administration for device listing; (2) Any distribution of a device in- (3) Maintenance and submission of a tended for human use which has in ef- current list of officers and directors to fect an approved exemption for inves- the Food and Drug Administration tigational use under section 520(g) of upon the request of the Commissioner; the act and part 812 of this chapter; and (3) Any distribution of a device, be- (4) The receipt of pertinent cor- fore the effective date of part 812 of respondence from the Food and Drug this chapter, that was not introduced Administration directed to and involv- or delivered for introduction into inter- ing the owner or operator and/or any of state commerce for commercial dis- the firm’s establishments. tribution before May 28, 1976, and that (f) Owner or operator means the cor- is classified into class III under section poration, subsidiary, affiliated com- 513(f) of the act: Provided, That the de- pany, partnership, or proprietor divice is intended solely for investiga- rectly responsible for the activities of tional use, and under section the registering establishment. 501(f)(2)(A) of the act the device is not (g) Initial importer means any im- required to have an approved pre- porter who furthers the marketing of a

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device from a foreign manufacturer to mitted under section 513(i) of the act, the person who makes the final deliv- of the safety and effectiveness informa- ery or sale of the device to the ulti- tion contained in a premarket notifica- mate consumer or user, but does not tion submission upon which a deter- repackage, or otherwise change the mination of substantial equivalence container, wrapper, or labeling of the can be based. Safety and effectiveness device or device package. information refers to safety and effec- (h) Any term defined in section 201 of tiveness data and information sup- the act shall have that meaning. porting a finding of substantial equiva- (i) Restricted device means a device for lence, including all adverse safety and which a requirement restricting sale, effectiveness information. distribution, or use has been estab- (p) 510(k) statement means a state- lished by a regulation issued under sec- ment, made under section 513(i) of the tion 520(e) of the act, by order as a con- act, asserting that all information in a dition of premarket approval under premarket notification submission resection 515(d)(1)(B)(ii) of the act, or by garding safety and effectiveness will be a performance standard issued in ac- made available within 30 days of re- cordance with sections 514(a)(2)(B)(v) quest by any person if the device de- and 514(b) of the act. scribed in the premarket notification (j) Classification name means the term submission is determined to be sub- used by the Food and Drug Administra- stantially equivalent. The information tion and its classification panels to de- to be made available will be a duplicate scribe a device or class of devices for of the premarket notification submis- purposes of classifying devices under sion, including any adverse safety and section 513 of the act. effectiveness information, but exclud- (k) Product code means the code used ing all patient identifiers, and trade se- by FDA to identify the generic cat- cret or confidential commercial infor- egory of a device. mation, as defined in § 20.61 of this (l) Representative sampling of advertise- chapter. ments means typical advertising mate- (q) Class III certification means a cer- rial that gives the promotional claims tification that the submitter of the made for the device. 510(k) has conducted a reasonable (m) Representative sampling of any search of all known information about other labeling means typical labeling the class III device and other similar, material (excluding labels and package legally marketed devices. inserts) that gives the promotional (r) Class III summary means a sum- claims made for the device. mary of the types of safety and effec- (n) Material change includes any tiveness problems associated with the change or modification in the labeling type of device being compared and a ci- or advertisements that affects the tation to the information upon which identity or safety and effectiveness of the summary is based. The summary the device. These changes may include, must be comprehensive and describe but are not limited to, changes in the the problems to which the type of de- common or usual or proprietary name, vice is susceptible and the causes of declared ingredients or components, in- such problems. tended use, contraindications, warn- (s) United States agent means a person ings, or instructions for use. Changes residing or maintaining a place of busi- that are not material may include ness in the United States whom a for- graphic layouts, grammar, or correc- eign establishment designates as its tion of typographical errors which do agent. This definition excludes mail- not change the content of the labeling, boxes, answering machines or services, changes in lot number, and, for devices or other places where an individual where the biological activity or known acting as the foreign establishment’s composition differs with each lot pro- agent is not physically present. duced, the labeling containing the ac- (t) Wholesale distributor means any tual values for each lot. person (other than the manufacturer or (o) 510(k) summary (summary of any the initial importer) who distributes a information respecting safety and ef- device from the original place of manu- fectiveness) means a summary, sub- facture to the person who makes the

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final delivery or sale of the device to and listing information may be sub- the ultimate consumer or user. mitted by the parent, subsidiary, or af- (u) Fiscal year means the FDA fiscal filiate company for all the domestic or year, which runs from October 1 foreign establishments under the con- through September 30. trol of one of these organizations when (v) FURLS means the Food and Drug operations are conducted at more than Administration’s Unified one establishment and there exists Registration and Listing System, joint ownership and control among all (w) FDA premarket submission number the establishments. The term ‘‘device’’ means the number assigned by FDA to includes all in vitro diagnostic prod- a premarket device submission, such as ucts and in vitro diagnostic biological a Premarket Approval Application (PMA); Humanitarian Device Exemp- products not subject to licensing under tion (HDE); New Drug Application section 351 of the Public Health Service (NDA); Biologics License Application Act. An owner or operator of an estab- (BLA); de novo classification petition; lishment located in any State as de- or Premarket Notification (510(k)). fined in section 201(a)(1) of the Federal (x) Importer means, for purposes of Food, Drug, and Cosmetic Act shall this part, a company or individual in register its name, places of business, the United States that is an owner, and all establishments and list the de- consignee, or recipient, even if not the vices whether or not the output of the initial owner, consignee, or recipient, establishments or any particular de- of the foreign establishment’s device vice so listed enters interstate com- that is imported into the United merce. The registration and listing re- States. An importer does not include quirements shall pertain to any person the consumer or patient who ulti- who is engaged in the manufacture, mately purchases, receives, or uses the preparation, propagation, device, unless the foreign establish- compounding, assembly, or processing ment ships the device directly to the of a device intended for human use, in- consumer or patient. cluding any person who: (y) Person who imports or offers for im- (1) Initiates or develops specifica- port means, for purposes of this part, tions for a device that is to be manu- an agent, broker, or other entity, other factured by a second party; than a carrier, that the foreign establishment uses to facilitate the import (2) Sterilizes or otherwise makes a of its device into the United States. device for or on behalf of a specifications developer or any other person; [42 FR 42526, Aug. 23, 1977, as amended at 43 (3) Repackages or relabels a device; FR 37997, Aug. 25, 1978; 57 FR 18066, Apr. 28, 1992; 58 FR 46522, Sept. 1, 1993; 59 FR 64295, (4) Reprocesses a single use device Dec. 14, 1994; 60 FR 63606, Dec. 11, 1995; 63 FR that has previously been used on a pa- 51826, Sept. 29, 1998; 66 FR 59159, Nov. 27, 2001; tient; 77 FR 45940, Aug. 2, 2012] (5) Acts as an initial importer as defined in § 807.3(g), except that initial Subpart B—Procedures for Device importers may fulfill their listing obli- Establishments gation for any device for which they did not initiate or develop the speci- § 807.20 Who must register and submit fications for the device or repackage or a device list? relabel the device by submitting the (a) An owner or operator of an estab- name and address of the manufacturer. lishment not exempt under section Initial importers shall also be prepared 510(g) of the Federal Food, Drug, and to submit, when requested by FDA, the Cosmetic Act or subpart D of this part proprietary name, if any, and the com- who is engaged in the manufacture, mon or usual name of each device for preparation, propagation, which they are the initial importer; compounding, assembly, or processing of a device intended for human use (6) Manufactures components or ac- shall register and submit listing infor- cessories that are ready to be used for mation for those devices in commercial any intended health-related purpose distribution, except that registration

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and are packaged or labeled for com- vice registration and listing system, mercial distribution for such health-re- except as provided in paragraphs (b), lated purpose, e.g. blood filters, hemo- (c), and (d) of this section: dialysis tubing, or devices which of ne- (1) Initial establishment registration cessity must be further processed by a information as required by §§ 807.22(a) licensed practitioner or other qualified and 807.25; person to meet the needs of a par- (2) Updates to registration informa- ticular patient, e.g., a manufacturer of tion as required by §§ 807.22(b) and ophthalmic lens blanks. 807.25; (b) Registration or listing does not (3) Initial device listing information constitute an admission or agreement as required by §§ 807.22(a), 807.25, and or determination that a product is a 807.28; device within the meaning of section (4) Updates to device listing informa- 201(h) of the Federal Food, Drug, and tion as required by §§ 807.22(b), 807.25, Cosmetic Act. and 807.28, including updates to reflect (c) Registration and listing require- the discontinuance or resumption of ments shall not pertain to any person the commercial distribution of a pre- who acts as a wholesale distributor, as viously-listed device as specified at defined in § 807.3(t), and who does not paragraphs (d) and (e) of § 807.28. manufacture, repackage, process, or (b) If the information under § 807.21(a) relabel a device. cannot be submitted electronically, a (d) Owners and operators of establish- waiver may be requested. Waivers will ments or persons engaged in the recov- be granted only if use of electronic ery, screening, testing, processing, means is not reasonable for the person storage, or distribution of human cells, requesting the waiver. To request a tissues, and cellular and tissue-based waiver, applicants must send a letter products, as defined in § 1271.3(d) of this to the Office of Compliance, Center for chapter, that are regulated under the Devices and Radiological Health, Food Federal Food, Drug, and Cosmetic Act and Drug Administration, 10903 New must register and list those human Hampshire Ave., Bldg. 66, rm. 2621, Sil- cells, tissues, and cellular and tissue- ver Spring, MD 20993–0002, that in- based products with the Center for Bio- cludes the following information: logics Evaluation and Research on (1) The name and address of the de- Form FDA 3356 following the proce- vice establishment(s) to be registered, dures set out in subpart B of part 1271 a contact person for the owner or oper- of this chapter, instead of the proce- ator of the establishment, and the tele- dures for registration and listing con- phone number at which that person can tained in this part, except that the ad- be reached. If the establishment has al- ditional listing information require- ready registered in the past, the letter ments of § 807.26 remain applicable. should also include the owner or oper- (e) Owners and operators of establish- ator number, registration number, and ments that manufacture devices li- any listing numbers previously as- censed under section 351 of the Public signed by FDA for devices manufac- Health Service Act as well as licensed tured at that establishment. biological products used in the manu- (2) Information about whether the facture of a licensed device must reg- company is an initial importer as de- ister and list following the procedures fined in § 807.3(g) and, if so, whether it set out in part 607 of this chapter, in- also conducts any other activities or stead of the procedures for registration operations relating to devices. and listing contained in this part. (3) A statement that use of the Inter- [77 FR 45941, Aug. 2, 2012] net is not reasonable for the person requesting the waiver, and an expla- § 807.21 How to register establish- nation of why such use is not reason- ments and list devices. able. The statement must be signed by (a) Owners or operators of establish- the owner or operator of the establishments that are subject to the registra- ment, or by a person employed by the tion and listing requirements of this owner or operator who is authorized to part must provide the following infor- make the declaration on behalf of the mation to us using our electronic de- owner or operator.

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(c) Those owners or operators who change is made to a previously-listed have obtained a waiver from filing reg- device, or when a previously-listed de- istration and listing information elec- vice is removed from commercial dis- tronically should refer to § 807.34 for in- tribution. formation on how to submit such infor- (c) Failure to submit required informa- mation by postal mail. tion. Failure to submit any of the re- (d) When additional device listing in- quired information on time, as speci- formation (e.g., copies of labeling or fied in paragraphs (a) and (b) of this advertisements) is requested by FDA as section, will put the establishment in a described at § 807.26(e), such informa- ‘‘failed to register’’ or ‘‘failed to list’’ tion may be submitted by postal mail status as applicable. The establishment or electronically by email, but will not will not be considered active and the be submitted using the FDA electronic establishment registration and device device registration and listing system. listing information may not appear on the FDA Web site until such time as [77 FR 45941, Aug. 2, 2012] the owner or operator submits and § 807.22 Times for establishment reg- FDA processes the required informa- istration and device listing. tion. (a) Initial registration and listing. An [77 FR 45942, Aug. 2, 2012] owner or operator of an establishment who has not previously entered into an § 807.25 Information required for de- operation described in § 807.20(a) shall vice establishment registration and register within 30 days after entering device listing. into such an operation and submit de- (a) All owners or operators that are vice listing information at that time. subject to the registration and listing (b) Registration and listing updates. requirements of this part shall provide Owners or operators shall review and such information to us by using the update all of their establishment reg- FDA electronic device registration and istration and device listing informa- listing system, unless granted a waiver tion that is on file at FDA, docu- from electronic submission in accord- menting any changes that were not ance with § 807.21(b). Electronic submis- previously reported as follows: sions of registration and listing infor- (1) Annual registration for each fiscal mation must comply with part 11 of year is required for all establishments. this chapter, except for the require- Annual registration shall take place ments in § 11.10(b), (c), and (e), and the during the period beginning on October corresponding requirements in § 11.30 of 1 and ending on December 31 of each this chapter. Those owners or opera- fiscal year; tors granted a waiver from electronic (2) Updates to the registration infor- submission should refer to paragraphs mation as described in § 807.25(b) shall (c) and (g) of this section and § 807.34 be made within 30 days of any change for instructions on how to submit de- to such information; vice registration and listing informa- (3) Every fiscal year, during the pe- tion. riod beginning on October 1 and ending (b) Registration information required on December 31, owners or operators to be submitted includes: The name shall review and update all of their de- and mailing address of the device es- vice listing information that is on file tablishment; the Web site address of at FDA, reporting any changes or dele- the device establishment, if any; the tions to listings and any new listings name, address, phone number, fax num- that were not previously reported. The ber, and email address of the owner or accuracy of all information on file operator; the name, address, phone must be confirmed each year regardless number, fax number, and email address of whether any changes were made to of the establishment’s official cor- the owner or operator’s list of devices; respondent; and all trade names used and by the establishment. (4) Changes to listing information (c) Owners or operators who have may also be made at other times, such been granted a waiver from electronic as when a device is introduced into filing must submit the establishment commercial distribution, when a registration information described in

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paragraph (b) of this section, except for quired by this paragraph, § 807.28, and the Web site and email address infor- any listing information requested by mation, in paper form using the proce- FDA under § 807.26(e), in paper form dures set forth in § 807.34. using the procedures set forth in (d) Each owner or operator is re- § 807.34. The information required for quired to maintain a listing of all offi- each device listed includes: cers, directors, and partners for each (1) The current registration number establishment registered by the owner and name of each establishment under or operator and to furnish this infor- the ownership and control of the owner mation to FDA upon request. or operator where the device is manu- (e) For each establishment, an offi- factured, repackaged, relabeled, or oth- cial correspondent must be designated erwise processed, or where specifica- by the owner or operator to serve as a tions are developed. point of contact with FDA on matters (2) The product code for each device relating to the registration of device that is exempt from premarket notifi- establishments and the listing of de- cation and approval or which was in vice products. Each owner or operator commercial distribution prior to May shall also provide FDA with the name 28, 1976. of a contact person at the owner or op- (3) The proprietary or brand name(s) erator’s offices who will be responsible under which each device is marketed. for identifying the official cor- (4) The FDA-assigned premarket sub- respondent for each establishment. The mission number of the approved appli- owner or operator contact person will cation, cleared premarket notification, be the official correspondent in the granted de novo classification petition, event no one else has been properly or approved humanitarian device ex- designated. The official correspondent emption for each device listed that is is responsible for: subject to sections 505, 510(k), 513(f)(2), (1) Providing FDA with all required 515, or 520(m) of the Federal Food, registration and listing information Drug, and Cosmetic Act, which in- electronically unless a waiver from cludes devices that are not exempt electronic submission has been granted from premarket notification and ap- in accordance with § 807.21(b); proval. (2) Receiving all correspondence from (5) Each activity or process that is FDA concerning registration and list- conducted on or done to the device at ing; each establishment, such as manufac- (3) Supplying, when requested by turing, repacking, relabeling, devel- FDA, the names of all officers, direc- oping specifications, remanufacturing, tors, and partners; and single-use device reprocessing, con- (4) Receiving communications from tract manufacturing, contract steri- FDA by email, or by postal mail if the lizing, or manufacturing for export owner or operator has been granted a only. waiver from the requirement to file [77 FR 45942, Aug. 2, 2012] registration and listing information electronically. § 807.26 Additional listing information. (f) The designation of an official cor- (a) Each owner or operator shall respondent does not in any manner af- maintain a historical file containing fect the liability of the owner or oper- the labeling and advertisements in use ator of the establishment or any other on the date of initial listing, and in use individual under section 301(p) or any after October 10, 1978, but before the other provision of the Federal Food, date of initial listing, as follows: Drug, and Cosmetic Act. (1) For each device subject to section (g) Device listing information must 514 or 515 of the act that is not a re- be submitted to FDA electronically un- stricted device, a copy of all labeling less a waiver from electronic submis- for the device; sion has been granted in accordance (2) For each restricted device, a copy with § 807.21(b). Owners or operators of all labeling and advertisements for who have been granted a waiver must the device; submit the required device listing in- (3) For each device that is neither re- formation, including information restricted nor subject to section 514 or

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515 of the act, a copy of all labels, feasible, be accompanied by an expla- package inserts, and a representative nation of the basis for such request. sampling of any other labeling. (3) For a device that is neither a re- (b) In addition to the requirements stricted device, nor subject to section set forth in paragraph (a) of this sec- 514 of 515 of the act, the label and pack- tion, each owner or operator shall age insert for the device and a rep- maintain in the historical file any la- resentative sampling of any other labeling or advertisements in which a beling for the device. material change has been made any- (4) For a particular device, a state- time after initial listing. ment of the basis upon which the reg- (c) Each owner or operator may dis- istrant has determined that the device card labeling and advertisements from is not subject to section 514 or 515 of the historical file 3 years after the date the act. of the last shipment of a discontinued (5) For a particular device, a state- device by an owner or operator. ment of the basis upon which the reg- (d) Location of the file: istrant has determined the device is (1) Currently existing systems for not a restricted device. maintenance of labeling and adver- (6) For a particular device, a state- tising may be used for the purpose of ment of the basis for determining that maintaining the historical file as long the product is a device rather than a as the information included in the sys- drug. tems fulfills the requirements of this (7) For a device that the owner or op- section, but only if the labeling and ad- erator has manufactured for distribu- vertisements are retrievable in a time- tion under a label other than its own, ly manner. the names of all distributors for whom (2) The contents of the historical file it has been manufactured. may be physically located in more than one place in the establishment or in (f) Labeling, advertisements, and more than one establishment provided other information to be submitted there exists joint ownership and con- upon request in accordance with para- trol among all the establishments graph (e) of this section may be sub- maintaining the historical file. If no mitted by postal mail or electronically joint ownership and control exists, the by email, but will not be submitted registered establishment must provide using the FDA electronic device reg- the Food and Drug Administration istration and listing system. Electronic with a letter authorizing the establish- submissions of such information must ment outside its control to maintain comply with part 11 of this chapter, ex- the historical file. cept for the requirements in § 11.10 (a), (3) A copy of the certification and (c) through (h), and (k), and the cor- disclosure statements as required by responding requirements in § 11.30 of part 54 of this chapter shall be retained this chapter. The information provided and physically located at the establish- in electronic format must be in a form ment maintaining the historical file. that we can process, review, and ar- (e) Each owner or operator shall be chive. prepared to submit to the Food and [43 FR 37999, Aug. 25, 1978, as amended at 51 Drug Administration, only upon spe- FR 33033, Sept. 18, 1986; 63 FR 5253, Feb. 2, cific request, the following informa- 1998. Redesignated and amended at 77 FR tion: 45943, Aug. 2, 2012] (1) For a device subject to section 514 or 515 of the act that is not a restricted § 807.28 Updating device listing infor- device, a copy of all labeling for the de- mation. vice. (a) Updating of device listing infor- (2) For a device that is a restricted mation is required if an additional es- device, a copy of all labeling for the de- tablishment begins to engage in any of vice, a representative sampling of ad- the activities described in § 807.3(d) vertisements for the device, and for with respect to a listed device, such as good cause, a copy of all advertise- manufacturing, developing specifica- ments for a particular device. A re- tions, repackaging, relabeling, or oth- quest for all advertisements will, where erwise processing the device. Updating

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of the listing is also required if an es- § 807.34 Summary of requirements for tablishment begins performing another owners or operators granted a activity on or to the device, or ceases waiver from submitting required in- to perform an activity on or to the de- formation electronically. vice that had previously been identi- (a) For initial registration and list- fied on the device listing. ing, owners or operators who have been (b) An owner or operator shall create granted a waiver from electronic filing a new device listing using the FDA using the procedures set forth in electronic device registration and list- § 807.21(b) must send a letter containing ing system: all of the registration and listing infor- (1) If introducing into commercial mation described in §§ 807.22, 807.25, distribution an exempt device identi- (and § 807.26 when such information is fied with a product code that is not requested by FDA), at the times de- currently listed by the owner or oper- scribed in § 807.22, to: The Office of ator; or Compliance, Center for Devices and Ra- (2) If introducing into commercial diological Health, Food and Drug Ad- distribution a non-exempt device with ministration, 10903 New Hampshire an FDA premarket submission number Ave., Bldg. 66, rm. 3521, Silver Spring, that is not currently listed by the MD 20993–0002. owner or operator. (b) As specified in § 807.22(b)(1) and (c) All device listings for foreign es- (b)(3), all owners or operators shall up- tablishments must be submitted before date their establishment registration the device may be imported or offered and device listings annually during the for import into the United States. period beginning on October 1 and end- (d) An owner or operator who discon- ing on December 31 of each fiscal year. tinues commercial distribution of a de- (c) Failure to submit any of the re- vice shall discontinue the device list- quired information on time, as speci- ing using the FDA electronic device fied in § 807.22(a) and (b), will put the registration and listing system. A de- establishment in a ‘‘failed to register’’ vice listing is considered discontinued or ‘‘failed to list’’ status as applicable. if: The establishment will not be consid- (1) All devices under an exempt prod- ered active and the establishment reg- uct code have been discontinued or istration and device listing informa- (2) All devices associated with an tion may not appear on the FDA Web FDA premarket submission number site until the required information is have been discontinued. submitted to and processed by FDA. (e) If commercial distribution of a [77 FR 45943, Aug. 2, 2012] discontinued device is resumed, the owner or operator must reactivate the § 807.35 Notification of registrant. previously-discontinued listing using the electronic device registration and (a) The Food and Drug Administra- tion will assign each device establish- listing system. Any changes to the list- ment a registration number after ing information for the product that is verifying the initial establishment reg- the subject of the listing such as a new istration information that has been establishment, new activity, or new submitted. The owner or operator of proprietary name must be made using the establishment will also be assigned the electronic device registration and an identifying number. Both numbers listing system at the time the listing is will be sent to the official cor- reactivated. respondent by email, or by postal mail (f) FDA will assign one listing num- if the owner or operator has been ber for all devices exempt from pre- granted a waiver from the requirement market notification requirements to file registration and listing informa- under a single product code. For prod- tion electronically. ucts not exempt from premarket noti- (b) Owners or operators of device es- fication requirements, a single listing tablishments who also manufacture or number will be assigned by FDA for process biological products (including each FDA premarket submission num- devices licensed under section 351 of ber. the Public Health Service Act) or drug [77 FR 45943, Aug. 2, 2012] products at the same establishment

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must also register and list those prod- (b) The following listing information ucts under part 607 or part 207 of this will not be available for public inspec- chapter, as appropriate. Registration tion or posted on the FDA Web site: and listing for human blood and blood (1) For contract manufacturers, con- products, devices licensed under sec- tract sterilizers, and private label man- tion 351 of the Public Health Service ufacturers, the proprietary or brand Act, and licensed biological products name(s) under which a device is mar- used in the manufacture of a device li- keted and the FDA-assigned premarket censed under section 351 of the Public submission number, if this information Health Service Act, are subject to part would reveal a confidential business re- 607 of this chapter; registration and lationship; listing for all other drug products (in- (2) FDA-assigned listing numbers. cluding other biological products that [77 FR 45943, Aug. 2, 2012] are also regulated as drug products) are subject to part 207 of this chapter. § 807.39 Misbranding by reference to (c) Although establishment registra- establishment registration or to tion and device listing are required to registration number. engage in the device activities de- Registration of a device establish- scribed in § 807.20, validation of reg- ment or assignment of a registration istration and the assignment of a de- number does not in any way denote ap- vice listing number in itself does not proval of the establishment or its prod- establish that the holder of the reg- ucts. Any representation that creates istration is legally qualified to deal in an impression of official approval be- such devices and does not represent a cause of registration or possession of a determination by the Food and Drug registration number is misleading and Administration as to the status of any constitutes misbranding. device. [69 FR 11312, Mar. 10, 2004, as amended at 77 Subpart C—Procedures for Foreign FR 45943, Aug. 2, 2012] Device Establishments

§ 807.37 Public availability of estab- § 807.40 Establishment registration lishment registration and device and device listing for foreign estab- listing information. lishments importing or offering for import devices into the United (a) Establishment registration and States. device listing information is available (a) Any establishment within any for public inspection in accordance foreign country engaged in the manu- with section 510(f) of the Federal Food, facture, preparation, propagation, Drug, and Cosmetic Act and will be compounding, or processing of a device posted on the FDA Web site, with the that is imported or offered for import exception of the information identified into the United States shall register in paragraph (b) of this section. Re- such establishment and list such de- quests for information by persons who vices using the FDA electronic device do not have access to the Internet registration and listing system in con- should be directed to the Office of Com- formance with the procedures in this pliance, Center for Devices and Radio- section, § 807.41, and subpart B of this logical Health, Food and Drug Admin- part. The official correspondent for the istration, 10903 New Hampshire Ave., foreign establishment shall facilitate Bldg. 66, rm. 3521, Silver Spring, MD communication between the foreign es- 20993–0002. In addition, there will be tablishment’s management and rep- available for inspection at each of the resentatives of FDA for matters relat- Food and Drug Administration district ing to the registration of device estab- offices the same information for firms lishments and the listing of device within the geographical area of such products. district offices. Upon request, (b) Each foreign establishment re- verification of a registration number or quired to register under paragraph (a) location of a registered establishment of this section shall submit the name, will be provided. address, and phone number of its

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United States agent as part of its ini- tronic device registration and listing tial and updated registration informa- system, submit the name, address, tele- tion in accordance with subpart B of phone and fax numbers, email address, this part. Each foreign establishment and registration number, if any has shall designate only one United States been assigned, of any importer (defined agent and may designate the United in § 807.3(x)) of the establishment’s de- States agent to act as its official cor- vices that is known to the foreign es- respondent. tablishment. The foreign establishment (1) The United States agent shall re- must also specify which of the estab- side or maintain a place of business in lishment’s listed products each im- the United States. porter receives from the foreign estab- (2) Upon request from FDA, the lishment. United States agent shall assist FDA (b) Upon initial registration, annu- in communications with the foreign es- ally, and at the time of any changes, tablishment, respond to questions con- each foreign establishment required to cerning the foreign establishment’s register and list as provided in products that are imported or offered § 807.40(a) must, using the FDA elec- for import into the United States, and tronic device registration and listing assist FDA in scheduling inspections of system, submit the name, address, tele- the foreign establishment. If the agen- phone and fax numbers, email address, cy is unable to contact the foreign es- and registration number, if any has tablishment directly or expeditiously, been assigned, of each person who im- FDA may provide information or docu- ports or offers for import the establishments to the United States agent, and ment’s devices into the United States. such an action shall be considered to be The term ‘‘person who imports or of- equivalent to providing the same infor- fers for import,’’ which is defined in mation or documents to the foreign es- § 807.3(y), includes agents, brokers, or tablishment. other parties used by the foreign estab- (3) The foreign establishment or the lishment to facilitate the import of its United States agent shall report device into the United States. changes in the United States agent’s (c) For each individual or organiza- name, address, or phone number to tion identified by the foreign establish- FDA within 10-business days of the ment under paragraphs (a) and (b) of change. this section, the foreign establishment (c) No device may be imported or of- must submit to FDA electronically the fered for import into the United States current FDA premarket submission unless it is the subject of a device list- number and any other identifying ining as required under subpart B of this formation that is known to the estab- part and is manufactured, prepared, lishment for each device being im- propagated, compounded, or processed ported or offered for import by the at a registered foreign establishment; named individuals or organizations. however, this restriction does not [77 FR 45944, Aug. 2, 2012] apply to devices imported or offered for import under the investigational use Subpart D—Exemptions provisions of part 812 of this chapter. (d) The device establishment reg- § 807.65 Exemptions for device estab- istration and device listing informa- lishments. tion shall be in the English language. The following classes of persons are [66 FR 59160, Nov. 27, 2001, as amended at 77 exempt from registration in accord- FR 45944, Aug. 2, 2012] ance with § 807.20 under the provisions of section 510(g)(1), (g)(2), and (g)(3) of § 807.41 Identification of importers the act, or because the Commissioner and persons who import or offer for of Food and Drugs has found, under import. section 510(g)(5) of the act, that such (a) Upon initial registration, annu- registration is not necessary for the ally, and at the time of any changes, protection of the public health. The ex- each foreign establishment required to emptions in paragraphs (d), (e), (f), and register and list as provided in (i) of this section are limited to those § 807.40(a) must, using the FDA elec- classes of persons located in any State

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as defined in section 201(a)(1) of the vide a service through the use of a pre- act. viously manufactured device. (a) A manufacturer of raw materials [42 FR 42526, Aug. 23, 1977, as amended at 58 or components to be used in the manu- FR 46523, Sept. 1, 1993; 61 FR 44615, Aug. 28, facture or assembly of a device who 1996; 65 FR 17136, Mar. 31, 2000; 66 FR 59160, would otherwise not be required to reg- Nov. 27, 2001] ister under the provisions of this part. (b) A manufacturer of devices to be Subpart E—Premarket Notification used solely for veterinary purposes. Procedures (c) A manufacturer of general purpose articles such as chemical reagents § 807.81 When a premarket notification submission is required. or laboratory equipment whose uses are generally known by persons trained (a) Except as provided in paragraph in their use and which are not labeled (b) of this section, each person who is required to register his establishment or promoted for medical uses. pursuant to § 807.20 must submit a pre- (d) Licensed practitioners, including market notification submission to the physicians, dentists, and optometrists, Food and Drug Administration at least who manufacture or otherwise alter de- 90 days before he proposes to begin the vices solely for use in their practice. introduction or delivery for introduc- (e) Pharmacies, surgical supply out- tion into interstate commerce for com- lets, or other similar retail establish- mercial distribution of a device in- ments making final delivery or sale to tended for human use which meets any the ultimate user. This exemption also of the following criteria: applies to a pharmacy or other similar (1) The device is being introduced retail establishment that purchases a into commercial distribution for the device for subsequent distribution first time; that is, the device is not of under its own name, e.g., a properly la- the same type as, or is not substan- beled health aid such as an elastic ban- tially equivalent to, (i) a device in dage or crutch, indicating ‘‘distributed commercial distribution before May 28, by’’ or ‘‘manufactured for’’ followed by 1976, or (ii) a device introduced for commercial distribution after May 28, the name of the pharmacy. 1976, that has subsequently been reclas- (f) Persons who manufacture, pre- sified into class I or II. pare, propagate, compound, or process (2) The device is being introduced devices solely for use in research, into commercial distribution for the teaching, or analysis and do not intro- first time by a person required to reg- duce such devices into commercial dis- ister, whether or not the device meets tribution. the criteria in paragraph (a)(1) of this (g) [Reserved] section. (h) Carriers by reason of their re- (3) The device is one that the person ceipt, carriage, holding or delivery of currently has in commercial distribu- devices in the usual course of business tion or is reintroducing into commer- as carriers. cial distribution, but that is about to (i) Persons who dispense devices to be significantly changed or modified in the ultimate consumer or whose major design, components, method of manu- responsibility is to render a service facture, or intended use. The following necessary to provide the consumer (i.e., constitute significant changes or modi- patient, physician, layman, etc.) with a fications that require a premarket no- device or the benefits to be derived tification: (i) A change or modification in the from the use of a device; for example, a device that could significantly affect hearing aid dispenser, optician, clinical the safety or effectiveness of the de- laboratory, assembler of diagnostic x- vice, e.g., a significant change or modi- ray systems, and personnel from a hos- fication in design, material, chemical pital, clinic, dental laboratory, composition, energy source, or manu- orthotic or prosthetic retail facility, facturing process. whose primary responsibility to the ul- (ii) A major change or modification timate consumer is to dispense or pro- in the intended use of the device.

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(b)(1) A premarket notification under § 807.87 Information required in a pre- this subpart is not required for a device market notification submission. for which a premarket approval appli- Each premarket notification submis- cation under section 515 of the act, or sion shall contain the following infor- for which a petition to reclassify under mation: section 513(f)(2) of the act, is pending (a) The device name, including both before the Food and Drug Administra- the trade or proprietary name and the tion. common or usual name or classifica- (2) The appropriate FDA Center Di- tion name of the device. rector may determine that the submis- (b) The establishment registration sion and grant of a written request for number, if applicable, of the owner or an exception or alternative under operator submitting the premarket no- § 801.128 or § 809.11 of this chapter satis- tification submission. fies the requirement in paragraph (a)(3) (c) The class in which the device has of this section. been put under section 513 of the act (c) In addition to complying with the and, if known, its appropriate panel; requirements of this part, owners or or, if the owner or operator determines operators of device establishments that that the device has not been classified manufacture radiation-emitting elec- under such section, a statement of that tronic products, as defined in § 1000.3 of determination and the basis for the this chapter, shall comply with the re- person’s determination that the device porting requirements of part 1002 of is not so classified. this chapter. (d) Action taken by the person required to register to comply with the [42 FR 42526, Aug. 23, 1977, as amended at 72 FR 73601, Dec. 28, 2007] requirements of the act under section 514 for performance standards. § 807.85 Exemption from premarket (e) Proposed labels, labeling, and ad- notification. vertisements sufficient to describe the device, its intended use, and the direc- (a) A custom device is exempt from tions for its use. Where applicable, pho- premarket notification requirements of tographs or engineering drawings this subpart if the device is within the should be supplied. meaning of section 520(b) of the Fed- (f) A statement indicating the device eral Food, Drug, and Cosmetic Act. is similar to and/or different from (1) It is intended for use by a patient other products of comparable type in named in the order of the physician or commercial distribution, accompanied dentist (or other specially qualified by data to support the statement. This person); or information may include an identifica- (2) It is intended solely for use by a tion of similar products, materials, de- physician or dentist (or other specially sign considerations, energy expected to qualified person) and is not generally be used or delivered by the device, and available to, or generally used by, a description of the operational prin- other physicians or dentists (or other ciples of the device. specially qualified persons). (g) Where a person required to reg- (b) A distributor who places a device ister intends to introduce into com- into commercial distribution for the mercial distribution a device that has first time under his own name and a re- undergone a significant change or packager who places his own name on a modification that could significantly device and does not change any other affect the safety or effectiveness of the labeling or otherwise affect the device device, or the device is to be marketed shall be exempted from the premarket for a new or different indication for notification requirements of this sub- use, the premarket notification subpart if: mission must include appropriate sup- (1) The device was in commercial dis- porting data to show that the manufac- tribution before May 28, 1976; or turer has considered what con- (2) A premarket notification submis- sequences and effects the change or sion was filed by another person. modification or new use might have on [42 FR 42526, Aug. 23, 1977, as amended at 81 the safety and effectiveness of the de- FR 70340, Oct. 12, 2016] vice.

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(h) A 510(k) summary as described in mation at least 90 days before the § 807.92 or a 510(k) statement as de- owner or operator intends to market scribed in § 807.93. the device, or submit a premarket ap- (i) A financial certification or disclo- proval application in accordance with sure statement or both, as required by section 515 of the act. If the additional part 54 of this chapter. information is not submitted within 30 (j) For submissions claiming substan- days following the date of the request, tial equivalence to a device which has the Commissioner will consider the been classified into class III under sec- premarket notification to be with- tion 513(b) of the act: drawn. (1) Which was introduced or delivered for introduction into interstate com- (Information collection requirements in this section were approved by the Office of Man- merce for commercial distribution be- agement and Budget (OMB) and assigned fore December 1, 1990; and OMB control number 0910–0281) (2) For which no final regulation requiring premarket approval has been [42 FR 42526, Aug. 23, 1977, as amended at 57 issued under section 515(b) of the act, a FR 18066, Apr. 28, 1992; 59 FR 64295, Dec. 14, 1994; 63 FR 5253, Feb. 2, 1998] summary of the types of safety and effectiveness problems associated with § 807.90 Format of a premarket notifi- the type of devices being compared and cation submission. a citation to the information upon which the summary is based (class III Each premarket notification submis- summary). The 510(k) submitter shall sion pursuant to this part shall be sub- also certify that a reasonable search of mitted in accordance with this section. all information known or otherwise Each submission shall: available about the class III device and (a)(1) For devices regulated by the other similar legally marketed devices Center for Devices and Radiological has been conducted (class III certifi- Health, be addressed to the Food and cation), as described in § 807.94. This in- Drug Administration, Center for De- formation does not refer to informa- vices and Radiological Health, Docu- tion that already has been submitted ment Mail Center, 10903 New Hamp- to the Food and Drug Administration shire Ave., Bldg. 66, rm. G609, Silver (FDA) under section 519 of the act. Spring, MD 20993–0002. FDA may require the submission of the (2) For devices regulated by the Cen- adverse safety and effectiveness data ter for Biologics Evaluation and Re- described in the class III summary or search, be addressed to the Food and citation. Drug Administration, Center for Bio- (k) A statement that the submitter logics Evaluation and Research, Docu- believes, to the best of his or her ment Control Center, 10903 New Hamp- knowledge, that all data and informa- shire Ave., Bldg. 71, Rm. G112, Silver tion submitted in the premarket notifi- Spring, MD 20993–0002; or for devices cation are truthful and accurate and regulated by the Center for Drug Eval- that no material fact has been omitted. uation and Research, be addressed to (l) Any additional information re- the Central Document Room, Center garding the device requested by the for Drug Evaluation and Research, Commissioner that is necessary for the Food and Drug Administration, 5901–B Commissioner to make a finding as to Ammendale Rd., Beltsville, MD 20705– whether or not the device is substan- 1266. Information about devices regu- tially equivalent to a device in com- lated by the Center for Biologics Eval- mercial distribution. A request for ad- uation and Research is available by ditional information will advise the using the Center for Biologics Evalua- owner or operator that there is insuffi- tion and Research electronic Web- cient information contained in the based application on the Internet. original premarket notification sub- (3) All inquiries regarding a pre- mission for the Commissioner to make market notification submission should this determination and that the owner be in writing and sent to one of the ad- or operator may either submit the re- dresses above. quested data or a new premarket noti- (b) Be bound into a volume or vol- fication containing the requested infor- umes, where necessary.

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(c) Be submitted in duplicate on design, material used, and physical standard size paper, including the properties; original and two copies of the cover (5) A statement of the intended use of letter. the device that is the subject of the (d) Be submitted separately for each premarket notification submission, in- product the manufacturer intends to cluding a general description of the market. diseases or conditions that the device (e) Designated ‘‘510(k) Notification’’ will diagnose, treat, prevent, cure, or in the cover letter. mitigate, including a description, where appropriate, of the patient popu- [42 FR 42526, Aug. 23, 1977, as amended at 53 lation for which the device is intended. FR 11252, Apr. 6, 1988; 55 FR 11169, Mar. 27, If the indication statements are dif- 1990; 65 FR 17137, Mar. 31, 2000; 70 FR 14986, ferent from those of the legally mar- Mar. 24, 2005; 75 FR 20915, Apr. 22, 2010; 80 FR 18094, Apr. 3, 2015] keted device identified in paragraph (a)(3) of this section, the 510(k) sum- § 807.92 Content and format of a 510(k) mary shall contain an explanation as summary. to why the differences are not critical to the intended therapeutic, diag- (a) A 510(k) summary shall be in suf- nostic, prosthetic, or surgical use of ficient detail to provide an under- the device, and why the differences do standing of the basis for a determina- not affect the safety and effectiveness tion of substantial equivalence. FDA of the device when used as labeled; and will accept summaries as well as (6) If the device has the same techno- amendments thereto until such time as logical characteristics (i.e., design, ma- FDA issues a determination of substan- terial, chemical composition, energy tial equivalence. All 510(k) summaries source) as the predicate device identi- shall contain the following informa- fied in paragraph (a)(3) of this section, tion: a summary of the technological char- (1) The submitter’s name, address, acteristics of the new device in com- telephone number, a contact person, parison to those of the predicate de- and the date the summary was pre- vice. If the device has different techno- pared; logical characteristics from the predi- (2) The name of the device, including cate device, a summary of how the the trade or proprietary name if appli- technological characteristics of the de- cable, the common or usual name, and vice compare to a legally marketed de- the classification name, if known; vice identified in paragraph (a)(3) of (3) An identification of the legally this section. marketed device to which the sub- (b) 510(k) summaries for those pre- mitter claims equivalence. A legally market submissions in which a deter- marketed device to which a new device mination of substantial equivalence is may be compared for a determination also based on an assessment of per- regarding substantial equivalence is a formance data shall contain the fol- device that was legally marketed prior lowing information: to May 28, 1976, or a device which has (1) A brief discussion of the nonclin- been reclassified from class III to class ical tests submitted, referenced, or re- II or I (the predicate), or a device lied on in the premarket notification which has been found to be substan- submission for a determination of sub- tially equivalent through the 510(k) stantial equivalence; premarket notification process; (2) A brief discussion of the clinical (4) A description of the device that is tests submitted, referenced, or relied the subject of the premarket notifica- on in the premarket notification sub- tion submission, such as might be mission for a determination of substan- found in the labeling or promotional tial equivalence. This discussion shall material for the device, including an include, where applicable, a description explanation of how the device func- of the subjects upon whom the device tions, the scientific concepts that form was tested, a discussion of the safety or the basis for the device, and the signifi- effectiveness data obtained from the cant physical and performance charac- testing, with specific reference to ad- teristics of the device, such as device verse effects and complications, and

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any other information from the clin- (c) The information provided to re- ical testing relevant to a determina- questors will be a duplicate of the pre- tion of substantial equivalence; and market notification submission, in- (3) The conclusions drawn from the cluding any adverse information, but nonclinical and clinical tests that dem- excluding all patient identifiers, and onstrate that the device is as safe, as trade secret and confidential commer- effective, and performs as well as or cial information as defined in § 20.61 of better than the legally marketed de- this chapter. vice identified in paragraph (a)(3) of [59 FR 64295, Dec. 14, 1994] this section. (c) The summary should be in a sepa- § 807.94 Format of a class III certifi- rate section of the submission, begin- cation. ning on a new page and ending on a (a) A class III certification submitted page not shared with any other section as part of a premarket notification of the premarket notification submis- shall state as follows: sion, and should be clearly identified as a ‘‘510(k) summary.’’ I certify, in my capacity as (position held in company), of (company name), that I have (d) Any other information reasonably conducted a reasonable search of all infor- deemed necessary by the agency. mation known or otherwise available about the types and causes of safety or effective- [57 FR 18066, Apr. 28, 1992, as amended at 59 ness problems that have been reported for FR 64295, Dec. 14, 1994] the (type of device). I further certify that I am aware of the types of problems to which § 807.93 Content and format of a 510(k) the (type of device) is susceptible and that, statement. to the best of my knowledge, the following (a)(1) A 510(k) statement submitted summary of the types and causes of safety or as part of a premarket notification effectiveness problems about the (type of device) is complete and accurate. shall state as follows: (b) The statement in paragraph (a) of I certify that, in my capacity as (the posi- this section should be signed by the tion held in company by person required to certifier, clearly identified as ‘‘class III submit the premarket notification, preferably the official correspondent in the certification,’’ and included at the be- firm), of (company name), I will make avail- ginning of the section of the premarket able all information included in this pre- notification submission that sets forth market notification on safety and effective- the class III summary. ness within 30 days of request by any person [59 FR 64296, Dec. 14, 1994] if the device described in the premarket notification submission is determined to be substantially equivalent. The information I § 807.95 Confidentiality of information. agree to make available will be a duplicate (a) The Food and Drug Administra- of the premarket notification submission, in- tion will disclose publicly whether cluding any adverse safety and effectiveness there exists a premarket notification information, but excluding all patient iden- submission under this part: tifiers, and trade secret and confidential (1) Where the device is on the mar- commercial information, as defined in 21 CFR 20.61. ket, i.e., introduced or delivered for introduction into interstate commerce (2) The statement in paragraph (a)(1) for commercial distribution; of this section should be signed by the (2) Where the person submitting the certifier, made on a separate page of premarket notification submission has the premarket notification submission, disclosed, through advertising or any and clearly identified as ‘‘510(k) state- other manner, his intent to market the ment.’’ device to scientists, market analysts, (b) All requests for information in- exporters, or other individuals who are cluded in paragraph (a) of this section not employees of, or paid consultants shall be made in writing to the cer- to, the establishment and who are not tifier, whose name will be published by in an advertising or law firm pursuant FDA on the list of premarket notifica- to commercial arrangements with ap- tion submissions for which substantial propriate safeguards for secrecy; or equivalence determinations have been (3) Where the device is not on the made. market and the intent to market the

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device has not been so disclosed, except where the intent to market the device where the submission is subject to an has not been disclosed, and the Com- exception under paragraph (b) or (c) of missioner agrees that the intent to this section. market the device is confidential com- (b) The Food and Drug Administra- mercial information, the Commissioner tion will not disclose publicly the ex- will not disclose the existence of the istence of a premarket notification submission for 90 days from the date of submission for a device that is not on its receipt by the agency. In addition, the market and where the intent to the Commissioner will continue not to market the device has not been dis- disclose the existence of such a submis- closed for 90 days from the date of re- sion for the device for an additional ceipt of the submission, if: time when any of the following occurs: (1) The person submitting the pre- (1) The Commissioner requests in market notification submission re- writing additional information regard- quests in the submission that the Food ing the device pursuant to § 807.87(h), in and Drug Administration hold as con- which case the Commissioner will not fidential commercial information the disclose the existence of the submis- intent to market the device and sub- sion until 90 days after the Food and mits a written certification to the Drug Administration’s receipt of a Commissioner: complete premarket notification sub- (i) That the person considers his in- mission; tent to market the device to be con- (2) The Commissioner determines fidential commercial information; that the device intended to be intro- (ii) That neither the person nor, to duced is a class III device and cannot the best of his knowledge, anyone else, be marketed without premarket ap- has disclosed through advertising or proval or reclassification, in which any other manner, his intent to mar- case the Commissioner will not dis- ket the device to scientists, market an- close the existence of the submission alysts, exporters, or other individuals, unless a petition for reclassification is except employees of, or paid consult- submitted under section 513(f)(2) of the ants to, the establishment or individ- act and its existence can be disclosed uals in an advertising or law firm pur- under § 860.5(d) of this chapter; or suant to commercial arrangements (d) FDA will make a 510(k) summary with appropriate safeguards for se- of the safety and effectiveness data crecy; available to the public within 30 days (iii) That the person will imme- of the issuance of a determination that diately notify the Food and Drug Ad- the device is substantially equivalent ministration if he discloses the intent to another device. Accordingly, even to market the device to anyone, except when a 510(k) submitter has complied employees of, or paid consultants to, with the conditions set forth in para- the establishment or individuals in an graphs (b) and (c) of this section, con- advertising or law firm pursuant to fidentiality for a premarket notifica- commercial arrangements with appro- tion submission cannot be granted be- priate safeguards for secrecy; yond 30 days after FDA issues a deter- (iv) That the person has taken pre- mination of equivalency. cautions to protect the confidentiality (e) Data or information submitted of the intent to market the device; and with, or incorporated by reference in, a (v) That the person understands that premarket notification submission the submission to the government of (other than safety and effectiveness false information is prohibited by 18 data that have not been disclosed to U.S.C. 1001 and 21 U.S.C. 331(q); and the public) shall be available for disclo- (2) The Commissioner agrees that the sure by the Food and Drug Administra- intent to market the device is con- tion when the intent to market the de- fidential commercial information. vice is no longer confidential in accord- (c) Where the Commissioner deter- ance with this section, unless exempt mines that the person has complied from public disclosure in accordance with the procedures described in para- with part 20 of this chapter. Upon final graph (b) of this section with respect to classification, data and information re- a device that is not on the market and lating to safety and effectiveness of a

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device classified in class I (general con- alent, the applicant may not proceed to trols) or class II (performance stand- market the device. ards) shall be available for public dis- (b) FDA will determine that a device closure. Data and information relating is substantially equivalent to a predi- to safety and effectiveness of a device cate device using the following cri- classified in class III (premarket ap- teria: proval) that have not been released to (1) The device has the same intended the public shall be retained as con- use as the predicate device; and fidential unless such data and informa- (2) The device: tion become available for release to the (i) Has the same technological char- public under § 860.5(d) or other provi- acteristics as the predicate device; or sions of this chapter. (ii)(A) Has different technological characteristics, such as a significant [42 FR 42526, Aug. 23, 1977, as amended at 53 change in the materials, design, energy FR 11252, Apr. 6, 1988; 57 FR 18067, Apr. 28, 1992; 59 FR 64296, Dec. 14, 1994] source, or other features of the device from those of the predicate device; § 807.97 Misbranding by reference to (B) The data submitted establishes premarket notification. that the device is substantially equivalent to the predicate device and con- Submission of a premarket notifica- tains information, including clinical tion in accordance with this subpart, data if deemed necessary by the Com- and a subsequent determination by the missioner, that demonstrates that the Commissioner that the device intended device is as safe and as effective as a for introduction into commercial dis- legally marketed device; and tribution is substantially equivalent to (C) Does not raise different questions a device in commercial distribution be- of safety and effectiveness than the fore May 28, 1976, or is substantially predicate device. equivalent to a device introduced into (3) The predicate device has not been commercial distribution after May 28, removed from the market at the initia- 1976, that has subsequently been reclas- tive of the Commissioner of Food and sified into class I or II, does not in any Drugs or has not been determined to be way denote official approval of the de- misbranded or adulterated by a judicial vice. Any representation that creates order. an impression of official approval of a device because of complying with the [57 FR 58403, Dec. 10, 1992, as amended at 63 premarket notification regulations is FR 5253, Feb. 2, 1998] misleading and constitutes misbranding. PART 808—EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE § 807.100 FDA action on a premarket AND LOCAL MEDICAL DEVICE notification. REQUIREMENTS (a) After review of a premarket notification, FDA will: Subpart A—General Provisions (1) Issue an order declaring the device to be substantially equivalent to a le- Sec. 808.1 Scope. gally marketed predicate device; 808.3 Definitions. (2) Issue an order declaring the device 808.5 Advisory opinions. to be not substantially equivalent to any legally marketed predicate device; Subpart B—Exemption Procedures (3) Request additional information; 808.20 Application. or 808.25 Procedures for processing an applica- (4) Withhold the decision until a cer- tion. tification or disclosure statement is 808.35 Revocation of an exemption. submitted to FDA under part 54 of this chapter. Subpart C—Listing of Specific State and (5) Advise the applicant that the pre- Local Exemptions market notification is not required. 808.53 Arizona. Until the applicant receives an order 808.55 California declaring a device substantially equiv- 808.57 Connecticut.

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808.59 Florida. regulation in accordance with this part 808.61 Hawaii. exempting the State or local require- 808.67 Kentucky. ment from preemption. The granting of 808.69 Maine. 808.71 Massachusetts. an exemption does not affect the appli- 808.73 Minnesota. cability to the device of any require- 808.74 Mississippi. ments under the act. The Commis- 808.77 Nebraska. sioner may promulgate an exemption 808.80 New Jersey. regulation for the preempted require- 808.81 New Mexico. ment if he makes either of the fol- 808.82 New York. lowing findings: 808.85 Ohio. 808.87 Oregon. (1) That the requirement is more 808.88 Pennsylvania. stringent than a requirement under the 808.89 Rhode Island. act applicable to the device; or 808.93 Texas. (2) That the requirement is required 808.97 Washington. by compelling local conditions and 808.98 West Virginia. compliance with the requirement 808.101 District of Columbia. would not cause the device to be in vio- AUTHORITY: 21 U.S.C. 360j, 360k, 371. lation of any applicable requirement SOURCE: 43 FR 18665, May 2, 1978, unless under the act. otherwise noted. (d) State or local requirements are preempted only when the Food and Subpart A—General Provisions Drug Administration has established specific counterpart regulations or § 808.1 Scope. there are other specific requirements (a) This part prescribes procedures applicable to a particular device under for the submission, review, and ap- the act, thereby making any existing proval of applications for exemption divergent State or local requirements from Federal preemption of State and applicable to the device different from, local requirements applicable to med- or in addition to, the specific Food and ical devices under section 521 of the Drug Administration requirements. act. There are other State or local require- (b) Section 521(a) of the act contains ments that affect devices that are not special provisions governing the regu- preempted by section 521(a) of the act lation of devices by States and local- because they are not ‘‘requirements ap- ities. That section prescribes a general plicable to a device’’ within the mean- rule that after May 28, 1976, no State or ing of section 521(a) of the act. The fol- political subdivision of a State may es- lowing are examples of State or local tablish or continue in effect any re- requirements that are not regarded as quirement with respect to a medical preempted by section 521 of the act: device intended for human use having (1) Section 521(a) does not preempt the force and effect of law (whether es- State or local requirements of general tablished by statute, ordinance, regula- applicability where the purpose of the tion, or court decision), which is dif- requirement relates either to other ferent from, or in addition to, any re- products in addition to devices (e.g., requirement applicable to such device quirements such as general electrical under any provision of the act and codes, and the Uniform Commercial which relates to the safety or effective- Code (warranty of fitness)), or to unfair ness of the device or to any other mat- trade practices in which the require- ter included in a requirement applica- ments are not limited to devices. ble to the device under the act. (2) Section 521(a) does not preempt (c) Section 521(b) of the act contains State or local requirements that are a provision whereby the Commissioner equal to, or substantially identical to, of Food and Drugs may, upon applica- requirements imposed by or under the tion by a State or political subdivision, act. allow imposition of a requirement (3) Section 521(a) does not preempt which is different from, or in addition State or local permits, licensing, reg- to, any requirement applicable under istration, certification, or other re- the act to the device (and which is quirements relating to the approval or thereby preempted) by promulgating a sanction of the practice of medicine,

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dentistry, optometry, pharmacy, nurs- the statute, which may be identical to ing, podiatry, or any other of the heal- a provision in the act. ing arts or allied medical sciences or (7) Section 521(a) does not preempt related professions or occupations that State or local provisions respecting administer, dispense, or sell devices. delegations of authority and related However, regulations issued under sec- administrative matters relating to de- tion 520(e) or (g) of the act may impose vices. restrictions on the sale, distribution, (8) Section 521(a) does not preempt a or use of a device beyond those pre- State or local requirement whose sole scribed in State or local requirements. purpose is raising revenue or charging If there is a conflict between such re- fees for services, registration, or regu- strictions and State or local require- latory programs. ments, the Federal regulations shall (9) Section 521(a) does not preempt prevail. State or local requirements of the (4) Section 521(a) does not preempt types that have been developed under specifications in contracts entered into the Atomic Energy Act of 1954 (42 by States or localities for procurement U.S.C. 2011 note), as amended, Sub- of devices. chapter C—Electronic Product Radi- (5) Section 521(a) does not preempt ation Control of the Federal Food, criteria for payment of State or local Drug, and Cosmetic Act (formerly the obligations under Medicaid and similar Radiation Control for Health and Safe- Federal, State or local health-care pro- ty Act of 1968), and other Federal stat- grams. utes, until such time as the Food and (6)(i) Section 521(a) does not preempt Drug Administration issues specific re- State or local requirements respecting quirements under the Federal Food, general enforcement, e.g., require- Drug, and Cosmetic Act applicable to ments that State inspection be per- these types of devices. mitted of factory records concerning (10) Part 820 of this chapter (21 CFR all devices, registration, and licensing part 820) (CGMP requirements) does requirements for manufacturers and not preempt remedies created by others, and prohibition of manufacture States or Territories of the United of devices in unlicensed establish- States, the District of Columbia, or the ments. However, Federal regulations Commonwealth of Puerto Rico. issued under sections 519 and 520(f) of (e) It is the responsibility of the Food the act may impose requirements for and Drug Administration, subject to records and reports and good manufac- review by Federal courts, to determine turing practices beyond those pre- whether a State or local requirement is scribed in State or local requirements. equal to, or substantially identical to, If there is a conflict between such regu- requirements imposed by or under the lations and State or local require- act, or is different from, or in addition ments, the Federal regulations shall to, such requirements, in accordance prevail. with the procedures provided by this (ii) Generally, section 521(a) does not part. However, it is the responsibility preempt a State or local requirement of States and political subdivisions to prohibiting the manufacture of adul- determine initially whether to seek ex- terated or misbranded devices. Where, emptions from preemption. Any State however, such a prohibition has the ef- or political subdivision whose require- fect of establishing a substantive re- ments relating to devices are pre- quirement for a specific device, e.g., a empted by section 521(a) may petition specific labeling requirement, then the the Commissioner of Food and Drugs prohibition will be preempted if the re- for exemption from preemption, in ac- quirement is different from, or in addi- cordance with the procedures provided tion to, a Federal requirement estab- by this part. lished under the act. In determining (f) The Federal requirement with re- whether such a requirement is pre- spect to a device applies whether or not empted, the determinative factor is a corresponding State or local require- how the requirement is interpreted and ment is preempted or exempted from enforced by the State or local govern- preemption. As a result, if a State or ment and not the literal language of local requirement that the Food and

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Drug Administration has exempted (1) Such an advisory opinion may be from preemption is not as broad in its requested and may be granted in ac- application as the Federal require- cordance with § 10.85 of this chapter. ment, the Federal requirement applies (2) The Food and Drug Administra- to all circumstances not covered by the tion, in its discretion and after con- State or local requirement. sultation with the State or political subdivision, may treat a request by a [43 FR 18665, May 2, 1978, as amended at 45 State or political subdivision for an ad- FR 67336, Oct. 10, 1980; 61 FR 52654, Oct. 7, 1996; 73 FR 34859, June 19, 2008] visory opinion as an application for exemption from preemption under § 808.3 Definitions. § 808.20. (b) The Commissioner may issue an (a) Act means the Federal Food, advisory opinion relating to a State or Drug, and Cosmetic Act. local requirement on his own initiative (b) Compelling local conditions includes when he makes one of the following de- any factors, considerations, or cir- terminations: cumstances prevailing in, or char- (1) A requirement with respect to a acteristic of, the geographic area or device for which an application for ex- population of the State or political emption from preemption has been sub- subdivision that justify exemption mitted under § 808.20 is not preempted from preemption. by section 521(a) of the act because it (c) More stringent refers to a require- is: (i) Equal to or substantially iden- ment of greater restrictiveness or one tical to a requirement under the act that is expected to afford to those who applicable to the device, or (ii) is not a may be exposed to a risk of injury from requirement within the meaning of sec- a device a higher degree of protection tion 521 of the act and therefore is not than is afforded by a requirement ap- preempted; plicable to the device under the act. (2) A proposed State or local require- (d) Political subdivision or locality ment with respect to a device is not el- means any lawfully established local igible for exemption from preemption governmental unit within a State because the State or local requirement which unit has the authority to estab- has not been issued in final form. In lish or continue in effect any require- such a case, the advisory opinion may ment having the force and effect of law indicate whether the proposed require- with respect to a device intended for ment would be preempted and, if it human use. would be preempted, whether the Food (e) State means a State, American and Drug Administration would pro- Samoa, the Canal Zone, the Common- pose to grant an exemption from pre- wealth of Puerto Rico, the District of emption; Columbia, Guam, Johnston Island, (3) Issuance of such an advisory opin- Kingman Reef, Midway Island, the ion is in the public interest. Trust Territory of the Pacific Islands, the Virgin Islands, and Wake Island. Subpart B—Exemption Procedures (f) Substantially identical to refers to the fact that a State or local require- § 808.20 Application. ment does not significantly differ in ef- (a) Any State or political subdivision fect from a Federal requirement. may apply to the Food and Drug Ad- ministration for an exemption from § 808.5 Advisory opinions. preemption for any requirement that it (a) Any State, political subdivision, has enacted and that is preempted. An or other interested person may request exemption may only be granted for a an advisory opinion from the Commis- requirement that has been enacted, sioner with respect to any general mat- promulgated, or issued in final form by ter concerning preemption of State or the authorized body or official of the local device requirements or with re- State or political subdivision so as to spect to whether the Food and Drug have the force and effect of law. How- Administration regards particular ever, an application for exemption may State or local requirements, or probe submitted before the effective date posed requirements, as preempted. of the requirement.

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(b) An application for exemption (i) The requirement is more stringent shall be in the form of a letter to the than a requirement applicable to a de- Commissioner of Food and Drugs and vice under the act. If the State or po- shall be signed by an individual who is litical subdivision relies upon this authorized to request the exemption on basis for exemption from preemption, behalf of the State or political subdivi- the application shall include informa- sion. An original and two copies of the tion, data, or material showing how letter and any accompanying material, and why the requirement of the State as well as any subsequent reports or or political subdivision is more strin- correspondence concerning an applica- gent than requirements under the act. tion, shall be submitted to the Division (ii) The requirement is required by of Dockets Management (HFA–305), compelling local conditions, and com- Food and Drug Administration, 5630 pliance with the requirement would Fishers Lane, rm. 1061, Rockville, MD not cause the device to be in violation 20852. The outside wrapper of any appli- of any applicable requirement under cation, report, or correspondence the act. If the State or political sub- should indicate that it concerns an application for exemption from preemp- division relies upon this basis for ex- tion of device requirements. emption from preemption, the applica- (c) For each requirement for which tion shall include information, data, or an exemption is sought, the application material showing why compliance with shall include the following information the requirement of the State or polit- to the fullest extent possible, or an ex- ical subdivision would not cause a de- planation of why such information has vice to be in violation of any applicable not been included: requirement under the act and why the (1) Identification and a current copy requirement is required by compelling of any statute, rule, regulation, or or- local conditions. The application shall dinance of the State or political sub- also explain in detail the compelling division considered by the State or po- local conditions that justify the re- litical subdivision to be a requirement quirement. which is preempted, with a reference to (5) The title of the chief administra- the date of enactment, promulgation, tive or legal officers of that State or or issuance in final form. The applica- local agency that has primary respon- tion shall also include, where avail- sibility for administration of the re- able, copies of any legislative history quirement. or background materials pertinent to (6) When requested by the Food and enactment, promulgation, or issuance Drug Administration, any records con- of the requirement, including hearing cerning administration of any require- reports or studies concerning development which is the subject of an exemp- ment or consideration of the require- tion or an application for an exemption ment. If the requirement has been sub- from preemption. ject to any judicial or administrative (7) Information on how the public interpretations, the State or political health may be benefitted and how subdivision shall furnish copies of such interstate commerce may be affected, judicial or administrative interpreta- if an exemption is granted. tions. (8) Any other pertinent information (2) A comparison of the requirement respecting the requirement voluntarily of the State or political subdivision submitted by the applicant. and any applicable Federal requirements to show similarities and dif- (d) If litigation regarding applica- ferences. bility of the requirement is pending, (3) Information on the nature of the the State or political subdivision may problem addressed by the requirement so indicate in its application and re- of the State or political subdivision. quest expedited action on such applica- (4) Identification of which (or both) tion. of the following bases is relied upon for [43 FR 18665, May 2, 1978; 43 FR 22010, May 23, seeking an exemption from preemp- 1978, as amended at 49 FR 3646, Jan. 30, 1984; tion: 59 FR 14365, Mar. 28, 1994]

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§ 808.25 Procedures for processing an application shall be excluded from the application. administrative record of the hearing. (a) Upon receipt of an application for (f) If a request for hearing is not an exemption from preemption sub- timely made or a notice of appearance mitted in accordance with § 808.20, the is not filed pursuant to § 15.21 of this Commissioner shall notify the State or chapter, the Commissioner shall con- political subdivision of the date of such sider all written comments submitted receipt. and publish a final rule in accordance (b) If the Commissioner finds that an with paragraph (g) of this section. application does not meet the require- (g)(1) The Commissioner shall review ments of § 808.20, he shall notify the all written comments submitted on the State or political subdivision of the de- proposed rule and the administrative ficiencies in the application and of the record of the oral hearing, if an oral opportunity to correct such defi- hearing has been granted, and shall ciencies. A deficient application may publish in the FEDERAL REGISTER a be corrected at any time. final rule in subpart C of this part iden- (c) After receipt of an application tifying any requirement in the applica- meeting the requirements of § 808.20, tion for which exemption from preemp- the Commissioner shall review such ap- tion is granted, or conditionally grant- plication and determine whether to ed, and any requirement in the applica- grant or deny an exemption from pre- tion for which exemption from preemp- emption for each requirement which is tion is not granted. the subject of the application. The (2) The Commissioner may issue a Commissioner shall then issue in the regulation granting or conditionally FEDERAL REGISTER a proposed regula- granting an application for an exemption either to grant or to deny an ex- tion from preemption for any require- emption from preemption. The Com- ment if the Commissioner makes ei- missioner shall also issue in the FED- ther of the following findings: ERAL REGISTER a notice of opportunity (i) The requirement is more stringent to request an oral hearing before the than a requirement applicable to the Commissioner or the Commissioner’s device under the act; designee. (ii) The requirement is required by (d) A request for an oral hearing may compelling local conditions, and com- be made by the State or political sub- pliance with the requirement would division or any other interested person. not cause the device to be in violation Such request shall be submitted to the of any requirement applicable to the Division of Dockets Management with- device under the act. in the period of time prescribed in the (3) The Commissioner may not grant notice and shall include an explanation an application for an exemption from of why an oral hearing, rather than preemption for any requirement with submission of written comments only, respect to a device if the Commissioner is essential to the presentation of determines that the granting of an ex- views on the application for exemption emption would not be in the best inter- from preemption and the proposed reg- est of public health, taking into ac- ulation. count the potential burden on inter- (e) If a timely request for an oral state commerce. hearing is made, the Commissioner shall review such a request and may (h) An advisory opinion pursuant to grant a legislative-type informal oral § 808.5 or a regulation pursuant to para- hearing pursuant to part 15 of this graph (g) of this section constitutes final agency action. chapter by publishing in the FEDERAL REGISTER a notice of the hearing in ac- § 808.35 Revocation of an exemption. cordance with § 15.20 of this chapter. The scope of the oral hearing shall be (a) An exemption from preemption limited to matters relevant to the ap- pursuant to a regulation under this plication for exemption from preemp- part shall remain effective until the tion and the proposed regulation. Oral Commissioner revokes such exemption. or written presentations at the oral (b) The Commissioner may by regula- hearing which are not relevant to the tion, in accordance with § 808.25, revoke

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an exemption from preemption for any (b) Arizona Code of Revised Regula- of the following reasons: tions, Title 9, Article 3, sections R9–16– (1) An exemption may be revoked 303 and R9–16–304. upon the effective date of a newly established requirement under the act [45 FR 67336, Oct. 10, 1980] which, in the Commissioner’s view, addresses the objectives of an exempt re- § 808.55 California. quirement and which is described, (a) The following California medical when issued, as preempting a pre- device requirements are enforceable viously exempt State or local require- notwithstanding section 521 of the act ment. because the Food and Drug Adminis- (2) An exemption may be revoked tration exempted them from preemp- upon a finding that there has occurred tion under section 521(b) of the act: a change in the bases listed in Business and Professions Code sections § 808.20(c)(4) upon which the exemption 3365 and 3365.6. was granted. (b) The following California medical (3) An exemption may be revoked if it device requirements are preempted by is determined that a condition placed section 521 of the act, and FDA has de- on the exemption by the regulation under which the exemption was grant- nied them an exemption from preemp- ed has not been met or is no longer tion: being met. (1) Sherman Food, Drug, and Cos- (4) An exemption may be revoked if a metic Law (Division 21 of the Cali- State or local jurisdiction fails to sub- fornia Health and Safety Code), sec- mit records as provided in § 808.20(c)(6). tions 26207, 26607, 26614, 26615, 26618, (5) An exemption may be revoked if a 26631, 26640, and 26641, to the extent State or local jurisdiction to whom the that they apply to devices. exemption was originally granted re- (2) Sherman Food, Drug, and Cos- quests revocation. metic Law, section 26463(m) to the ex- (6) An exemption may be revoked if it tent that it applies to hearing aids. is determined that it is no longer in (3) Business and Professions Code sec- the best interests of the public health tion 2541.3, to the extent that it re- to continue the exemption. quires adoption of American National (c) An exemption that has been re- Standards Institute standards Z–80.1 voked may be reinstated, upon request and Z–80.2. from the State or political subdivision, if the Commissioner, in accordance [45 FR 67324, Oct. 10, 1980] with the procedures in § 808.25, determines that the grounds for revocation § 808.57 Connecticut. are no longer applicable except that The following Connecticut medical the Commissioner may permit abbre- device requirements are enforceable viated submissions of the documents notwithstanding section 521(a) of the and materials normally required for an act because the Food and Drug Admin- application for exemption under istration has exempted them from pre- § 808.20. emption under section 521(b) of the act: Connecticut General Statutes, sections Subpart C—Listing of Specific 20–403 and 20–404. State and Local Exemptions [45 FR 67336, Oct. 10, 1980] § 808.53 Arizona. § 808.59 Florida. The following Arizona medical device requirements are preempted by section The following Florida medical device 521(a) of the act, and the Food and requirements are preempted by section Drug Administration has denied them 521(a) of the act, and the Food and exemptions from preemption under sec- Drug Administration has denied them tion 521(b) of the act: an exemption from preemption under (a) Arizona Revised Statutes, Chap- section 521(b) of the act: ter 17, sections 36–1901.7(s) and 36– (a) Florida Statutes, section 1901.7(t). 468.135(5).

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(b) Florida Administrative Code, section 521(b) of the act: Maine Revised tion 10D–48.25(26). Statutes Annotated, Title 32, section 1658–D and the last sentence of section [45 FR 67336, Oct. 10, 1980] 1658–E. § 808.61 Hawaii. [45 FR 67336, Oct. 10, 1980] (a) The following Hawaii medical device requirements are enforceable not- § 808.71 Massachusetts. withstanding section 521 of the act, be- (a) The following Massachusetts med- cause the Food and Drug Administra- ical device requirements are enforce- tion has exempted them from preemp- able notwithstanding section 521 of the tion under section 521(b) of the act: Ha- act because the Food and Drug Admin- waii Revised Statutes, chapter 451A, istration has exempted them from pre- § 14.1, subsection (a) with respect to emption under section 521(b) of the act: medical examination of a child 10 years (1) Massachusetts General Laws, of age or under, and subsection (c). Chapter 93, Section 72, to the extent (b) The following Hawaii medical de- that it requires a hearing test evalua- vice requirements are preempted by tion for a child under the age of 18. section 521(a) of the act, and the Food (2) Massachusetts General Laws, and Drug Administration has denied Chapter 93, Section 74, except as pro- them exemption from preemption: Ha- vided in paragraph (6) of the Section, waii Revised Statutes, chapter 451A, on the condition that, in enforcing this § 14.1, subsection (a) to the extent that requirement, Massachusetts apply the it requires a written authorization by a definition of ‘‘used hearing aid’’ in physician and does not allow adults to § 801.420(a)(6) of this chapter. waive this requirement for personal, as (b) The following Massachusetts med- well as religious reasons, and sub- ical device requirements are preempted section (b). by section 521(a) of the act, and the Food and Drug Administration has de- [50 FR 30699, July 29, 1985; 50 FR 32694, Aug. 14, 1985] nied them exemptions from preemption under section 521(b) of the act. § 808.67 Kentucky. (1) Massachusetts General Laws, Chapter 93, Section 72, except as pro- The following Kentucky medical de- vided in paragraph (a) of this section. vice requirement is preempted by sec- (2) Massachusetts General Laws, tion 521(a) of the act, and the Food and Chapter 93, Section 74, to the extent Drug Administration has denied it an that it requires that the sales receipt exemption from preemption under sec- contain a statement that State law re- tion 521(b) of the act: Kentucky Re- quires a medical examination and a vised Statutes, section 334.200(1). hearing test evaluation before the sale [45 FR 67336, Oct. 10, 1980] of a hearing aid. § 808.69 Maine. [45 FR 67326, Oct. 10, 1980] (a) The following Maine medical de- § 808.73 Minnesota. vice requirement is enforceable not- The following Minnesota medical de- withstanding section 521(a) of the act vice requirements are preempted by because the Food and Drug Adminis- section 521(a) of the act, and the Food tration has exempted it from preemp- and Drug Administration has denied tion under section 521(b) of the act: them an exemption from preemption Maine Revised Statutes Annotated, under section 521(b) of the act: Min- Title 32, section 1658–C, on the condi- nesota Statutes, sections 145.43 and tion that, in enforcing this require- 145.44. ment, Maine apply the definition of ‘‘used hearing aid’’ in § 801.420(a)(6) of [45 FR 67336, Oct. 10, 1980] this chapter. (b) The following Maine medical de- § 808.74 Mississippi. vice requirement is preempted by sec- The following Mississippi medical de- tion 521(a) of the act, and the Food and vice requirement is preempted by sec- Drug Administration has denied it an tion 521(a) of the act, and the Food and exemption from preemption under sec- Drug Administration has denied it an

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exemption from preemption under sec- § 808.81 New Mexico. tion 521(b) of the act: Mississippi Code, The following New Mexico medical section 73–14–3(g)(9). device requirement is enforceable not- [45 FR 67336, Oct. 10, 1980] withstanding section 521(a) of the act because the Food and Drug Adminis- § 808.77 Nebraska. tration has exempted it from preemp- (a) The following Nebraska medical tion under section 521(b) of the act: device requirement is enforceable not- New Mexico Statutes Annotated, sec- withstanding section 521(a) of the act tion 67–36–16(F). because the Food and Drug Adminis- [45 FR 67337, Oct. 10, 1980] tration has exempted it from preemption under section 521(b) of the act: Ne- § 808.82 New York. braska Revised Statutes, section 71– (a) The following New York medical 4712(2)(c)(vi). device requirements are enforceable (b) The following Nebraska medical notwithstanding section 521(a) of the device requirement is preempted by act because the Food and Drug Admin- section 521(a) of the act, and the Food istration has exempted them from pre- and Drug Administration has denied it emption under section 521(b) of the act: an exemption from preemption under (1) General Business Law, Article 37, section 521(b) of the act: Nebraska Re- sections 784(3) and (4). vised Statutes, section 71– (2) Official Compilation of Codes, 4712(2)(c)(vii). Rules and Regulations of the State of [45 FR 67336, Oct. 10, 1980] New York, Chapter V, Title 19, Sub- chapter G, section 191.10 and section § 808.80 New Jersey. 191.11(a) on the condition that, in en- (a) The following New Jersey medical forcing these requirements, New York device requirements are enforceable apply the definition of ‘‘used hearing notwithstanding section 521(a) of the aid’’ in § 801.420(a)(6) of this chapter and act because the Food and Drug Admin- section 191.11(b), (c), (d), and (e). istration has exempted them from pre- (b) The following New York medical emption under section 521(b) of the act: device requirements are preempted by (1) New Jersey Statutes Annotated, section 521(a) of the act, and the Food section 45:9A–23 on the condition that, and Drug Administration has denied in enforcing this requirement, New Jer- them an exemptions from preemption sey apply the definition of ‘‘used hear- under section 521(b) of the act: ing aid’’ in § 801.420(a)(6) of this chap- (1) General Business Law, Article 37, ter; section 784.1. (2) New Jersey Statutes Annotated, (2) Official Compilation of Codes, sections 45:9A–24 and 45:9A–25; Rules and Regulations of the State of (3) Chapter 3, Section 5 of the Rules New York, Chapter V, Title 19, Sub- and Regulations adopted pursuant to chapter G, sections 191.6, 191.7, 191.8, New Jersey Statutes Annotated 45:9A–1 and 191.9. et seq. except as provided in paragraph [45 FR 67337, Oct. 10, 1980] (b) of this section. (b) The following New Jersey medical § 808.85 Ohio. device requirement is preempted by (a) The following Ohio medical device section 521(a) of the act, and the Food requirement is enforceable notwith- and Drug Administration has denied it standing section 521(a) of the act be- an exemption from preemption under cause the Food and Drug Administra- section 521(b) of the act: Chapter 3, tion has exempted it from preemption Section 5 of the Rules and Regulations under section 521(b) of the act: Ohio adopted pursuant to New Jersey Stat- Revised Code, section 4747.09, the first utes Annotated 45:9A–1 et seq. to the ex- two sentences with respect to disclo- tent that it requires testing to be con- sure of information to purchasers on ducted in an environment which meets the condition that, in enforcing these or exceeds the American National requirements, Ohio apply the definition Standards Institute S3.1 Standard. of ‘‘used hearing aid’’ in § 801.420(a)(6) [45 FR 67337, Oct. 10, 1980] of this chapter.

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(b) The following Ohio medical device § 808.89 Rhode Island. requirement is preempted by section The following Rhode Island medical 521(a) of the act, and the Food and device requirements are preempted by Drug Administration has denied it an section 521(a) of the act, and the Food exemption from preemption under sec- and Drug Administration has denied tion 521(b) of the act: Ohio Revised them an exemption from preemption Code, section 4747.09, the last two sen- under section 521(b) of the act: Rhode tences with respect to medical exam- Island General Laws, Section 5–49–2.1, ination of children. and Section 2.2, to the extent that Sec- [45 FR 67337, Oct. 10, 1980] tion 2.2 requires hearing aid dispensers to keep copies of the certificates of § 808.87 Oregon. need. (a) The following Oregon medical de- [45 FR 67337, Oct. 10, 1980] vice requriements are enforceable notwithstanding section 521(a) of the act § 808.93 Texas. because the Food and Drug Adminis- (a) The following Texas medical de- tration has exempted them from pre- vice requirement is enforceable not- emption under section 521(b) of the act: withstanding section 521(a) of the act Oregon Revised Statutes, section because the Food and Drug Adminis- 694.036 on the condition that, in enforc- tration has exempted it from preemp- ing this requirement, Oregon apply the tion under section 521(b) of the act: definition of ‘‘used hearing aid’’ in Vernon’s Civil Statutes, Article 4566, § 801.420(a)(6) of this chapter. section 14(b) on the condition that, in (b) The following Oregon medical de- enforcing this requirement, Texas vice requirements are preempted by apply the definition of ‘‘used hearing section 521(a) of the act, and the Food aid’’ in § 801.420(a)(6) of this chapter. and Drug Administration has denied (b) The following Texas medical de- them exemptions from preemption vice requirement is preempted by sec- under section 521(b) of the act: Oregon tion 521(a) of the act, and the Food and Revised Statutes, sections 694.136(6) Drug Administration has denied it an and (7). exemption from preemption under sec- [45 FR 67337, Oct. 10, 1980, as amended at 53 tion 521(b) of the act: Vernon’s Civil FR 11252, Apr. 6, 1988] Statutes, Article 4566, section 14(d). [45 FR 67337, Oct. 10, 1980] § 808.88 Pennsylvania. (a) The following Pennsylvania med- § 808.97 Washington. ical device requirements are enforce- (a) The following Washington med- able notwithstanding section 521(a) of ical device requirement is enforceable the act because the Food and Drug Ad- notwithstanding section 521(a) of the ministration has exempted them from act because the Food and Drug Admin- preemption under section 521(b) of the istration has exempted it from preemp- act: 35 Purdon’s Statutes 6700, section tion under section 521(b) of the act: Re- 504(4) on the condition that, in enforc- vised Code of Washington 18.35.110(2)(e) ing this requirement, Pennsylvania (i) and (iii) on the condition that it is apply the definition of ‘‘used hearing enforced in addition to the applicable aid’’ in § 801.420(a)(6) of this chapter; requirements of this chapter. section 506; and, section 507(2). (b) The following Washington med- (b) The following Pennsylvania medical device requirements are preempted ical device requirement is preempted by section 521(a) of the act, and the by section 521(a) of the act and the Food and Drug Administration has de- Food and Drug Administration has denied them an exemption from preemp- nied it an exemption from preemption tion under section 521(b) of the act: Re- under section 521(b) of the act: 35 vised Code of Washington Purdon’s Statutes 6700, section 402. 18.35.110(2)(e)(ii). [45 FR 67326, Oct. 10, 1980] [45 FR 67337, Oct. 10, 1980]

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§ 808.98 West Virginia. Subpart B—Labeling (a) The following West Virginia med- 809.10 Labeling for in vitro diagnostic prod- ical device requirements are enforce- ucts. able notwithstanding section 521(a) of 809.11 Exceptions or alternatives to labeling the act because the Food and Drug Ad- requirements for in vitro diagnostic products for human use held by the Stra- ministration has exempted them from tegic National Stockpile. preemption: West Virginia Code, sections 30–26–14 (b) and (c) and section 30– Subpart C—Requirements for 26–15(a) on the condition that in enforc- Manufacturers and Producers ing section 30–26–15(a) West Virginia apply the definition of ‘‘used hearing 809.20 General requirements for manufac- aid’’ in § 801.420(a)(6) of this chapter. turers and producers of in vitro diagnostic products. (b) The following West Virginia med- 809.30 Restrictions on the sale, distribution ical device requirement is preempted and use of analyte specific reagents. by section 521(a) of the act, and the 809.40 Restrictions on the sale, distribution, Food and Drug Administration has de- and use of OTC test sample collection nied it an exemption from preemption systems for drugs of abuse testing. under section 521(b) of the act: West AUTHORITY: 21 U.S.C. 331, 351, 352, 355, 360b, Virginia Code, section 30–26–14(a). 360c, 360d, 360h, 360i, 360j, 371, 372, 374, 381. [45 FR 67337, Oct. 10, 1980, as amended at 53 FR 35314, Sept. 13, 1988] Subpart A—General Provisions

§ 808.101 District of Columbia. § 809.3 Definitions. (a) In vitro diagnostic products are (a) The following District of Colum- those reagents, instruments, and sys- bia medical device requirements are tems intended for use in the diagnosis enforceable, notwithstanding section of disease or other conditions, includ- 521 of the act, because the Food and ing a determination of the state of Drug Administration has exempted health, in order to cure, mitigate, them from preemption under section treat, or prevent disease or its 521(b) of the act: sequelae. Such products are intended (1) Act 2–79, section 5, to the extent for use in the collection, preparation, that it requires an audiological evalua- and examination of specimens taken tion for children under the age of 18. from the human body. These products (2) Act 2–79, section 6, on the condi- are devices as defined in section 201(h) tion that in enforcing section 6(a)(5), of the Federal Food, Drug, and Cos- the District of Columbia apply the defi- metic Act (the act), and may also be bi- nition of ‘‘used hearing aid’’ in ological products subject to section 351 § 801.420(a)(6) of this chapter. of the Public Health Service Act. (b) The following District of Colum- (b) A product class is all those prod- bia medical device requirement is pre- ucts intended for use for a particular empted by section 521(a) of the act, and determination or for a related group of the Food and Drug Administration has determinations or products with com- denied it an exemption from preemp- mon or related characteristics or those tion under section 521(b) of the act: Act intended for common or related uses. A 2–79, section 5, except as provided in class may be further divided into sub- paragraph (a) of this section. classes when appropriate. [46 FR 59236, Dec. 4, 1981] (c) [Reserved] (d) Act means the Federal Food, Drug, and Cosmetic Act. PART 809—IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE [41 FR 6903, Feb. 13, 1976, as amended at 45 FR 7484, Feb. 1, 1980]

Subpart A—General Provisions § 809.4 Confidentiality of submitted information. Sec. 809.3 Definitions. Data and information submitted 809.4 Confidentiality of submitted informa- under § 809.10(c) that are shown to fall tion. within the exemption established in

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§ 20.61 of this chapter shall be treated use of the product. The limiting state- as confidential by the Food and Drug ment appropriate to the intended use Administration and any person to of a prescription in vitro diagnostic whom the data and information are re- product shall bear the symbol state- ferred. The Food and Drug Administra- ment ‘‘Rx only’’ or ‘‘) only’’ or the tion will determine whether informa- statement ‘‘Caution: Federal law re- tion submitted will be treated as con- stricts this device to sale by or on the fidential in accordance with the provi- order of a lll’’, the blank to be filled sions of part 20 of this chapter. with the word ‘‘physician’’, ‘‘dentist’’, [45 FR 7484, Feb. 1, 1980] ‘‘veterinarian’’, or with the descriptive designation of any other practitioner licensed by the law of the State in Subpart B—Labeling which the practitioner practices to use § 809.10 Labeling for in vitro diag- or order the use of the device. nostic products. (5) For a reagent, appropriate storage instructions adequate to protect the (a) The label for an in vitro diag- stability of the product. When applica- nostic product shall state the following ble, these instructions shall include information, except where such infor- such information as conditions of tem- mation is not applicable, or as otherwise specified in a standard for a par- perature, light, humidity, and other ticular product class or as provided in pertinent factors. For products requir- paragraph (e) of this section. Section ing manipulation, such as reconstitu- 201(k) of the act provides that ‘‘a re- tion and/or mixing before use, appro- quirement made by or under authority priate storage instructions shall be of this act that any word, statement, provided for the reconstituted or mixed or other information appear on the product which is to be stored in the label shall not be considered to be com- original container. The basis for such plied with unless such word, statement, instructions shall be determined by re- or other information also appears on liable, meaningful, and specific test the outside container or wrapper, if methods such as those described in any there be, of the retail package of § 211.166 of this chapter. such article, or is easily legible (6) For a reagent, a means by which through the outside container or wrap- the user may be assured that the prod- per.’’ uct meets appropriate standards of (1) The proprietary name and estab- identity, strength, quality and purity lished name (common or usual name), at the time of use. This shall be pro- if any. vided, both for the product as provided (2) The intended use or uses of the and for any resultant reconstituted or product. mixed product, by including on the (3) For a reagent, a declaration of the label one or more of the following: established name (common or usual (i) An expiration date based upon the name), if any, and quantity, proportion stated storage instructions. or concentration of each reactive in- (ii) A statement of an observable ingredient; and for a reagent derived dication of an alteration of the prod- from biological material, the source uct, e.g., turbidity, color change, pre- and a measure of its activity. The cipitate, beyond its appropriate stand- quantity, proportion, concentration, or ards. activity shall be stated in the system (iii) Instructions for a simple method generally used and recognized by the by which the user can reasonably de- intended user, e.g., metric, inter- termine that the product meets its ap- national units, etc. propriate standards. (4) A statement of warnings or pre- (7) For a reagent, a declaration of the cautions for users as established in the net quantity of contents, expressed in regulations contained in 16 CFR part terms of weight or volume, numerical 1500 and any other warnings appro- count, or any combination of these or priate to the hazard presented by the other terms which accurately reflect product; and a statement ‘‘For In Vitro the contents of the package. The use of Diagnostic Use’’ and any other limiting metric designations is encouraged, statements appropriate to the intended wherever appropriate. If more than a

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single determination may be performed limited to that information necessary using the product, any statement of to identify the reagent adequately and the number of tests shall be consistent to describe its proper use in the sys- with instructions for use and amount tem. of material provided. (1) The proprietary name and estab- (8) Name and place of business of lished name, i.e., common or usual manufacturer, packer, or distributor. name, if any. (9) A lot or control number, identi- (2) The intended use or uses of the fied as such, from which it is possible product and the type of procedure, e.g., to determine the complete manufac- qualitative or quantitative. turing history of the product. (3) Summary and explanation of the (i) If it is a multiple unit product, the test. Include a short history of the lot or control number shall permit methodology, with pertinent references tracing the identity of the individual and a balanced statement of the special units. merits and limitations of this method (ii) For an instrument, the lot or con- or product. If the product labeling re- trol number shall permit tracing the fers to any other procedure, appro- identity of all functional subassem- priate literature citations shall be in- blies. cluded and the labeling shall explain (iii) For multiple unit products which the nature of any differences from the require the use of included units to- original and their effect on the results. gether as a system, all units should (4) The chemical, physical, physio- bear the same lot or control number, if logical, or biological principles of the appropriate, or other suitable uniform procedure. Explain concisely, with identification should be used. chemical reactions and techniques in- (10) Except that for items in para- volved, if applicable. graphs (a) (1) through (9) of this sec- (5) Reagents: tion: (i) In the case of immediate con- (i) A declaration of the established tainers too small or otherwise unable name (common or usual name), if any, to accommodate a label with sufficient and quantity, proportion or concentra- space to bear all such information and tion or each reactive ingredient; and which are packaged within an outer for biological material, the source and container from which they are removed a measure of its activity. The quantity, for use, the information required by proportion, concentration or activity paragraphs (a) (2), (3), (4), (5), (6) (ii), shall be stated in the system generally (iii) and (7) of this section may appear used and recognized by the intended in the outer container labeling only. user, e.g., metric, international units, (ii) In any case in which the presence etc. A statement indicating the pres- of this information on the immediate ence of and characterizing any cata- container will interfere with the test, lytic or nonreactive ingredients, e.g., the information may appear on the buffers, preservatives, stabilizers. outside container or wrapper rather (ii) A statement of warnings or pre- than on the immediate container label. cautions for users as established in the (b) Labeling accompanying each regulations contained in 16 CFR part product, e.g., a package insert, shall 1500 and any other warnings appro- state in one place the following infor- priate to the hazard presented by the mation in the format and order speci- product; and a statement ‘‘For In Vitro fied below, except where such informa- Diagnostic Use’’ and any other limiting tion is not applicable, or as specified in statements appropriate to the intended a standard for a particular product use of the product. The limiting state- class. The labeling for a multiple-pur- ment appropriate to the intended use pose instrument used for diagnostic of a prescription in vitro diagnostic purposes, and not committed to spe- product shall bear the symbol state- cific diagnostic procedures or systems, ment ‘‘Rx only’’ or ‘‘) only’’ or the may bear only the information indi- statement ‘‘Caution: Federal law re- cated in paragraphs (b) (1), (2), (6), (14), stricts this device to sale by or on the and (15) of this section. The labeling for order of a lll’’, the blank to be filled a reagent intended for use as a replace- with the word ‘‘physician’’, ‘‘dentist’’, ment in a diagnostic system may be ‘‘veterinarian’’, or with the descriptive

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designation of any other practitioner results. List any points that may be licensed by the law of the State in useful in improving precision and accu- which the practitioner practices to use racy. or order the use of the device. (i) A list of all materials provided, (iii) Adequate instructions for recon- e.g., reagents, instruments and equip- stitution, mixing, dilution, etc. ment, with instructions for their use. (iv) Appropriate storage instructions (ii) A list of all materials required adequate to protect the stability of the but not provided. Include such details product. When applicable, these in- as sizes, numbers, types, and quality. structions shall include such informa- (iii) A description of the amounts of tion as conditions of temperature, reagents necessary, times required for light, humidity, and other pertinent specific steps, proper temperatures, factors. For products requiring manip- wavelengths, etc. ulation, such as reconstitution and/or (iv) A statement describing the sta- mixing before use, appropriate storage bility of the final reaction material to instructions shall be provided for the be measured and the time within which reconstituted or mixed product. The it shall be measured to assure accurate basis for such instructions shall be de- results. termined by reliable, meaningful, and specific test methods such as those de- (v) Details of calibration: Identify scribed in § 211.166 of this chapter. reference material. Describe prepara- (v) A statement of any purification tion of reference sample(s), use of or treatment required for use. blanks, preparation of the standard (vi) Physical, biological, or chemical curve, etc. The description of the range indications of instability or deteriora- of calibration should include the high- tion. est and the lowest values measurable (6) Instruments: by the procedure. (i) Use or function. (vi) Details of kinds of quality con- (ii) Installation procedures and spe- trol procedures and materials required. cial requirements. If there is need for both positive and (iii) Principles of operation. negative controls, this should be stat- (iv) Performance characteristics and ed. State what are considered satisfac- specifications. tory limits of performance. (v) Operating instructions. (9) Results: Explain the procedure for (vi) Calibration procedures including calculating the value of the unknown. materials and/or equipment to be used. Give an explanation for each compo- (vii) Operational precautions and nent of the formula used for the cal- limitations. culation of the unknown. Include a (viii) Hazards. sample calculation, step-by-step, ex- (ix) Service and maintenance infor- plaining the answer. The values shall mation. be expressed to the appropriate number (7) Specimen collection and prepara- of significant figures. If the test pro- tion for analysis, including a descrip- vides other than quantitative results, tion of: provide an adequate description of ex- (i) Special precautions regarding pected results. specimen collection including special (10) Limitation of the procedure: In- preparation of the patient as it bears clude a statement of limitations of the on the validity of the test. procedure. State known extrinsic fac- (ii) Additives, preservatives, etc., tors or interfering substances affecting necessary to maintain the integrity of results. If further testing, either more the specimen. specific or more sensitive, is indicated (iii) Known interfering substances. in all cases where certain results are (iv) Recommended storage, handling obtained, the need for the additional or shipping instructions for the protec- test shall be stated. tion and maintenance of stability of (11) Expected values: State the the specimen. range(s) of expected values as obtained (8) Procedure: A step-by-step outline with the product from studies of var- of recommended procedures from re- ious populations. Indicate how the ception of the specimen to obtaining range(s) was established and identify

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the population(s) on which it was es- quired by § 809.10(a) and (b), if their la- tablished. beling meets the requirements of this (12) Specific performance characteris- paragraph. tics: Include, as appropriate, informa- (1) The label of a reagent shall bear tion describing such things as accu- the following information: racy, precision, specificity, and sensi- (i) The proprietary name and estab- tivity. These shall be related to a gen- lished name (common or usual name), erally accepted method using biologi- if any, of the reagent. cal specimens from normal and abnor- (ii) A declaration of the established mal populations. Include a statement name (common or usual name), if any, summarizing the data upon which the and quantity, proportion or concentra- specific performance characteristics tion of the reagent ingredient (e.g., hy- are based. drochloric acid: Formula weight 36.46, (13) Bibliography: Include pertinent assay 37.9 percent, specific gravity 1.192 references keyed to the text. at 60 °F); and for a reagent derived (14) Name and place of business of from biological material, the source manufacturer, packer, or distributor. and where applicable a measure of its (15) Date of issuance of the last revi- activity. The quantity, proportion, sion of the labeling identified as such. concentration or activity shall be stat- (c) A shipment or other delivery of an ed in the system generally used and in vitro diagnostic product shall be ex- recognized by the intended user, e.g., empt from the requirements of para- metric, international units, etc. graphs (a) and (b) of this section and from a standard promulgated under (iii) A statement of the purity and part 861 provided that the following quality of the reagent, including a conditions are met: quantitative declaration of any impuri- (1) In the case of a shipment or deliv- ties present. The requirement for this ery for an investigation subject to part information may be met by a state- 812, if there has been compliance with ment of conformity with a generally part 812; or recognized and generally available (2) In the case of a shipment or deliv- standard which contains the same in- ery for an investigation that is not formation, e.g., those established by subject to part 812 (see § 812.2(c)), if the the American Chemical Society, U.S. following conditions are met: Pharmacopeia, National Formulary, (i) For a product in the laboratory re- National Research Council. search phase of development, and not (iv) A statement of warnings or pre- represented as an effective in vitro di- cautions for users as established in the agnostic product, all labeling bears the regulations contained in 16 CFR part statement, prominently placed: ‘‘For 1500 and any other warnings appro- Research Use Only. Not for use in diag- priate to the hazard presented by the nostic procedures.’’ product; and a statement ‘‘For Labora- (ii) For a product being shipped or de- tory Use.’’ livered for product testing prior to full (v) Appropriate storage instructions commercial marketing (for example, adequate to protect the stability of the for use on specimens derived from hu- product. When applicable, these in- mans to compare the usefulness of the structions shall include such informa- product with other products or proce- tion as conditions of temperature, dures which are in current use or rec- light, humidity, and other pertinent ognized as useful), all labeling bears factors. The basis for such information the statement, prominently placed: shall be determined by reliable, mean- ‘‘For Investigational Use Only. The ingful, and specific test methods such performance characteristics of this as those described in § 211.166 of this product have not been established.’’ chapter. (d) The labeling of general purpose (vi) A declaration of the net quantity laboratory reagents (e.g., hydrochloric of contents, expressed in terms of acid) and equipment (e.g., test tubes weight or volume, numerical count, or and pipettes) whose uses are generally any combination of these or other known by persons trained in their use terms which accurately reflect the con- need not bear the directions for use re- tents of the package. The use of metric

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designations is encouraged, wherever position, nucleic acid sequence, binding appropriate. affinity, cross-reactivities, and inter- (vii) Name and place of business of action with substances of known clin- manufacturer, packer, or distributor. ical significance; (viii) A lot or control number, identi- (v) A statement of warnings or pre- fied as such, from which it is possible cautions for users as established in the to determine the complete manufac- regulations contained in 16 CFR part turing history of the product. 1500 and any other warnings appro- (ix) In the case of immediate con- priate to the hazard presented by the tainers too small or otherwise unable product; to accommodate a label with sufficient (vi) The date of manufacture and ap- space to bear all such information, and propriate storage instructions ade- which are packaged within an outer quate to protect the stability of the container from which they are removed product. When applicable, these infor use, the information required by structions shall include such informa- paragraphs (d)(1)(ii), (iii), (iv), (v), and tion as conditions of temperature, (vi) of this section may appear in the light, humidity, date of expiration, and outer container labeling only. other pertinent factors. The basis for (2) The label of general purpose lab- such instructions shall be determined oratory equipment, e.g., a beaker or a by reliable, meaningful, and specific pipette, shall bear a statement ade- test methods, such as those described quately describing the product, its in § 211.166 of this chapter; composition, and physical characteris- (vii) A declaration of the net quan- tics if necessary for its proper use. tity of contents, expressed in terms of (e)(1) The labeling for analyte spe- weight or volume, numerical count, or cific reagents (e.g., monoclonal anti- any combination of these or other bodies, deoxyribonucleic acid (DNA) terms that accurately reflect the con- probes, viral antigens, ligands) shall tents of the package. The use of metric bear the following information: designations is encouraged, wherever (i) The proprietary name and established name (common or usual name), appropriate; if any, of the reagent; (viii) The name and place of business (ii) A declaration of the established of manufacturer, packer, or dis- name (common or usual name), if any; tributor; (iii) The quantity, proportion, or con- (ix) A lot or control number, identi- centration of the reagent ingredient; fied as such, from which it is possible and for a reagent derived from biologi- to determine the complete manufac- cal material, the source and where ap- turing history of the product; plicable, a measure of its activity. The (x) For class I exempt ASR’s, the quantity, proportion, concentration, or statement: ‘‘Analyte Specific Reagent. activity shall be stated in the system Analytical and performance character- generally used and recognized by the istics are not established’’; and intended user, e.g., metric, inter- (xi) For class II and III ASR’s, the national units, etc.; statement: ‘‘Analyte Specific Reagent. (iv) A statement of the purity and Except as a component of the approved/ quality of the reagent, including a cleared test (Name of approved/cleared quantitative declaration of any impuri- test), analytical and performance char- ties present and method of analysis or acteristics of this ASR are not estab- characterization. The requirement for lished.’’ this information may be met by a (2) In the case of immediate con- statement of conformity with a gen- tainers too small or otherwise unable erally recognized and generally avail- to accommodate a label with sufficient able standard that contains the same space to bear all such information, and information, e.g., those established by which are packaged within an outer the American Chemical Society, U.S. container from which they are removed Pharmacopeia, National Formulary, for use, the information required by and National Research Council. The la- paragraphs (e)(1) through (e)(6) of this beling may also include information section may appear in the outer con- concerning chemical/molecular com- tainer labeling only.

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(f) The labeling for over-the-counter age containing the device bears a (OTC) test sample collection systems prominent and conspicuous statement for drugs of abuse testing shall bear identifying the location of the symbols the following information in language glossary that is written in English or, appropriate for the intended users: in the case of articles distributed sole- (1) Adequate instructions for speci- ly in Puerto Rico or in a Territory men collection and handling, and for where the predominant language is one preparation and mailing of the speci- other than English, the predominant men to the laboratory for testing. language may be used; (2) An identification system to en- (iii) A symbol not accompanied by sure that specimens are not mixed up adjacent explanatory text that: or otherwise misidentified at the lab- (A) Is established in a standard devel- oratory, and that user anonymity is oped by a standards development orga- maintained. nization (SDO); (3) The intended use or uses of the (B) Is not contained in a standard product, including what drugs are to be that is recognized by FDA under its au- identified in the specimen, a quan- thority in section 514(c) of the act or is titative description of the performance contained in a standard that is recog- characteristics for those drugs (e.g., nized by FDA but is not used according sensitivity and specificity) in terms to the specifications for use of the sym- understandable to lay users, and the bol set forth in FDA’s section 514(c) detection period. recognition; (4) A statement that confirmatory (C) Is determined by the manufac- testing will be conducted on all sam- turer to be likely to be read and under- ples that initially test positive. stood by the ordinary individual under (5) A statement of warnings or pre- customary conditions of purchase and cautions for users as established in the use in compliance with section 502(c) of regulations contained in 16 CFR part the act; 1500 and any other warnings appropriate to the hazard presented by the (D) Is used according to the specifica- product. tions for use of the symbol set forth in (6) Adequate instructions on how to the SDO-developed standard; and obtain test results from a person who (E) Is explained in a paper or elec- can explain their meaning, including tronic symbols glossary that is in- the probability of false positive and cluded in the labeling for the device false negative results, as well as how to and the labeling on or within the pack- contact a trained health professional if age containing the device bears a additional information on interpreta- prominent and conspicuous statement tion of test results from the laboratory identifying the location of the symbols or followup counseling is desired. glossary that is written in English or, (7) Name and place of business of the in the case of articles distributed sole- manufacturer, packer, or distributor. ly in Puerto Rico or in a Territory (g)(1) The applicant may provide the where the predominant language is one labeling information referenced in this other than English, the predominant section in the form of: language may be used; or (i) A symbol accompanied by explan- (iv) The symbol statement ‘‘Rx only’’ atory text adjacent to the symbol; or ‘‘) only’’ used as provided under (ii) A symbol not accompanied by ad- paragraphs (a)(4) and (b)(5)(ii) of this jacent explanatory text that: section. (A) Is contained in a standard that (2) The use of symbols in device la- FDA recognizes under its authority in beling which do not meet the require- section 514(c) of the act; ments of paragraph (g)(1) of this sec- (B) Is used according to the specification renders a device misbranded under tions for use of the symbol set forth in section 502(c) of the act. FDA’s section 514(c) recognition; and (3) For purposes of paragraph (g)(1) of (C) Is explained in a paper or elec- this section: tronic symbols glossary that is in- (i) An SDO is an organization that is cluded in the labeling for the device nationally or internationally recog- and the labeling on or within the pack- nized and that follows a process for

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standard development that is trans- product for human use that is or will parent, (i.e., open to public scrutiny), be included in the Strategic National where the participation is balanced, Stockpile may submit, with written where an appeals process is included, concurrence from a Strategic National where the standard is not in conflict Stockpile official, a written request for with any statute, regulation, or policy an exception or alternative described under which FDA operates, and where in paragraph (a) of this section to the the standard is national or inter- Center Director. national in scope. (ii) The Center Director may grant (ii) The term ‘‘symbols glossary’’ an exception or alternative described means a compiled listing of: in paragraph (a) of this section on his (A) Each SDO-established symbol or her own initiative. used in the labeling for the device; (2) A written request for an exception (B) The title and designation number or alternative described in paragraph of the SDO-developed standard con- (a) of this section must: taining the symbol; (i) Identify the specified lots, (C) The title of the symbol and its batches, or other units of an in vitro reference number, if any, in the stand- diagnostic product for human use that ard; and would be subject to the exception or al- (D) The meaning or explanatory text ternative; for the symbol as provided in the FDA (ii) Identify the labeling provision(s) recognition or, if FDA has not recog- listed in paragraph (f) of this section nized the standard or portion of the that are the subject of the exception or standard in which the symbol is lo- alternative request; cated or the symbol is not used accord- (iii) Explain why compliance with ing to the specifications for use of the such labeling provision(s) could ad- symbol set forth in FDA’s section versely affect the safety, effectiveness, 514(c) recognition, the explanatory text or availability of the specified lots, as provided in the standard. batches, or other units of the in vitro [41 FR 6903, Feb. 13, 1976, as amended at 45 diagnostic product for human use that FR 3750, Jan. 18, 1980; 45 FR 7484, Feb. 1, 1980; are or will be held in the Strategic Na- 47 FR 41107, Sept. 17, 1982; 47 FR 51109, Nov. tional Stockpile; 12, 1982; 48 FR 34470, July 29, 1983; 62 FR 62259, (iv) Describe any proposed safeguards Nov. 21, 1997; 65 FR 18234, Apr. 7, 2000; 81 FR or conditions that will be implemented 38931, June 15, 2016] so that the labeling of the product in- § 809.11 Exceptions or alternatives to cludes appropriate information nec- labeling requirements for in vitro essary for the safe and effective use of diagnostic products for human use the product, given the anticipated cir- held by the Strategic National cumstances of use of the product; Stockpile. (v) Provide a draft of the proposed la- (a) The appropriate FDA Center Di- beling of the specified lots, batches, or rector may grant an exception or alter- other units of the in vitro diagnostic native to any provision listed in para- products for human use subject to the graph (f) of this section and not explic- exception or alternative; and itly required by statute, for specified (vi) Provide any other information lots, batches, or other units of an in requested by the Center Director in vitro diagnostic product for human support of the request. use, if the Center Director determines (c) The Center Director must respond that compliance with such labeling rein writing to all requests under this quirement could adversely affect the section. The Center Director may im- safety, effectiveness, or availability of pose appropriate conditions or safe- such products that are or will be in- guards when granting such an excep- cluded in the Strategic National tion or alternative under this section. Stockpile. (d) A grant of an exception or alter- (b)(1)(i) A Strategic National Stock- native under this section will include pile official or any entity that manu- any safeguards or conditions deemed factures (including labeling, packing, appropriate by the Center Director to relabeling, or repackaging), distrib- ensure that the labeling of the product utes, or stores an in vitro diagnostic subject to the exception or alternative

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includes the information necessary for § 809.30 Restrictions on the sale, dis- the safe and effective use of the prod- tribution and use of analyte specific uct, given the anticipated cir- reagents. cumstances of use. (a) Analyte specific reagents (ASR’s) (e) If the Center Director grants a re- (§ 864.4020 of this chapter) are restricted quest for an exception or alternative to devices under section 520(e) of the Fed- the labeling requirements under this eral Food, Drugs, and Cosmetic Act section: (the act) subject to the restrictions set (1) The Center Director may deter- forth in this section. mine that the submission and grant of (b) ASR’s may only be sold to: a written request under this section (1) In vitro diagnostic manufacturers; satisfies the provisions relating to pre- (2) Clinical laboratories regulated market notification submissions under under the Clinical Laboratory Improve- § 807.81(a)(3) of this chapter. ment Amendments of 1988 (CLIA), as (2)(i) For a Premarket Approval Ap- qualified to perform high complexity plication (PMA)-approved in vitro diag- testing under 42 CFR part 493 or clin- nostic product for human use, the sub- ical laboratories regulated under VHA mission and grant of a written request Directive 1106 (available from Depart- under this section satisfies the provi- ment of Veterans Affairs, Veterans sions relating to submission of PMA Health Administration, Washington, supplements under § 814.39 of this chap- DC 20420); and ter; however, (3) Organizations that use the re- (ii) The grant of the request must be agents to make tests for purposes other identified in a periodic report under than providing diagnostic information § 814.84 of this chapter. to patients and practitioners, e.g., fo- (f) The Center Director may grant an rensic, academic, research, and other exception or alternative under this sec- nonclinical laboratories. tion to the following provisions of this (c) ASR’s must be labeled in accord- part, to the extent that the require- ance with § 809.10(e). ments in these provisions are not ex- (d) Advertising and promotional ma- plicitly required by statute: terials for ASR’s: (1) § 809.10(a)(1) through (a)(6) and (1) Shall include the identity and pu- (a)(9); rity (including source and method of (2) § 809.10(b); acquisition) of the analyte specific rea- (3) § 809.10(c)(2); gent and the identity of the analyte; (4) § 809.10(d)(1)(i) through (d)(1)(v), (2) Shall include the statement for (d)(1)(viii), and (d)(2); and class I exempt ASR’s: ‘‘Analyte Spe- (5) § 809.10(e)(1)(i) through (e)(1)(vi) cific Reagent. Analytical and perform- and (e)(1)(ix) through (e)(1)(xi). ance characteristics are not established’’; [72 FR 73601, Dec. 28, 2007] (3) Shall include the statement for class II or III ASR’s: ‘‘Analyte Specific Subpart C—Requirements for Reagent. Except as a component of the Manufacturers and Producers approved/cleared test (name of approved/cleared test), analytical and § 809.20 General requirements for performance characteristics are not es- manufacturers and producers of in tablished’’; and vitro diagnostic products. (4) Shall not make any statement re- (a) [Reserved] garding analytical or clinical perform- (b) Compliance with good manufac- ance. turing practices. In vitro diagnostic (e) The laboratory that develops an products shall be manufactured in ac- in-house test using the ASR shall in- cordance with the good manufacturing form the ordering person of the test re- practices requirements found in part sult by appending to the test report the 820 of this chapter and, if applicable, statement: ‘‘This test was developed with § 610.44 of this chapter. and its performance characteristics de- [41 FR 6903, Feb. 13, 1976, as amended at 42 termined by (Laboratory Name). It has FR 42530, Aug. 23, 1977; 43 FR 31527, July 21, not been cleared or approved by the 1978; 66 FR 31165, June 11, 2001] U.S. Food and Drug Administration.’’

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This statement would not be applicable tion of test results from the laboratory or required when test results are gen- to the lay purchaser. erated using the test that was cleared [65 FR 18234, Apr. 7, 2000] or approved in conjunction with review of the class II or III ASR. PART 810—MEDICAL DEVICE (f) Ordering in-house tests that are developed using analyte specific re- RECALL AUTHORITY agents is limited under section 520(e) of Subpart A—General Provisions the act to physicians and other persons authorized by applicable State law to Sec. order such tests. 810.1 Scope. (g) The restrictions in paragraphs (c) 810.2 Definitions. 810.3 Computation of time. through (f) of this section do not apply 810.4 Service of orders. when reagents that otherwise meet the analyte specific reagent definition are Subpart B—Mandatory Medical Device sold to: Recall Procedures (1) In vitro diagnostic manufacturers; 810.10 Cease distribution and notification or order. (2) Organizations that use the re- 810.11 Regulatory hearing. agents to make tests for purposes other 810.12 Written request for review of cease than providing diagnostic information distribution and notification order. to patients and practitioners, e.g., fo- 810.13 Mandatory recall order. rensic, academic, research, and other 810.14 Cease distribution and notification or mandatory recall strategy. nonclinical laboratories. 810.15 Communications concerning a cease [62 FR 62259, Nov. 21, 1997] distribution and notification or mandatory recall order. § 809.40 Restrictions on the sale, dis- 810.16 Cease distribution and notification or tribution, and use of OTC test sam- mandatory recall order status reports. ple collection systems for drugs of 810.17 Termination of a cease distribution and notification or mandatory recall abuse testing. order. (a) Over-the-counter (OTC) test sam- 810.18 Public notice. ple collection systems for drugs of AUTHORITY: 21 U.S.C. 321, 331, 332, 333, 334, abuse testing (§ 864.3260 of this chapter) 351, 352, 355, 360h, 360i, 371, 374, 375. are restricted devices under section SOURCE: 61 FR 59018, Nov. 20, 1996, unless 520(e) of the Act subject to the restric- otherwise noted. tions set forth in this section. (b) Sample testing shall be performed Subpart A—General Provisions in a laboratory using screening tests that have been approved, cleared, or § 810.1 Scope. otherwise recognized by the Food and Part 810 describes the procedures Drug Administration as accurate and that the Food and Drug Administra- reliable for the testing of such speci- tion will follow in exercising its med- mens for identifying drugs of abuse or ical device recall authority under sec- their metabolites. tion 518(e) of the Federal Food, Drug, (c) The laboratory performing the and Cosmetic Act. test(s) shall have, and shall be recognized as having, adequate capability to § 810.2 Definitions. reliably perform the necessary screen- As used in this part: ing and confirmatory tests, including (a) Act means the Federal Food, adequate capability to perform integ- Drug, and Cosmetic Act. rity checks of the biological specimens (b) Agency or FDA means the Food for possible adulteration. and Drug Administration. (d) All OTC test sample collection (c) Cease distribution and notification systems for drugs of abuse testing shall strategy or mandatory recall strategy be labeled in accordance with § 809.10(f) means a planned, specific course of ac- and shall provide an adequate system tion to be taken by the person named to communicate the proper interpreta- in a cease distribution and notification

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order or in a mandatory recall order, (m) Unique device identifier (UDI) which addresses the extent of the noti- means an identifier that adequately fication or recall, the need for public identifies a device through its distribu- warnings, and the extent of effective- tion and use by meeting the require- ness checks to be conducted. ments of § 830.20 of this chapter. A (d) Consignee means any person or unique device identifier is composed of: firm that has received, purchased, or (1) A device identifier—a mandatory, used a device that is subject to a cease fixed portion of a UDI that identifies distribution and notification order or a the specific version or model of a de- mandatory recall order. Consignee does vice and the labeler of that device; and not mean lay individuals or patients, (2) A production identifier—a condi- i.e., nonhealth professionals. tional, variable portion of a UDI that (e) Correction means repair, modifica- identifies one or more of the following tion, adjustment, relabeling, destruc- when included on the label of the de- tion, or inspection (including patient vice: monitoring) of a device, without its (i) The lot or batch within which a physical removal from its point of use device was manufactured; to some other location. (ii) The serial number of a specific (f) Device user facility means a hos- device; pital, ambulatory surgical facility, (iii) The expiration date of a specific nursing home, or outpatient treatment device; or diagnostic facility that is not a phy- (iv) The date a specific device was sician’s office. manufactured. (v) For an HCT/P regulated as a de- (g) Health professionals means practi- vice, the distinct identification code tioners, including physicians, nurses, required by § 1271.290(c) of this chapter. pharmacists, dentists, respiratory therapists, physical therapists, tech- [61 FR 59018, Nov. 20, 1996, as amended at 78 nologists, or any other practitioners or FR 55821, Sept. 24, 2013] allied health professionals that have a role in using a device for human use. § 810.3 Computation of time. (h) Human cell, tissue, or cellular or tis- In computing any period of time pre- sue-based product (HCT/P) regulated as a scribed or allowed by this part, the day device means an HCT/P as defined in of the act or event from which the des- § 1271.3(d) of this chapter that does not ignated period of time begins to run meet the criteria in § 1271.10(a) and that shall not be included. The computation is also regulated as a device. of time is based only on working days. (i) Reasonable probability means that it is more likely than not that an event § 810.4 Service of orders. will occur. Orders issued under this part will be (j) Serious, adverse health consequence served in person by a designated em- means any significant adverse experi- ployee of FDA, or by certified or reg- ence, including those that may be ei- istered mail or similar mail delivery ther life-threatening or involve perma- service with a return receipt record re- nent or long-term injuries, but exclud- flecting receipt, to the named person or ing injuries that are nonlife-threat- designated agent at the named person’s ening and that are temporary and rea- or designated agent’s last known ad- sonably reversible. dress in FDA’s records. (k) Recall means the correction or removal of a device for human use where Subpart B—Mandatory Medical FDA finds that there is a reasonable Device Recall Procedures probability that the device would cause serious, adverse health consequences or § 810.10 Cease distribution and notifi- death. cation order. (l) Removal means the physical re- (a) If, after providing the appropriate moval of a device from its point of use person with an opportunity to consult to some other location for repair, with the agency, FDA finds that there modification, adjustment, relabeling, is a reasonable probability that a de- destruction, or inspection. vice intended for human use would

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cause serious, adverse health con- (2) The total number of units of the sequences or death, the agency may device estimated to be in distribution issue a cease distribution and notifica- channels; tion order requiring the person named (3) The total number of units of the in the order to immediately: device estimated to be distributed to (1) Cease distribution of the device; health professionals and device user fa- (2) Notify health professionals and cilities; device user facilities of the order; and (4) The total number of units of the (3) Instruct these professionals and device estimated to be in the hands of device user facilities to cease use of the home users; device. (b) FDA will include the following in- (5) Distribution information, includ- formation in the order: ing the names and addresses of all con- (1) The requirements of the order re- signees; lating to cessation of distribution and (6) A copy of any written communica- notification of health professionals and tion used by the person named in the device user facilities; order to notify health professionals and (2) Pertinent descriptive information device user facilities; to enable accurate and immediate iden- (7) A proposed strategy for complying tification of the device subject to the with the cease distribution and notifi- order, including, where known: cation order; (i) The brand name of the device; (8) Progress reports to be made at (ii) The common name, classification specified intervals, showing the names name, or usual name of the device; and addresses of health professionals (iii) The model, catalog, or product and device user facilities that have code numbers of the device; been notified, names of specific individ- (iv) The manufacturing lot numbers uals contacted within device user fa- or serial numbers of the device or other cilities, and the dates of such contacts; identification numbers; and and (v) The unique device identifier (UDI) (9) The name, address, and telephone that appears on the device label or on the device package; and number of the person who should be (3) A statement of the grounds for contacted concerning implementation FDA’s finding that there is a reason- of the order. able probability that the device would (e) FDA will provide the person cause serious, adverse health con- named in a cease distribution and noti- sequences or death. fication order with an opportunity for (c) FDA may also include in the order a regulatory hearing on the actions re- a model letter for notifying health pro- quired by the cease distribution and fessionals and device user facilities of notification order and on whether the the order and a requirement that noti- order should be modified, or vacated, or fication of health professionals and de- amended to require a mandatory recall vice user facilities be completed within of the device. a specified timeframe. The model letter (f) FDA will also provide the person will include the key elements of infor- named in the cease distribution and no- mation that the agency in its discre- tification order with an opportunity, in tion has determined, based on the cir- lieu of a regulatory hearing, to submit cumstances surrounding the issuance a written request to FDA asking that of each order, are necessary to inform the order be modified, or vacated, or health professionals and device user fa- amended. cilities about the order. (g) FDA will include in the cease dis- (d) FDA may also require that the tribution and notification order the person named in the cease distribution name, address, and telephone number and notification order submit any or of an agency employee to whom any re- all of the following information to the quest for a regulatory hearing or agen- agency by a time specified in the order: cy review is to be addressed. (1) The total number of units of the device produced and the timespan of [61 FR 59018, Nov. 20, 1996, as amended at 78 the production; FR 55821, Sept. 24, 2013]

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§ 810.11 Regulatory hearing. any provision of part 16 under § 10.19 of (a) Any request for a regulatory hear- this chapter. As provided in § 16.26(b), ing shall be submitted in writing to the after the hearing commences, the pre- agency employee identified in the siding officer may issue a summary de- order within the timeframe specified cision on any issue if the presiding offi- by FDA. Under § 16.22(b) of this chapter, cer determines that there is no genuine this timeframe ordinarily will not be and substantial issue of fact respecting fewer than 3 working days after receipt that issue. of the cease distribution and notifica- (d) If the person named in the cease tion order. However, as provided in distribution and notification order does § 16.60(h) of this chapter, the Commis- not request a regulatory hearing with- sioner of Food and Drugs or presiding in the timeframe specified by FDA in officer may waive, suspend, or modify the cease distribution and notification any provision of part 16 under § 10.19 of order, that person will be deemed to this chapter, including those per- have waived his or her right to request taining to the timing of the hearing. a hearing. As provided in § 16.26(a), the Commis- (e) The presiding officer will ordi- sioner or presiding officer may deny a narily hold any regulatory hearing re- request for a hearing, in whole or in quested under paragraph (a) of this sec- part, if he or she determines that no tion no fewer than 2 working days after genuine and substantial issue of fact is receipt of the request for a hearing, raised by the material submitted in the under § 16.24(e) of this chapter, and no request. later than 10 working days after the (b) If a request for a regulatory hear- date of issuance of the cease distribu- ing is granted, the regulatory hearing tion and notification order. However, shall be limited to: FDA and the person named in the order (1) Reviewing the actions required by may agree to a later date or the pre- the cease distribution and notification siding officer may determine that the order, determining if FDA should af- hearing should be held in fewer than 2 firm, modify, or vacate the order, and days. Moreover, as provided for in addressing an appropriate cease dis- § 16.60(h) of this chapter, the Commis- tribution and notification strategy; sioner of Food and Drugs or presiding and officer may waive, suspend, or modify (2) Determining whether FDA should any provision of part 16 under § 10.19 of amend the cease distribution and noti- this chapter, including those per- fication order to require a recall of the taining to the timing of the hearing. device that was the subject of the After the presiding officer prepares a order. The hearing may also address written report of the hearing and the the actions that might be required by a agency issues a final decision based on recall order, including an appropriate the report, the presiding officer shall recall strategy, if FDA later orders a provide the requestor written notifica- recall. tion of the final decision to affirm, (c) If a request by the person named modify, or vacate the order or to in a cease distribution and notification amend the order to require a recall of order for a regulatory hearing is grant- the device within 15 working days of ed, the regulatory hearing will be con- conducting a regulatory hearing. ducted in accordance with the procedures set out in section 201(x) of the § 810.12 Written request for review of act (21 U.S.C. 321(x)) and part 16 of this cease distribution and notification chapter, except that the order issued order. under § 810.10, rather than a notice (a) In lieu of requesting a regulatory under § 16.22(a) of this chapter, provides hearing under § 810.11, the person the notice of opportunity for a hearing named in a cease distribution and noti- and is part of the administrative record fication order may submit a written re- of the regulatory hearing under quest to FDA asking that the order be § 16.80(a) of this chapter. As provided in modified or vacated. Such person shall § 16.60(h) of this chapter, the Commis- address the written request to the sioner of Food and Drugs or presiding agency employee identified in the officer may waive, suspend, or modify order and shall submit the request

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within the timeframe specified in the ceipt of a written request for review of order, unless FDA and the person a cease distribution and notification named in the order agree to a later order under § 810.12. date. (b) In a mandatory recall order, FDA (b) A written request for review of a may: cease distribution and notification (1) Specify that the recall is to ex- order shall identify each ground upon tend to the wholesale, retail, or user which the requestor relies in asking level; that the order be modified or vacated, (2) Specify a timetable in accordance as well as addressing an appropriate with which the recall is to begin and be cease distribution and notification completed; strategy, and shall address whether the order should be amended to require a (3) Require the person named in the recall of the device that was the sub- order to submit to the agency a project of the order and the actions re- posed recall strategy, as described in quired by such a recall order, including § 810.14, and periodic reports describing an appropriate recall strategy. the progress of the mandatory recall, (c) The agency official who issued the as described in § 810.16; and cease distribution and notification (4) Provide the person named in the order shall provide the requestor writ- order with a model recall notification ten notification of the agency’s deci- letter that includes the key elements sion to affirm, modify, or vacate the of information that FDA has deter- order or amend the order to require a mined are necessary to inform health recall of the device within 15 working professionals and device user facilities. days of receipt of the written request. (c) FDA will not include in a manda- The agency official shall include in tory recall order a requirement for: this written notification: (1) Recall of a device from individ- (1) A statement of the grounds for uals; or the decision to affirm, modify, vacate, (2) Recall of a device from device user or amend the order; and facilities, if FDA determines that the (2) The requirements of any modified risk of recalling the device from the fa- or amended order. cilities presents a greater health risk than the health risk of not recalling § 810.13 Mandatory recall order. the device from use, unless the device (a) If the person named in a cease dis- can be replaced immediately with an tribution and notification order does equivalent device. not request a regulatory hearing or (d) FDA will include in a mandatory submit a request for agency review of recall order provisions for notification the order, or, if the Commissioner of to individuals subject to the risks asso- Food and Drugs or the presiding officer ciated with use of the device. If a sig- denies a request for a hearing, or, if nificant number of such individuals after conducting a regulatory hearing cannot be identified, FDA may notify under § 810.11 or completing agency re- such individuals under section 705(b) of view of a cease distribution and notification order under § 810.12, FDA deter- the act. mines that the order should be amend- § 810.14 Cease distribution and notified to require a recall of the device with cation or mandatory recall strategy. respect to which the order was issued, FDA shall amend the order to require (a) General. The person named in a such a recall. FDA shall amend the cease distribution and notification order to require such a recall within 15 order issued under § 810.10 shall comply working days of issuance of a cease dis- with the order, which FDA will fashion tribution and notification order if a as appropriate for the individual cir- regulatory hearing or agency review of cumstances of the case. The person the order is not requested, or within 15 named in a cease distribution and noti- working days of denying a request for a fication order modified under § 810.11(e) hearing, or within 15 working days of or § 810.12(c) or a mandatory recall completing a regulatory hearing under order issued under § 810.13 shall develop § 810.11, or within 15 working days of re- a strategy for complying with the

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order that is appropriate for the indi- ject to the risks associated with use of vidual circumstances and that takes the recalled device. The notice may be into account the following factors: provided through the individuals’ (1) The nature of the serious, adverse health professionals if FDA determines health consequences related to the de- that such consultation is appropriate vice; and would be the most effective meth- (2) The ease of identifying the device; od of notifying patients. (3) The extent to which the risk pre- (3) Effectiveness checks by the person sented by the device is obvious to a named in the order are required to health professional or device user facil- verify that all health professionals, de- ity; and vice user facilities, consignees, and in- (4) The extent to which the device is dividuals, as appropriate, have been no- used by health professionals and device tified of the cease distribution and no- user facilities. tification order or mandatory recall (b) Submission and review. (1) The per- order and of the need to take appro- son named in the cease distribution priate action. The person named in the and notification order modified under cease distribution and notification § 810.11(e) or § 810.12(c) or mandatory re- order or the mandatory recall order call order shall submit a copy of the shall specify in the strategy the meth- proposed strategy to the agency within od(s) to be used in addition to written the timeframe specified in the order. communications as required by § 810.15, (2) The agency will review the pro- i.e., personal visits, telephone calls, or posed strategy and make any changes a combination thereof to contact all to the strategy that it deems necessary within 7 working days of receipt of the health professionals, device user facili- proposed strategy. The person named ties, consignees, and individuals, as ap- in the order shall act in accordance propriate. The agency may conduct ad- with a strategy determined by FDA to ditional audit checks where appro- be appropriate. priate. (c) Elements of the strategy. A pro- § 810.15 Communications concerning a posed strategy shall meet all of the fol- cease distribution and notification lowing requirements: or mandatory recall order. (1)(i) The person named in the order shall specify the level in the chain of (a) General. The person named in a distribution to which the cease dis- cease distribution and notification tribution and notification order or order issued under § 810.10 or a manda- mandatory recall order is to extend as tory recall order issued under § 810.13 is follows: responsible for promptly notifying (A) Consumer or user level, e.g., each health professional, device user health professionals, consignee, or de- facility, consignee, or individual, as ap- vice user facility level, including any propriate, of the order. In accordance intermediate wholesale or retail level; with § 810.10(c) or § 810.13(b)(4), FDA or may provide the person named in the (B) Retail level, to the level imme- cease distribution and notification or diately preceding the consumer or user mandatory recall order with a model level, and including any intermediate letter for notifying each health profes- level; or sional, device user facility, consignee, (C) Wholesale level. or individual, as appropriate, of the (ii) The person named in the order order. However, if FDA does not pro- shall not recall a device from individ- vide the person named in the cease dis- uals; and tribution and notification or manda- (iii) The person named in the order tory recall order with a model letter, shall not recall a device from device the person named in a cease distribu- user facilities if FDA notifies the per- tion and notification order issued son not to do so because of a risk deter- under § 810.10, or a mandatory recall mination under § 810.13(c)(2). order issued under § 810.13, is respon- (2) The person named in a recall sible for providing such notification. order shall ensure that the strategy The purpose of the communication is provides for notice to individuals sub- to convey:

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(1) That FDA has found that there is post card or a toll-free call to the per- a reasonable probability that use of the son named in the order; and device would cause a serious, adverse (6) Does not contain irrelevant quali- health consequence or death; fications, promotional materials, or (2) That the person named in the any other statement that may detract order has ceased distribution of the de- from the message. vice; (d) Followup communications. The per- (3) That health professionals and de- son named in the cease distribution vice user facilities should cease use of and notification order or mandatory the device immediately; recall order shall ensure that followup (4) Where appropriate, that the de- communications are sent to all who vice is subject to a mandatory recall fail to respond to the initial commu- order; and nication. (5) Specific instructions on what (e) Responsibility of the recipient. should be done with the device. Health professionals, device user facili- (b) Implementation. The person named ties, and consignees who receive a com- in a cease distribution and notification munication concerning a cease disorder, or a mandatory recall order, tribution and notification order or a shall notify the appropriate person(s) mandatory recall order should imme- of the order by verified written com- diately follow the instructions set munication, e.g., telegram, mailgram, forth in the communication. Where ap- or fax. The written communication and propriate, these recipients should im- any envelope in which it is sent or en- mediately notify their consignees of closed shall be conspicuously marked, the order in accordance with para- preferably in bold red ink: ‘‘URGENT— graphs (b) and (c) of this section. [DEVICE CEASE DISTRIBUTION AND § 810.16 Cease distribution and notifi- NOTIFICATION ORDER] or [MANDA- cation or mandatory recall order TORY DEVICE RECALL ORDER].’’ status reports. Telephone calls or other personal con- (a) The person named in a cease dis- tacts may be made in addition to, but tribution and notification order issued not as a substitute for, the verified under § 810.10 or a mandatory recall written communication, and shall be order issued under § 810.13 shall submit documented in an appropriate manner. periodic status reports to FDA to en- (c) Contents. The person named in the able the agency to assess the person’s order shall ensure that the notice of a progress in complying with the order. cease distribution and notification The frequency of such reports and the order or mandatory recall order: agency official to whom such reports (1) Is brief and to the point; shall be submitted will be specified in (2) Identifies clearly the device, size, the order. lot number(s), code(s), or serial num- (b) Unless otherwise specified in the ber(s), and any other pertinent descrip- order, each status report shall contain tive information to facilitate accurate the following information: and immediate identification of the de- (1) The number and type of health vice; professionals, device user facilities, (3) Explains concisely the serious, ad- consignees, or individuals notified verse health consequences that may about the order and the date and meth- occur if use of the device were contin- od of notification; ued; (2) The number and type of health (4) Provides specific instructions on professionals, device user facilities, what should be done with the device; consignees, or individuals who have re- (5) Provides a ready means for the responded to the communication and the cipient of the communication to con- quantity of the device on hand at these firm receipt of the communication and locations at the time they received the to notify the person named in the order communication; of the actions taken in response to the (3) The number and type of health communication. Such means may in- professionals, device user facilities, clude, but are not limited to, the re- consignees, or individuals who have not turn of a postage-paid, self-addressed responded to the communication;

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(4) The number of devices returned or (c) FDA will provide written notifica- corrected by each health professional, tion to the person named in the order device user facility, consignee, or indi- when a request for termination of a vidual contacted, and the quantity of cease distribution and notification products accounted for; order or a mandatory recall order has (5) The number and results of effec- been granted or denied. FDA will re- tiveness checks that have been made; spond to a written request for termi- and nation of a cease distribution and noti- (6) Estimated timeframes for comple- fication or recall order within 30 work- tion of the requirements of the cease ing days of its receipt. distribution and notification order or § 810.18 Public notice. mandatory recall order. (c) The person named in the cease The agency will make available to distribution and notification order or the public in the weekly FDA Enforce- recall order may discontinue the sub- ment Report a descriptive listing of mission of status reports when the each new mandatory recall issued agency terminates the order in accord- under § 810.13. The agency will delay ance with § 810.17. public notification of orders when the agency determines that such notifica- § 810.17 Termination of a cease dis- tion may cause unnecessary and harm- tribution and notification or man- ful anxiety in individuals and that ini- datory recall order. tial consultation between individuals (a) The person named in a cease dis- and their health professionals is essen- tribution and notification order issued tial. under § 810.10 or a mandatory recall order issued under § 810.13 may request PART 812—INVESTIGATIONAL termination of the order by submitting DEVICE EXEMPTIONS a written request to FDA. The person submitting a request shall certify that Subpart A—General Provisions he or she has complied in full with all Sec. of the requirements of the order and 812.1 Scope. shall include a copy of the most cur- 812.2 Applicability. rent status report submitted to the 812.3 Definitions. agency under § 810.16. A request for ter- 812.5 Labeling of investigational devices. mination of a recall order shall include 812.7 Prohibition of promotion and other a description of the disposition of the practices. 812.10 Waivers. recalled device. 812.18 Import and export requirements. (b) FDA may terminate a cease dis- 812.19 Address for IDE correspondence. tribution and notification order issued under § 810.10 or a mandatory recall Subpart B—Application and Administrative order issued under § 810.13 when the Action agency determines that the person 812.20 Application. named in the order: 812.25 Investigational plan. (1) Has taken all reasonable efforts to 812.27 Report of prior investigations. ensure and to verify that all health 812.30 FDA action on applications. professionals, device user facilities, 812.35 Supplemental applications. consignees, and, where appropriate, in- 812.36 Treatment use of an investigational dividuals have been notified of the device. cease distribution and notification 812.38 Confidentiality of data and information. order, and to verify that they have been instructed to cease use of the de- Subpart C—Responsibilities of Sponsors vice and to take other appropriate action; or 812.40 General responsibilities of sponsors. (2) Has removed the device from the 812.42 FDA and IRB approval. 812.43 Selecting investigators and monitors. market or has corrected the device so 812.45 Informing investigators. that use of the device would not cause 812.46 Monitoring investigations. serious, adverse health consequences or 812.47 Emergency research under § 50.24 of death. this chapter.

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Subpart D—IRB Review and Approval tion 514, premarket approval under section 515, a banned device regulation 812.60 IRB composition, duties, and func- under section 516, records and reports tions. 812.62 IRB approval. under section 519, restricted device re- 812.64 IRB’s continuing review. quirements under section 520(e), good 812.65 [Reserved] manufacturing practice requirements 812.66 Significant risk device determina- under section 520(f) except for the re- tions. quirements found in § 820.30, if applicable (unless the sponsor states an inten- Subpart E—Responsibilities of Investigators tion to comply with these require- 812.100 General responsibilities of investiga- ments under § 812.20(b)(3) or tors. § 812.140(b)(4)(v)) and color additive re- 812.110 Specific responsibilities of investiga- quirements under section 721. tors. (b) References in this part to regu- 812.119 Disqualification of a clinical investi- latory sections of the Code of Federal gator. Regulations are to chapter I of title 21, Subpart F [Reserved] unless otherwise noted. [45 FR 3751, Jan. 18, 1980, as amended at 59 Subpart G—Records and Reports FR 14366, Mar. 28, 1994; 61 FR 52654, Oct. 7, 812.140 Records. 1996] 812.145 Inspections. 812.150 Reports. § 812.2 Applicability.

AUTHORITY: 21 U.S.C. 331, 351, 352, 353, 355, (a) General. This part applies to all 360, 360c–360f, 360h–360j, 371, 372, 374, 379e, 381, clinical investigations of devices to de- 382, 383; 42 U.S.C. 216, 241, 262, 263b–263n. termine safety and effectiveness, ex- SOURCE: 45 FR 3751, Jan. 18, 1980, unless cept as provided in paragraph (c) of otherwise noted. this section. (b) Abbreviated requirements. The fol- Subpart A—General Provisions lowing categories of investigations are considered to have approved applica- § 812.1 Scope. tions for IDE’s, unless FDA has noti- (a) The purpose of this part is to en- fied a sponsor under § 812.20(a) that ap- courage, to the extent consistent with proval of an application is required: the protection of public health and (1) An investigation of a device other safety and with ethical standards, the than a significant risk device, if the de- discovery and development of useful vice is not a banned device and the devices intended for human use, and to sponsor: that end to maintain optimum freedom (i) Labels the device in accordance for scientific investigators in their pur- with § 812.5; suit of this purpose. This part provides (ii) Obtains IRB approval of the in- procedures for the conduct of clinical vestigation after presenting the re- investigations of devices. An approved viewing IRB with a brief explanation of investigational device exemption (IDE) why the device is not a significant risk permits a device that otherwise would device, and maintains such approval; be required to comply with a perform- (iii) Ensures that each investigator ance standard or to have premarket ap- participating in an investigation of the proval to be shipped lawfully for the device obtains from each subject under purpose of conducting investigations of the investigator’s care, informed con- that device. An IDE approved under sent under part 50 and documents it, § 812.30 or considered approved under unless documentation is waived by an § 812.2(b) exempts a device from the re- IRB under § 56.109(c). quirements of the following sections of (iv) Complies with the requirements the Federal Food, Drug, and Cosmetic of § 812.46 with respect to monitoring Act (the act) and regulations issued investigations; thereunder: Misbranding under section (v) Maintains the records required 502 of the act, registration, listing, and under § 812.140(b) (4) and (5) and makes premarket notification under section the reports required under § 812.150(b) 510, performance standards under sec- (1) through (3) and (5) through (10);

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(vi) Ensures that participating inves- (6) A device shipped solely for re- tigators maintain the records required search on or with laboratory animals by § 812.140(a)(3)(i) and make the re- and labeled in accordance with ports required under § 812.150(a) (1), (2), § 812.5(c). (5), and (7); and (7) A custom device as defined in (vii) Complies with the prohibitions § 812.3(b), unless the device is being in § 812.7 against promotion and other used to determine safety or effective- practices. ness for commercial distribution. (2) An investigation of a device other (d) Limit on certain exemptions. In the than one subject to paragraph (e) of case of class II or class III device de- this section, if the investigation was scribed in paragraph (c)(1) or (2) of this begun on or before July 16, 1980, and to section, this part applies beginning on be completed, and is completed, on or the date stipulated in an FDA regula- before January 19, 1981. tion or order that calls for the submis- (c) Exempted investigations. This part, sion of premarket approval applica- with the exception of § 812.119, does not tions for an unapproved class III de- apply to investigations of the following vice, or establishes a performance categories of devices: standard for a class II device. (1) A device, other than a transi- (e) Investigations subject to IND’s. A tional device, in commercial distribu- sponsor that, on July 16, 1980, has an tion immediately before May 28, 1976, effective investigational new drug ap- when used or investigated in accord- plication (IND) for an investigation of ance with the indications in labeling in a device shall continue to comply with effect at that time. the requirements of part 312 until 90 days after that date. To continue the (2) A device, other than a transi- investigation after that date, a sponsor tional device, introduced into commer- shall comply with paragraph (b)(1) of cial distribution on or after May 28, this section, if the device is not a sig- 1976, that FDA has determined to be nificant risk device, or shall have ob- substantially equivalent to a device in tained FDA approval under § 812.30 of commercial distribution immediately an IDE application for the investiga- before May 28, 1976, and that is used or tion of the device. investigated in accordance with the indications in the labeling FDA reviewed [45 FR 3751, Jan. 18, 1980, as amended at 46 under subpart E of part 807 in deter- FR 8956, Jan. 27, 1981; 46 FR 14340, Feb. 27, mining substantial equivalence. 1981; 53 FR 11252, Apr. 6, 1988; 62 FR 4165, Jan. 29, 1997; 62 FR 12096, Mar. 14, 1997] (3) A diagnostic device, if the sponsor complies with applicable requirements § 812.3 Definitions. in § 809.10(c) and if the testing: (a) Act means the Federal Food, (i) Is noninvasive, Drug, and Cosmetic Act (sections 201– (ii) Does not require an invasive sam- 901, 52 Stat. 1040 et seq., as amended (21 pling procedure that presents signifi- U.S.C. 301–392)). cant risk, (b) A custom device means a device (iii) Does not by design or intention within the meaning of section 520(b) of introduce energy into a subject, and the Federal Food, Drug, and Cosmetic (iv) Is not used as a diagnostic proce- Act. dure without confirmation of the diag- (c) FDA means the Food and Drug nosis by another, medically established Administration. diagnostic product or procedure. (d) Implant means a device that is (4) A device undergoing consumer placed into a surgically or naturally preference testing, testing of a modi- formed cavity of the human body if it fication, or testing of a combination of is intended to remain there for a period two or more devices in commercial dis- of 30 days or more. FDA may, in order tribution, if the testing is not for the to protect public health, determine purpose of determining safety or effec- that devices placed in subjects for tiveness and does not put subjects at shorter periods are also ‘‘implants’’ for risk. purposes of this part. (5) A device intended solely for vet- (e) Institution means a person, other erinary use. than an individual, who engages in the

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conduct of research on subjects or in noninvasive, and the use of surplus the delivery of medical services to indi- samples of body fluids or tissues that viduals as a primary activity or as an are left over from samples taken for adjunct to providing residential or cus- noninvestigational purposes is also todial care to humans. The term in- considered noninvasive. cludes, for example, a hospital, retire- (l) Person includes any individual, ment home, confinement facility, aca- partnership, corporation, association, demic establishment, and device manu- scientific or academic establishment, facturer. The term has the same mean- Government agency or organizational ing as ‘‘facility’’ in section 520(g) of the unit of a Government agency, and any act. other legal entity. (f) Institutional review board (IRB) (m) Significant risk device means an means any board, committee, or other investigational device that: group formally designated by an insti- (1) Is intended as an implant and pre- tution to review biomedical research sents a potential for serious risk to the involving subjects and established, op- health, safety, or welfare of a subject; erated, and functioning in conformance (2) Is purported or represented to be with part 56. The term has the same for a use in supporting or sustaining meaning as ‘‘institutional review com- human life and presents a potential for mittee’’ in section 520(g) of the act. serious risk to the health, safety, or (g) Investigational device means a de- welfare of a subject; vice, including a transitional device, (3) Is for a use of substantial impor- that is the object of an investigation. tance in diagnosing, curing, miti- (h) Investigation means a clinical in- gating, or treating disease, or other- vestigation or research involving one wise preventing impairment of human or more subjects to determine the safe- health and presents a potential for se- ty or effectiveness of a device. rious risk to the health, safety, or wel- (i) Investigator means an individual fare of a subject; or who actually conducts a clinical inves- (4) Otherwise presents a potential for tigation, i.e., under whose immediate serious risk to the health, safety, or direction the test article is adminis- welfare of a subject. tered or dispensed to, or used involv- (n) Sponsor means a person who initi- ing, a subject, or, in the event of an in- ates, but who does not actually con- vestigation conducted by a team of in- duct, the investigation, that is, the individuals, is the responsible leader of vestigational device is administered, that team. dispensed, or used under the immediate (j) Monitor, when used as a noun, direction of another individual. A per- means an individual designated by a son other than an individual that uses sponsor or contract research organiza- one or more of its own employees to tion to oversee the progress of an in- conduct an investigation that it has vestigation. The monitor may be an initiated is a sponsor, not a sponsor-in- employee of a sponsor or a consultant vestigator, and the employees are in- to the sponsor, or an employee of or vestigators. consultant to a contract research orga- (o) Sponsor-investigator means an indi- nization. Monitor, when used as a verb, vidual who both initiates and actually means to oversee an investigation. conducts, alone or with others, an in- (k) Noninvasive, when applied to a di- vestigation, that is, under whose im- agnostic device or procedure, means mediate direction the investigational one that does not by design or inten- device is administered, dispensed, or tion: (1) Penetrate or pierce the skin or used. The term does not include any mucous membranes of the body, the oc- person other than an individual. The ular cavity, or the urethra, or (2) enter obligations of a sponsor-investigator the ear beyond the external auditory under this part include those of an in- canal, the nose beyond the nares, the vestigator and those of a sponsor. mouth beyond the pharynx, the anal (p) Subject means a human who par- canal beyond the rectum, or the vagina ticipates in an investigation, either as beyond the cervical os. For purposes of an individual on whom or on whose this part, blood sampling that involves specimen an investigational device is simple venipuncture is considered used or as a control. A subject may be

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in normal health or may have a med- or other tests that do not involve ical condition or disease. human subjects.’’ (q) Termination means a discontinu- (d) The appropriate FDA Center Di- ance, by sponsor or by withdrawal of rector, according to the procedures set IRB or FDA approval, of an investiga- forth in § 801.128 or § 809.11 of this chap- tion before completion. ter, may grant an exception or alter- (r) Transitional device means a device native to the provisions in paragraphs subject to section 520(l) of the act, that (a) and (c) of this section, to the extent is, a device that FDA considered to be that these provisions are not explicitly a new drug or an antibiotic drug before required by statute, for specified lots, May 28, 1976. batches, or other units of a device that are or will be included in the Strategic (s) Unanticipated adverse device effect National Stockpile. means any serious adverse effect on health or safety or any life-threatening [45 FR 3751, Jan. 18, 1980, as amended at 45 problem or death caused by, or associ- FR 58842, Sept. 5, 1980; 72 FR 73602, Dec. 28, ated with, a device, if that effect, prob- 2007] lem, or death was not previously identified in nature, severity, or degree of § 812.7 Prohibition of promotion and other practices. incidence in the investigational plan or application (including a supplementary A sponsor, investigator, or any per- plan or application), or any other un- son acting for or on behalf of a sponsor anticipated serious problem associated or investigator shall not: with a device that relates to the rights, (a) Promote or test market an inves- safety, or welfare of subjects. tigational device, until after FDA has approved the device for commercial [45 FR 3751, Jan. 18, 1980, as amended at 46 distribution. FR 8956, Jan. 27, 1981; 48 FR 15622, Apr. 12, (b) Commercialize an investigational 1983; 81 FR 70340, Oct. 12, 2016] device by charging the subjects or investigators for a device a price larger § 812.5 Labeling of investigational de- than that necessary to recover costs of vices. manufacture, research, development, (a) Contents. An investigational de- and handling. vice or its immediate package shall (c) Unduly prolong an investigation. bear a label with the following infor- If data developed by the investigation mation: the name and place of business indicate in the case of a class III device of the manufacturer, packer, or dis- that premarket approval cannot be jus- tributor (in accordance with § 801.1), tified or in the case of a class II device the quantity of contents, if appro- that it will not comply with an appli- priate, and the following statement: cable performance standard or an ‘‘CAUTION—Investigational device. amendment to that standard, the spon- Limited by Federal (or United States) sor shall promptly terminate the inves- law to investigational use.’’ The label tigation. or other labeling shall describe all rel- (d) Represent that an investigational evant contraindications, hazards, ad- device is safe or effective for the pur- verse effects, interfering substances or poses for which it is being investigated. devices, warnings, and precautions. (b) Prohibitions. The labeling of an in- § 812.10 Waivers. vestigational device shall not bear any (a) Request. A sponsor may request statement that is false or misleading in FDA to waive any requirement of this any particular and shall not represent part. A waiver request, with supporting that the device is safe or effective for documentation, may be submitted sep- the purposes for which it is being in- arately or as part of an application to vestigated. the address in § 812.19. (c) Animal research. An investiga- (b) FDA action. FDA may by letter tional device shipped solely for re- grant a waiver of any requirement that search on or with laboratory animals FDA finds is not required by the act shall bear on its label the following and is unnecessary to protect the statement: ‘‘CAUTION—Device for in- rights, safety, or welfare of human sub- vestigational use in laboratory animals jects.

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(c) Effect of request. Any requirement (b) You must state on the outside shall continue to apply unless and wrapper of each submission what the until FDA waives it. submission is, for example, an ‘‘IDE application,’’ a ‘‘supplemental IDE appli- § 812.18 Import and export require- cation,’’ or a ‘‘correspondence con- ments. cerning an IDE (or an IDE applica- (a) Imports. In addition to complying tion).’’ with other requirements of this part, a [71 FR 42048, July 25, 2006, as amended at 75 person who imports or offers for impor- FR 20915, Apr. 22, 2010; 80 FR 18094, Apr. 3, tation an investigational device sub- 2015] ject to this part shall be the agent of the foreign exporter with respect to in- Subpart B—Application and vestigations of the device and shall act as the sponsor of the clinical investiga- Administrative Action tion, or ensure that another person § 812.20 Application. acts as the agent of the foreign exporter and the sponsor of the investiga- (a) Submission. (1) A sponsor shall tion. submit an application to FDA if the (b) Exports. A person exporting an in- sponsor intends to use a significant vestigational device subject to this risk device in an investigation, intends part shall obtain FDA’s prior approval, to conduct an investigation that in- as required by section 801(e) of the act volves an exception from informed con- or comply with section 802 of the act. sent under § 50.24 of this chapter, or if FDA notifies the sponsor that an appli- [45 FR 3751, Jan. 18, 1980, as amended at 62 cation is required for an investigation. FR 26229, May 13, 1997] (2) A sponsor shall not begin an investigation for which FDA’s approval § 812.19 Address for IDE correspond- of an application is required until FDA ence. has approved the application. (a) If you are sending an application, (3) A sponsor shall submit three cop- supplemental application, report, re- ies of a signed ‘‘Application for an In- quest for waiver, request for import or vestigational Device Exemption’’ (IDE export approval, or other correspond- application), together with accom- ence relating to matters covered by panying materials, by registered mail this part, you must send the submis- or by hand to the address in § 812.19. sion to the appropriate address as fol- Subsequent correspondence concerning lows: an application or a supplemental appli- (1) For devices regulated by the Cen- cation shall be submitted by registered ter for Devices and Radiological mail or by hand. Health, send it to Food and Drug Ad- (4)(i) A sponsor shall submit a sepa- ministration, Center for Devices and rate IDE for any clinical investigation Radiological Health, Document Mail involving an exception from informed Center, 10903 New Hampshire Ave., consent under § 50.24 of this chapter. Bldg. 66, rm. G609, Silver Spring, MD Such a clinical investigation is not 20993–0002. permitted to proceed without the prior (2) For devices regulated by the Cen- written authorization of FDA. FDA ter for Biologics Evaluation and Re- shall provide a written determination search, send it to the Food and Drug 30 days after FDA receives the IDE or Administration, Center for Biologics earlier. Evaluation and Research, Document (ii) If the investigation involves an Control Center, 10903 New Hampshire exception from informed consent under Ave., Bldg. 71, Rm. G112, Silver Spring, § 50.24 of this chapter, the sponsor shall MD 20993–0002. prominently identify on the cover (3) For devices regulated by the Cen- sheet that the investigation is subject ter for Drug Evaluation and Research, to the requirements in § 50.24 of this send it to Central Document Control chapter. Room, Center for Drug Evaluation and (b) Contents. An IDE application shall Research, Food and Drug Administra- include, in the following order: tion, 5901–B Ammendale Rd., Beltsville, (1) The name and address of the spon- MD 20705–1266. sor.

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(2) A complete report of prior inves- (11) Copies of all forms and informa- tigations of the device and an accurate tional materials to be provided to sub- summary of those sections of the inves- jects to obtain informed consent. tigational plan described in § 812.25(a) (12) Any other relevant information through (e) or, in lieu of the summary, FDA requests for review of the applica- the complete plan. The sponsor shall tion. submit to FDA a complete investiga- (c) Additional information. FDA may tional plan and a complete report of request additional information con- prior investigations of the device if no cerning an investigation or revision in IRB has reviewed them, if FDA has the investigational plan. The sponsor found an IRB’s review inadequate, or if may treat such a request as a dis- FDA requests them. approval of the application for purposes of requesting a hearing under (3) A description of the methods, fa- part 16. cilities, and controls used for the man- (d) Information previously submitted. ufacture, processing, packing, storage, Information previously submitted to and, where appropriate, installation of the Center for Devices and Radio- the device, in sufficient detail so that a logical Health, the Center for Biologics person generally familiar with good Evaluation and Research, or the Center manufacturing practices can make a for Drug Evaluation and Research, as knowledgeable judgment about the applicable, in accordance with this quality control used in the manufac- chapter ordinarily need not be resub- ture of the device. mitted, but may be incorporated by (4) An example of the agreements to reference. be entered into by all investigators to [45 FR 3751, Jan. 18, 1980, as amended at 46 comply with investigator obligations FR 8956, Jan. 27, 1981; 50 FR 16669, Apr. 26, under this part, and a list of the names 1985; 53 FR 11252, Apr. 6, 1988; 61 FR 51530, and addresses of all investigators who Oct. 2, 1996; 62 FR 40600, July 29, 1997; 64 FR have signed the agreement. 10942, Mar. 8, 1999; 73 FR 49942, Aug. 25, 2008] (5) A certification that all investigators who will participate in the inves- § 812.25 Investigational plan. tigation have signed the agreement, The investigational plan shall in- that the list of investigators includes clude, in the following order: all the investigators participating in (a) Purpose. The name and intended the investigation, and that no inves- use of the device and the objectives and tigators will be added to the investiga- duration of the investigation. tion until they have signed the agree- (b) Protocol. A written protocol de- ment. scribing the methodology to be used (6) A list of the name, address, and and an analysis of the protocol dem- chairperson of each IRB that has been onstrating that the investigation is or will be asked to review the inves- scientifically sound. tigation and a certification of the ac- (c) Risk analysis. A description and tion concerning the investigation analysis of all increased risks to which taken by each such IRB. subjects will be exposed by the investigation; the manner in which these (7) The name and address of any in- risks will be minimized; a justification stitution at which a part of the inves- for the investigation; and a description tigation may be conducted that has not of the patient population, including the been identified in accordance with number, age, sex, and condition. paragraph (b)(6) of this section. (d) Description of device. A description (8) If the device is to be sold, the of each important component, ingre- amount to be charged and an expla- dient, property, and principle of oper- nation of why sale does not constitute ation of the device and of each antici- commercialization of the device. pated change in the device during the (9) A claim for categorical exclusion course of the investigation. under § 25.30 or § 25.34 or an environ- (e) Monitoring procedures. The spon- mental assessment under § 25.40. sor’s written procedures for monitoring (10) Copies of all labeling for the de- the investigation and the name and advice. dress of any monitor.

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(f) Labeling. Copies of all labeling for justify failure to provide information the device. on a relevant nonclinical test study. (g) Consent materials. Copies of all [45 FR 3751, Jan. 18, 1980, as amended at 50 forms and informational materials to FR 7518, Feb. 22, 1985] be provided to subjects to obtain informed consent. § 812.30 FDA action on applications. (h) IRB information. A list of the (a) Approval or disapproval. FDA will names, locations, and chairpersons of notify the sponsor in writing of the all IRB’s that have been or will be date it receives an application. FDA asked to review the investigation, and may approve an investigation as pro- a certification of any action taken by posed, approve it with modifications, any of those IRB’s with respect to the or disapprove it. An investigation may investigation. not begin until: (i) Other institutions. The name and (1) Thirty days after FDA receives address of each institution at which a the application at the address in § 812.19 part of the investigation may be con- for the investigation of a device other ducted that has not been identified in than a banned device, unless FDA noti- paragraph (h) of this section. fies the sponsor that the investigation (j) Additional records and reports. A de- may not begin; or scription of records and reports that (2) FDA approves, by order, an IDE will be maintained on the investigation for the investigation. in addition to those prescribed in sub- (b) Grounds for disapproval or with- part G. drawal. FDA may disapprove or withdraw approval of an application if FDA § 812.27 Report of prior investigations. finds that: (1) There has been a failure to comply (a) General. The report of prior inves- with any requirement of this part or tigations shall include reports of all the act, any other applicable regula- prior clinical, animal, and laboratory tion or statute, or any condition of ap- testing of the device and shall be com- proval imposed by an IRB or FDA. prehensive and adequate to justify the (2) The application or a report con- proposed investigation. tains an untrue statement of a mate- (b) Specific contents. The report also rial fact, or omits material informa- shall include: tion required by this part. (1) A bibliography of all publications, (3) The sponsor fails to respond to a whether adverse or supportive, that are request for additional information relevant to an evaluation of the safety within the time prescribed by FDA. or effectiveness of the device, copies of (4) There is reason to believe that the all published and unpublished adverse risks to the subjects are not out- information, and, if requested by an weighed by the anticipated benefits to IRB or FDA, copies of other significant the subjects and the importance of the publications. knowledge to be gained, or informed (2) A summary of all other unpub- consent is inadequate, or the investiga- lished information (whether adverse or tion is scientifically unsound, or there supportive) in the possession of, or rea- is reason to believe that the device as sonably obtainable by, the sponsor that used is ineffective. is relevant to an evaluation of the safe- (5) It is otherwise unreasonable to ty or effectiveness of the device. begin or to continue the investigation (3) If information on nonclinical lab- owing to the way in which the device is oratory studies is provided, a state- used or the inadequacy of: ment that all such studies have been (i) The report of prior investigations conducted in compliance with applica- or the investigational plan; ble requirements in the good labora- (ii) The methods, facilities, and con- tory practice regulations in part 58, or trols used for the manufacturing, proc- if any such study was not conducted in essing, packaging, storage, and, where compliance with such regulations, a appropriate, installation of the device; brief statement of the reason for the or noncompliance. Failure or inability to (iii) Monitoring and review of the in- comply with this requirement does not vestigation.

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(c) Notice of disapproval or withdrawal. meet the criteria described in para- If FDA disapproves an application or graphs (a)(3)(i) and (a)(3)(ii) of this sec- proposes to withdraw approval of an tion, on the basis of credible informa- application, FDA will notify the spon- tion defined in paragraph (a)(3)(iii) of sor in writing. this section, and the sponsor provides (1) A disapproval order will contain a notice to FDA within 5-working days of complete statement of the reasons for making these changes. disapproval and a statement that the (i) Developmental changes. The re- sponsor has an opportunity to request quirements in paragraph (a)(1) of this a hearing under part 16. section regarding FDA approval of a (2) A notice of a proposed withdrawal supplement do not apply to develop- of approval will contain a complete mental changes in the device (includ- statement of the reasons for with- ing manufacturing changes) that do drawal and a statement that the spon- not constitute a significant change in sor has an opportunity to request a design or basic principles of operation hearing under part 16. FDA will provide and that are made in response to infor- the opportunity for hearing before mation gathered during the course of withdrawal of approval, unless FDA de- an investigation. termines in the notice that continu- (ii) Changes to clinical protocol. The ation of testing under the exemption requirements in paragraph (a)(1) of this will result in an unreasonble risk to section regarding FDA approval of a the public health and orders with- supplement do not apply to changes to drawal of approval before any hearing. clinical protocols that do not affect: [45 FR 3751, Jan. 18, 1980, as amended at 45 (A) The validity of the data or infor- FR 58842, Sept. 5, 1980] mation resulting from the completion of the approved protocol, or the rela- § 812.35 Supplemental applications. tionship of likely patient risk to ben- (a) Changes in investigational plan—(1) efit relied upon to approve the pro- Changes requiring prior approval. Except tocol; as described in paragraphs (a)(2) (B) The scientific soundness of the in- through (a)(4) of this section, a sponsor vestigational plan; or must obtain approval of a supple- (C) The rights, safety, or welfare of mental application under § 812.30(a), the human subjects involved in the in- and IRB approval when appropriate vestigation. (see §§ 56.110 and 56.111 of this chapter), (iii) Definition of credible information. prior to implementing a change to an (A) Credible information to support de- investigational plan. If a sponsor in- velopmental changes in the device (intends to conduct an investigation that cluding manufacturing changes) in- involves an exception to informed concludes data generated under the design sent under § 50.24 of this chapter, the control procedures of § 820.30, pre- sponsor shall submit a separate inves- clinical/animal testing, peer reviewed tigational device exemption (IDE) ap- published literature, or other reliable plication in accordance with § 812.20(a). information such as clinical informa- (2) Changes effected for emergency use. tion gathered during a trial or mar- The requirements of paragraph (a)(1) of keting. this section regarding FDA approval of (B) Credible information to support a supplement do not apply in the case changes to clinical protocols is defined of a deviation from the investigational as the sponsor’s documentation sup- plan to protect the life or physical porting the conclusion that a change well-being of a subject in an emer- does not have a significant impact on gency. Such deviation shall be reported the study design or planned statistical to FDA within 5-working days after the analysis, and that the change does not sponsor learns of it (see § 812.150(a)(4)). affect the rights, safety, or welfare of (3) Changes effected with notice to FDA the subjects. Documentation shall in- within 5 days. A sponsor may make cer- clude information such as peer retain changes without prior approval of viewed published literature, the rec- a supplemental application under para- ommendation of the clinical investi- graph (a)(1) of this section if the spon- gator(s), and/or the data gathered dur- sor determines that these changes ing the clinical trial or marketing.

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(iv) Notice of IDE change. Changes (4) Changes submitted in annual report. meeting the criteria in paragraphs The requirements of paragraph (a)(1) of (a)(3)(i) and (a)(3)(ii) of this section this section do not apply to minor that are supported by credible informa- changes to the purpose of the study, tion as defined in paragraph (a)(3)(iii) risk analysis, monitoring procedures, of this section may be made without labeling, informed consent materials, prior FDA approval if the sponsor sub- and IRB information that do not affect: mits a notice of the change to the IDE (i) The validity of the data or infor- not later than 5-working days after mation resulting from the completion making the change. Changes to devices of the approved protocol, or the rela- are deemed to occur on the date the de- tionship of likely patient risk to ben- vice, manufactured incorporating the efit relied upon to approve the pro- design or manufacturing change, is distributed to the investigator(s). Changes tocol; to a clinical protocol are deemed to (ii) The scientific soundness of the occur when a clinical investigator is investigational plan; or notified by the sponsor that the change (iii) The rights, safety, or welfare of should be implemented in the protocol the human subjects involved in the in- or, for sponsor-investigator studies, vestigation. Such changes shall be re- when a sponsor-investigator incor- ported in the annual progress report porates the change in the protocol. for the IDE, under § 812.150(b)(5). Such notices shall be identified as a (b) IRB approval for new facilities. A ‘‘notice of IDE change.’’ sponsor shall submit to FDA a certifi- (A) For a developmental or manufac- cation of any IRB approval of an inves- turing change to the device, the notice tigation or a part of an investigation shall include a summary of the rel- not included in the IDE application. If evant information gathered during the the investigation is otherwise un- course of the investigation upon which changed, the supplemental application the change was based; a description of shall consist of an updating of the in- the change to the device or manufac- formation required by § 812.20(b) and (c) turing process (cross-referenced to the and a description of any modifications appropriate sections of the original de- in the investigational plan required by vice description or manufacturing the IRB as a condition of approval. A process); and, if design controls were used to assess the change, a statement certification of IRB approval need not that no new risks were identified by be included in the initial submission of appropriate risk analysis and that the the supplemental application, and such verification and validation testing, as certification is not a precondition for appropriate, demonstrated that the de- agency consideration of the applica- sign outputs met the design input re- tion. Nevertheless, a sponsor may not quirements. If another method of as- begin a part of an investigation at a fa- sessment was used, the notice shall in- cility until the IRB has approved the clude a summary of the information investigation, FDA has received the which served as the credible informa- certification of IRB approval, and FDA, tion supporting the change. under § 812.30(a), has approved the sup- (B) For a protocol change, the notice plemental application relating to that shall include a description of the part of the investigation (see change (cross-referenced to the appro- § 56.103(a)). priate sections of the original protocol); an assessment supporting the [50 FR 25909, June 24, 1985; 50 FR 28932, July conclusion that the change does not 17, 1985, as amended at 61 FR 51531, Oct. 2, have a significant impact on the study 1996; 63 FR 64625, Nov. 23, 1998] design or planned statistical analysis; § 812.36 Treatment use of an investiga- and a summary of the information that tional device. served as the credible information supporting the sponsor’s determination (a) General. A device that is not ap- that the change does not affect the proved for marketing may be under rights, safety, or welfare of the sub- clinical investigation for a serious or jects. immediately life-threatening disease or

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condition in patients for whom no com- (i) The name, address, and telephone parable or satisfactory alternative de- number of the sponsor of the treatment vice or other therapy is available. Dur- IDE; ing the clinical trial or prior to final (ii) The intended use of the device, action on the marketing application, it the criteria for patient selection, and a may be appropriate to use the device in written protocol describing the treat- the treatment of patients not in the ment use; trial under the provisions of a treat- (iii) An explanation of the rationale ment investigational device exemption for use of the device, including, as ap- (IDE). The purpose of this section is to propriate, either a list of the available facilitate the availability of promising regimens that ordinarily should be new devices to desperately ill patients tried before using the investigational as early in the device development device or an explanation of why the use process as possible, before general mar- of the investigational device is pref- keting begins, and to obtain additional erable to the use of available marketed data on the device’s safety and effec- treatments; tiveness. In the case of a serious dis- (iv) A description of clinical proce- ease, a device ordinarily may be made dures, laboratory tests, or other meas- available for treatment use under this ures that will be used to evaluate the section after all clinical trials have effects of the device and to minimize been completed. In the case of an im- risk; mediately life-threatening disease, a (v) Written procedures for moni- device may be made available for treat- toring the treatment use and the name ment use under this section prior to and address of the monitor; the completion of all clinical trials. (vi) Instructions for use for the de- For the purpose of this section, an vice and all other labeling as required ‘‘immediately life-threatening’’ disease under § 812.5(a) and (b); means a stage of a disease in which (vii) Information that is relevant to there is a reasonable likelihood that the safety and effectiveness of the de- death will occur within a matter of vice for the intended treatment use. In- months or in which premature death is formation from other IDE’s may be in- likely without early treatment. For corporated by reference to support the purposes of this section, ‘‘treatment treatment use; use’’of a device includes the use of a de- (viii) A statement of the sponsor’s vice for diagnostic purposes. commitment to meet all applicable responsibilities under this part and part (b) Criteria. FDA shall consider the 56 of this chapter and to ensure compli- use of an investigational device under a ance of all participating investigators treatment IDE if: with the informed consent require- (1) The device is intended to treat or ments of part 50 of this chapter; diagnose a serious or immediately life- (ix) An example of the agreement to threatening disease or condition; be signed by all investigators partici- (2) There is no comparable or satis- pating in the treatment IDE and cer- factory alternative device or other tification that no investigator will be therapy available to treat or diagnose added to the treatment IDE before the that stage of the disease or condition agreement is signed; and in the intended patient population; (x) If the device is to be sold, the (3) The device is under investigation price to be charged and a statement in- in a controlled clinical trial for the dicating that the price is based on same use under an approved IDE, or manufacturing and handling costs such clinical trials have been com- only. pleted; and (2) A licensed practitioner who re- (4) The sponsor of the investigation is ceives an investigational device for actively pursuing marketing approval/ treatment use under a treatment IDE clearance of the investigational device is an ‘‘investigator’’ under the IDE and with due diligence. is responsible for meeting all applica- (c) Applications for treatment use. (1) A ble investigator responsibilities under treatment IDE application shall in- this part and parts 50 and 56 of this clude, in the following order: chapter.

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(d) FDA action on treatment IDE appli- (ix) The clinical investigator(s) cations—(1) Approval of treatment IDE’s. named in the treatment IDE are not Treatment use may begin 30 days after qualified by reason of their scientific FDA receives the treatment IDE sub- training and/or experience to use the mission at the address specified in investigational device for the intended § 812.19, unless FDA notifies the sponsor treatment use. in writing earlier than the 30 days that (3) Notice of disapproval or withdrawal. the treatment use may or may not If FDA disapproves or proposes to with- begin. FDA may approve the treatment draw approval of a treatment IDE, use as proposed or approve it with FDA will follow the procedures set modifications. forth in § 812.30(c). (2) Disapproval or withdrawal of ap- (e) Safeguards. Treatment use of an proval of treatment IDE’s. FDA may dis- investigational device is conditioned approve or withdraw approval of a upon the sponsor and investigators treatment IDE if: complying with the safeguards of the (i) The criteria specified in § 812.36(b) IDE process and the regulations gov- are not met or the treatment IDE does erning informed consent (part 50 of this not contain the information required chapter) and institutional review in § 812.36(c); boards (part 56 of this chapter). (ii) FDA determines that any of the (f) Reporting requirements. The spon- grounds for disapproval or withdrawal sor of a treatment IDE shall submit of approval listed in § 812.30(b)(1) progress reports on a semi-annual basis through (b)(5) apply; to all reviewing IRB’s and FDA until (iii) The device is intended for a seri- the filing of a marketing application. ous disease or condition and there is These reports shall be based on the pe- insufficient evidence of safety and ef- riod of time since initial approval of fectiveness to support such use; the treatment IDE and shall include (iv) The device is intended for an im- the number of patients treated with mediately life-threatening disease or the device under the treatment IDE, condition and the available scientific the names of the investigators partici- evidence, taken as a whole, fails to pro- pating in the treatment IDE, and a vide a reasonable basis for concluding brief description of the sponsor’s ef- that the device: forts to pursue marketing approval/ (A) May be effective for its intended clearance of the device. Upon filing of use in its intended population; or a marketing application, progress re- (B) Would not expose the patients to ports shall be submitted annually in whom the device is to be administered accordance with § 812.150(b)(5). The to an unreasonable and significant ad- sponsor of a treatment IDE is respon- ditional risk of illness or injury; sible for submitting all other reports required under § 812.150. (v) There is reasonable evidence that the treatment use is impeding enroll- [62 FR 48947, Sept. 18, 1997] ment in, or otherwise interfering with the conduct or completion of, a con- § 812.38 Confidentiality of data and in- trolled investigation of the same or an- formation. other investigational device; (a) Existence of IDE. FDA will not dis- (vi) The device has received mar- close the existence of an IDE unless its keting approval/clearance or a com- existence has previously been publicly parable device or therapy becomes disclosed or acknowledged, until FDA available to treat or diagnose the same approves an application for premarket indication in the same patient popu- approval of the device subject to the lation for which the investigational de- IDE; or a notice of completion of a vice is being used; product development protocol for the (vii) The sponsor of the controlled device has become effective. clinical trial is not pursuing marketing (b) Availability of summaries or data. approval/clearance with due diligence; (1) FDA will make publicly available, (viii) Approval of the IDE for the con- upon request, a detailed summary of trolled clinical investigation of the de- information concerning the safety and vice has been withdrawn; or effectiveness of the device that was the

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basis for an order approving, dis- Subpart C—Responsibilities of approving, or withdrawing approval of Sponsors an application for an IDE for a banned device. The summary shall include in- § 812.40 General responsibilities of formation on any adverse effect on sponsors. health caused by the device. Sponsors are responsible for selecting (2) If a device is a banned device or if qualified investigators and providing the existence of an IDE has been pub- them with the information they need licly disclosed or acknowledged, data to conduct the investigation properly, or information contained in the file is ensuring proper monitoring of the in- not available for public disclosure be- vestigation, ensuring that IRB review fore approval of an application for pre- and approval are obtained, submitting market approval or the effective date an IDE application to FDA, and ensur- of a notice of completion of a product ing that any reviewing IRB and FDA development protocol except as pro- are promptly informed of significant vided in this section. FDA may, in its new information about an investiga- discretion, disclose a summary of se- tion. Additional responsibilities of lected portions of the safety and effec- sponsors are described in subparts B and G. tiveness data, that is, clinical, animal, or laboratory studies and tests of the § 812.42 FDA and IRB approval. device, for public consideration of a A sponsor shall not begin an inves- specific pending issue. tigation or part of an investigation (3) If the existence of an IDE file has until an IRB and FDA have both ap- not been publicly disclosed or acknowl- proved the application or supplemental edged, no data or information in the application relating to the investiga- file are available for public disclosure tion or part of an investigation. except as provided in paragraphs (b)(1) and (c) of this section. [46 FR 8957, Jan. 27, 1981] (4) Notwithstanding paragraph (b)(2) § 812.43 Selecting investigators and of this section, FDA will make avail- monitors. able to the public, upon request, the in- (a) Selecting investigators. A sponsor formation in the IDE that was required shall select investigators qualified by to be filed in Docket Number 95S–0158 training and experience to investigate in the Division of Dockets Management the device. (HFA–305), Food and Drug Administra- (b) Control of device. A sponsor shall tion, 5630 Fishers Lane, rm. 1061, Rock- ship investigational devices only to ville, MD 20852, for investigations in- qualified investigators participating in volving an exception from informed the investigation. consent under § 50.24 of this chapter. (c) Obtaining agreements. A sponsor Persons wishing to request this infor- shall obtain from each participating mation shall submit a request under investigator a signed agreement that the Freedom of Information Act. includes: (c) Reports of adverse effects. Upon re- (1) The investigator’s curriculum quest or on its own initiative, FDA vitae. shall disclose to an individual on whom (2) Where applicable, a statement of an investigational device has been used the investigator’s relevant experience, a copy of a report of adverse device ef- including the dates, location, extent, fects relating to that use. and type of experience. (d) Other rules. Except as otherwise (3) If the investigator was involved in provided in this section, the avail- an investigation or other research that ability for public disclosure of data and was terminated, an explanation of the circumstances that led to termination. information in an IDE file shall be han- (4) A statement of the investigator’s dled in accordance with § 814.9. commitment to: [45 FR 3751, Jan. 18, 1980, as amended at 53 (i) Conduct the investigation in ac- FR 11253, Apr. 6, 1988; 61 FR 51531, Oct. 2, cordance with the agreement, the in- 1996] vestigational plan, this part and other

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applicable FDA regulations, and condi- duct an evaluation of any unantici- tions of approval imposed by the re- pated adverse device effect. viewing IRB or FDA; (2) A sponsor who determines that an (ii) Supervise all testing of the device unanticipated adverse device effect involving human subjects; and presents an unreasonable risk to sub- (iii) Ensure that the requirements for jects shall terminate all investigations obtaining informed consent are met. or parts of investigations presenting (5) Sufficient accurate financial dis- that risk as soon as possible. Termi- closure information to allow the spon- nation shall occur not later than 5 sor to submit a complete and accurate working days after the sponsor makes certification or disclosure statement as this determination and not later than required under part 54 of this chapter. 15 working days after the sponsor first The sponsor shall obtain a commit- received notice of the effect. ment from the clinical investigator to (c) Resumption of terminated studies. If promptly update this information if the device is a significant risk device, any relevant changes occur during the a sponsor may not resume a termi- course of the investigation and for 1 nated investigation without IRB and year following completion of the study. FDA approval. If the device is not a This information shall not be sub- significant risk device, a sponsor may mitted in an investigational device exemption application, but shall be sub- not resume a terminated investigation mitted in any marketing application without IRB approval and, if the inves- involving the device. tigation was terminated under para- (d) Selecting monitors. A sponsor shall graph (b)(2) of this section, FDA ap- select monitors qualified by training proval. and experience to monitor the investigational study in accordance with § 812.47 Emergency research under § 50.24 of this chapter. this part and other applicable FDA regulations. (a) The sponsor shall monitor the progress of all investigations involving [45 FR 3751, Jan. 18, 1980, as amended at 63 an exception from informed consent FR 5253, Feb. 2, 1998] under § 50.24 of this chapter. When the § 812.45 Informing investigators. sponsor receives from the IRB information concerning the public disclosures A sponsor shall supply all investiga- under § 50.24(a)(7)(ii) and (a)(7)(iii) of tors participating in the investigation this chapter, the sponsor shall prompt- with copies of the investigational plan ly submit to the IDE file and to Docket and the report of prior investigations Number 95S–0158 in the Division of of the device. Dockets Management (HFA–305), Food § 812.46 Monitoring investigations. and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, (a) Securing compliance. A sponsor copies of the information that was dis- who discovers that an investigator is closed, identified by the IDE number. not complying with the signed agreement, the investigational plan, the re- (b) The sponsor also shall monitor quirements of this part or other appli- such investigations to determine when cable FDA regulations, or any condi- an IRB determines that it cannot ap- tions of approval imposed by the re- prove the research because it does not viewing IRB or FDA shall promptly ei- meet the criteria in the exception in ther secure compliance, or discontinue § 50.24(a) of this chapter or because of shipments of the device to the investi- other relevant ethical concerns. The gator and terminate the investigator’s sponsor promptly shall provide this in- participation in the investigation. A formation in writing to FDA, inves- sponsor shall also require such an in- tigators who are asked to participate vestigator to dispose of or return the in this or a substantially equivalent device, unless this action would jeop- clinical investigation, and other IRB’s ardize the rights, safety, or welfare of a that are asked to review this or a sub- subject. stantially equivalent investigation. (b) Unanticipated adverse device effects. [61 FR 51531, Oct. 2, 1996, as amended at 64 FR (1) A sponsor shall immediately con- 10943, Mar. 8, 1999]

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Subpart D—IRB Review and under investigation. An investigator Approval also is responsible for ensuring that informed consent is obtained in accord- § 812.60 IRB composition, duties, and ance with part 50 of this chapter. Addi- functions. tional responsibilities of investigators An IRB reviewing and approving in- are described in subpart G. vestigations under this part shall com- [45 FR 3751, Jan. 18, 1980, as amended at 46 ply with the requirements of part 56 in FR 8957, Jan. 27, 1981] all respects, including its composition, duties, and functions. § 812.110 Specific responsibilities of in- [46 FR 8957, Jan. 27, 1981] vestigators. (a) Awaiting approval. An investigator § 812.62 IRB approval. may determine whether potential sub- (a) An IRB shall review and have au- jects would be interested in partici- thority to approve, require modifica- pating in an investigation, but shall tions in (to secure approval), or dis- not request the written informed con- approve all investigations covered by sent of any subject to participate, and this part. shall not allow any subject to partici- (b) If no IRB exists or if FDA finds pate before obtaining IRB and FDA ap- that an IRB’s review is inadequate, a proval. sponsor may submit an application to (b) Compliance. An investigator shall FDA. conduct an investigation in accordance [46 FR 8957, Jan. 27, 1981] with the signed agreement with the sponsor, the investigational plan, this § 812.64 IRB’s continuing review. part and other applicable FDA regula- The IRB shall conduct its continuing tions, and any conditions of approval review of an investigation in accord- imposed by an IRB or FDA. ance with part 56. (c) Supervising device use. An investigator shall permit an investigational [46 FR 8957, Jan. 27, 1981] device to be used only with subjects § 812.65 [Reserved] under the investigator’s supervision. An investigator shall not supply an in- § 812.66 Significant risk device deter- vestigational device to any person not minations. authorized under this part to receive If an IRB determines that an inves- it. tigation, presented for approval under (d) Financial disclosure. A clinical in- § 812.2(b)(1)(ii), involves a significant vestigator shall disclose to the sponsor risk device, it shall so notify the inves- sufficient accurate financial informa- tigator and, where appropriate, the tion to allow the applicant to submit sponsor. A sponsor may not begin the complete and accurate certification or investigation except as provided in disclosure statements required under § 812.30(a). part 54 of this chapter. The investi- [46 FR 8957, Jan. 27, 1981] gator shall promptly update this information if any relevant changes occur during the course of the investigation Subpart E—Responsibilities of and for 1 year following completion of Investigators the study. § 812.100 General responsibilities of in- (e) Disposing of device. Upon comple- vestigators. tion or termination of a clinical investigation or the investigator’s part of an An investigator is responsible for en- investigation, or at the sponsor’s re- suring that an investigation is con- quest, an investigator shall return to ducted according to the signed agree- the sponsor any remaining supply of ment, the investigational plan and ap- the device or otherwise dispose of the plicable FDA regulations, for pro- tecting the rights, safety, and welfare device as the sponsor directs. of subjects under the investigator’s [45 FR 3751, Jan. 18, 1980, as amended at 63 care, and for the control of devices FR 5253, Feb. 2, 1998]

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§ 812.119 Disqualification of a clinical vestigation that supports an applica- investigator. tion for a research or marketing per- (a) If FDA has information indicating mit for products regulated by FDA, in- that an investigator (including a spon- cluding drugs, biologics, devices, new sor-investigator) has repeatedly or de- animal drugs, foods, including dietary liberately failed to comply with the re- supplements, that bear a nutrient con- quirements of this part, part 50, or part tent claim or a health claim, infant 56 of this chapter, or has repeatedly or formulas, food and color additives, and deliberately submitted to FDA or to tobacco products. the sponsor false information in any (c) Each application or submission to required report, the Center for Devices FDA under the provisions of this chap- and Radiological Health, the Center for ter containing data reported by an in- Biologics Evaluation and Research, or vestigator who has been determined to the Center for Drug Evaluation and Re- be ineligible to receive FDA-regulated search will furnish the investigator test articles is subject to examination written notice of the matter com- to determine whether the investigator plained of and offer the investigator an has submitted unreliable data that are opportunity to explain the matter in essential to the continuation of an in- writing, or, at the option of the inves- vestigation or essential to the clear- tigator, in an informal conference. If ance or approval of a marketing appli- an explanation is offered and accepted cation, or essential to the continued by the applicable Center, the Center marketing of an FDA-regulated prod- will discontinue the disqualification uct. proceeding. If an explanation is offered (d) If the Commissioner determines, but not accepted by the applicable Cen- after the unreliable data submitted by ter, the investigator will be given an the investigator are eliminated from opportunity for a regulatory hearing under part 16 of this chapter on the consideration, that the data remaining question of whether the investigator is are inadequate to support a conclusion eligible to receive test articles under that it is reasonably safe to continue this part and eligible to conduct any the investigation, the Commissioner clinical investigation that supports an will notify the sponsor, who shall have application for a research or marketing an opportunity for a regulatory hear- permit for products regulated by FDA. ing under part 16 of this chapter. If a (b) After evaluating all available in- danger to the public health exists, how- formation, including any explanation ever, the Commissioner shall termi- presented by the investigator, if the nate the investigational device exemp- Commissioner determines that the in- tion (IDE) immediately and notify the vestigator has repeatedly or delib- sponsor and the reviewing IRBs of the erately failed to comply with the re- termination. In such case, the sponsor quirements of this part, part 50, or part shall have an opportunity for a regu- 56 of this chapter, or has repeatedly or latory hearing before FDA under part deliberately submitted to FDA or to 16 of this chapter on the question of the sponsor false information in any whether the IDE should be reinstated. required report, the Commissioner will The determination that an investiga- notify the investigator, the sponsor of tion may not be considered in support any investigation in which the investi- of a research or marketing application gator has been named as a participant, or a notification or petition submission and the reviewing investigational re- does not, however, relieve the sponsor view boards (IRBs) that the investi- of any obligation under any other ap- gator is not eligible to receive test ar- plicable regulation to submit to FDA ticles under this part. The notification the results of the investigation. to the investigator, sponsor and IRBs (e) If the Commissioner determines, will provide a statement of the basis after the unreliable data submitted by for such determination. The notifica- the investigator are eliminated from tion also will explain that an investi- consideration, that the continued gator determined to be ineligible to re- clearance or approval of the product ceive test articles under this part will for which the data were submitted can- be ineligible to conduct any clinical in- not be justified, the Commissioner will

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proceed to rescind clearance or with- tion of the circumstances justifying draw approval of the product in accord- the failure to obtain informed consent. ance with the applicable provisions of The case history for each individual the relevant statutes. shall document that informed consent (f) An investigator who has been de- was obtained prior to participation in termined to be ineligible under para- the study. graph (b) of this section may be rein- (ii) All relevant observations, includ- stated as eligible when the Commis- ing records concerning adverse device sioner determines that the investigator effects (whether anticipated or unan- has presented adequate assurances that ticipated), information and data on the the investigator will employ all test condition of each subject upon enter- articles, and will conduct any clinical ing, and during the course of, the in- investigation that supports an application for a research or marketing per- vestigation, including information mit for products regulated by FDA, about relevant previous medical his- solely in compliance with the applica- tory and the results of all diagnostic ble provisions of this chapter. tests. (iii) A record of the exposure of each [77 FR 25360, Apr. 30, 2012] subject to the investigational device, including the date and time of each Subpart F [Reserved] use, and any other therapy. (4) The protocol, with documents Subpart G—Records and Reports showing the dates of and reasons for each deviation from the protocol. § 812.140 Records. (5) Any other records that FDA re- (a) Investigator records. A partici- quires to be maintained by regulation pating investigator shall maintain the or by specific requirement for a cat- following accurate, complete, and cur- egory of investigations or a particular rent records relating to the investiga- investigation. tor’s participation in an investigation: (b) Sponsor records. A sponsor shall (1) All correspondence with another maintain the following accurate, com- investigator, an IRB, the sponsor, a plete, and current records relating to monitor, or FDA, including required reports. an investigation: (2) Records of receipt, use or disposi- (1) All correspondence with another tion of a device that relate to: sponsor, a monitor, an investigator, an (i) The type and quantity of the de- IRB, or FDA, including required re- vice, the dates of its receipt, and the ports. batch number or code mark. (2) Records of shipment and disposi- (ii) The names of all persons who re- tion. Records of shipment shall include ceived, used, or disposed of each device. the name and address of the consignee, (iii) Why and how many units of the type and quantity of device, date of device have been returned to the spon- shipment, and batch number or code sor, repaired, or otherwise disposed of. mark. Records of disposition shall de- (3) Records of each subject’s case his- scribe the batch number or code marks tory and exposure to the device. Case of any devices returned to the sponsor, histories include the case report forms repaired, or disposed of in other ways and supporting data including, for ex- by the investigator or another person, ample, signed and dated consent forms and the reasons for and method of dis- and medical records including, for ex- posal. ample, progress notes of the physician, (3) Signed investigator agreements the individual’s hospital chart(s), and including the financial disclosure in- the nurses’ notes. Such records shall include: formation required to be collected (i) Documents evidencing informed under § 812.43(c)(5) in accordance with consent and, for any use of a device by part 54 of this chapter. the investigator without informed consent, any written concurrence of a licensed physician and a brief descrip-

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(4) For each investigation subject to given to FDA not later than 10 working § 812.2(b)(1) of a device other than a sig- days after transfer occurs. nificant risk device, the records de- [45 FR 3751, Jan. 18, 1980, as amended at 45 scribed in paragraph (b)(5) of this sec- FR 58843, Sept. 5, 1980; 46 FR 8957, Jan. 27, tion and the following records, consoli- 1981; 61 FR 57280, Nov. 5, 1996; 63 FR 5253, Feb. dated in one location and available for 2, 1998] FDA inspection and copying: (i) The name and intended use of the § 812.145 Inspections. device and the objectives of the inves- (a) Entry and inspection. A sponsor or tigation; an investigator who has authority to (ii) A brief explanation of why the de- grant access shall permit authorized vice is not a significant risk device: FDA employees, at reasonable times (iii) The name and address of each in- and in a reasonable manner, to enter vestigator: and inspect any establishment where (iv) The name and address of each devices are held (including any estab- IRB that has reviewed the investiga- lishment where devices are manufac- tion: tured, processed, packed, installed, used, or implanted or where records of (v) A statement of the extent to results from use of devices are kept). which the good manufacturing practice (b) Records inspection. A sponsor, IRB, regulation in part 820 will be followed or investigator, or any other person in manufacturing the device; and acting on behalf of such a person with (vi) Any other information required respect to an investigation, shall per- by FDA. mit authorized FDA employees, at rea- (5) Records concerning adverse device sonable times and in a reasonable man- effects (whether anticipated or unan- ner, to inspect and copy all records re- ticipated) and complaints and lating to an investigation. (6) Any other records that FDA re- (c) Records identifying subjects. An in- quires to be maintained by regulation vestigator shall permit authorized FDA or by specific requirement for a cat- employees to inspect and copy records egory of investigation or a particular that identify subjects, upon notice that investigation. FDA has reason to suspect that ade- (c) IRB records. An IRB shall main- quate informed consent was not obtain records in accordance with part 56 tained, or that reports required to be of this chapter. submitted by the investigator to the (d) Retention period. An investigator sponsor or IRB have not been sub- or sponsor shall maintain the records mitted or are incomplete, inaccurate, required by this subpart during the in- false, or misleading. vestigation and for a period of 2 years § 812.150 Reports. after the latter of the following two dates: The date on which the investiga- (a) Investigator reports. An investi- tion is terminated or completed, or the gator shall prepare and submit the fol- date that the records are no longer re- lowing complete, accurate, and timely quired for purposes of supporting a pre- reports: market approval application or a no- (1) Unanticipated adverse device effects. An investigator shall submit to the tice of completion of a product devel- sponsor and to the reviewing IRB a re- opment protocol. port of any unanticipated adverse de- (e) Records custody. An investigator vice effect occurring during an inves- or sponsor may withdraw from the re- tigation as soon as possible, but in no sponsibility to maintain records for the event later than 10 working days after period required in paragraph (d) of this the investigator first learns of the ef- section and transfer custody of the fect. records to any other person who will (2) Withdrawal of IRB approval. An in- accept responsibility for them under vestigator shall report to the sponsor, this part, including the requirements within 5 working days, a withdrawal of of § 812.145. Notice of a transfer shall be approval by the reviewing IRB of the investigator’s part of an investigation.

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(3) Progress. An investigator shall of an investigation or a part of an in- submit progress reports on the inves- vestigation by a reviewing IRB within tigation to the sponsor, the monitor, 5 working days after receipt of the and the reviewing IRB at regular inter- withdrawal of approval. vals, but in no event less often than (3) Withdrawal of FDA approval. A yearly. sponsor shall notify all reviewing IRB’s (4) Deviations from the investigational and participating investigators of any plan. An investigator shall notify the withdrawal of FDA approval of the in- sponsor and the reviewing IRB (see vestigation, and shall do so within 5 § 56.108(a) (3) and (4)) of any deviation working days after receipt of notice of from the investigational plan to pro- the withdrawal of approval. tect the life or physical well-being of a (4) Current investigator list. A sponsor subject in an emergency. Such notice shall submit to FDA, at 6-month inter- shall be given as soon as possible, but vals, a current list of the names and in no event later than 5 working days after the emergency occurred. Except addresses of all investigators partici- in such an emergency, prior approval pating in the investigation. The spon- by the sponsor is required for changes sor shall submit the first such list 6 in or deviations from a plan, and if months after FDA approval. these changes or deviations may affect (5) Progress reports. At regular inter- the scientific soundness of the plan or vals, and at least yearly, a sponsor the rights, safety, or welfare of human shall submit progress reports to all re- subjects, FDA and IRB in accordance viewing IRB’s. In the case of a signifi- with § 812.35(a) also is required. cant risk device, a sponsor shall also (5) Informed consent. If an investi- submit progress reports to FDA. A gator uses a device without obtaining sponsor of a treatment IDE shall sub- informed consent, the investigator mit semi-annual progress reports to all shall report such use to the sponsor reviewing IRB’s and FDA in accordance and the reviewing IRB within 5 work- with § 812.36(f) and annual reports in ac- ing days after the use occurs. cordance with this section. (6) Final report. An investigator shall, (6) Recall and device disposition. A within 3 months after termination or sponsor shall notify FDA and all re- completion of the investigation or the viewing IRB’s of any request that an investigator’s part of the investigation, investigator return, repair, or other- submit a final report to the sponsor wise dispose of any units of a device. and the reviewing IRB. Such notice shall occur within 30 work- (7) Other. An investigator shall, upon ing days after the request is made and request by a reviewing IRB or FDA, shall state why the request was made. provide accurate, complete, and cur- (7) Final report. In the case of a sig- rent information about any aspect of nificant risk device, the sponsor shall the investigation. notify FDA within 30 working days of (b) Sponsor reports. A sponsor shall prepare and submit the following com- the completion or termination of the plete, accurate, and timely reports: investigation and shall submit a final (1) Unanticipated adverse device effects. report to FDA and all reviewing the A sponsor who conducts an evaluation IRB’s and participating investigators of an unanticipated adverse device ef- within 6 months after completion or fect under § 812.46(b) shall report the re- termination. In the case of a device sults of such evaluation to FDA and to that is not a significant risk device, all reviewing IRB’s and participating the sponsor shall submit a final report investigators within 10 working days to all reviewing IRB’s within 6 months after the sponsor first receives notice after termination or completion. of the effect. Thereafter the sponsor (8) Informed consent. A sponsor shall shall submit such additional reports submit to FDA a copy of any report by concerning the effect as FDA requests. an investigator under paragraph (a)(5) (2) Withdrawal of IRB approval. A of this section of use of a device with- sponsor shall notify FDA and all re- out obtaining informed consent, within viewing IRB’s and participating inves- 5 working days of receipt of notice of tigators of any withdrawal of approval such use.

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(9) Significant risk device determina- Subparts F–G [Reserved] tions. If an IRB determines that a device is a significant risk device, and Subpart H—Humanitarian Use Devices the sponsor had proposed that the IRB 814.100 Purpose and scope. consider the device not to be a signifi- 814.102 Designation of HUD status. cant risk device, the sponsor shall sub- 814.104 Original applications. mit to FDA a report of the IRB’s deter- 814.106 HDE amendments and resubmitted mination within 5 working days after HDE’s. the sponsor first learns of the IRB’s de- 814.108 Supplemental applications. termination. 814.110 New indications for use. (10) Other. A sponsor shall, upon re- 814.112 Filing an HDE. quest by a reviewing IRB or FDA, pro- 814.114 Timeframes for reviewing an HDE. 814.116 Procedures for review of an HDE. vide accurate, complete, and current 814.118 Denial of approval or withdrawal of information about any aspect of the in- approval of an HDE. vestigation. 814.120 Temporary suspension of approval of [45 FR 3751, Jan. 18, 1980, as amended at 45 an HDE. FR 58843, Sept. 5, 1980; 48 FR 15622, Apr. 12, 814.122 Confidentiality of data and informa- 1983; 62 FR 48948, Sept. 18, 1997] tion. 814.124 Institutional Review Board requirements. PART 813 [RESERVED] 814.126 Postapproval requirements and reports.

PART 814—PREMARKET APPROVAL AUTHORITY: 21 U.S.C. 351, 352, 353, 360, 360c– OF MEDICAL DEVICES 360j, 371, 372, 373, 374, 375, 379, 379e, 381. SOURCE: 51 FR 26364, July 22, 1986, unless Subpart A—General otherwise noted. Sec. 814.1 Scope. Subpart A—General 814.2 Purpose. 814.3 Definitions. § 814.1 Scope. 814.9 Confidentiality of data and informa- (a) This section implements sections tion in a premarket approval application (PMA) file. 515 and 515A of the act by providing 814.15 Research conducted outside the procedures for the premarket approval United States. of medical devices intended for human 814.17 Service of orders. use. 814.19 Product development protocol (PDP). (b) References in this part to regulatory sections of the Code of Federal Subpart B—Premarket Approval Regulations are to chapter I of title 21, Application (PMA) unless otherwise noted. 814.20 Application. (c) This part applies to any class III 814.37 PMA amendments and resubmitted medical device, unless exempt under PMAs. section 520(g) of the act, that: 814.39 PMA supplements. (1) Was not on the market (introduced or delivered for introduction into Subpart C—FDA Action on a PMA commerce for commercial distribution) 814.40 Time frames for reviewing a PMA. before May 28, 1976, and is not substan- 814.42 Filing a PMA. tially equivalent to a device on the 814.44 Procedures for review of a PMA. market before May 28, 1976, or to a de- 814.45 Denial of approval of a PMA. vice first marketed on, or after that 814.46 Withdrawal of approval of a PMA. 814.47 Temporary suspension of approval of date, which has been classified into a PMA. class I or class II; or (2) Is required to have an approved Subpart D—Administrative Review premarket approval application (PMA) [Reserved] or a declared completed product development protocol under a regulation Subpart E—Postapproval Requirements issued under section 515(b) of the act; 814.80 General. or 814.82 Postapproval requirements. (3) Was regulated by FDA as a new 814.84 Reports. drug or antibiotic drug before May 28,

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1976, and therefore is governed by sec- modify a pending PMA or a pending tion 520(1) of the act. PMA supplement. (d) This part amends the conditions (g) PMA supplement means a supple- to approval for any PMA approved be- mental application to an approved fore the effective date of this part. Any PMA for approval of a change or modi- condition to approval for an approved fication in a class III medical device, PMA that is inconsistent with this part including all information submitted is revoked. Any condition to approval with or incorporated by reference for an approved PMA that is consistent therein. with this part remains in effect. (h) Person includes any individual, partnership, corporation, association, [51 FR 26364, July 22, 1986, as amended at 79 FR 1740, Jan. 10, 2014] scientific or academic establishment, Government agency, or organizational § 814.2 Purpose. unit thereof, or any other legal entity. (i) Statement of material fact means a The purpose of this part is to estab- representation that tends to show that lish an efficient and thorough device the safety or effectiveness of a device review process— is more probable than it would be in (a) To facilitate the approval of the absence of such a representation. A PMA’s for devices that have been false affirmation or silence or an omis- shown to be safe and effective and that sion that would lead a reasonable per- otherwise meet the statutory criteria son to draw a particular conclusion as for approval; and to the safety or effectiveness of a de- (b) To ensure the disapproval of vice also may be a false statement of PMA’s for devices that have not been material fact, even if the statement shown to be safe and effective or that was not intended by the person making do not otherwise meet the statutory it to be misleading or to have any pro- criteria for approval. This part shall be bative effect. construed in light of these objectives. (j) 30-day PMA supplement means a supplemental application to an ap- § 814.3 Definitions. proved PMA in accordance with For the purposes of this part: § 814.39(e). (a) Act means the Federal Food, (k) Reasonable probability means that Drug, and Cosmetic Act (sections 201– it is more likely than not that an event 902, 52 Stat. 1040 et seq., as amended (21 will occur. U.S.C. 321–392)). (l) Serious, adverse health consequences (b) FDA means the Food and Drug means any significant adverse experi- Administration. ence, including those which may be ei- (c) IDE means an approved or consid- ther life-threatening or involve perma- ered approved investigational device nent or long term injuries, but exclud- exemption under section 520(g) of the ing injuries that are nonlife-threat- act and parts 812 and 813. ening and that are temporary and rea- (d) Master file means a reference sonably reversible. source that a person submits to FDA. A (m) HDE means a premarket approval master file may contain detailed infor- application submitted pursuant to this mation on a specific manufacturing fa- subpart seeking a humanitarian device cility, process, methodology, or compo- exemption from the effectiveness re- nent used in the manufacture, proc- quirements of sections 514 and 515 of essing, or packaging of a medical de- the act as authorized by section vice. 520(m)(2) of the act. (e) PMA means any premarket ap- (n) HUD (humanitarian use device) proval application for a class III med- means a medical device intended to ical device, including all information benefit patients in the treatment or di- submitted with or incorporated by ref- agnosis of a disease or condition that erence therein. ‘‘PMA’’ includes a new affects or is manifested in fewer than drug application for a device under sec- 4,000 individuals in the United States tion 520(1) of the act. per year. (f) PMA amendment means informa- (o) Newly acquired information means tion an applicant submits to FDA to data, analyses, or other information

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not previously submitted to the agen- ducting biomedical, regulatory, and cy, which may include (but are not lim- medical product research. ited to) data derived from new clinical [51 FR 26364, July 22, 1986, as amended at 61 studies, reports of adverse events, or FR 15190, Apr. 5, 1996; 61 FR 33244, June 26, new analyses of previously submitted 1996; 73 FR 49610, Aug. 22, 2008; 78 FR 55821, data (e.g., meta-analyses) if the stud- Sept. 24, 2013; 79 FR 1740, Jan. 10, 2014] ies, events or analyses reveal risks of a different type or greater severity or § 814.9 Confidentiality of data and in- frequency than previously included in formation in a premarket approval submissions to FDA. application (PMA) file. (p) Human cell, tissue, or cellular or tis- (a) A ‘‘PMA file’’ includes all data sue-based product (HCT/P) regulated as a and information submitted with or in- device means an HCT/P as defined in corporated by reference in the PMA, § 1271.3(d) of this chapter that does not any IDE incorporated into the PMA, meet the criteria in § 1271.10(a) and that any PMA supplement, any report under is also regulated as a device. § 814.82, any master file, or any other (q) Unique device identifier (UDI) related submission. Any record in the means an identifier that adequately PMA file will be available for public disclosure in accordance with the pro- identifies a device through its distribu- visions of this section and part 20. The tion and use by meeting the require- confidentiality of information in a ments of § 830.20 of this chapter. A color additive petition submitted as unique device identifier is composed of: part of a PMA is governed by § 71.15. (1) A —a mandatory, device identifier (b) The existence of a PMA file may fixed portion of a UDI that identifies not be disclosed by FDA before an ap- the specific version or model of a de- proval order is issued to the applicant vice and the labeler of that device; and unless it previously has been publicly (2) A production identifier—a condi- disclosed or acknowledged. tional, variable portion of a UDI that (c) If the existence of a PMA file has identifies one or more of the following not been publicly disclosed or acknowl- when included on the label of the de- edged, data or information in the PMA vice: file are not available for public disclo- (i) The lot or batch within which a sure. device was manufactured; (d)(1) If the existence of a PMA file (ii) The serial number of a specific has been publicly disclosed or acknowl- device; edged before an order approving, or an (iii) The expiration date of a specific order denying approval of the PMA is device; issued, data or information contained (iv) The date a specific device was in the file are not available for public manufactured. disclosure before such order issues. (v) For an HCT/P regulated as a de- FDA may, however, disclose a sum- vice, the distinct identification code mary of portions of the safety and ef- required by § 1271.290(c) of this chapter. fectiveness data before an approval (r) Universal product code (UPC) order or an order denying approval of means the product identifier used to the PMA issues if disclosure is relevant to public consideration of a specific identify an item sold at retail in the pending issue. United States. (2) Notwithstanding paragraph (d)(1) (s) Pediatric patients means patients of this section, FDA will make avail- who are 21 years of age or younger able to the public upon request the in- (that is, from birth through the twen- formation in the IDE that was required ty-first year of life, up to but not in- to be filed in Docket Number 95S–0158 cluding the twenty-second birthday) at in the Division of Dockets Management the time of the diagnosis or treatment. (HFA–305), Food and Drug Administra- (t) Readily available means available tion, 12420 Parklawn Dr., rm. 1–23, in the public domain through com- Rockville, MD 20857, for investigations monly used public resources for con- involving an exception from informed consent under § 50.24 of this chapter.

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Persons wishing to request this infor- (g) All safety and effectiveness data mation shall submit a request under and other information not previously the Freedom of Information Act. disclosed to the public are available for (e) Upon issuance of an order approv- public disclosure if any one of the fol- ing, or an order denying approval of lowing events occurs and the data and any PMA, FDA will make available to information do not constitute trade se- the public the fact of the existence of cret or confidential commercial or fi- the PMA and a detailed summary of in- nancial information under § 20.61: formation submitted to FDA respect- (1) The PMA has been abandoned. ing the safety and effectiveness of the FDA will consider a PMA abandoned if: device that is the subject of the PMA (i)(A) The applicant fails to respond and that is the basis for the order. (f) After FDA issues an order approv- to a request for additional information ing, or an order denying approval of within 180 days after the date FDA any PMA, the following data and infor- issues the request or mation in the PMA file are imme- (B) Other circumstances indicate diately available for public disclosure: that further work is not being under- (1) All safety and effectiveness data taken with respect to it, and and information previously disclosed to (ii) The applicant fails to commu- the public, as such disclosure is defined nicate with FDA within 7 days after in § 20.81. the date on which FDA notifies the ap- (2) Any protocol for a test or study plicant that the PMA appears to have unless the protocol is shown to con- been abandoned. stitute trade secret or confidential (2) An order denying approval of the commercial or financial information PMA has issued, and all legal appeals under § 20.61. have been exhausted. (3) Any adverse reaction report, prod- (3) An order withdrawing approval of uct experience report, consumer com- the PMA has issued, and all legal ap- plaint, and other similar data and in- peals have been exhausted. formation, after deletion of: (4) The device has been reclassified. (i) Any information that constitutes trade secret or confidential commer- (5) The device has been found to be cial or financial information under substantially equivalent to a class I or § 20.61; and class II device. (ii) Any personnel, medical, and simi- (6) The PMA is considered volun- lar information disclosure of which tarily withdrawn under § 814.44(g). would constitute a clearly unwarranted (h) The following data and informa- invasion of personal privacy under tion in a PMA file are not available for § 20.63; provided, however, that except public disclosure unless they have been for the information that constitutes previously disclosed to the public, as trade secret or confidential commer- such disclosure is defined in § 20.81, or cial or financial information under they relate to a device for which a § 20.61, FDA will disclose to a patient PMA has been abandoned and they no who requests a report all the informa- longer represent a trade secret or con- tion in the report concerning that pa- fidential commercial or financial infor- tient. mation as defined in § 20.61: (4) A list of components previously (1) Manufacturing methods or proc- disclosed to the public, as such disclo- esses, including quality control proce- sure is defined in § 20.81. dures. (5) An assay method or other analytical method, unless it does not serve (2) Production, sales, distribution, any regulatory purpose and is shown to and similar data and information, ex- fall within the exemption in § 20.61 for cept that any compilation of such data trade secret or confidential commer- and information aggregated and pre- cial or financial information. pared in a way that does not reveal (6) All correspondence and written data or information which are not summaries of oral discussions relating available for public disclosure under to the PMA file, in accordance with the this provision is available for public provisions of §§ 20.103 and 20.104. disclosure.

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(3) Quantitative or semiquantitative validate the data through an on-site in- formulas. spection or other appropriate means. (e) Consultation between FDA and ap- [51 FR 26364, July 22, 1986, as amended at 61 plicants. Applicants are encouraged to FR 51531, Oct. 2, 1996] meet with FDA officials in a ‘‘pre- § 814.15 Research conducted outside submission’’ meeting when approval the United States. based solely on foreign data will be sought. (a) A study conducted outside the United States submitted in support of (Approved by the Office of Management and a PMA and conducted under an IDE Budget under control number 0910–0231) shall comply with part 812. A study [51 FR 26364, July 22, 1986; 51 FR 40415, Nov. conducted outside the United States 7, 1986, as amended at 51 FR 43344, Dec. 2, submitted in support of a PMA and not 1986] conducted under an IDE shall comply with the provisions in paragraph (b) or § 814.17 Service of orders. (c) of this section, as applicable. Orders issued under this part will be (b) Research begun on or after effective served in person by a designated officer date. FDA will accept studies sub- or employee of FDA on, or by reg- mitted in support of a PMA which have istered mail to, the applicant or the been conducted outside the United designated agent at the applicant’s or States and begun on or after November designated agent’s last known address 19, 1986, if the data are valid and the in- in FDA’s records. vestigator has conducted the studies in conformance with the ‘‘Declaration of § 814.19 Product development protocol Helsinki’’ or the laws and regulations (PDP). of the country in which the research is A class III device for which a product conducted, whichever accords greater development protocol has been de- protection to the human subjects. If clared completed by FDA under this the standards of the country are used, chapter will be considered to have an the applicant shall state in detail any approved PMA. differences between those standards and the ‘‘Declaration of Helsinki’’ and Subpart B—Premarket Approval explain why they offer greater protec- Application (PMA) tion to the human subjects. (c) Research begun before effective § 814.20 Application. date. FDA will accept studies sub- (a) The applicant or an authorized mitted in support of a PMA which have representative shall sign the PMA. If been conducted outside the United the applicant does not reside or have a States and begun before November 19, place of business within the United 1986, if FDA is satisfied that the data States, the PMA shall be countersigned are scientifically valid and that the by an authorized representative resid- rights, safety, and welfare of human ing or maintaining a place of business subjects have not been violated. in the United States and shall identify (d) As sole basis for marketing approval. the representative’s name and address. A PMA based solely on foreign clinical (b) Unless the applicant justifies an data and otherwise meeting the cri- omission in accordance with paragraph teria for approval under this part may (d) of this section, a PMA shall include: be approved if: (1) The name and address of the ap- (1) The foreign data are applicable to plicant. the U.S. population and U.S. medical (2) A table of contents that specifies practice; the volume and page number for each (2) The studies have been performed item referred to in the table. A PMA by clinical investigators of recognized shall include separate sections on non- competence; and clinical laboratory studies and on clin- (3) The data may be considered valid ical investigations involving human without the need for an on-site inspec- subjects. A PMA shall be submitted in tion by FDA or, if FDA considers such six copies each bound in one or more an inspection to be necessary, FDA can numbered volumes of reasonable size.

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The applicant shall include informa- the objective of the study, a description that it believes to be trade secret tion of the experimental design of the or confidential commercial or financial study, a brief description of how the information in all copies of the PMA data were collected and analyzed, and a and identify in at least one copy the in- brief description of the results, wheth- formation that it believes to be trade er positive, negative, or inconclusive. secret or confidential commercial or fi- This section shall include the fol- nancial information. lowing: (3) A summary in sufficient detail (A) A summary of the nonclinical that the reader may gain a general un- laboratory studies submitted in the ap- derstanding of the data and informa- plication; tion in the application. The summary (B) A summary of the clinical inves- shall contain the following informa- tigations involving human subjects tion: submitted in the application including (i) Indications for use. A general de- a discussion of subject selection and scription of the disease or condition exclusion criteria, study population, the device will diagnose, treat, prevent, study period, safety and effectiveness cure, or mitigate, including a descrip- data, adverse reactions and complication of the patient population for tions, patient discontinuation, patient which the device is intended. complaints, device failures and replace- (ii) Device description. An explanation ments, results of statistical analyses of of how the device functions, the basic the clinical investigations, contra- scientific concepts that form the basis indications and precautions for use of for the device, and the significant the device, and other information from physical and performance characteris- the clinical investigations as appro- tics of the device. A brief description of priate (any investigation conducted the manufacturing process should be under an IDE shall be identified as included if it will significantly enhance such). the reader’s understanding of the de- (vi) Conclusions drawn from the stud- vice. The generic name of the device as ies. A discussion demonstrating that well as any proprietary name or trade the data and information in the appli- name should be included. cation constitute valid scientific evi- (iii) Alternative practices and proce- dence within the meaning of § 860.7 and dures. A description of existing alter- provide reasonable assurance that the native practices or procedures for diag- device is safe and effective for its in- nosing, treating, preventing, curing, or tended use. A concluding discussion mitigating the disease or condition for shall present benefit and risk consider- which the device is intended. ations related to the device including a (iv) Marketing history. A brief descrip- discussion of any adverse effects of the tion of the foreign and U.S. marketing device on health and any proposed ad- history, if any, of the device, including ditional studies or surveillance the ap- a list of all countries in which the de- plicant intends to conduct following vice has been marketed and a list of all approval of the PMA. countries in which the device has been (4) A complete description of: withdrawn from marketing for any rea- (i) The device, including pictorial son related to the safety or effective- representations; ness of the device. The description (ii) Each of the functional compo- shall include the history of the mar- nents or ingredients of the device if the keting of the device by the applicant device consists of more than one phys- and, if known, the history of the mar- ical component or ingredient; keting of the device by any other per- (iii) The properties of the device rel- son. evant to the diagnosis, treatment, pre- (v) Summary of studies. An abstract of vention, cure, or mitigation of a dis- any information or report described in ease or condition; the PMA under paragraph (b)(8)(ii) of (iv) The principles of operation of the this section and a summary of the re- device; and sults of technical data submitted under (v) The methods used in, and the fa- paragraph (b)(6) of this section. Such cilities and controls used for, the man- summary shall include a description of ufacture, processing, packing, storage,

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and, where appropriate, installation of safety and effectiveness data, adverse the device, in sufficient detail so that a reactions and complications, patient person generally familiar with current discontinuation, patient complaints, good manufacturing practice can make device failures and replacements, tab- a knowledgeable judgment about the ulations of data from all individual quality control used in the manufac- subject report forms and copies of such ture of the device. forms for each subject who died during (5) Reference to any performance a clinical investigation or who did not standard under section 514 of the act or complete the investigation, results of under section 534 of Subchapter C— statistical analyses of the clinical in- Electronic Product Radiation Control vestigations, device failures and re- of the Federal Food, Drug, and Cos- placements, contraindications and pre- metic Act (formerly the Radiation cautions for use of the device, and any Control for Health and Safety Act of other appropriate information from the 1968) in effect or proposed at the time clinical investigations. Any investiga- of the submission and to any voluntary tion conducted under an IDE shall be standard that is relevant to any aspect identified as such. Information on clin- of the safety or effectiveness of the de- ical investigations involving human vice and that is known to or that subjects shall include the following: should reasonably be known to the ap- (A) A statement with respect to each plicant. The applicant shall— study that it either was conducted in (i) Provide adequate information to compliance with the institutional re- demonstrate how the device meets, or view board regulations in part 56, or justify any deviation from, any per- was not subject to the regulations formance standard established under under § 56.104 or § 56.105, and that it was section 514 of the act or under section conducted in compliance with the in- 534 of Subchapter C—Electronic Prod- formed consent regulations in part 50; uct Radiation Control of the Federal or if the study was not conducted in Food, Drug, and Cosmetic Act (for- compliance with those regulations, a merly the Radiation Control for Health brief statement of the reason for the and Safety Act of 1968), and noncompliance. (ii) Explain any deviation from a vol- (B) A statement that each study was untary standard. conducted in compliance with part 812 (6) The following technical sections or part 813 concerning sponsors of clin- which shall contain data and informa- ical investigations and clinical inves- tion in sufficient detail to permit FDA tigators, or if the study was not con- to determine whether to approve or deny approval of the application: ducted in compliance with those regu- (i) A section containing results of the lations, a brief statement of the reason nonclinical laboratory studies with the for the noncompliance. device including microbiological, toxi- (7) For a PMA supported solely by cological, immunological, biocompat- data from one investigation, a jus- ibility, stress, wear, shelf life, and tification showing that data and other other laboratory or animal tests as ap- information from a single investigator propriate. Information on nonclinical are sufficient to demonstrate the safe- laboratory studies shall include a ty and effectiveness of the device and statement that each such study was to ensure reproducibility of test re- conducted in compliance with part 58, sults. or, if the study was not conducted in (8)(i) A bibliography of all published compliance with such regulations, a reports not submitted under paragraph brief statement of the reason for the (b)(6) of this section, whether adverse noncompliance. or supportive, known to or that should (ii) A section containing results of reasonably be known to the applicant the clinical investigations involving and that concern the safety or effec- human subjects with the device includ- tiveness of the device. ing clinical protocols, number of inves- (ii) An identification, discussion, and tigators and subjects per investigator, analysis of any other data, informa- subject selection and exclusion cri- tion, or report relevant to an evalua- teria, study population, study period, tion of the safety and effectiveness of

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the device known to or that should rea- plicant may be incorporated into a sonably be known to the applicant PMA by reference. Information in a from any source, foreign or domestic, master file or other information sub- including information derived from in- mitted to FDA by a person other than vestigations other than those proposed the applicant will not be considered in the application and from commer- part of a PMA unless such reference is cial marketing experience. authorized in writing by the person (iii) Copies of such published reports who submitted the information or the or unpublished information in the pos- master file. If a master file is not ref- session of or reasonably obtainable by erenced within 5 years after the date the applicant if an FDA advisory com- that it is submitted to FDA, FDA will mittee or FDA requests. return the master file to the person (9) One or more samples of the device who submitted it. and its components, if requested by (d) If the applicant believes that cer- FDA. If it is impractical to submit a tain information required under para- requested sample of the device, the ap- graph (b) of this section to be in a PMA plicant shall name the location at is not applicable to the device that is which FDA may examine and test one the subject of the PMA, and omits any or more devices. such information from its PMA, the ap- (10) Copies of all proposed labeling plicant shall submit a statement that for the device. Such labeling may in- identifies the omitted information and clude, e.g., instructions for installation justifies the omission. The statement and any information, literature, or ad- shall be submitted as a separate sec- vertising that constitutes labeling tion in the PMA and identified in the under section 201(m) of the act. table of contents. If the justification (11) An environmental assessment for the omission is not accepted by the under § 25.20(n) prepared in the applica- agency, FDA will so notify the appli- ble format in § 25.40, unless the action cant. qualifies for exclusion under § 25.30 or (e) The applicant shall periodically § 25.34. If the applicant believes that update its pending application with the action qualifies for exclusion, the new safety and effectiveness informa- PMA shall under § 25.15(a) and (d) pro- tion learned about the device from on- vide information that establishes to going or completed studies that may FDA’s satisfaction that the action re- reasonably affect an evaluation of the quested is included within the excluded safety or effectiveness of the device or category and meets the criteria for the that may reasonably affect the state- applicable exclusion. ment of contraindications, warnings, (12) A financial certification or dis- precautions, and adverse reactions in closure statement or both as required the draft labeling. The update report by part 54 of this chapter. shall be consistent with the data re- (13) Information concerning uses in pe- porting provisions of the protocol. The diatric patients. The application must applicant shall submit three copies of include the following information, if any update report and shall include in readily available: the report the number assigned by FDA (i) A description of any pediatric sub- to the PMA. These updates are consid- populations (neonates, infants, chil- ered to be amendments to the PMA. dren, adolescents) that suffer from the The time frame for review of a PMA disease or condition that the device is will not be extended due to the submis- intended to treat, diagnose, or cure; sion of an update report unless the up- and date is a major amendment under (ii) The number of affected pediatric § 814.37(c)(1). The applicant shall submit patients. these reports— (14) Such other information as FDA (1) 3 months after the filing date, may request. If necessary, FDA will ob- (2) Following receipt of an approv- tain the concurrence of the appropriate able letter, and FDA advisory committee before re- (3) At any other time as requested by questing additional information. FDA. (c) Pertinent information in FDA (f) If a color additive subject to sec- files specifically referred to by an ap- tion 721 of the act is used in or on the

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device and has not previously been list- tion, 5901–B Ammendale Rd., Beltsville, ed for such use, then, in lieu of submit- MD 20705–1266. ting a color additive petition under [51 FR 26364, July 22, 1986; 51 FR 40415, Nov. part 71, at the option of the applicant, 7, 1986, as amended at 51 FR 43344, Dec. 2, the information required to be sub- 1986; 55 FR 11169, Mar. 27, 1990; 62 FR 40600, mitted under part 71 may be submitted July 29, 1997; 63 FR 5253, Feb. 2, 1998; 65 FR as part of the PMA. When submitted as 17137, Mar. 31, 2000; 65 FR 56480, Sept. 19, 2000; 67 FR 9587, Mar. 4, 2002; 71 FR 42048, July 25, part of the PMA, the information shall 2006; 72 FR 17399, Apr. 9, 2007; 73 FR 34859, be submitted in three copies each June 19, 2008; 74 FR 14478, Mar. 31, 2009; 75 FR bound in one or more numbered vol- 20915, Apr. 22, 2010; 78 FR 18233, Mar. 26, 2013; umes of reasonable size. A PMA for a 79 FR 1740, Jan. 10, 2014; 80 FR 18094, Apr. 3, device that contains a color additive 2015] that is subject to section 721 of the act § 814.37 PMA amendments and resub- will not be approved until the color ad- mitted PMAs. ditive is listed for use in or on the de- (a) An applicant may amend a pend- vice. ing PMA or PMA supplement to revise (g) Additional information on FDA existing information or provide addi- policies and procedures, as well as tional information. links to PMA guidance documents, is (b)(1) FDA may request the applicant available on the Internet at http:// to amend a PMA or PMA supplement www.fda.gov/MedicalDevices/ with any information regarding the de- DeviceRegulationandGuidance/ vice that is necessary for FDA or the HowtoMarketYourDevice/ appropriate advisory committee to PremarketSubmissions/ complete the review of the PMA or PremarketApprovalPMA/default.htm. PMA supplement. (h) If you are sending a PMA, PMA (2) FDA may request the applicant to amendment, PMA supplement, or cor- amend a PMA or PMA supplement with respondence with respect to a PMA, information concerning pediatric uses you must send the submission to the as required under §§ 814.20(b)(13) and appropriate address as follows: 814.39(c)(2). (1) For devices regulated by the Cen- (c) A PMA amendment submitted to FDA shall include the PMA or PMA ter for Devices and Radiological supplement number assigned to the Health, Food and Drug Administration, original submission and, if submitted Center for Devices and Radiological on the applicant’s own initiative, the Health, Document Mail Center, 10903 reason for submitting the amendment. New Hampshire Ave., Bldg. 66, rm. FDA may extend the time required for G609, Silver Spring, MD 20993–0002. its review of the PMA, or PMA supple- (2) For devices regulated by the Cen- ment, as follows: ter for Biologics Evaluation and Re- (1) If the applicant on its own initia- search, send it to: Food and Drug Ad- tive or at FDA’s request submits a ministration, Center for Biologics major PMA amendment (e.g., an Evaluation and Research, Document amendment that contains significant Control Center, 10903 New Hampshire new data from a previously unreported Ave., Bldg. 71, Rm. G112, Silver Spring, study, significant updated data from a MD 20993–0002. previously reported study, detailed new (3) For devices regulated by the Cen- analyses of previously submitted data, ter for Drug Evaluation and Research, or significant required information send it to: Central Document Control previously omitted), the review period Room, Center for Drug Evaluation and may be extended up to 180 days. Research, Food and Drug Administra- (2) If an applicant declines to submit a major amendment requested by FDA, the review period may be extended for the number of days that elapse between the date of such request and the date that FDA receives the written response declining to submit the requested amendment.

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(d) An applicant may on its own ini- (5) Changes in packaging. tiative withdraw a PMA or PMA sup- (6) Changes in the performance or de- plement. If FDA requests an applicant sign specifications, circuits, compo- to submit a PMA amendment and a nents, ingredients, principle of oper- written response to FDA’s request is ation, or physical layout of the device. not received within 180 days of the date (7) Extension of the expiration date of the request, FDA will consider the of the device based on data obtained pending PMA or PMA supplement to be under a new or revised stability or ste- withdrawn voluntarily by the appli- rility testing protocol that has not cant. been approved by FDA. If the protocol (e) An applicant may resubmit a has been approved, the change shall be PMA or PMA supplement after with- reported to FDA under paragraph (b) of drawing it or after it is considered this section. withdrawn under paragraph (d) of this (b) An applicant may make a change section, or after FDA has refused to ac- in a device after FDA’s approval of a cept it for filing, or has denied ap- PMA for the device without submitting proval of the PMA or PMA supplement. a PMA supplement if the change does A resubmitted PMA or PMA supple- not affect the device’s safety or effec- ment shall comply with the require- tiveness and the change is reported to ments of § 814.20 or § 814.39, respec- FDA in postapproval periodic reports tively, and shall include the PMA num- required as a condition to approval of ber assigned to the original submission the device, e.g., an editorial change in and the applicant’s reasons for resub- labeling which does not affect the safe- mission of the PMA or PMA supple- ty or effectiveness of the device. ment. (c)(1) All procedures and actions that [51 FR 26364, July 22, 1986, as amended at 79 apply to an application under § 814.20 FR 1740, Jan. 10, 2014] also apply to PMA supplements except that the information required in a sup- § 814.39 PMA supplements. plement is limited to that needed to (a) After FDA’s approval of a PMA, support the change. A summary under an applicant shall submit a PMA sup- § 814.20(b)(3) is required for only a supplement for review and approval by plement submitted for new indications FDA before making a change affecting for use of the device, significant the safety or effectiveness of the device changes in the performance or design for which the applicant has an ap- specifications, circuits, components, proved PMA, unless the change is of a ingredients, principles of operation, or type for which FDA, under paragraph physical layout of the device, or when (e) of this section, has advised that an otherwise required by FDA. The appli- alternate submission is permitted or is cant shall submit three copies of a of a type which, under section PMA supplement and shall include in- 515(d)(6)(A) of the act and paragraph (f) formation relevant to the proposed of this section, does not require a PMA changes in the device. A PMA supple- supplement under this paragraph. ment shall include a separate section While the burden for determining that identifies each change for which whether a supplement is required is approval is being requested and ex- primarily on the PMA holder, changes plains the reason for each such change. for which an applicant shall submit a The applicant shall submit additional PMA supplement include, but are not copies and additional information if re- limited to, the following types of quested by FDA. The time frames for changes if they affect the safety or ef- review of, and FDA action on, a PMA fectiveness of the device: supplement are the same as those pro- (1) New indications for use of the de- vided in § 814.40 for a PMA. vice. (2) The supplement must include the (2) Labeling changes. following information: (3) The use of a different facility or (i) Information concerning pediatric establishment to manufacture, process, uses as required under § 814.20(b)(13). or package the device. (ii) If information concerning the de- (4) Changes in sterilization proce- vice that is the subject of the supple- dures. ment was previously submitted under

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§ 814.20(b)(13) or under this section in a supplement under paragraph (a) is not previous supplement, that information required. FDA will identify such a may be included by referencing a pre- change in an advisory opinion under vious application or submission that § 10.85, if the change applies to a ge- contains the information. However, if neric type of device, or in correspond- additional information required under ence to the applicant, if the change ap- § 814.20(b)(13) has become readily avail- plies only to the applicant’s device. able to the applicant since the previous FDA will require that a change for submission, the applicant must submit which a PMA supplement under para- that information as part of the supple- graph (a) is not required be reported to ment. FDA in: (d)(1) After FDA approves a PMA, (i) A periodic report under § 814.84 or any change described in paragraph (ii) A 30-day PMA supplement under (d)(2) of this section to reflect newly this paragraph. acquired information that enhances (2) FDA will identify, in the advisory the safety of the device or the safety in opinion or correspondence, the type of the use of the device may be placed information that is to be included in into effect by the applicant prior to the the report or 30-day PMA supplement. receipt under § 814.17 of a written FDA If the change is required to be reported order approving the PMA supplement to FDA in a periodic report, the change provided that: may be made before it is reported to (i) The PMA supplement and its mail- FDA. If the change is required to be re- ing cover are plainly marked ‘‘Special ported in a 30-day PMA supplement, PMA Supplement—Changes Being Ef- the change may be made 30 days after fected’’; FDA files the 30-day PMA supplement (ii) The PMA supplement provides a unless FDA requires the PMA holder to full explanation of the basis for the provide additional information, in- changes; forms the PMA holder that the supple- (iii) The applicant has received ac- ment is not approvable, or disapproves knowledgement from FDA of receipt of the supplement. The 30-day PMA sup- the supplement; and plement shall follow the instructions (iv) The PMA supplement specifically in the correspondence or advisory opin- identifies the date that such changes ion. Any 30-day PMA supplement that are being effected. does not meet the requirements of the (2) The following changes are per- correspondence or advisory opinion mitted by paragraph (d)(1) of this sec- will not be filed and, therefore, will not tion: be deemed approved 30 days after re- (i) Labeling changes that add or ceipt. strengthen a contraindication, warn- (f) Under section 515(d) of the act, ing, precaution, or information about modifications to manufacturing proce- an adverse reaction for which there is dures or methods of manufacture that reasonable evidence of a causal asso- affect the safety and effectiveness of a ciation. device subject to an approved PMA do (ii) Labeling changes that add or not require submission of a PMA sup- strengthen an instruction that is in- plement under paragraph (a) of this tended to enhance the safe use of the section and are eligible to be the sub- device. ject of a 30-day notice. A 30-day notice (iii) Labeling changes that delete shall describe in detail the change, misleading, false, or unsupported indi- summarize the data or information cations. supporting the change, and state that (iv) Changes in quality controls or the change has been made in accord- manufacturing process that add a new ance with the requirements of part 820 specification or test method, or other- of this chapter. The manufacturer may wise provide additional assurance of distribute the device 30 days after the purity, identity, strength, or reli- date on which FDA receives the 30-day ability of the device. notice, unless FDA notifies the appli- (e)(1) FDA will identify a change to a cant within 30 days from receipt of the device for which an applicant has an notice that the notice is not adequate. approved PMA and for which a PMA If the notice is not adequate, FDA shall

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inform the applicant in writing that a will notify the applicant in writing of 135-day PMA supplement is needed and the filing. The notice will include the shall describe what further information PMA reference number and the date or action is required for acceptance of FDA filed the PMA. The date of filing such change. The number of days under is the date that a PMA accepted for fil- review as a 30-day notice shall be de- ing was received by the agency. The ducted from the 135-day PMA supple- 180-day period for review of a PMA ment review period if the notice meets starts on the date of filing. appropriate content requirements for a (c) If FDA refuses to file a PMA, the PMA supplement. agency will notify the applicant of the (g) The submission and grant of a reasons for the refusal. This notice will written request for an exception or al- identify the deficiencies in the applica- ternative under § 801.128 or § 809.11 of tion that prevent filing and will in- this chapter satisfies the requirement clude the PMA reference number. in paragraph (a) of this section. (d) If FDA refuses to file the PMA, [51 FR 26364, July 22, 1986, as amended at 51 the applicant may: FR 43344, Dec. 2, 1986; 63 FR 54044, Oct. 8, 1998; (1) Resubmit the PMA with addi- 67 FR 9587, Mar. 4, 2002; 69 FR 11313, Mar. 10, tional information necessary to comply 2004; 72 FR 73602, Dec. 28, 2007; 73 FR 49610, with the requirements of section Aug. 22, 2008; 79 FR 1740, Jan. 10, 2014] 515(c)(1) (A)–(G) of the act and § 814.20. A resubmitted PMA shall include the Subpart C—FDA Action on a PMA PMA reference number of the original submission. If the resubmitted PMA is § 814.40 Time frames for reviewing a accepted for filing, the date of filing is PMA. the date FDA receives the resubmis- Within 180 days after receipt of an sion; application that is accepted for filing (2) Request in writing within 10 and to which the applicant does not working days of the date of receipt of submit a major amendment, FDA will the notice refusing to file the PMA, an review the PMA and, after receiving informal conference with the Director the report and recommendation of the of the Office of Device Evaluation to appropriate FDA advisory committee, review FDA’s decision not to file the send the applicant an approval order PMA. FDA will hold the informal con- under § 814.44(d), an approvable letter ference within 10 working days of its under § 814.44(e), a not approvable letter receipt of the request and will render under § 814.44(f), or an order denying ap- its decision on filing within 5 working proval under § 814.45. The approvable days after the informal conference. If, letter and the not approvable letter after the informal conference, FDA ac- will provide an opportunity for the ap- cepts the PMA for filing, the date of plicant to amend or withdraw the ap- filing will be the date of the decision to plication, or to consider the letter to accept the PMA for filing. If FDA does be a denial of approval of the PMA not reverse its decision not to file the under § 814.45 and to request adminis- PMA, the applicant may request recon- trative review under section 515 (d)(3) sideration of the decision from the Di- and (g) of the act. rector of the Center for Devices and Radiological Health, the Director of § 814.42 Filing a PMA. the Center for Biologics Evaluation (a) The filing of an application means and Research, or the Director of the that FDA has made a threshold deter- Center for Drug Evaluation and Re- mination that the application is suffi- search, as applicable. The Director’s ciently complete to permit a sub- decision will constitute final adminis- stantive review. Within 45 days after a trative action for the purpose of judi- PMA is received by FDA, the agency cial review. will notify the applicant whether the (e) FDA may refuse to file a PMA if application has been filed. any of the following applies: (b) If FDA does not find that any of (1) The application is incomplete be- the reasons in paragraph (e) of this sec- cause it does not on its face contain all tion for refusing to file the PMA ap- the information required under section plies, the agency will file the PMA and 515(c)(1) (A)–(G) of the act;

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(2) The PMA does not contain each of in the later of 180 days from the date of the items required under § 814.20 and filing of the PMA under § 814.42 or the justification for omission of any item number of days after the date of filing is inadequate; as determined under § 814.37(c), issue an (3) The applicant has a pending pre- approval order under paragraph (d) of market notification under section this section, an approvable letter under 510(k) of the act with respect to the paragraph (e) of this section, a not ap- same device, and FDA has not deter- provable letter under paragraph (f) of mined whether the device falls within this section, or an order denying ap- the scope of § 814.1(c). proval of the application under (4) The PMA contains a false state- § 814.45(a). ment of material fact. (d)(1) FDA will issue to the applicant (5) The PMA is not accompanied by a an order approving a PMA if none of statement of either certification or dis- the reasons in § 814.45 for denying ap- closure as required by part 54 of this proval of the application applies. FDA chapter. will approve an application on the [51 FR 26364, July 22, 1986, as amended at 63 basis of draft final labeling if the only FR 5254, Feb. 2, 1998; 73 FR 49942, Aug. 25, deficiencies in the application concern 2008] editorial or similar minor deficiencies in the draft final labeling. Such ap- § 814.44 Procedures for review of a proval will be conditioned upon the ap- PMA. plicant incorporating the specified la- (a) FDA will begin substantive review beling changes exactly as directed and of a PMA after the PMA is accepted for upon the applicant submitting to FDA filing under § 814.42. FDA may refer the a copy of the final printed labeling be- PMA to a panel on its own initiative, fore marketing. FDA will also give the and will do so upon request of an appli- public notice of the order, including cant, unless FDA determines that the notice of and opportunity for any in- application substantially duplicates interested persons to request review formation previously reviewed by a under section 515(d)(3) of the act. The panel. If FDA refers an application to a notice of approval will be placed on panel, FDA will forward the PMA, or FDA’s home page on the Internet relevant portions thereof, to each (http://www.fda.gov), and it will state member of the appropriate FDA panel that a detailed summary of informa- for review. During the review process, tion respecting the safety and effec- FDA may communicate with the appli- tiveness of the device, which was the cant as set forth under § 814.37(b), or basis for the order approving the PMA, with a panel to respond to questions including information about any ad- that may be posed by panel members or verse effects of the device on health, is to provide additional information to available on the Internet and has been the panel. FDA will maintain a record placed on public display, and that cop- of all communications with the appli- ies are available upon request. FDA cant and with the panel. will publish in the FEDERAL REGISTER (b) The advisory committee shall after each quarter a list of the approv- submit a report to FDA which includes als announced in that quarter. When a the committee’s recommendation and notice of approval is published, data the basis for such recommendation on and information in the PMA file will be the PMA. Before submission of this re- available for public disclosure in ac- port, the committee shall hold a public cordance with § 814.9. meeting to review the PMA in accord- (2) A request for copies of the current ance with part 14. This meeting may be PMA approvals and denials document held by a telephone conference under and for copies of summaries of safety § 14.22(g). The advisory committee re- and effectiveness shall be sent in writ- port and recommendation may be in ing to the Division of Dockets Manage- the form of a meeting transcript signed ment (HFA–305), Food and Drug Ad- by the chairperson of the committee. ministration, 5630 Fishers Lane, rm. (c) FDA will complete its review of 1061, Rockville, MD 20852. the PMA and the advisory committee (e) FDA will send the applicant an report and recommendation and, with- approvable letter if the application

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substantially meets the requirements (2) Consider the not approvable letter of this part and the agency believes it to be a denial of approval of the PMA can approve the application if specific under § 814.45 and request administra- additional information is submitted or tive review under section 515(d)(3) of specific conditions are agreed to by the the act by filing a petition in the form applicant. of a petition for reconsideration under (1) The approvable letter will de- § 10.33; or scribe the information FDA requires to (3) Withdraw the PMA. be provided by the applicant or the (g) FDA will consider a PMA to have conditions the applicant is required to been withdrawn voluntarily if: meet to obtain approval. For example, (1) The applicant fails to respond in FDA may require, as a condition to ap- writing to a written request for an proval: amendment within 180 days after the (i) The submission of certain infor- date FDA issues such request; mation identified in the approvable let- (2) The applicant fails to respond in ter, e.g., final labeling; writing to an approvable or not approv- (ii) The submission of additional in- able letter within 180 days after the formation concerning pediatric uses re- date FDA issues such letter; or (3) The applicant submits a written quired by § 814.20(b)(13); notice to FDA that the PMA has been (iii) An FDA inspection that finds the withdrawn. manufacturing facilities, methods, and controls in compliance with part 820 [51 FR 26364, July 22, 1986, as amended at 57 and, if applicable, that verifies records FR 58403, Dec. 10, 1992; 63 FR 4572, Jan. 30, pertinent to the PMA; 1998; 79 FR 1740, Jan. 10, 2014] (iv) Restrictions imposed on the de- § 814.45 Denial of approval of a PMA. vice under section 515(d)(1)(B)(ii) or 520(e) of the act; (a) FDA may issue an order denying approval of a PMA if the applicant fails (v) Postapproval requirements as de- to follow the requirements of this part scribed in subpart E of this part. or if, upon the basis of the information (2) In response to an approvable let- submitted in the PMA or any other inter the applicant may: formation before the agency, FDA de- (i) Amend the PMA as requested in termines that any of the grounds for the approvable letter; or denying approval of a PMA specified in (ii) Consider the approvable letter to section 515(d)(2) (A)–(E) of the act ap- be a denial of approval of the PMA plies. In addition, FDA may deny ap- under § 814.45 and request administra- proval of a PMA for any of the fol- tive review under section 515(d)(3) of lowing reasons: the act by filing a petition in the form (1) The PMA contains a false state- of a petition for reconsideration under ment of material fact; § 10.33; or (2) The device’s proposed labeling (iii) Withdraw the PMA. does not comply with the requirements (f) FDA will send the applicant a not in part 801 or part 809; approvable letter if the agency believes (3) The applicant does not permit an that the application may not be ap- authorized FDA employee an oppor- proved for one or more of the reasons tunity to inspect at a reasonable time given in § 814.45(a). The not approvable and in a reasonable manner the facili- letter will describe the deficiencies in ties, controls, and to have access to the application, including each applica- and to copy and verify all records per- ble ground for denial under section tinent to the application; 515(d)(2) (A)–(E) of the act, and, where (4) A nonclinical laboratory study practical, will identify measures re- that is described in the PMA and that quired to place the PMA in approvable is essential to show that the device is form. In response to a not approvable safe for use under the conditions pre- letter, the applicant may: scribed, recommended, or suggested in (1) Amend the PMA as requested in its proposed labeling, was not con- the not approvable letter (such an ducted in compliance with the good amendment will be considered a major laboratory practice regulations in part amendment under § 814.37(c)(1)); or 58 and no reason for the noncompliance

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is provided or, if it is, the differences dress listed on the Agency’s Web site at between the practices used in con- http://www.fda.gov. ducting the study and the good labora- (e) FDA will issue an order denying tory practice regulations do not sup- approval of a PMA after an approvable port the validity of the study; or or not approvable letter has been sent (5) Any clinical investigation involv- and the applicant: ing human subjects described in the (1) Submits a requested amendment PMA, subject to the institutional re- but any ground for denying approval of view board regulations in part 56 or in- the application under section 515(d)(2) formed consent regulations in part 50, of the act still applies; or was not conducted in compliance with (2) Notifies FDA in writing that the those regulations such that the rights requested amendment will not be sub- or safety of human subjects were not mitted; or adequately protected. (3) Petitions for review under section (b) FDA will issue any order denying 515(d)(3) of the act by filing a petition approval of the PMA in accordance in the form of a petition for reconsider- with § 814.17. The order will inform the ation under § 10.33. applicant of the deficiencies in the [51 FR 26364, July 22, 1986, as amended at 63 PMA, including each applicable ground FR 4572, Jan. 30, 1998; 73 FR 34859, June 19, for denial under section 515(d)(2) of the 2008; 76 FR 31470, June 1, 2011; 79 FR 68115, act and the regulations under this part, Nov. 14, 2014] and, where practical, will identify measures required to place the PMA in approvable form. The order will include § 814.46 Withdrawal of approval of a a notice of an opportunity to request PMA. review under section 515(d)(4) of the (a) FDA may issue an order with- act. drawing approval of a PMA if, from any (c) FDA will use the criteria specified information available to the agency, in § 860.7 to determine the safety and FDA determines that: effectiveness of a device in deciding (1) Any of the grounds under section whether to approve or deny approval of 515(e)(1) (A)–(G) of the act applies. a PMA. FDA may use information (2) Any postapproval requirement im- other than that submitted by the appli- posed by the PMA approval order or by cant in making such determination. regulation has not been met. (d)(1) FDA will give the public notice (3) A nonclinical laboratory study of an order denying approval of the that is described in the PMA and that PMA. The notice will be placed on the is essential to show that the device is FDA’s home page on the Internet safe for use under the conditions pre- (http://www.fda.gov), and it will state scribed, recommended, or suggested in that a detailed summary of informa- its proposed labeling, was not con- tion respecting the safety and effec- ducted in compliance with the good tiveness of the device, including infor- laboratory practice regulations in part mation about any adverse effects of the 58 and no reason for the noncompliance device on health, is available on the is provided or, if it is, the differences Internet and has been placed on public between the practices used in con- display and that copies are available ducting the study and the good labora- upon request. FDA will publish in the tory practice regulations do not sup- FEDERAL REGISTER after each quarter a port the validity of the study. list of the denials announced in that (4) Any clinical investigation involv- quarter. When a notice of denial of ap- ing human subjects described in the proval is made publicly available, data PMA, subject to the institutional re- and information in the PMA file will be view board regulations in part 56 or in- available for public disclosure in ac- formed consent regulations in part 50, cordance with § 814.9. was not conducted in compliance with (2) A request for copies of the current those regulations such that the rights PMA approvals and denials document or safety of human subjects were not and copies of summaries of safety and adequately protected. effectiveness shall be sent in writing to (b)(1) FDA may seek advice on sci- the Freedom of Information Staff’s ad- entific matters from any appropriate

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FDA advisory committee in deciding of a device subject to an approved PMA whether to withdraw approval of a would cause serious, adverse health PMA. consequences or death, FDA may ini- (2) FDA may use information other tiate and conduct a regulatory hearing than that submitted by the applicant to determine whether to issue an order in deciding whether to withdraw ap- temporarily suspending approval of the proval of a PMA. PMA. (c) Before issuing an order with- (2) Any regulatory hearing to deter- drawing approval of a PMA, FDA will mine whether to issue an order tempo- issue the holder of the approved appli- rarily suspending approval of a PMA cation a notice of opportunity for an shall be initiated and conducted by informal hearing under part 16. FDA pursuant to part 16 of this chap- (d) If the applicant does not request a hearing or if after the part 16 hearing ter. If FDA believes that immediate ac- is held the agency decides to proceed tion to remove a dangerous device from with the withdrawal, FDA will issue to the market is necessary to protect the the holder of the approved application public health, the agency may, in ac- an order withdrawing approval of the cordance with § 16.60(h) of this chapter, application. The order will be issued waive, suspend, or modify any part 16 under § 814.17, will state each ground procedure pursuant to § 10.19 of this for withdrawing approval, and will in- chapter. clude a notice of an opportunity for ad- (3) FDA shall deem the PMA holder’s ministrative review under section failure to request a hearing within the 515(e)(2) of the act. timeframe specified by FDA in the no- (e) FDA will give the public notice of tice of opportunity for hearing to be a an order withdrawing approval of a waiver. PMA. The notice will be published in (c) Temporary suspension order. If the the FEDERAL REGISTER and will state PMA holder does not request a regu- that a detailed summary of informa- latory hearing or if, after the hearing, tion respecting the safety and effec- and after consideration of the adminis- tiveness of the device, including infor- trative record of the hearing, FDA de- mation about any adverse effects of the termines that there is a reasonable device on health, has been placed on probability that the continued dis- public display and that copies are tribution of a device under an approved available upon request. When a notice of withdrawal of approval is published, PMA would cause serious, adverse data and information in the PMA file health consequences or death, the will be available for public disclosure agency shall, under the authority of in accordance with § 814.9. section 515(e)(3) of the act, issue an order to the PMA holder temporarily § 814.47 Temporary suspension of ap- suspending approval of the PMA. proval of a PMA. (d) Permanent withdrawal of approval (a) Scope. (1) This section describes of the PMA. If FDA issues an order tem- the procedures that FDA will follow in porarily suspending approval of a PMA, exercising its authority under section the agency shall proceed expeditiously, 515(e)(3) of the act (21 U.S.C. 360e(e)(3)). but within 60 days, to hold a hearing on This authority applies to the original whether to permanently withdraw ap- PMA, as well as any PMA supple- proval of the PMA in accordance with ment(s), for a medical device. section 515(e)(1) of the act and the pro- (2) FDA will issue an order tempo- cedures set out in § 814.46. rarily suspending approval of a PMA if FDA determines that there is a reason- [61 FR 15190, Apr. 5, 1996] able probability that continued distribution of the device would cause se- Subpart D—Administrative Review rious, adverse health consequences or [Reserved] death. (b) Regulatory hearing. (1) If FDA believes that there is a reasonable probability that the continued distribution

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Subpart E—Postapproval record, report, or information sub- Requirements mitted to the agency. (6) Maintenance of records for speci- § 814.80 General. fied periods of time and organization and indexing of records into identifi- A device may not be manufactured, able files to enable FDA to determine packaged, stored, labeled, distributed, whether there is reasonable assurance or advertised in a manner that is in- of the continued safety and effective- consistent with any conditions to ap- ness of the device. proval specified in the PMA approval (7) Submission to FDA at intervals order for the device. specified in the approval order of periodic reports containing the informa- § 814.82 Postapproval requirements. tion required by § 814.84(b). (a) FDA may impose postapproval re- (8) Batch testing of the device. quirements in a PMA approval order or (9) Such other requirements as FDA by regulation at the time of approval determines are necessary to provide of the PMA or by regulation subse- reasonable assurance, or continued rea- quent to approval. Postapproval re- sonable assurance, of the safety and ef- quirements may include as a condition fectiveness of the device. to approval of the device: (b) An applicant shall grant to FDA (1) Restriction of the sale, distribu- access to any records and reports re- tion, or use of the device as provided by quired under the provisions of this section 515(d)(1)(B)(ii) or 520(e) of the part, and shall permit authorized FDA act. employees to copy and verify such (2) Continuing evaluation and peri- records and reports and to inspect at a odic reporting on the safety, effective- reasonable time and in a reasonable ness, and reliability of the device for manner all manufacturing facilities to its intended use. FDA will state in the verify that the device is being manu- PMA approval order the reason or pur- factured, stored, labeled, and shipped pose for such requirement and the under approved conditions. number of patients to be evaluated and (c) Failure to comply with any post- the reports required to be submitted. approval requirement constitutes a (3) Prominent display in the labeling ground for withdrawal of approval of a of a device and in the advertising of PMA. any restricted device of warnings, haz- (Approved by the Office of Management and ards, or precautions important for the Budget under control number 0910–0231) device’s safe and effective use, includ- [51 FR 26364, July 22, 1986, as amended at 51 ing patient information, e.g., informa- FR 43344, Dec. 2, 1986] tion provided to the patient on alternative modes of therapy and on risks § 814.84 Reports. and benefits associated with the use of (a) The holder of an approved PMA the device. shall comply with the requirements of (4) Inclusion of identification codes part 803 and with any other require- on the device or its labeling, or in the ments applicable to the device by other case of an implant, on cards given to regulations in this subchapter or by patients if necessary to protect the order approving the device. public health. (b) Unless FDA specifies otherwise, (5) Maintenance of records that will any periodic report shall: enable the applicant to submit to FDA (1) Identify changes described in information needed to trace patients if § 814.39(a) and changes required to be such information is necessary to pro- reported to FDA under § 814.39(b). tect the public health. Under section (2) Contain a summary and bibliog- 519(a)(4) of the act, FDA will require raphy of the following information not that the identity of any patient be dis- previously submitted as part of the closed in records maintained under this PMA: paragraph only to the extent required (i) Unpublished reports of data from for the medical welfare of the indi- any clinical investigations or nonclin- vidual, to determine the safety or ef- ical laboratory studies involving the fectiveness of the device, or to verify a device or related devices and known to

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or that reasonably should be known to (c) Section 515A of the act is intended the applicant. to ensure the submission of readily (ii) Reports in the scientific lit- available information concerning: erature concerning the device and (1) Any pediatric subpopulations known to or that reasonably should be (neonates, infants, children, adoles- known to the applicant. If, after re- cents) that suffer from the disease or viewing the summary and bibliog- condition that the device is intended to raphy, FDA concludes that the agency treat, diagnose, or cure; and needs a copy of the unpublished or pub- (2) The number of affected pediatric lished reports, FDA will notify the ap- patients. plicant that copies of such reports (d) Although a HUD may also have shall be submitted. uses that differ from the humanitarian (3) Identify changes made pursuant use, applicants seeking approval of any to an exception or alternative granted non-HUD use shall submit a PMA as re- under § 801.128 or § 809.11 of this chapter. quired under § 814.20, or a premarket (4) Identify each device identifier notification as required under part 807 currently in use for the device, and of this chapter. each device identifier for the device (e) Obtaining marketing approval for that has been discontinued since the a HUD involves two steps: previous periodic report. It is not nec- (1) Obtaining designation of the de- essary to identify any device identifier vice as a HUD from FDA’s Office of Or- discontinued prior to December 23, phan Products Development, and 2013. (2) Submitting an HDE to the Office of Device Evaluation (ODE), Center for [51 FR 26364, July 22, 1986, as amended at 51 FR 43344, Dec. 2, 1986; 67 FR 9587, Mar. 4, 2002; Devices and Radiological Health 72 FR 73602, Dec. 28, 2007; 78 FR 58822, Sept. (CDRH), the Center for Biologics Eval- 24, 2013] uation and Research (CBER), or the Center for Drug Evaluation and Re- Subparts F–G [Reserved] search (CDER), as applicable. (f) A person granted an exemption under section 520(m) of the act shall Subpart H—Humanitarian Use submit periodic reports as described in Devices § 814.126(b). (g) FDA may suspend or withdraw ap- SOURCE: 61 FR 33244, June 26, 1996, unless proval of an HDE after providing notice otherwise noted. and an opportunity for an informal hearing. § 814.100 Purpose and scope. [61 FR 33244, June 26, 1996, as amended at 63 (a) This subpart H implements sec- FR 59220, Nov. 3, 1998; 73 FR 49942, Aug. 25, tions 515A and 520(m) of the act. 2008; 79 FR 1740, Jan. 10, 2014] (b) The purpose of section 520(m) is, to the extent consistent with the pro- § 814.102 Designation of HUD status. tection of the public health and safety (a) Request for designation. Prior to and with ethical standards, to encour- submitting an HDE application, the ap- age the discovery and use of devices in- plicant shall submit a request for HUD tended to benefit patients in the treat- designation to FDA’s Office of Orphan ment or diagnosis of diseases or condi- Products Development. The request tions that affect or are manifested in shall contain the following: fewer than 4,000 individuals in the (1) A statement that the applicant re- United States per year. This subpart quests HUD designation for a rare dis- provides procedures for obtaining: ease or condition or a valid subset of a (1) HUD designation of a medical de- disease or condition which shall be vice; and identified with specificity; (2) Marketing approval for the HUD (2) The name and address of the ap- notwithstanding the absence of reason- plicant, the name of the applicant’s able assurance of effectiveness that primary contact person and/or resident would otherwise be required under sec- agent, including title, address, and tions 514 and 515 of the act. telephone number;

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(3) A description of the rare disease (i) There is insufficient evidence to or condition for which the device is to support the estimate that the disease be used, the proposed indication or in- or condition for which the device is de- dications for use of the device, and the signed to treat or diagnose affects or is reasons why such therapy is needed. If manifested in fewer than 4,000 people in the device is proposed for an indication the United States per year; that represents a subset of a common (ii) FDA determines that, for a diag- disease or condition, a demonstration nostic device, 4,000 or more patients in that the subset is medically plausible the United States would be subjected should be included; to diagnosis using the device per year; (4) A description of the device and a or discussion of the scientific rationale (iii) FDA determines that the patient for the use of the device for the rare population defined in the request is not disease or condition; and a medically plausible subset of a larger (5) Documentation, with appended population. authoritative references, to dem- (c) Revocation of designation. FDA onstrate that the device is designed to may revoke a HUD designation if the treat or diagnose a disease or condition agency finds that: that affects or is manifested in fewer (1) The request for designation con- than 4,000 people in the United States tained an untrue statement of material per year. If the device is for diagnostic fact or omitted material information; purposes, the documentation must or demonstrate that fewer than 4,000 pa- (2) Based on the evidence available, tients per year would be subjected to the device is not eligible for HUD des- diagnosis by the device in the United ignation. States. Authoritative references in- (d) Submission. The applicant shall clude literature citations in specialized submit two copies of a completed, medical journals, textbooks, special- dated, and signed request for HUD des- ized medical society proceedings, or ignation to: Office of Orphan Products governmental statistics publications. Development (HF–35), Food and Drug When no such studies or literature ci- Administration, 5600 Fishers Lane, tations exist, the applicant may be Rockville, MD 20857. able to demonstrate the prevalence of the disease or condition in the United § 814.104 Original applications. States by providing credible conclusions from appropriate research or sur- (a) United States applicant or represent- veys. ative. The applicant or an authorized (b) FDA action. Within 45 days of re- representative shall sign the HDE. If ceipt of a request for HUD designation, the applicant does not reside or have a FDA will take one of the following ac- place of business within the United tions: States, the HDE shall be countersigned (1) Approve the request and notify by an authorized representative resid- the applicant that the device has been ing or maintaining a place of business designated as a HUD based on the in- in the United States and shall identify formation submitted; the representative’s name and address. (2) Return the request to the appli- (b) Contents. Unless the applicant jus- cant pending further review upon sub- tifies an omission in accordance with mission of additional information. This paragraph (d) of this section, an HDE action will ensue if the request is in- shall include: complete because it does not on its face (1) A copy of or reference to the de- contain all of the information required termination made by FDA’s Office of under § 814.102(a). Upon receipt of this Orphan Products Development (in ac- additional information, the review pe- cordance with § 814.102) that the device riod may be extended up to 45 days; or qualifies as a HUD; (3) Disapprove the request for HUD (2) An explanation of why the device designation based on a substantive re- would not be available unless an HDE view of the information submitted. were granted and a statement that no FDA may disapprove a request for HUD comparable device (other than another designation if: HUD approved under this subpart or a

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device under an approved IDE) is avail- port by an independent certified public able to treat or diagnose the disease or accountant or an attestation by a recondition. The application also shall sponsible individual of the organiza- contain a discussion of the risks and tion is waived; and benefits of currently available devices (6) Information concerning pediatric or alternative forms of treatment in uses of the device, as required by the United States; § 814.20(b)(13). (3) An explanation of why the prob- (c) Omission of information. If the ap- able benefit to health from the use of plicant believes that certain informa- the device outweighs the risk of injury tion required under paragraph (b) of or illness from its use, taking into ac- this section is not applicable to the de- count the probable risks and benefits of vice that is the subject of the HDE, and currently available devices or alter- omits any such information from its native forms of treatment. Such expla- HDE, the applicant shall submit a nation shall include a description, ex- statement that identifies and justifies planation, or theory of the underlying the omission. The statement shall be disease process or condition, and submitted as a separate section in the known or postulated mechanism(s) of HDE and identified in the table of con- action of the device in relation to the tents. If the justification for the omis- disease process or condition; sion is not accepted by the agency, (4) All of the information required to FDA will so notify the applicant. be submitted under § 814.20(b), except (d) Address for submissions and cor- that: respondence. Copies of all original HDEs (i) In lieu of the summaries, conclu- amendments and supplements, as well sions, and results from clinical inves- as any correspondence relating to an tigations required under HDE, must be sent or delivered to the §§ 814.20(b)(3)(v)(B), (b)(3)(vi), and following: (b)(6)(ii), the applicant shall include (1) For devices regulated by the Cen- the summaries, conclusions, and re- ter for Devices and Radiological sults of all clinical experience or inves- Health, send to Document Mail Center, tigations (whether adverse or sup- 10903 New Hampshire Ave., Bldg. 66, rm. portive) reasonably obtainable by the G609, Silver Spring, MD 20993–0002. applicant that are relevant to an as- (2) For devices regulated by the Cen- sessment of the risks and probable ben- ter for Biologics Evaluation and Re- efits of the device; and search, send this information to the (ii) In addition to the proposed label- Food and Drug Administration, Center ing requirement set forth in for Biologics Evaluation and Research, § 814.20(b)(10), the labeling shall bear Document Control Center, 10903 New the following statement: Humanitarian Hampshire Ave., Bldg. 71, Rm. G112, Device. Authorized by Federal law for Silver Spring, MD 20993–0002. use in the [treatment or diagnosis] of (3) For devices regulated by the Cen- [specify disease or condition]. The ef- ter for Drug Evaluation and Research, fectiveness of this device for this use send this information to the Central has not been demonstrated; Document Control Room, Center for (5) The amount to be charged for the Drug Evaluation and Research, Food device and, if the amount is more than and Drug Administration, 5901–B $250, a report by an independent cer- Ammendale Rd., Beltsville, MD 20705– tified public accountant, made in ac- 1266. cordance with the Statement on Stand- [61 FR 33244, June 26, 1996, as amended at 63 ards for Attestation established by the FR 59220, Nov. 3, 1998; 73 FR 49942, Aug. 25, American Institute of Certified Public 2008; 75 FR 20915, Apr. 22, 2010; 79 FR 1740, Accountants, or in lieu of such a re- Jan. 10, 2014; 80 FR 18094, Apr. 3, 2015] port, an attestation by a responsible individual of the organization, § 814.106 HDE amendments and resub- verifying that the amount charged does mitted HDE’s. not exceed the costs of the device’s re- An HDE or HDE supplement may be search, development, fabrication, and amended or resubmitted upon an appli- distribution. If the amount charged is cant’s own initiative, or at the request $250 or less, the requirement for a re- of FDA, for the same reasons and in

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the same manner as prescribed for the information required under PMA’s in § 814.37, except that the time- § 814.104(b); frames set forth in § 814.37(c)(1) and (d) (2) FDA determines that there is a do not apply. If FDA requests an HDE comparable device available (other applicant to submit an HDE amend- than another HUD approved under this ment, and a written response to FDA’s subpart or a device under an approved request is not received within 75 days IDE) to treat or diagnose the disease or of the date of the request, FDA will condition for which approval of the consider the pending HDE or HDE sup- HUD is being sought; or plement to be withdrawn voluntarily (3) The application contains an un- by the applicant. Furthermore, if the true statement of material fact or HDE applicant, on its own initiative or omits material information. at FDA’s request, submits a major (4) The HDE is not accompanied by a amendment as described in statement of either certification or dis- § 814.37(c)(1), the review period may be closure, or both, as required by part 54 extended up to 75 days. of this chapter. [63 FR 59220, Nov. 3, 1998] (b) The provisions contained in § 814.42(b), (c), and (d) regarding notifi- § 814.108 Supplemental applications. cation of filing decisions, filing dates, After FDA approval of an original the start of the 75-day review period, HDE, an applicant shall submit supple- and applicant’s options in response to ments in accordance with the require- FDA refuse to file decisions shall apply ments for PMA’s under § 814.39, except to HDE’s. that a request for a new indication for use of a HUD shall comply with re- [61 FR 33244, June 26, 1996, as amended at 63 FR 5254, Feb. 2, 1998; 63 FR 59221, Nov. 3, 1998] quirements set forth in § 814.110. The timeframes for review of, and FDA ac- § 814.114 Timeframes for reviewing an tion on, an HDE supplement are the HDE. same as those provided in § 814.114 for an HDE. Within 75 days after receipt of an HDE that is accepted for filing and to [63 FR 59220, Nov. 3, 1998] which the applicant does not submit a major amendment, FDA shall send the § 814.110 New indications for use. applicant an approval order, an approv- (a) An applicant seeking a new indi- able letter, a not approvable letter cation for use of a HUD approved under (under § 814.116), or an order denying this subpart H shall obtain a new des- approval (under § 814.118). ignation of HUD status in accordance with § 814.102 and shall submit an origi- [63 FR 59221, Nov. 3, 1998] nal HDE in accordance with § 814.104. (b) An application for a new indica- § 814.116 Procedures for review of an tion for use made under § 814.104 may HDE. incorporate by reference any informa- (a) Substantive review. FDA will begin tion or data previously submitted to substantive review of an HDE after the the agency under an HDE. HDE is accepted for filing under § 814.112. FDA may refer an original § 814.112 Filing an HDE. HDE application to a panel on its own (a) The filing of an HDE means that initiative, and shall do so upon the re- FDA has made a threshold determina- quest of an applicant, unless FDA de- tion that the application is sufficiently termines that the application substan- complete to permit substantive review. tially duplicates information pre- Within 30 days from the date an HDE is viously reviewed by a panel. If the HDE received by FDA, the agency will no- is referred to a panel, the agency shall tify the applicant whether the applica- follow the procedures set forth under tion has been filed. FDA may refuse to § 814.44, with the exception that FDA file an HDE if any of the following ap- will complete its review of the HDE plies: and the advisory committee report and (1) The application is incomplete be- recommendations within 75 days from cause it does not on its face contain all receipt of an HDE that is accepted for

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filing under § 814.112 or the date of fil- (5) An FDA inspection that finds the ing as determined under § 814.106, manufacturing facilities, methods, and whichever is later. Within the later of controls in compliance with part 820 of these two timeframes, FDA will issue this chapter and, if applicable, that an approval order under paragraph (b) verifies records pertinent to the HDE. of this section, an approvable letter (d) Not approvable letter. FDA will under paragraph (c) of this section, a send the applicant a not approvable not approvable letter under paragraph letter if the agency believes that the (d) of this section, or an order denying application may not be approved for approval of the application under one or more of the reasons given in § 814.118(a). § 814.118. The not approvable letter will (b) Approval order. FDA will issue to describe the deficiencies in the applica- the applicant an order approving an tion and, where practical, will identify HDE if none of the reasons in § 814.118 measures required to place the HDE in for denying approval of the application approvable form. The applicant may applies. FDA will approve an applica- respond to the not approvable letter in tion on the basis of draft final labeling the same manner as permitted for not if the only deficiencies in the applica- approvable letters for PMA’s under tion concern editorial or similar minor § 814.44(f), with the exception that if a deficiencies in the draft final labeling. major HDE amendment is submitted, Such approval will be conditioned upon the review period may be extended up the applicant incorporating the speci- to 75 days. fied labeling changes exactly as di- (e) FDA will consider an HDE to have rected and upon the applicant submit- been withdrawn voluntarily if: ting to FDA a copy of the final printed (1) The applicant fails to respond in labeling before marketing. The notice writing to a written request for an of approval of an HDE will be published amendment within 75 days after the in the FEDERAL REGISTER in accord- date FDA issues such request; ance with the rules and policies appli- (2) The applicant fails to respond in cable to PMA’s submitted under writing to an approvable or not approv- § 814.20. Following the issuance of an able letter within 75 days after the date approval order, data and information FDA issues such letter; or in the HDE file will be available for (3) The applicant submits a written public disclosure in accordance with notice to FDA that the HDE has been § 814.9(b) through (h), as applicable. withdrawn. (c) Approvable letter. FDA will send [61 FR 33244, June 26, 1996, as amended at 63 the applicant an approvable letter if FR 59221, Nov. 3, 1998; 79 FR 1741, Jan. 10, the application substantially meets the 2014] requirements of this subpart and the agency believes it can approve the ap- § 814.118 Denial of approval or with- plication if specific additional informa- drawal of approval of an HDE. tion is submitted or specific conditions (a) FDA may deny approval or with- are agreed to by the applicant. The ap- draw approval of an application if the provable letter will describe the infor- applicant fails to meet the require- mation FDA requires to be provided by ments of section 520(m) of the act or of the applicant or the conditions the ap- this part, or of any condition of applicant is required to meet to obtain proval imposed by an IRB or by FDA, approval. For example, FDA may re- or any postapproval requirements im- quire as a condition to approval: posed under § 814.126. In addition, FDA (1) The submission of certain infor- may deny approval or withdraw ap- mation identified in the approvable let- proval of an application if, upon the ter, e.g., final labeling; basis of the information submitted in (2) The submission of additional in- the HDE or any other information be- formation concerning pediatric uses of fore the agency, FDA determines that: the device, as required by § 814.20(b)(13); (1) There is a lack of a showing of (3) Restrictions imposed on the de- reasonable assurance that the device is vice under section 520(e) of the act; safe under the conditions of use pre- (4) Postapproval requirements as described, recommended, or suggested in scribed in subpart E of this part; and the labeling thereof;

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(2) The device is ineffective under the PMA’s under § 814.45(b) and (d), as ap- conditions of use prescribed, rec- plicable. ommended, or suggested in the labeling (c) FDA will issue an order denying thereof; approval of an HDE after an approvable (3) The applicant has not dem- or not approvable letter has been sent onstrated that there is a reasonable and the applicant: basis from which to conclude that the (1) Submits a requested amendment probable benefit to health from the use but any ground for denying approval of of the device outweighs the risk of in- the application under § 814.118(a) still jury or illness, taking into account the applies; probable risks and benefits of currently (2) Notifies FDA in writing that the available devices or alternative forms requested amendment will not be sub- of treatment; (4) The application or a report submitted; or mitted by or on behalf of the applicant (3) Petitions for review under section contains an untrue statement of mate- 515(d)(3) of the act by filing a petition rial fact, or omits material informa- in the form of a petition for reconsider- tion; ation under § 10.33 of this chapter. (5) The device’s labeling does not (d) Before issuing an order with- comply with the requirements in part drawing approval of an HDE, FDA will 801 or part 809 of this chapter; provide the applicant with notice and (6) A nonclinical laboratory study an opportunity for a hearing as re- that is described in the HDE and that quired for PMA’s under § 814.46(c) and is essential to show that the device is (d), and will provide the public with no- safe for use under the conditions pre- tice in accordance with § 814.46(e), as scribed, recommended, or suggested in applicable. its proposed labeling, was not conducted in compliance with the good [61 FR 33244, June 26, 1996, as amended at 63 laboratory practice regulations in part FR 59221, Nov. 3, 1998] 58 of this chapter and no reason for the § 814.120 Temporary suspension of ap- noncompliance is provided or, if it is, proval of an HDE. the differences between the practices used in conducting the study and the An HDE or HDE supplement may be good laboratory practice regulations do temporarily suspended for the same not support the validity of the study; reasons and in the same manner as pre- (7) Any clinical investigation involv- scribed for PMA’s in § 814.47. ing human subjects described in the [63 FR 59221, Nov. 3, 1998] HDE, subject to the institutional review board regulations in part 56 of § 814.122 Confidentiality of data and this chapter or the informed consent information. regulations in part 50 of this chapter, was not conducted in compliance with (a) Requirement for disclosure. The those regulations such that the rights ‘‘HDE file’’ includes all data and infor- or safety of human subjects were not mation submitted with or referenced in adequately protected; the HDE, any IDE incorporated into (8) The applicant does not permit an the HDE, any HDE amendment or sup- authorized FDA employee an oppor- plement, any report submitted under tunity to inspect at a reasonable time § 814.126, any master file, or any other and in a reasonable manner the facili- related submission. Any record in the ties and controls, and to have access to HDE file will be available for public and to copy and verify all records per- disclosure in accordance with the pro- tinent to the application; or visions of this section and part 20 of (9) The device’s HUD designation this chapter. should be revoked in accordance with (b) Extent of disclosure. Disclosure by § 814.102(c). FDA of the existence and contents of (b) If FDA issues an order denying an HDE file shall be subject to the approval of an application, the agency same rules that pertain to PMA’s will comply with the same notice and under § 814.9(b) through (h), as applica- disclosure provisions required for ble.

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§ 814.124 Institutional Review Board prepare and submit the following com- requirements. plete, accurate, and timely reports: (a) IRB approval. The HDE holder is (1) Periodic reports. An HDE applicant responsible for ensuring that a HUD is required to submit reports in accord- approved under this subpart is adminis- ance with the approval order. Unless tered only in facilities having an Insti- FDA specifies otherwise, any periodic tutional Review Board (IRB) con- report shall include: stituted and acting pursuant to part 56 (i) An update of the information re- of this chapter, including continuing quired under § 814.102(a) in a separately review of use of the device. In addition, bound volume; a HUD may be administered only if (ii) An update of the information re- such use has been approved by the IRB quired under § 814.104(b)(2), (b)(3), and located at the facility or by a similarly (b)(5); constituted IRB that has agreed to (iii) The number of devices that have oversee such use and to which the local been shipped or sold since initial mar- IRB has deferred in a letter to the HDE keting approval under this subpart H holder, signed by the IRB chair or an and, if the number shipped or sold ex- authorized designee. If, however, a phy- ceeds 4,000, an explanation and esti- sician in an emergency situation deter- mate of the number of devices used per mines that approval from an IRB can- patient. If a single device is used on not be obtained in time to prevent seri- multiple patients, the applicant shall ous harm or death to a patient, a HUD submit an estimate of the number of may be administered without prior ap- patients treated or diagnosed using the proval by the IRB located at the facil- device together with an explanation of ity or by a similarly constituted IRB the basis for the estimate; that has agreed to oversee such use. In (iv) Information describing the appli- such an emergency situation, the phy- cant’s clinical experience with the de- sician shall, within 5 days after the use vice since the HDE was initially ap- of the device, provide written notifica- proved. This information shall include tion to the chairman of the IRB of such safety information that is known or use. Such written notification shall in- reasonably should be known to the ap- clude the identification of the patient plicant, medical device reports made involved, the date on which the device under part 803 of this chapter, any data was used, and the reason for the use. generated from the postmarketing studies, and information (whether pub- (b) Withdrawal of IRB approval. A holder of an approved HDE shall notify lished or unpublished) that is known or FDA of any withdrawal of approval for reasonably expected to be known by the use of a HUD by a reviewing IRB the applicant that may affect an eval- within 5 working days after being noti- uation of the safety of the device or fied of the withdrawal of approval. that may affect the statement of contraindications, warnings, precautions, [61 FR 33244, June 26, 1996, as amended at 63 and adverse reactions in the device’s FR 59221, Nov. 3, 1998] labeling; and (v) A summary of any changes made § 814.126 Postapproval requirements to the device in accordance with sup- and reports. plements submitted under § 814.108. If (a) An HDE approved under this sub- information provided in the periodic part H shall be subject to the post- reports, or any other information in approval requirements and reports set the possession of FDA, gives the agen- forth under subpart E of this part, as cy reason to believe that a device applicable, with the exception of raises public health concerns or that § 814.82(a)(7). In addition, medical de- the criteria for exemption are no vice reports submitted to FDA in com- longer met, the agency may require the pliance with the requirements of part HDE holder to submit additional infor- 803 of this chapter shall also be sub- mation to demonstrate continued committed to the IRB of record. pliance with the HDE requirements. (b) In addition to the reports identi- (2) Other. An HDE holder shall main- fied in paragraph (a) of this section, tain records of the names and addresses the holder of an approved HDE shall of the facilities to which the HUD has

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been shipped, correspondence with re- Subpart K—Labeling and Packaging viewing IRB’s, as well as any other in- Control formation requested by a reviewing IRB or FDA. Such records shall be 820.120 Device labeling. 820.130 Device packaging. maintained in accordance with the HDE approval order. Subpart L—Handling, Storage, Distribution, [61 FR 33244, June 26, 1996, as amended at 63 and Installation FR 59221, Nov. 3, 1998, 71 FR 16228, Mar. 31, 820.140 Handling. 2006] 820.150 Storage. 820.160 Distribution. PART 820—QUALITY SYSTEM 820.170 Installation. REGULATION Subpart M—Records Subpart A—General Provisions 820.180 General requirements. 820.181 Device master record. Sec. 820.184 Device history record. 820.1 Scope. 820.186 Quality system record. 820.3 Definitions. 820.198 Complaint files. 820.5 Quality system. Subpart N—Servicing Subpart B—Quality System Requirements 820.200 Servicing. 820.20 Management responsibility. 820.22 Quality audit. Subpart O—Statistical Techniques 820.25 Personnel. 820.250 Statistical techniques. Subpart C—Design Controls AUTHORITY: 21 U.S.C. 351, 352, 360, 360c, 360d, 820.30 Design controls. 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.

Subpart D—Document Controls SOURCE: 61 FR 52654, Oct. 7, 1996, unless otherwise noted. 820.40 Document controls.

Subpart E—Purchasing Controls Subpart A—General Provisions 820.50 Purchasing controls. § 820.1 Scope. Subpart F—Identification and Traceability (a) Applicability. (1) Current good manufacturing practice (CGMP) re- 820.60 Identification. quirements are set forth in this quality 820.65 Traceability. system regulation. The requirements in this part govern the methods used Subpart G—Production and Process in, and the facilities and controls used Controls for, the design, manufacture, pack- 820.70 Production and process controls. aging, labeling, storage, installation, 820.72 Inspection, measuring, and test and servicing of all finished devices in- equipment. tended for human use. The require- 820.75 Process validation. ments in this part are intended to ensure that finished devices will be safe Subpart H—Acceptance Activities and effective and otherwise in compli- 820.80 Receiving, in-process, and finished ance with the Federal Food, Drug, and device acceptance. Cosmetic Act (the act). This part es- 820.86 Acceptance status. tablishes basic requirements applicable to manufacturers of finished medical Subpart I—Nonconforming Product devices. If a manufacturer engages in only some operations subject to the re- 820.90 Nonconforming product. quirements in this part, and not in oth- Subpart J—Corrective and Preventive ers, that manufacturer need only com- Action ply with those requirements applicable to the operations in which it is en- 820.100 Corrective and preventive action. gaged. With respect to class I devices,

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design controls apply only to those de- the event of a conflict between applica- vices listed in § 820.30(a)(2). This regula- ble regulations in this part and in tion does not apply to manufacturers other parts of this chapter, the regula- of components or parts of finished de- tions specifically applicable to the devices, but such manufacturers are en- vice in question shall supersede any couraged to use appropriate provisions other generally applicable require- of this regulation as guidance. Manu- ments. facturers of blood and blood compo- (c) Authority. Part 820 is established nents used for transfusion or for fur- and issued under authority of sections ther manufacturing are not subject to 501, 502, 510, 513, 514, 515, 518, 519, 520, this part, but are subject to subchapter 522, 701, 704, 801, 803 of the act (21 U.S.C. F of this chapter. Manufacturers of 351, 352, 360, 360c, 360d, 360e, 360h, 360i, human cells, tissues, and cellular and 360j, 360l, 371, 374, 381, 383). The failure tissue-based products (HCT/Ps), as de- to comply with any applicable provi- fined in § 1271.3(d) of this chapter, that sion in this part renders a device adul- are medical devices (subject to premarket review or notification, or ex- terated under section 501(h) of the act. empt from notification, under an appli- Such a device, as well as any person re- cation submitted under the device pro- sponsible for the failure to comply, is visions of the act or under a biological subject to regulatory action. product license application under sec- (d) Foreign manufacturers. If a manu- tion 351 of the Public Health Service facturer who offers devices for import Act) are subject to this part and are into the United States refuses to per- also subject to the donor-eligibility mit or allow the completion of a Food procedures set forth in part 1271 sub- and Drug Administration (FDA) inspec- part C of this chapter and applicable tion of the foreign facility for the pur- current good tissue practice procedures pose of determining compliance with in part 1271 subpart D of this chapter. this part, it shall appear for purposes In the event of a conflict between ap- of section 801(a) of the act, that the plicable regulations in part 1271 and in methods used in, and the facilities and other parts of this chapter, the regula- controls used for, the design, manufac- tion specifically applicable to the de- ture, packaging, labeling, storage, in- vice in question shall supersede the stallation, or servicing of any devices more general. produced at such facility that are of- (2) The provisions of this part shall fered for import into the United States be applicable to any finished device as do not conform to the requirements of defined in this part, intended for section 520(f) of the act and this part human use, that is manufactured, im- and that the devices manufactured at ported, or offered for import in any that facility are adulterated under sec- State or Territory of the United tion 501(h) of the act. States, the District of Columbia, or the (e) Exemptions or variances. (1) Any Commonwealth of Puerto Rico. person who wishes to petition for an (3) In this regulation the term exemption or variance from any device ‘‘where appropriate’’ is used several times. When a requirement is qualified quality system requirement is subject by ‘‘where appropriate,’’ it is deemed to the requirements of section 520(f)(2) to be ‘‘appropriate’’ unless the manu- of the act. Petitions for an exemption facturer can document justification or variance shall be submitted accord- otherwise. A requirement is ‘‘appro- ing to the procedures set forth in § 10.30 priate’’ if nonimplementation could of this chapter, the FDA’s administra- reasonably be expected to result in the tive procedures. Guidance is available product not meeting its specified re- from the Food and Drug Administra- quirements or the manufacturer not tion, Center for Devices and Radio- being able to carry out any necessary logical Health, Division of Small Man- corrective action. ufacturers, International and Con- (b) The quality system regulation in sumer Assistance, 10903 New Hampshire this part supplements regulations in Ave., Bldg. 66, rm. 4613, Silver Spring, other parts of this chapter except MD 20993–0002, 1–800–638–2041 or 301–796– where explicitly stated otherwise. In 7100, FAX: 301–847–8149.

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(2) FDA may initiate and grant a amination of a design to evaluate the variance from any device quality sys- adequacy of the design requirements, tem requirement when the agency de- to evaluate the capability of the design termines that such variance is in the to meet these requirements, and to best interest of the public health. Such identify problems. variance will remain in effect only so (i) Device history record (DHR) means long as there remains a public health a compilation of records containing the need for the device and the device production history of a finished device. would not likely be made sufficiently (j) Device master record (DMR) means available without the variance. a compilation of records containing the procedures and specifications for a fin- [61 FR 52654, Oct. 7, 1996, as amended at 65 FR 17136, Mar. 31, 2000; 65 FR 66636, Nov. 7, 2000; ished device. 69 FR 29829, May 25, 2005; 72 FR 17399, Apr. 9, (k) Establish means define, document 2007; 75 FR 20915, Apr. 22, 2010; 80 FR 29906, (in writing or electronically), and im- May 22, 2015] plement. (l) Finished device means any device § 820.3 Definitions. or accessory to any device that is suit- (a) Act means the Federal Food, able for use or capable of functioning, Drug, and Cosmetic Act, as amended whether or not it is packaged, labeled, (secs. 201–903, 52 Stat. 1040 et seq., as or sterilized. amended (21 U.S.C. 321–394)). All defini- (m) Lot or batch means one or more tions in section 201 of the act shall components or finished devices that apply to the regulations in this part. consist of a single type, model, class, (b) Complaint means any written, size, composition, or software version electronic, or oral communication that that are manufactured under essen- alleges deficiencies related to the iden- tially the same conditions and that are tity, quality, durability, reliability, intended to have uniform characteris- safety, effectiveness, or performance of tics and quality within specified limits. a device after it is released for dis- (n) Management with executive respon- tribution. sibility means those senior employees of (c) Component means any raw mate- a manufacturer who have the authority rial, substance, piece, part, software, to establish or make changes to the firmware, labeling, or assembly which manufacturer’s quality policy and is intended to be included as part of the quality system. finished, packaged, and labeled device. (o) Manufacturer means any person (d) Control number means any distinc- who designs, manufactures, fabricates, tive symbols, such as a distinctive assembles, or processes a finished de- combination of letters or numbers, or vice. Manufacturer includes but is not both, from which the history of the limited to those who perform the func- manufacturing, packaging, labeling, tions of contract sterilization, installa- and distribution of a unit, lot, or batch tion, relabeling, remanufacturing, re- of finished devices can be determined. packing, or specification development, (e) Design history file (DHF) means a and initial distributors of foreign enti- compilation of records which describes ties performing these functions. the design history of a finished device. (p) Manufacturing material means any (f) Design input means the physical material or substance used in or used and performance requirements of a de- to facilitate the manufacturing proc- vice that are used as a basis for device ess, a concomitant constituent, or a design. byproduct constituent produced during (g) Design output means the results of the manufacturing process, which is a design effort at each design phase and present in or on the finished device as at the end of the total design effort. a residue or impurity not by design or The finished design output is the basis intent of the manufacturer. for the device master record. The total (q) Nonconformity means the non- finished design output consists of the fulfillment of a specified requirement. device, its packaging and labeling, and (r) Product means components, manu- the device master record. facturing materials, in- process de- (h) Design review means a docu- vices, finished devices, and returned mented, comprehensive, systematic ex- devices.

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(s) Quality means the totality of fea- (bb) Human cell, tissue, or cellular or tures and characteristics that bear on tissue-based product (HCT/P) regulated as the ability of a device to satisfy fit- a device means an HCT/P as defined in ness-for-use, including safety and per- § 1271.3(d) of this chapter that does not formance. meet the criteria in § 1271.10(a) and that (t) Quality audit means a systematic, is also regulated as a device. independent examination of a manufac- (cc) Unique device identifier (UDI) turer’s quality system that is per- means an identifier that adequately formed at defined intervals and at suf- identifies a device through its distribu- ficient frequency to determine whether tion and use by meeting the require- both quality system activities and the ments of § 830.20 of this chapter. A results of such activities comply with unique device identifier is composed of: quality system procedures, that these (1) A device identifier—a mandatory, procedures are implemented effec- fixed portion of a UDI that identifies tively, and that these procedures are the specific version or model of a de- suitable to achieve quality system ob- vice and the labeler of that device; and jectives. (2) A production identifier—a condi- (u) Quality policy means the overall tional, variable portion of a UDI that intentions and direction of an organi- identifies one or more of the following zation with respect to quality, as es- when included on the label of the de- tablished by management with execu- vice: tive responsibility. (i) The lot or batch within which a (v) Quality system means the organi- device was manufactured; zational structure, responsibilities, (ii) The serial number of a specific procedures, processes, and resources for device; implementing quality management. (iii) The expiration date of a specific (w) Remanufacturer means any person device; who processes, conditions, renovates, (iv) The date a specific device was repackages, restores, or does any other manufactured. act to a finished device that significantly changes the finished device’s (v) For an HCT/P regulated as a de- performance or safety specifications, vice, the distinct identification code or intended use. required by § 1271.290(c) of this chapter. (x) Rework means action taken on a (dd) Universal product code (UPC) nonconforming product so that it will means the product identifier used to fulfill the specified DMR requirements identify an item sold at retail in the before it is released for distribution. United States. (y) Specification means any require- [61 FR 52654, Oct. 7, 1996, as amended at 78 FR ment with which a product, process, 58822, Sept. 24, 2013] service, or other activity must conform. § 820.5 Quality system. (z) Validation means confirmation by Each manufacturer shall establish examination and provision of objective and maintain a quality system that is evidence that the particular require- appropriate for the specific medical de- ments for a specific intended use can vice(s) designed or manufactured, and be consistently fulfilled. that meets the requirements of this (1) Process validation means estab- part. lishing by objective evidence that a process consistently produces a result or product meeting its predetermined Subpart B—Quality System specifications. Requirements (2) Design validation means establishing by objective evidence that de- § 820.20 Management responsibility. vice specifications conform with user (a) Quality policy. Management with needs and intended use(s). executive responsibility shall establish (aa) Verification means confirmation its policy and objectives for, and com- by examination and provision of objec- mitment to, quality. Management with tive evidence that specified require- executive responsibility shall ensure ments have been fulfilled. that the quality policy is understood,

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implemented, and maintained at all (e) Quality system procedures. Each levels of the organization. manufacturer shall establish quality (b) Organization. Each manufacturer system procedures and instructions. An shall establish and maintain an ade- outline of the structure of the docu- quate organizational structure to en- mentation used in the quality system sure that devices are designed and pro- shall be established where appropriate. duced in accordance with the requirements of this part. § 820.22 Quality audit. (1) Responsibility and authority. Each Each manufacturer shall establish manufacturer shall establish the appro- procedures for quality audits and con- priate responsibility, authority, and duct such audits to assure that the interrelation of all personnel who man- quality system is in compliance with age, perform, and assess work affecting the established quality system require- quality, and provide the independence ments and to determine the effective- and authority necessary to perform ness of the quality system. Quality au- these tasks. dits shall be conducted by individuals who do not have direct responsibility (2) Resources. Each manufacturer for the matters being audited. Correc- shall provide adequate resources, in- tive action(s), including a reaudit of cluding the assignment of trained per- deficient matters, shall be taken when sonnel, for management, performance necessary. A report of the results of of work, and assessment activities, in- each quality audit, and reaudit(s) cluding internal quality audits, to where taken, shall be made and such meet the requirements of this part. reports shall be reviewed by manage- (3) Management representative. Man- ment having responsibility for the agement with executive responsibility matters audited. The dates and results shall appoint, and document such ap- of quality audits and reaudits shall be pointment of, a member of manage- documented. ment who, irrespective of other responsibilities, shall have established au- § 820.25 Personnel. thority over and responsibility for: (a) General. Each manufacturer shall (i) Ensuring that quality system re- have sufficient personnel with the nec- quirements are effectively established essary education, background, train- and effectively maintained in according, and experience to assure that all ance with this part; and activities required by this part are cor- (ii) Reporting on the performance of rectly performed. the quality system to management (b) Training. Each manufacturer shall with executive responsibility for reestablish procedures for identifying view. training needs and ensure that all per- (c) Management review. Management sonnel are trained to adequately per- with executive responsibility shall re- form their assigned responsibilities. view the suitability and effectiveness Training shall be documented. of the quality system at defined inter- (1) As part of their training, per- vals and with sufficient frequency ac- sonnel shall be made aware of device cording to established procedures to defects which may occur from the im- ensure that the quality system satis- proper performance of their specific fies the requirements of this part and jobs. the manufacturer’s established quality (2) Personnel who perform policy and objectives. The dates and re- verification and validation activities sults of quality system reviews shall be shall be made aware of defects and er- documented. rors that may be encountered as part (d) Quality planning. Each manufac- of their job functions. turer shall establish a quality plan which defines the quality practices, re- Subpart C—Design Controls sources, and activities relevant to devices that are designed and manufac- § 820.30 Design controls. tured. The manufacturer shall estab- (a) General. (1) Each manufacturer of lish how the requirements for quality any class III or class II device, and the will be met. class I devices listed in paragraph (a)(2)

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of this section, shall establish and approved before release. The approval, maintain procedures to control the de- including the date and signature of the sign of the device in order to ensure individual(s) approving the output, that specified design requirements are shall be documented. met. (e) Design review. Each manufacturer (2) The following class I devices are shall establish and maintain proce- subject to design controls: dures to ensure that formal docu- (i) Devices automated with computer mented reviews of the design results software; and are planned and conducted at appro- (ii) The devices listed in the fol- priate stages of the device’s design de- lowing chart. velopment. The procedures shall ensure Section Device that participants at each design review include representatives of all functions 868.6810 ...... Catheter, Tracheobronchial Suction. concerned with the design stage being 878.4460 ...... Glove, Surgeon’s. 880.6760 ...... Restraint, Protective. reviewed and an individual(s) who does 892.5650 ...... System, Applicator, Radionuclide, Manual. not have direct responsibility for the 892.5740 ...... Source, Radionuclide Teletherapy. design stage being reviewed, as well as any specialists needed. The results of a (b) Design and development planning. design review, including identification Each manufacturer shall establish and of the design, the date, and the indi- maintain plans that describe or ref- vidual(s) performing the review, shall erence the design and development ac- be documented in the design history tivities and define responsibility for file (the DHF). implementation. The plans shall iden- (f) Design verification. Each manufac- tify and describe the interfaces with turer shall establish and maintain pro- different groups or activities that procedures for verifying the device design. vide, or result in, input to the design Design verification shall confirm that and development process. The plans the design output meets the design shall be reviewed, updated, and ap- input requirements. The results of the proved as design and development evolves. design verification, including identi- (c) Design input. Each manufacturer fication of the design, method(s), the shall establish and maintain proce- date, and the individual(s) performing dures to ensure that the design require- the verification, shall be documented ments relating to a device are appro- in the DHF. priate and address the intended use of (g) Design validation. Each manufac- the device, including the needs of the turer shall establish and maintain pro- user and patient. The procedures shall cedures for validating the device de- include a mechanism for addressing in- sign. Design validation shall be per- complete, ambiguous, or conflicting re- formed under defined operating condi- quirements. The design input require- tions on initial production units, lots, ments shall be documented and shall be or batches, or their equivalents. Design reviewed and approved by a designated validation shall ensure that devices individual(s). The approval, including conform to defined user needs and in- the date and signature of the indi- tended uses and shall include testing of vidual(s) approving the requirements, production units under actual or simu- shall be documented. lated use conditions. Design validation (d) Design output. Each manufacturer shall include software validation and shall establish and maintain proce- risk analysis, where appropriate. The dures for defining and documenting de- results of the design validation, includ- sign output in terms that allow an ade- ing identification of the design, meth- quate evaluation of conformance to de- od(s), the date, and the individual(s) sign input requirements. Design output performing the validation, shall be doc- procedures shall contain or make ref- umented in the DHF. erence to acceptance criteria and shall (h) Design transfer. Each manufac- ensure that those design outputs that turer shall establish and maintain pro- are essential for the proper functioning cedures to ensure that the device de- of the device are identified. Design out- sign is correctly translated into pro- put shall be documented, reviewed, and duction specifications.

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(i) Design changes. Each manufac- Subpart E—Purchasing Controls turer shall establish and maintain procedures for the identification, docu- § 820.50 Purchasing controls. mentation, validation or where appro- Each manufacturer shall establish priate verification, review, and ap- and maintain procedures to ensure that proval of design changes before their all purchased or otherwise received implementation. product and services conform to speci- (j) Design history file. Each manufac- fied requirements. turer shall establish and maintain a (a) Evaluation of suppliers, contractors, DHF for each type of device. The DHF and consultants. Each manufacturer shall contain or reference the records shall establish and maintain the re- necessary to demonstrate that the de- quirements, including quality require- sign was developed in accordance with ments, that must be met by suppliers, the approved design plan and the re- contractors, and consultants. Each quirements of this part. manufacturer shall: (1) Evaluate and select potential sup- Subpart D—Document Controls pliers, contractors, and consultants on the basis of their ability to meet speci- § 820.40 Document controls. fied requirements, including quality re- Each manufacturer shall establish quirements. The evaluation shall be and maintain procedures to control all documented. documents that are required by this (2) Define the type and extent of con- part. The procedures shall provide for trol to be exercised over the product, the following: services, suppliers, contractors, and (a) Document approval and distribu- consultants, based on the evaluation tion. Each manufacturer shall des- results. ignate an individual(s) to review for (3) Establish and maintain records of adequacy and approve prior to issuance acceptable suppliers, contractors, and all documents established to meet the consultants. requirements of this part. The ap- (b) Purchasing data. Each manufac- proval, including the date and signa- turer shall establish and maintain data ture of the individual(s) approving the document, shall be documented. Docu- that clearly describe or reference the ments established to meet the require- specified requirements, including qual- ments of this part shall be available at ity requirements, for purchased or oth- all locations for which they are des- erwise received product and services. ignated, used, or otherwise necessary, Purchasing documents shall include, and all obsolete documents shall be where possible, an agreement that the promptly removed from all points of suppliers, contractors, and consultants use or otherwise prevented from unin- agree to notify the manufacturer of tended use. changes in the product or service so (b) Document changes. Changes to doc- that manufacturers may determine uments shall be reviewed and approved whether the changes may affect the by an individual(s) in the same func- quality of a finished device. Purchasing tion or organization that performed data shall be approved in accordance the original review and approval, un- with § 820.40. less specifically designated otherwise. Approved changes shall be commu- Subpart F—Identification and nicated to the appropriate personnel in Traceability a timely manner. Each manufacturer shall maintain records of changes to § 820.60 Identification. documents. Change records shall in- Each manufacturer shall establish clude a description of the change, iden- and maintain procedures for identi- tification of the affected documents, fying product during all stages of re- the signature of the approving indi- ceipt, production, distribution, and in- vidual(s), the approval date, and when stallation to prevent mixups. the change becomes effective.

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§ 820.65 Traceability. mented. Changes shall be approved in accordance with § 820.40. Each manufacturer of a device that is (c) Environmental control. Where envi- intended for surgical implant into the ronmental conditions could reasonably body or to support or sustain life and be expected to have an adverse effect whose failure to perform when properly on product quality, the manufacturer used in accordance with instructions shall establish and maintain proce- for use provided in the labeling can be dures to adequately control these envi- reasonably expected to result in a sig- ronmental conditions. Environmental nificant injury to the user shall estab- control system(s) shall be periodically lish and maintain procedures for iden- inspected to verify that the system, in- tifying with a control number each cluding necessary equipment, is ade- unit, lot, or batch of finished devices quate and functioning properly. These and where appropriate components. activities shall be documented and re- The procedures shall facilitate correc- viewed. tive action. Such identification shall (d) Personnel. Each manufacturer be documented in the DHR. shall establish and maintain requirements for the health, cleanliness, per- Subpart G—Production and sonal practices, and clothing of per- Process Controls sonnel if contact between such personnel and product or environment § 820.70 Production and process con- could reasonably be expected to have trols. an adverse effect on product quality. (a) General. Each manufacturer shall The manufacturer shall ensure that develop, conduct, control, and monitor maintenance and other personnel who production processes to ensure that a are required to work temporarily under device conforms to its specifications. special environmental conditions are Where deviations from device specifica- appropriately trained or supervised by tions could occur as a result of the a trained individual. manufacturing process, the manufac- (e) Contamination control. Each manu- turer shall establish and maintain facturer shall establish and maintain process control procedures that de- procedures to prevent contamination of scribe any process controls necessary equipment or product by substances to ensure conformance to specifica- that could reasonably be expected to tions. Where process controls are need- have an adverse effect on product qual- ed they shall include: ity. (1) Documented instructions, stand- (f) Buildings. Buildings shall be of ard operating procedures (SOP’s), and suitable design and contain sufficient methods that define and control the space to perform necessary operations, manner of production; prevent mixups, and assure orderly (2) Monitoring and control of process handling. parameters and component and device (g) Equipment. Each manufacturer characteristics during production; shall ensure that all equipment used in (3) Compliance with specified ref- the manufacturing process meets speci- erence standards or codes; fied requirements and is appropriately (4) The approval of processes and designed, constructed, placed, and in- process equipment; and stalled to facilitate maintenance, ad- (5) Criteria for workmanship which justment, cleaning, and use. shall be expressed in documented (1) Maintenance schedule. Each manu- standards or by means of identified and facturer shall establish and maintain approved representative samples. schedules for the adjustment, cleaning, (b) Production and process changes. and other maintenance of equipment to Each manufacturer shall establish and ensure that manufacturing specifica- maintain procedures for changes to a tions are met. Maintenance activities, specification, method, process, or pro- including the date and individual(s) cedure. Such changes shall be verified performing the maintenance activities, or where appropriate validated accord- shall be documented. ing to § 820.75, before implementation (2) Inspection. Each manufacturer and these activities shall be docu- shall conduct periodic inspections in

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accordance with established procedures When accuracy and precision limits are to ensure adherence to applicable not met, there shall be provisions for equipment maintenance schedules. The remedial action to reestablish the lim- inspections, including the date and in- its and to evaluate whether there was dividual(s) conducting the inspections, any adverse effect on the device’s qual- shall be documented. ity. These activities shall be docu- (3) Adjustment. Each manufacturer mented. shall ensure that any inherent limita- (1) Calibration standards. Calibration tions or allowable tolerances are visi- standards used for inspection, meas- bly posted on or near equipment re- uring, and test equipment shall be quiring periodic adjustments or are traceable to national or international readily available to personnel per- standards. If national or international forming these adjustments. standards are not practical or avail- (h) Manufacturing material. Where a able, the manufacturer shall use an manufacturing material could reason- independent reproducible standard. If ably be expected to have an adverse ef- no applicable standard exists, the man- fect on product quality, the manufac- ufacturer shall establish and maintain turer shall establish and maintain pro- an in-house standard. cedures for the use and removal of such (2) Calibration records. The equipment manufacturing material to ensure that identification, calibration dates, the it is removed or limited to an amount individual performing each calibration, that does not adversely affect the de- and the next calibration date shall be vice’s quality. The removal or reduc- documented. These records shall be dis- tion of such manufacturing material played on or near each piece of equip- shall be documented. ment or shall be readily available to (i) Automated processes. When com- the personnel using such equipment puters or automated data processing and to the individuals responsible for systems are used as part of production calibrating the equipment. or the quality system, the manufacturer shall validate computer software § 820.75 Process validation. for its intended use according to an es- (a) Where the results of a process tablished protocol. All software cannot be fully verified by subsequent changes shall be validated before ap- inspection and test, the process shall proval and issuance. These validation be validated with a high degree of as- activities and results shall be docu- surance and approved according to es- mented. tablished procedures. The validation activities and results, including the § 820.72 Inspection, measuring, and date and signature of the individual(s) test equipment. approving the validation and where ap- (a) Control of inspection, measuring, propriate the major equipment vali- and test equipment. Each manufacturer dated, shall be documented. shall ensure that all inspection, meas- (b) Each manufacturer shall establish uring, and test equipment, including and maintain procedures for moni- mechanical, automated, or electronic toring and control of process param- inspection and test equipment, is suit- eters for validated processes to ensure able for its intended purposes and is ca- that the specified requirements con- pable of producing valid results. Each tinue to be met. manufacturer shall establish and main- (1) Each manufacturer shall ensure tain procedures to ensure that equip- that validated processes are performed ment is routinely calibrated, inspected, by qualified individual(s). checked, and maintained. The proce- (2) For validated processes, the moni- dures shall include provisions for han- toring and control methods and data, dling, preservation, and storage of the date performed, and, where appro- equipment, so that its accuracy and priate, the individual(s) performing the fitness for use are maintained. These process or the major equipment used activities shall be documented. shall be documented. (b) Calibration. Calibration proce- (c) When changes or process devi- dures shall include specific directions ations occur, the manufacturer shall and limits for accuracy and precision. review and evaluate the process and

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perform revalidation where appro- (3) the results; priate. These activities shall be docu- (4) the signature of the individual(s) mented. conducting the acceptance activities; and Subpart H—Acceptance Activities (5) where appropriate the equipment used. These records shall be part of the § 820.80 Receiving, in-process, and fin- DHR. ished device acceptance. (a) General. Each manufacturer shall § 820.86 Acceptance status. establish and maintain procedures for Each manufacturer shall identify by acceptance activities. Acceptance ac- suitable means the acceptance status tivities include inspections, tests, or of product, to indicate the conformance other verification activities. or nonconformance of product with ac- (b) Receiving acceptance activities. ceptance criteria. The identification of Each manufacturer shall establish and acceptance status shall be maintained maintain procedures for acceptance of throughout manufacturing, packaging, incoming product. Incoming product labeling, installation, and servicing of shall be inspected, tested, or otherwise the product to ensure that only prod- verified as conforming to specified re- uct which has passed the required ac- quirements. Acceptance or rejection ceptance activities is distributed, used, shall be documented. or installed. (c) In-process acceptance activities. Each manufacturer shall establish and Subpart I—Nonconforming maintain acceptance procedures, where Product appropriate, to ensure that specified requirements for in-process product are § 820.90 Nonconforming product. met. Such procedures shall ensure that (a) Control of nonconforming product. in-process product is controlled until Each manufacturer shall establish and the required inspection and tests or maintain procedures to control product other verification activities have been that does not conform to specified re- completed, or necessary approvals are quirements. The procedures shall ad- received, and are documented. dress the identification, documenta- (d) Final acceptance activities. Each tion, evaluation, segregation, and dis- manufacturer shall establish and main- position of nonconforming product. tain procedures for finished device ac- The evaluation of nonconformance ceptance to ensure that each produc- shall include a determination of the tion run, lot, or batch of finished de- need for an investigation and notifica- vices meets acceptance criteria. Fin- tion of the persons or organizations re- ished devices shall be held in quar- sponsible for the nonconformance. The antine or otherwise adequately con- evaluation and any investigation shall trolled until released. Finished devices be documented. shall not be released for distribution (b) Nonconformity review and disposi- until: tion. (1) Each manufacturer shall estab- (1) The activities required in the lish and maintain procedures that de- DMR are completed; fine the responsibility for review and (2) the associated data and docu- the authority for the disposition of mentation is reviewed; nonconforming product. The proce- (3) the release is authorized by the dures shall set forth the review and dis- signature of a designated individual(s); position process. Disposition of non- and conforming product shall be docu- (4) the authorization is dated. mented. Documentation shall include (e) Acceptance records. Each manufac- the justification for use of noncon- turer shall document acceptance ac- forming product and the signature of tivities required by this part. These the individual(s) authorizing the use. records shall include: (2) Each manufacturer shall establish (1) The acceptance activities per- and maintain procedures for rework, to formed; include retesting and reevaluation of (2) the dates acceptance activities the nonconforming product after re- are performed; work, to ensure that the product meets

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its current approved specifications. Re- Subpart K—Labeling and work and reevaluation activities, in- Packaging Control cluding a determination of any adverse effect from the rework upon the prod- § 820.120 Device labeling. uct, shall be documented in the DHR. Each manufacturer shall establish and maintain procedures to control la- Subpart J—Corrective and beling activities. Preventive Action (a) Label integrity. Labels shall be printed and applied so as to remain leg- § 820.100 Corrective and preventive ac- ible and affixed during the customary tion. conditions of processing, storage, han- (a) Each manufacturer shall establish dling, distribution, and where appro- and maintain procedures for imple- priate use. menting corrective and preventive ac- (b) Labeling inspection. Labeling shall tion. The procedures shall include re- not be released for storage or use until quirements for: a designated individual(s) has exam- (1) Analyzing processes, work oper- ined the labeling for accuracy includ- ations, concessions, quality audit re- ing, where applicable, the correct ports, quality records, service records, unique device identifier (UDI) or uni- complaints, returned product, and versal product code (UPC), expiration other sources of quality data to iden- date, control number, storage instruc- tify existing and potential causes of tions, handling instructions, and any nonconforming product, or other qual- additional processing instructions. The ity problems. Appropriate statistical release, including the date and signa- methodology shall be employed where ture of the individual(s) performing the necessary to detect recurring quality examination, shall be documented in problems; the DHR. (2) Investigating the cause of (c) Labeling storage. Each manufac- nonconformities relating to product, turer shall store labeling in a manner processes, and the quality system; that provides proper identification and (3) Identifying the action(s) needed to is designed to prevent mixups. correct and prevent recurrence of non- (d) Labeling operations. Each manu- conforming product and other quality facturer shall control labeling and problems; packaging operations to prevent label- (4) Verifying or validating the correc- ing mixups. The label and labeling used tive and preventive action to ensure for each production unit, lot, or batch that such action is effective and does shall be documented in the DHR. not adversely affect the finished de- (e) Control number. Where a control vice; number is required by § 820.65, that con- (5) Implementing and recording trol number shall be on or shall accom- changes in methods and procedures pany the device through distribution. needed to correct and prevent identified quality problems; [61 FR 52654, Oct. 7, 1996, as amended at 78 FR 58822, Sept. 24, 2013] (6) Ensuring that information related to quality problems or nonconforming § 820.130 Device packaging. product is disseminated to those directly responsible for assuring the Each manufacturer shall ensure that quality of such product or the preven- device packaging and shipping con- tion of such problems; and tainers are designed and constructed to (7) Submitting relevant information protect the device from alteration or on identified quality problems, as well damage during the customary condi- as corrective and preventive actions, tions of processing, storage, handling, for management review. and distribution. (b) All activities required under this section, and their results, shall be documented.

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Subpart L—Handling, Storage, maintain adequate installation and in- Distribution, and Installation spection instructions, and where appropriate test procedures. Instructions § 820.140 Handling. and procedures shall include directions for ensuring proper installation so that Each manufacturer shall establish the device will perform as intended and maintain procedures to ensure that after installation. The manufacturer mixups, damage, deterioration, con- shall distribute the instructions and tamination, or other adverse effects to procedures with the device or other- product do not occur during handling. wise make them available to the person(s) installing the device. § 820.150 Storage. (b) The person installing the device (a) Each manufacturer shall establish shall ensure that the installation, in- and maintain procedures for the con- spection, and any required testing are trol of storage areas and stock rooms performed in accordance with the man- for product to prevent mixups, damage, ufacturer’s instructions and procedures deterioration, contamination, or other and shall document the inspection and adverse effects pending use or distribu- any test results to demonstrate proper tion and to ensure that no obsolete, re- installation. jected, or deteriorated product is used or distributed. When the quality of Subpart M—Records product deteriorates over time, it shall be stored in a manner to facilitate § 820.180 General requirements. proper stock rotation, and its condi- All records required by this part tion shall be assessed as appropriate. shall be maintained at the manufac- (b) Each manufacturer shall establish turing establishment or other location and maintain procedures that describe that is reasonably accessible to respon- the methods for authorizing receipt sible officials of the manufacturer and from and dispatch to storage areas and to employees of FDA designated to per- stock rooms. form inspections. Such records, including those not stored at the inspected § 820.160 Distribution. establishment, shall be made readily (a) Each manufacturer shall establish available for review and copying by and maintain procedures for control FDA employee(s). Such records shall be and distribution of finished devices to legible and shall be stored to minimize ensure that only those devices ap- deterioration and to prevent loss. proved for release are distributed and Those records stored in automated that purchase orders are reviewed to data processing systems shall be ensure that ambiguities and errors are backed up. resolved before devices are released for (a) Confidentiality. Records deemed distribution. Where a device’s fitness confidential by the manufacturer may for use or quality deteriorates over be marked to aid FDA in determining time, the procedures shall ensure that whether information may be disclosed expired devices or devices deteriorated under the public information regula- beyond acceptable fitness for use are tion in part 20 of this chapter. not distributed. (b) Record retention period. All records (b) Each manufacturer shall main- required by this part shall be retained tain distribution records which include for a period of time equivalent to the or refer to the location of: design and expected life of the device, (1) The name and address of the ini- but in no case less than 2 years from tial consignee; the date of release for commercial dis- (2) The identification and quantity of tribution by the manufacturer. devices shipped; (c) Exceptions. This section does not (3) The date shipped; and apply to the reports required by (4) Any control number(s) used. § 820.20(c) Management review, § 820.22 Quality audits, and supplier audit re- § 820.170 Installation. ports used to meet the requirements of (a) Each manufacturer of a device re- § 820.50(a) Evaluation of suppliers, con- quiring installation shall establish and tractors, and consultants, but does

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apply to procedures established under (e) The primary identification label these provisions. Upon request of a des- and labeling used for each production ignated employee of FDA, an employee unit; and in management with executive respon- (f) Any unique device identifier (UDI) sibility shall certify in writing that the or universal product code (UPC), and management reviews and quality au- any other device identification(s) and dits required under this part, and sup- control number(s) used. plier audits where applicable, have been performed and documented, the [61 FR 52654, Oct. 7, 1996, as amended at 78 FR 58822, Sept. 24, 2013] dates on which they were performed, and that any required corrective action § 820.186 Quality system record. has been undertaken. Each manufacturer shall maintain a § 820.181 Device master record. quality system record (QSR). The QSR shall include, or refer to the location Each manufacturer shall maintain of, procedures and the documentation device master records (DMR’s). Each of activities required by this part that manufacturer shall ensure that each are not specific to a particular type of DMR is prepared and approved in ac- device(s), including, but not limited to, cordance with § 820.40. The DMR for the records required by § 820.20. Each each type of device shall include, or manufacturer shall ensure that the refer to the location of, the following QSR is prepared and approved in ac- information: (a) Device specifications including cordance with § 820.40. appropriate drawings, composition, for- § 820.198 Complaint files. mulation, component specifications, and software specifications; (a) Each manufacturer shall main- (b) Production process specifications tain complaint files. Each manufac- including the appropriate equipment turer shall establish and maintain pro- specifications, production methods, cedures for receiving, reviewing, and production procedures, and production evaluating complaints by a formally environment specifications; designated unit. Such procedures shall (c) Quality assurance procedures and ensure that: specifications including acceptance cri- (1) All complaints are processed in a teria and the quality assurance equip- uniform and timely manner; ment to be used; (2) Oral complaints are documented (d) Packaging and labeling specifica- upon receipt; and tions, including methods and processes (3) Complaints are evaluated to de- used; and termine whether the complaint rep- (e) Installation, maintenance, and resents an event which is required to servicing procedures and methods. be reported to FDA under part 803 of this chapter, Medical Device Report- § 820.184 Device history record. ing. Each manufacturer shall maintain (b) Each manufacturer shall review device history records (DHR’s). Each and evaluate all complaints to deter- manufacturer shall establish and main- mine whether an investigation is nec- tain procedures to ensure that DHR’s essary. When no investigation is made, for each batch, lot, or unit are main- the manufacturer shall maintain a tained to demonstrate that the device record that includes the reason no in- is manufactured in accordance with the vestigation was made and the name of DMR and the requirements of this part. the individual responsible for the deci- The DHR shall include, or refer to the sion not to investigate. location of, the following information: (c) Any complaint involving the pos- (a) The dates of manufacture; sible failure of a device, labeling, or (b) The quantity manufactured; packaging to meet any of its specifica- (c) The quantity released for dis- tions shall be reviewed, evaluated, and tribution; investigated, unless such investigation (d) The acceptance records which has already been performed for a simi- demonstrate the device is manufac- lar complaint and another investiga- tured in accordance with the DMR; tion is not necessary.

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(d) Any complaint that represents an (2) The location of the initial dis- event which must be reported to FDA tributor. under part 803 of this chapter shall be [61 FR 52654, Oct. 7, 1996, as amended at 69 FR promptly reviewed, evaluated, and in- 11313, Mar. 10, 2004; 71 FR 16228, Mar. 31, 2006; vestigated by a designated indi- 78 FR 58822, Sept. 24, 2013] vidual(s) and shall be maintained in a separate portion of the complaint files Subpart N—Servicing or otherwise clearly identified. In addition to the information required by § 820.200 Servicing. § 820.198(e), records of investigation (a) Where servicing is a specified re- under this paragraph shall include a quirement, each manufacturer shall es- determination of: tablish and maintain instructions and (1) Whether the device failed to meet procedures for performing and specifications; verifying that the servicing meets the (2) Whether the device was being used specified requirements. for treatment or diagnosis; and (b) Each manufacturer shall analyze (3) The relationship, if any, of the de- service reports with appropriate statis- vice to the reported incident or adverse tical methodology in accordance with § 820.100. event. (c) Each manufacturer who receives a (e) When an investigation is made service report that represents an event under this section, a record of the in- which must be reported to FDA under vestigation shall be maintained by the part 803 of this chapter shall automati- formally designated unit identified in cally consider the report a complaint paragraph (a) of this section. The and shall process it in accordance with record of investigation shall include: the requirements of § 820.198. (1) The name of the device; (d) Service reports shall be docu- (2) The date the complaint was re- mented and shall include: ceived; (1) The name of the device serviced; (3) Any unique device identifier (UDI) (2) Any unique device identifier (UDI) or universal product code (UPC), and or universal product code (UPC), and any other device identification(s) and any other device identification(s) and control number(s) used; control number(s) used; (4) The name, address, and phone (3) The date of service; number of the complainant; (4) The individual(s) servicing the device; (5) The nature and details of the com- (5) The service performed; and plaint; (6) The test and inspection data. (6) The dates and results of the investigation; [61 FR 52654, Oct. 7, 1996, as amended at 69 FR (7) Any corrective action taken; and 11313, Mar. 10, 2004; 78 FR 58822, Sept. 24, 2013] (8) Any reply to the complainant. (f) When the manufacturer’s formally Subpart O—Statistical Techniques designated complaint unit is located at § 820.250 Statistical techniques. a site separate from the manufacturing (a) Where appropriate, each manufac- establishment, the investigated com- turer shall establish and maintain pro- plaint(s) and the record(s) of investiga- cedures for identifying valid statistical tion shall be reasonably accessible to techniques required for establishing, the manufacturing establishment. controlling, and verifying the accept- (g) If a manufacturer’s formally des- ability of process capability and prod- ignated complaint unit is located out- uct characteristics. side of the United States, records re- (b) Sampling plans, when used, shall quired by this section shall be reason- be written and based on a valid statis- ably accessible in the United States at tical rationale. Each manufacturer either: shall establish and maintain proce- (1) A location in the United States dures to ensure that sampling methods where the manufacturer’s records are are adequate for their intended use and regularly kept; or to ensure that when changes occur the

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sampling plans are reviewed. These ac- ferred to, in this part, as a ‘‘tracked de- tivities shall be documented. vice.’’ (b) These regulations are intended to PART 821—MEDICAL DEVICE ensure that tracked devices can be TRACKING REQUIREMENTS traced from the device manufacturing facility to the person for whom the de- Subpart A—General Provisions vice is indicated, that is, the patient. Effective tracking of devices from the Sec. manufacturing facility, through the 821.1 Scope. distributor network (including dis- 821.2 Exemptions and variances. tributors, retailers, rental firms and 821.3 Definitions. other commercial enterprises, device 821.4 Imported devices. user facilities, and licensed practitioners) and, ultimately, to the patient Subpart B—Tracking Requirements is necessary for the effectiveness of 821.20 Devices subject to tracking. remedies prescribed by the act, such as 821.25 Device tracking system and content patient notification (section 518(a) of requirements: manufacturer require- the act) or device recall (section 518(e) ments. of the act). Although these regulations do not preclude a manufacturer from Subpart C—Additional Requirements and involving outside organizations in that Responsibilities manufacturer’s device tracking effort, 821.30 Tracking obligations of persons other the legal responsibility for complying than device manufacturers: distributor with this part rests with manufactur- requirements. ers who are subject to tracking orders, and that responsibility cannot be al- Subpart D—Records and Inspections tered, modified, or in any way abro- 821.50 Availability. gated by contracts or other agree- 821.55 Confidentiality. ments. 821.60 Retention of records. (c) The primary burden for ensuring that the tracking system works rests AUTHORITY: 21 U.S.C. 331, 351, 352, 360, 360e, 360h, 360i, 371, 374. upon the manufacturer. A manufacturer or any other person, including a SOURCE: 58 FR 43447, Aug. 16, 1993, unless distributor, final distributor, or mul- otherwise noted. tiple distributor, who distributes a device subject to tracking, who fails to Subpart A—General Provisions comply with any applicable requirement of section 519(e) of the act or of § 821.1 Scope. this part, or any person who causes (a) The regulations in this part im- such failure, misbrands the device plement section 519(e) of the Federal within the meaning of section 502(t)(2) Food, Drug, and Cosmetic Act (the of the act and commits a prohibited act act), which provides that the Food and within the meaning of sections 301(e) Drug Administration may require a and 301(q)(1)(B) of the act. manufacturer to adopt a method of (d) Any person subject to this part tracking a class II or class III device, if who permanently discontinues doing the device meets one of the following business is required to notify FDA at three criteria and FDA issues an order the time the person notifies any gov- to the manufacturer: the failure of the ernment agency, court, or supplier, and device would be reasonably likely to provide FDA with a complete set of its have serious adverse health con- tracking records and information. sequences; or the device is intended to However, if a person ceases distribu- be implanted in the human body for tion of a tracked device but continues more than 1 year; or the device is a to do other business, that person con- life-sustaining or life-supporting device tinues to be responsible for compliance used outside a device user facility. A with this part unless another person, device that meets one of these criteria affirmatively and in writing, assumes and is the subject of an FDA order responsibility for continuing the track- must comply with this part and is re- ing of devices previously distributed

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under this part. Further, if a person subject to a tracking order. ‘‘Importer’’ subject to this part goes out of busi- does not include anyone who only fur- ness completely, but other persons ac- thers the marketing, e.g., brokers, job- quire the right to manufacture or dis- bers, or warehousers. tribute tracked devices, those other (c) Manufacturer means any person, persons are deemed to be responsible including any importer, repacker and/ for continuing the tracking responsi- or relabeler, who manufactures, pre- bility of the previous person under this pares, propagates, compounds, assem- part. bles, or processes a device or engages in [58 FR 43447, Aug. 16, 1993, as amended at 67 any of the activities described in FR 5951, Feb. 8, 2002; 73 FR 34860, June 19, § 807.3(d) of this chapter. 2008] (d) Device failure means the failure of a device to perform or function as in- § 821.2 Exemptions and variances. tended, including any deviations from (a) A manufacturer, importer, or dis- the device’s performance specifications tributor may seek an exemption or or intended use. variance from one or more require- (e) Serious adverse health consequences ments of this part. means any significant adverse experi- (b) A request for an exemption or ence related to a device, including de- variance shall be submitted in the form vice-related events which are life- of a petition under § 10.30 of this chap- threatening or which involve perma- ter and shall comply with the require- nent or long-term injuries or illnesses. ments set out therein, except that a re- (f) Device intended to be implanted in sponse shall be issued in 90 days. The the human body for more than 1 year Director or Deputy Directors, CDRH, means a device that is intended to be or the Director, Office of Compliance, CDRH, shall issue responses to requests placed into a surgically or naturally under this section. The petition shall formed cavity of the human body for also contain the following: more than 1 year to continuously as- (1) The name of the device and device sist, restore, or replace the function of class and representative labeling show- an organ system or structure of the ing the intended use(s) of the device; human body throughout the useful life (2) The reasons that compliance with of the device. The term does not in- the tracking requirements of this part clude a device that is intended and is unnecessary; used only for temporary purposes or (3) A complete description of alter- that is intended for explantation in 1 native steps that are available, or that year or less. the petitioner has already taken, to en- (g) Life-supporting or life-sustaining sure that an effective tracking system device used outside a device user facility is in place; and means a device which is essential, or (4) Other information justifying the yields information that is essential, to exemption or variance. the restoration or continuation of a (c) An exemption or variance is not bodily function important to the con- effective until the Director, Office of tinuation of human life that is in- Compliance, CDRH, approves the re- tended for use outside a hospital, nurs- quest under § 10.30(e)(2)(i) of this chap- ing home, ambulatory surgical facility, ter. or diagnostic or outpatient treatment [58 FR 43447, Aug. 16, 1993, as amended at 59 facility. Physicians’ offices are not de- FR 31138, June 17, 1994; 67 FR 5951, Feb. 8, vice user facilities and, therefore, de- 2002; 72 FR 17399, Apr. 9, 2007] vices used therein are subject to tracking if they otherwise satisfy the statu- § 821.3 Definitions. tory and regulatory criteria. The following definitions and terms (h) Distributor means any person who apply to this part: furthers the distribution of a device (a) Act means the Federal Food, from the original place of manufacture Drug, and Cosmetic Act, 21 U.S.C. 321 et to the person who makes delivery or seq., as amended. sale to the ultimate user, i.e., the final (b) Importer means the initial dis- or multiple distributor, but who does tributor of an imported device who is not repackage or otherwise change the

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container, wrapper, or labeling of the (ii) The serial number of a specific device or device package. device; (i) Final distributor means any person (iii) The expiration date of a specific who distributes a tracked device in- device; tended for use by a single patient over (iv) The date a specific device was the useful life of the device to the pa- manufactured. tient. This term includes, but is not (v) For an HCT/P regulated as a de- limited to, licensed practitioners, re- vice, the distinct identification code tail pharmacies, hospitals, and other required by § 1271.290(c) of this chapter. types of device user facilities. [58 FR 43447, Aug. 16, 1993, as amended at 67 (j) Distributes means any distribution FR 5951, Feb. 8, 2002; 78 FR 58822, Sept. 24, of a tracked device, including the char- 2013] itable distribution of a tracked device. This term does not include the dis- § 821.4 Imported devices. tribution of a device under an effective For purposes of this part, the im- investigational device exemption in ac- porter of a tracked device shall be con- cordance with section 520(g) of the act sidered the manufacturer and shall be and part 812 of this chapter or the dis- required to comply with all require- tribution of a device for teaching, law ments of this part applicable to manu- enforcement, research, or analysis as facturers. Importers must keep all in- specified in § 801.125 of this chapter. formation required under this part in (k) Multiple distributor means any de- the United States. vice user facility, rental company, or any other entity that distributes a life- sustaining or life-supporting device in- Subpart B—Tracking Requirements tended for use by more than one pa- § 821.20 Devices subject to tracking. tient over the useful life of the device. (l) Licensed practitioner means a phy- (a) A manufacturer of any class II or sician, dentist, or other health care class III device that fits within one of practitioner licensed by the law of the the three criteria within § 821.1(a) must State in which he or she practices to track that device in accordance with use or order the use of the tracked de- this part, if FDA issues a tracking vice. order to that manufacturer. (m) Any term defined in section 201 (b) When responding to premarket of the act shall have the same defini- notification submissions and remarket tion in this part. approval applications, FDA will notify (n) Human cell, tissue, or cellular or tis- the sponsor by issuing an order that sue-based product (HCT/P) regulated as a states that FDA believes the device device means an HCT/P as defined in meets the criteria of section 519(e)(1) of § 1271.3(d) of this chapter that does not the act and, by virtue of the order, the meet the criteria in § 1271.10(a) and that sponsor must track the device. is also regulated as a device. [67 FR 5951, Feb. 8, 2002] (o) Unique device identifier (UDI) means an identifier that adequately § 821.25 Device tracking system and identifies a device through its distribu- content requirements: manufac- tion and use by meeting the require- turer requirements. ments of § 830.20 of this chapter. A (a) A manufacturer of a tracked de- unique device identifier is composed of: vice shall adopt a method of tracking (1) A device identifier—a mandatory, for each such type of device that it dis- fixed portion of a UDI that identifies tributes that enables a manufacturer the specific version or model of a de- to provide FDA with the following in- vice and the labeler of that device; and formation in writing for each tracked (2) A production identifier—a condi- device distributed: tional, variable portion of a UDI that (1) Except as required by order under identifies one or more of the following section 518(e) of the act, within 3 work- when included on the label of the de- ing days of a request from FDA, prior vice: to the distribution of a tracked device (i) The lot or batch within which a to a patient, the name, address, and device was manufactured; telephone number of the distributor,

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multiple distributor, or final dis- vice, unless not released by the patient tributor holding the device for dis- under § 821.55(a); tribution and the location of the de- (v) The location of the device; vice; (vi) The date the device was provided (2) Within 10 working days of a re- for use by the patient; quest from FDA for tracked devices (vii) The name, address, and tele- that are intended for use by a single phone number of the prescribing physi- patient over the life of the device, after cian; and distribution to or implantation in a pa- (viii) If and when applicable, the date tient: the device was returned to the manu- (i) The unique device identifier (UDI), facturer, permanently retired from use, lot number, batch number, model num- or otherwise permanently disposed of. ber, or serial number of the device or (b) A manufacturer of a tracked de- other identifier necessary to provide vice shall keep current records in ac- for effective tracking of the devices; cordance with its standard operating (ii) The date the device was shipped procedure of the information identified by the manufacturer; in paragraphs (a)(1), (a)(2) and (a)(3)(i) (iii) The name, address, telephone through (a)(3)(iii) of this section on number, and social security number (if each tracked device released for dis- available) of the patient receiving the tribution for as long as such device is device, unless not released by the pain use or in distribution for use. tient under § 821.55(a); (c) A manufacturer of a tracked de- (iv) The date the device was provided vice shall establish a written standard to the patient; operating procedure for the collection, (v) The name, mailing address, and maintenance, and auditing of the data telephone number of the prescribing specified in paragraphs (a) and (b) of physician; this section. A manufacturer shall (vi) The name, mailing address, and make this standard operating proce- telephone number of the physician reg- dure available to FDA upon request. A ularly following the patient if different manufacturer shall incorporate the fol- than the prescribing physician; and lowing into the standard operating pro- (vii) If applicable, the date the device cedure: was explanted and the name, mailing (1) Data collection and recording pro- address, and telephone number of the cedures, which shall include a proce- explanting physician; the date of the dure for recording when data which is patient’s death; or the date the device required under this part is missing and was returned to the manufacturer, per- could not be collected and the reason manently retired from use, or other- why such required data is missing and wise permanently disposed of. could not be collected; (3) Except as required by order under (2) A method for recording all modi- section 518(e) of the act, within 10 fications or changes to the tracking working days of a request from FDA system or to the data collected and for tracked devices that are intended maintained under the tracking system, for use by more than one patient, after reasons for any modification or change, the distribution of the device to the and dates of any modification or multiple distributor: change. Modification and changes in- (i) The unique device identifier (UDI), cluded under this requirement include lot number, batch number, model num- modifications to the data (including ber, or serial number of the device or termination of tracking), the data for- other identifier necessary to provide mat, the recording system, and the file for effective tracking of the devices; maintenance procedures system; and (ii) The date the device was shipped (3) A quality assurance program that by the manufacturer; includes an audit procedure to be run (iii) The name, address, and tele- for each device product subject to phone number of the multiple dis- tracking, at not less than 6-month in- tributor; tervals for the first 3 years of distribu- (iv) The name, address, telephone tion and at least once a year there- number, and social security number (if after. This audit procedure shall pro- available) of the patient using the de- vide for statistically relevant sampling

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of the data collected to ensure the ac- permanently retired from use, or other- curacy of data and performance testing wise permanently disposed of. of the functioning of the tracking sys- (b) A final distributor, upon sale or tem. other distribution of a tracked device (d) When a manufacturer becomes for use in or by the patient, shall aware that a distributor, final dis- promptly provide the manufacturer tributor, or multiple distributor has tracking the device with the following not collected, maintained, or furnished information: any record or information required by (1) The name and address of the final this part, the manufacturer shall no- distributor, tify the FDA district office responsible (2) The unique device identifier for the area in which the distributor, (UDI), lot number, batch number, final distributor, or multiple dis- model number, or serial number of the tributor is located of the failure of device or other identifier used by the such persons to comply with the remanufacturer to track the device; quirements of this part. Manufacturers (3) The name, address, telephone shall have taken reasonable steps to obtain compliance by the distributor, number, and social security number (if multiple distributor, or final dis- available) of the patient receiving the tributor in question before notifying device, unless not released by the pa- FDA. tient under § 821.55(a); (e) A manufacturer may petition for (4) The date the device was provided an exemption or variance from one or to the patient or for use in the patient; more requirements of this part accord- (5) The name, mailing address, and ing to the procedures in § 821.2 of this telephone number of the prescribing chapter. physician; (6) The name, mailing address, and [58 FR 43447, Aug. 16, 1993, as amended at 67 telephone number of the physician reg- FR 5951, Feb. 8, 2002; 78 FR 58822, Sept. 24, 2013] ularly following the patient if different than the prescribing physician; and Subpart C—Additional (7) When applicable, the date the device was explanted and the name, mail- Requirements and Responsibilities ing address, and telephone number of § 821.30 Tracking obligations of per- the explanting physician, the date of sons other than device manufactur- the patient’s death, or the date the de- ers: distributor requirements. vice was returned to the manufacturer, permanently retired from use, or other- (a) A distributor, final distributor, or wise permanently disposed of. multiple distributor of any tracked device shall, upon purchasing or other- (c)(1) A multiple distributor shall wise acquiring any interest in such a keep written records of the following device, promptly provide the manufac- each time such device is distributed for turer tracking the device with the fol- use by a patient: lowing information: (i) The unique device identifier (UDI), (1) The name and address of the dis- lot number, batch number, model num- tributor, final distributor or multiple ber, or serial number of the device or distributor; other identifier used by the manufac- (2) The unique device identifier turer to track the device; (UDI), lot number, batch number, (ii) The name, address, telephone model number, or serial number of the number, and social security number (if device or other identifier used by the available) of the patient using the de- manufacturer to track the device; vice; (3) The date the device was received; (iii) The location of the device, un- (4) The person from whom the device less not released by the patient under was received; § 821.55(a); (5) If and when applicable, the date (iv) The date the device was provided the device was explanted, the date of for use by the patient; the patient’s death, or the date the de- (v) The name, address, and telephone vice was returned to the distributor, number of the prescribing physician;

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(vi) The name, address, and telephone a centralized point for each manufac- number of the physician regularly fol- turer or distributor within the United lowing the patient if different than the States. prescribing physician; and (vii) When applicable, the date the [58 FR 43447, Aug. 16, 1993, as amended at 65 device was permanently retired from FR 43690, July 14, 2000] use or otherwise permanently disposed § 821.55 Confidentiality. of. (2) Except as required by order under (a) Any patient receiving a device section 518(e) of the act, any person subject to tracking requirements under who is a multiple distributor subject to this part may refuse to release, or the recordkeeping requirement of para- refuse permission to release, the pa- graph (c)(1) of this section shall, within tient’s name, address, telephone num- 5 working days of a request from the ber, and social security number, or manufacturer or within 10 working other identifying information for the days of a request from FDA for the in- purpose of tracking. formation identified in paragraph (c)(1) (b) Records and other information of this section, provide such informa- submitted to FDA under this part shall tion to the manufacturer or FDA. be protected from public disclosure to (d) A distributor, final distributor, or the extent permitted under part 20 of multiple distributor shall make any this chapter, and in accordance with records required to be kept under this part available to the manufacturer of § 20.63 of this chapter, information con- the tracked device for audit upon writ- tained in such records that would iden- ten request by an authorized represent- tify patient or research subjects shall ative of the manufacturer. not be available for public disclosure (e) A distributor, final distributor, or except as provided in those parts. multiple distributor may petition for (c) Patient names or other identifiers an exemption or variance from one or may be disclosed to a manufacturer or more requirements of this part accord- other person subject to this part or to ing to the procedures in § 821.2. a physician when the health or safety [58 FR 43447, Aug. 16, 1993, as amended at 67 of the patient requires that such per- FR 5951, Feb. 8, 2002; 78 FR 58822, Sept. 24, sons have access to the information. 2013] Such notification will be pursuant to agreement that the record or informa- Subpart D—Records and tion will not be further disclosed ex- Inspections cept as the health aspects of the patient requires. Such notification does § 821.50 Availability. not constitute public disclosure and (a) Manufacturers, distributors, mul- will not trigger the availability of the tiple distributors, and final distribu- same information to the public gen- tors shall, upon the presentation by an erally. FDA representative of official creden- [58 FR 43447, Aug. 16, 1993, as amended at 67 tials and the issuance of Form FDA 482 FR 5951, Feb. 8, 2002] at the initiation of an inspection of an establishment or person under section § 821.60 Retention of records. 704 of the act, make each record and all information required to be collected Persons required to maintain records and maintained under this part and all under this part shall maintain such records and information related to the records for the useful life of each events and persons identified in such tracked device they manufacture or records available to FDA personnel. distribute. The useful life of a device is (b) Records and information ref- the time a device is in use or in dis- erenced in paragraph (a) of this section tribution for use. For example, a record shall be available to FDA personnel for may be retired if the person maintain- purposes of reviewing, copying, or any ing the record becomes aware of the other use related to the enforcement of fact that the device is no longer in use, the act and this part. Records required has been explanted, returned to the to be kept by this part shall be kept in manufacturer, or the patient has died.

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PART 822—POSTMARKET Subpart E—Responsibilities of SURVEILLANCE Manufacturers 822.24 What are my responsibilities once I Subpart A—General Provisions am notified that I am required to conduct postmarket surveillance? Sec. 822.25 What are my responsibilities after my 822.1 What does this part cover? postmarket surveillance plan has been 822.2 What is the purpose of this part? approved? 822.3 How do you define the terms used in 822.26 If my company changes ownership, this part? what must I do? 822.4 Does this part apply to me? 822.27 If I go out of business, what must I do? Subpart B—Notification 822.28 If I stop marketing the device subject to postmarket surveillance, what must I 822.5 How will I know if I must conduct do? postmarket surveillance? 822.6 When will you notify me that I am re- Subpart F—Waivers and Exemptions quired to conduct postmarket surveillance? 822.29 May I request a waiver of a specific 822.7 What should I do if I do not agree that requirement of this part? postmarket surveillance is appropriate? 822.30 May I request exemption from the requirement to conduct postmarket sur- Subpart C—Postmarket Surveillance Plan veillance? 822.8 When, where, and how must I submit Subpart G—Records and Reports my postmarket surveillance plan? 822.9 What must I include in my submis- 822.31 What records am I required to keep? sion? 822.32 What records are the investigators in 822.10 What must I include in my surveil- my surveillance plan required to keep? lance plan? 822.33 How long must we keep the records? 822.11 What should I consider when design- 822.34 What must I do with the records if ing my plan to conduct postmarket sur- the sponsor of the plan or an investigator veillance? in the plan changes? 822.12 Do you have any information that 822.35 Can you inspect my manufacturing will help me prepare my submission or site or other sites involved in my design my postmarket surveillance plan? postmarket surveillance plan? 822.13 [Reserved] 822.36 Can you inspect and copy the records 822.14 May I reference information pre- related to my postmarket surveillance viously submitted instead of submitting plan? it again? 822.37 Under what circumstances would you 822.15 How long must I conduct postmarket inspect records identifying subjects? 822.38 What reports must I submit to you? surveillance of my device? AUTHORITY: 21 U.S.C. 331, 352, 360i, 360l, 371, Subpart D—FDA Review and Action 374. 822.16 What will you consider in the review SOURCE: 67 FR 38887, June 6, 2002, unless of my submission? otherwise noted. 822.17 How long will your review of my submission take? Subpart A—General Provisions 822.18 How will I be notified of your decision? § 822.1 What does this part cover? 822.19 What kinds of decisions may you make? This part implements section 522 of 822.20 What are the consequences if I fail to the Federal Food, Drug, and Cosmetic submit a postmarket surveillance plan, Act (the act) by providing procedures my plan is disapproved and I fail to sub- and requirements for postmarket sur- mit a new plan, or I fail to conduct surveillance of class II and class III de- veillance in accordance with my ap- vices that meet any of the following proved plan? criteria: 822.21 What must I do if I want to make (a) Failure of the device would be changes to my postmarket surveillance plan after you have approved it? reasonably likely to have serious ad- 822.22 What recourse do I have if I do not verse health consequences; agree with your decision? (b) The device is intended to be im- 822.23 Is the information in my submission planted in the human body for more considered confidential? than 1 year; or

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(c) The device is intended to be used meet the criteria in § 1271.10(a) and that outside a user facility to support or is also regulated as a device. sustain life. If you fail to comply with (f) Investigator means an individual requirements that we order under sec- who collects data or information in tion 522 of the act and this part, your support of a postmarket surveillance device is considered misbranded under plan. section 502(t)(3) of the act and you are (g) Life-supporting or life-sustaining in violation of section 301(q)(1)(C) of device used outside a device user facility the act. means that a device is essential to, or yields information essential to, the res- § 822.2 What is the purpose of this toration or continuation of a bodily part? function important to the continuation The purpose of this part is to imple- of human life and is used outside a hos- ment our postmarket surveillance au- pital, nursing home, ambulatory sur- thority to maximize the likelihood gical facility, or diagnostic or out- that postmarket surveillance plans will patient treatment facility. A physi- result in the collection of useful data. cian’s office is not a device user facil- These data can reveal unforeseen ad- ity. verse events, the actual rate of antici- (h) Manufacturer means any person, pated adverse events, or other informa- including any importer, repacker, and/ tion necessary to protect the public or relabeler, who manufactures, pre- health. pares, propagates, compounds, assembles, processes a device, or engages in § 822.3 How do you define the terms any of the activities described in used in this part? § 807.3(d) of this chapter. Some of the terms we use in this part (i) Postmarket surveillance means the are specific to postmarket surveillance active, systematic, scientifically valid and reflect the language used in the collection, analysis, and interpretation statute (law). Other terms are more of data or other information about a general and reflect our interpretation marketed device. of the law. This section of the part de- (j) Prospective surveillance means that fines the following terms: the subjects are identified at the begin- (a) Act means the Federal Food, ning of the surveillance and data or Drug, and Cosmetic Act, 21 U.S.C. 301 et other information will be collected seq., as amended. from that time forward (as opposed to (b) Designated person means the indi- retrospective surveillance). vidual who conducts or supervises the (k) Serious adverse health consequences conduct of your postmarket surveil- means any significant adverse experi- lance. If your postmarket surveillance ence related to a device, including de- plan includes a team of investigators, vice-related events that are life-threat- as defined below, the designated person ening or that involve permanent or is the responsible leader of that team. long-term injuries or illnesses. (c) Device failure means a device does (l) Specific guidance means guidance not perform or function as intended, that provides information regarding and includes any deviation from the de- postmarket surveillance for specific vice’s performance specifications or in- types or categories of devices or spe- tended use. cific postmarket surveillance issues. (d) General plan guidance means agen- This type of guidance may be used to cy guidance that provides information supplement general guidance and may about the requirement to conduct address such topics as the type of sur- postmarket surveillance, the submis- veillance approach that is appropriate sion of a plan to us for approval, the for the device and the postmarket sur- content of the submission, and the con- veillance question, sample size, or spe- duct and reporting requirements of the cific reporting requirements. surveillance. (m) Surveillance question means the (e) Human cell, tissue, or cellular or tis- issue or issues to be addressed by the sue-based product (HCT/P) regulated as a postmarket surveillance. device means an HCT/P as defined in (n) Unforeseen adverse event means § 1271.3(d) of this chapter that does not any serious adverse health consequence

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that either is not addressed in the la- Subpart B—Notification beling of the device or occurs at a rate higher than anticipated. § 822.5 How will I know if I must con- (o) Unique device identifier (UDI) duct postmarket surveillance? means an identifier that adequately We will send you a letter (the identifies a device through its distribu- postmarket surveillance order) noti- tion and use by meeting the require- fying you of the requirement to con- ments of § 830.20 of this chapter. A UDI duct postmarket surveillance. Before is composed of: we send the order, or as part of the (1) A device identifier—a mandatory, order, we may require that you submit fixed portion of a UDI that identifies information about your device that the specific version or model of a de- will allow us better to define the scope vice and the labeler of that device; and of a surveillance order. We will specify the device(s) subject to the surveil- (2) A production identifier—a condi- lance order and the reason that we are tional, variable portion of a UDI that requiring postmarket surveillance of identifies one or more of the following the device under section 522 of the act. when included on the label of the de- We will also provide you with any gen- vice: eral or specific guidance that is avail- (i) The lot or batch within which a able to help you develop your plan for device was manufactured; conducting postmarket surveillance. (ii) The serial number of a specific device; § 822.6 When will you notify me that I (iii) The expiration date of a specific am required to conduct postmarket surveillance? device; (iv) The date a specific device was We will notify you as soon as we have manufactured. determined that postmarket surveil- (v) For an HCT/P regulated as a de- lance of your device is necessary, based vice, the distinct identification code on the identification of a surveillance question. This may occur during the required by § 1271.290(c) of this chapter. review of a marketing application for [67 FR 38887, June 6, 2002, as amended at 78 your device, as your device goes to FR 55823, Sept. 24, 2013] market, or after your device has been marketed for a period of time. § 822.4 Does this part apply to me? If we have ordered you to conduct § 822.7 What should I do if I do not agree that postmarket surveillance postmarket surveillance of a medical is appropriate? device under section 522 of the act, this (a) If you do not agree with our deci- part applies to you. We have the au- sion to order postmarket surveillance thority to order postmarket surveil- for a particular device, you may re- lance of any class II or class III med- quest review of our decision by: ical device, including a device reviewed (1) Requesting a meeting with the Di- under the licensing provisions of sec- rector, Office of Surveillance and Bio- tion 351 of the Public Health Service metrics, who generally issues the order Act, that meets any of the following for postmarket surveillance; criteria: (2) Seeking internal review of the (a) Failure of the device would be order under § 10.75 of this chapter; reasonably likely to have serious ad- (3) Requesting an informal hearing verse health consequences; under part 16 of this chapter; or (b) The device is intended to be im- (4) Requesting review by the Medical planted in the human body for more Devices Dispute Resolution Panel of than 1 year; or the Medical Devices Advisory Com- (c) The device is intended to be used mittee. to support or sustain life and to be (b) You may obtain guidance docu- used outside a user facility. ments that discuss these mechanisms from the Center for Devices and Radio- logical Health’s (CDRH’s) Web site (http://www.fda.gov/AboutFDA/

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CentersOffices/ (3) Name and address of the contact OfficeofMedicalProductsandTobacco/ person for the submission; CDRH/CDRHOmbudsman/default.htm.). (4) Premarket application/submission number and device identifiers for your [67 FR 38887, June 6, 2002, as amended at 72 device; FR 17399, Apr. 9, 2007; 78 FR 18233, Mar. 26, 2013] (5) Table of contents identifying the page numbers for each section of the submission; Subpart C—Postmarket (6) Description of the device (this Surveillance Plan may be incorporated by reference to the appropriate premarket application/ § 822.8 When, where, and how must I submission); submit my postmarket surveillance plan? (7) Product codes and a list of all relevant model numbers; and You must submit your plan to con- (8) Indications for use and claims for duct postmarket surveillance within 30 the device; days of the date you receive the (b) Postmarket surveillance plan; postmarket surveillance order. For de- (c) Designated person information; vices regulated by the Center for Bio- (1) Name, address, and telephone logics Evaluation and Research, send number; and three copies of your submission to the (2) Experience and qualifications. Food and Drug Administration, Center for Biologics Evaluation and Research, [67 FR 38887, June 6, 2002, as amended at 78 Document Control Center, 10903 New FR 55823, Sept. 24, 2013] Hampshire Ave., Bldg. 71, Rm. G112, § 822.10 What must I include in my Silver Spring, MD 20993–0002. For de- surveillance plan? vices regulated by the Center for Drug Evaluation and Research, send three Your surveillance plan must include copies of your submission to the Cen- a discussion of: tral Document Room, Center for Drug (a) The plan objective(s) addressing Evaluation and Research, Food and the surveillance question(s) identified Drug Administration, 5901–B, in our order; Ammendale Rd., Beltsville, MD 20705– (b) The subject of the study, e.g., pa- 1266. For devices regulated by the Cen- tients, the device, animals; ter for Devices and Radiological (c) The variables and endpoints that Health, send three copies of your sub- will be used to answer the surveillance mission to the Document Mail Center, question, e.g., clinical parameters or 10903 New Hampshire Ave., Bldg. 66, rm. outcomes; G609, Silver Spring, MD 20993–0002. (d) The surveillance approach or When we receive your original submis- methodology to be used; sion, we will send you an acknowledg- (e) Sample size and units of observa- ment letter identifying the unique doc- tion; ument number assigned to your sub- (f) The investigator agreement, if ap- mission. You must use this number in plicable; any correspondence related to this sub- (g) Sources of data, e.g., hospital mission. records; (h) The data collection plan and [75 FR 20915, Apr. 22, 2010, as amended at 80 forms; FR 18094, Apr. 3, 2015] (i) The consent document, if applicable; § 822.9 What must I include in my submission? (j) Institutional Review Board information, if applicable; Your submission must include the (k) The patient followup plan, if ap- following: plicable; (a) Organizational/administrative in- (l) The procedures for monitoring formation: conduct and progress of the surveil- (1) Your name and address; lance; (2) Generic and trade names of your (m) An estimate of the duration of device; surveillance;

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(n) All data analyses and statistical postmarket surveillance submissions. tests planned; You must specify the information to be (o) The content and timing of re- incorporated and the document number ports. and pages where the information is located. § 822.11 What should I consider when designing my plan to conduct § 822.15 How long must I conduct postmarket surveillance? postmarket surveillance of my de- You must design your surveillance to vice? address the postmarket surveillance The length of postmarket surveil- question identified in the order you re- lance will depend on the postmarket ceived. You should consider what, if surveillance question identified in our any, patient protection measures order. We may order prospective sur- should be incorporated into your plan. veillance for a period up to 36 months; You should also consider the function, operating characteristics, and intended longer periods require your agreement. use of your device when designing a If we believe that a prospective period surveillance approach. of greater than 36 months is necessary to address the surveillance question, § 822.12 Do you have any information and you do not agree, we will use the that will help me prepare my sub- Medical Devices Dispute Resolution mission or design my postmarket Panel to resolve the matter. You may surveillance plan? obtain guidance regarding dispute reso- Guidance documents that discuss our lution procedures from the Center for current thinking on preparing a Devices and Radiological Health’s postmarket surveillance submission (CDRH’) Web site (http://www.fda.gov/ and designing a postmarket surveil- AboutFDA/CentersOffices/ lance plan are available on the Center OfficeofMedicalProductsandTobacco/ for Devices and Radiological Health’s CDRH/CDRHOmbudsman/default.htm.). Web site and from the Food and Drug The 36-month period refers to the sur- Administration, Center for Devices and veillance period, not the length of time Radiological Health, Office of Surveil- from the issuance of the order. lance and Biometrics, 10903 New Hamp- shire Ave., Bldg. 66, rm. 3219, Silver [72 FR 17400, Apr. 9, 2007, as amended at 78 Spring, MD 20993–0002. Guidance docu- FR 18233, Mar. 26, 2013] ments represent our current interpretation of, or policy on, a regulatory Subpart D—FDA Review and issue. They do not establish legally en- Action forceable rights or responsibilities and do not legally bind you or FDA. You § 822.16 What will you consider in the may choose to use an approach other review of my submission? than the one set forth in a guidance document, as long as your alternative First, we will determine that the sub- approach complies with the relevant mission is administratively complete. statutes (laws) and regulations. If you Then, in accordance with the law, we wish, we will meet with you to discuss must determine whether the des- whether an alternative approach you ignated person has appropriate quali- are considering will satisfy the require- fications and experience to conduct the ments of the act and regulations. surveillance and whether the surveillance plan will result in the collection [75 FR 20915, Apr. 22, 2010] of useful data that will answer the sur- § 822.13 [Reserved] veillance question.

§ 822.14 May I reference information § 822.17 How long will your review of previously submitted instead of my submission take? submitting it again? We will review your submission with- Yes, you may reference information in 60 days of receipt. that you have submitted in premarket submissions as well as other

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§ 822.18 How will I be notified of your decision? We will send you a letter notifying you of our decision and identifying any action you must take.

§ 822.19 What kinds of decisions may you make?

If your plan: Then we will send you: And you must:

(a) Should result in the collection of useful data An approval order, identifying any Conduct postmarket surveillance of that will address the postmarket surveillance specific requirements related to your device in accordance with question your postmarket surveillance the approved plan (b) Should result in the collection of useful data An approvable letter identifying the Revise your postmarket surveillance that will address the postmarket surveillance specific revisions or information submission to address the con- question after specific revisions are made or that must be submitted before cerns in the approvable letter and specific information is provided your plan can be approved submit it to us within the specified timeframe. We will determine the timeframe case-by-case, based on the types of revisions or information that you must submit (c) Does not meet the requirements specified in A letter disapproving your plan and Revise your postmarket surveillance this part identifying the reasons for dis- submission and submit it to us approval within the specified timeframe. We will determine the timeframe case- by-case, based on the types of revisions or information that you must submit (d) Is not likely to result in the collection of useful A letter disapproving your plan and Revise your postmarket surveillance data that will address the postmarket surveil- identifying the reasons for dis- submission and submit it to us lance question approval within the specified timeframe. We will determine the timeframe case- by-case, based on the types of revisions or information that you must submit

§ 822.20 What are the consequences if I § 822.21 What must I do if I want to fail to submit a postmarket surveil- make changes to my postmarket lance plan, my plan is disapproved surveillance plan after you have ap- and I fail to submit a new plan, or I proved it? fail to conduct surveillance in ac- You must receive our approval in cordance with my approved plan? writing before making changes in your The failure to have an approved plan that will affect the nature or va- postmarket surveillance plan or failure lidity of the data collected in accord- to conduct postmarket surveillance in ance with the plan. To obtain our ap- accordance with the approved plan con- proval, you must submit three copies stitutes failure to comply with section of the request to make the proposed 522 of the act. Your failure would be a change and revised postmarket surveil- prohibited act under section lance plan to the applicable address 301(q)(1)(C) of the act, and your device listed in § 822.8. You may reference in- would be misbranded under section formation already submitted in accord- 502(t)(3) of the act. We have the author- ance with § 822.14. In your cover letter, ity to initiate actions against products you must identify your submission as a that are adulterated or misbranded, supplement and cite the unique docu- and against persons who commit pro- ment number that we assigned in our hibited acts. Adulterated or mis- acknowledgment letter for your origi- branded devices can be seized. Persons nal submission, specifically identify who commit prohibited acts can be en- the changes to the plan, and identify joined from committing such acts, re- the reasons and justification for mak- quired to pay civil money penalties, or ing the changes. You must report changes in your plan that will not af- prosecuted. fect the nature or validity of the data

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collected in accordance with the plan Subpart E—Responsibilities of in the next interim report required by Manufacturers your approval order. § 822.24 What are my responsibilities § 822.22 What recourse do I have if I once I am notified that I am re- do not agree with your decision? quired to conduct postmarket sur- (a) If you disagree with us about the veillance? content of your plan or if we dis- You must submit your plan to con- approve your plan, or if you believe duct postmarket surveillance to us there is a less burdensome approach within 30 days from receipt of the order that will answer the surveillance ques- (letter) notifying you that you are re- tion, you may request review of our de- quired to conduct postmarket surveil- cision by: lance of a device. (1) Requesting a meeting with the Di- § 822.25 What are my responsibilities rector, Office of Surveillance and Bio- after my postmarket surveillance metrics, Center for Devices and Radio- plan has been approved? logical Health (CDRH), who generally After we have approved your plan, issues the order for postmarket surveil- you must conduct the postmarket sur- lance; veillance of your device in accordance (2) Seeking internal review of the with your approved plan. This means order under § 10.75 of this chapter; that you must ensure that: (3) Requesting an informal hearing (a) Postmarket surveillance is initi- under part 16 of this chapter; or ated in a timely manner; (4) Requesting review by the Medical (b) The surveillance is conducted Devices Dispute Resolution Panel of with due diligence; the Medical Devices Advisory Com- (c) The data identified in the plan is mittee. collected; (b) You may obtain guidance docu- (d) Any reports required as part of ments that discuss these mechanisms your approved plan are submitted to us from the Center for Devices and Radio- in a timely manner; and logical Health’s (CDRH’s) Web site. (e) Any information that we request prior to your submission of a report or [67 FR 38887, June 6, 2002, as amended at 72 FR 17400, Apr. 9, 2007] in response to our review of a report is provided in a timely manner. § 822.23 Is the information in my submission considered confidential? § 822.26 If my company changes ownership, what must I do? We consider the content of your sub- You must notify us within 30 days of mission confidential until we have ap- any change in ownership of your com- proved your postmarket surveillance pany. Your notification should identify plan. After we have approved your any changes to the name or address of plan, the contents of the original sub- the company, the contact person, or mission and any amendments, supple- the designated person (as defined in ments, or reports may be disclosed in § 822.3(b)). Your obligation to conduct accordance with the Freedom of Infor- postmarket surveillance will generally mation Act. We will continue to pro- transfer to the new owner, unless you tect trade secret and confidential com- and the new owner have both agreed mercial information after your plan is that you will continue to conduct the approved. We will not disclose informa- surveillance. If you will continue to tion identifying individual patients. conduct the postmarket surveillance, You may wish to indicate in your sub- you still must notify us of the change mission which information you con- in ownership. sider trade secret or confidential commercial. § 822.27 If I go out of business, what must I do? You must notify us within 30 days of the date of your decision to close your

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business. You should provide the ex- vide information that answers the sur- pected date of closure and discuss your veillance question for your device, with plans to complete or terminate supporting documentation, to the ad- postmarket surveillance of your de- dress in § 822.8. vice. You must also identify who will retain the records related to the sur- Subpart G—Records and Reports veillance (described in subpart G of this part) and where the records will be § 822.31 What records am I required to kept. keep? § 822.28 If I stop marketing the device You must keep copies of: subject to postmarket surveillance, (a) All correspondence with your in- what must I do? vestigators or FDA, including required You must continue to conduct reports; postmarket surveillance in accordance (b) Signed agreements from each of with your approved plan even if you no your investigators, if your surveillance longer market the device. You may re- plan uses investigators, stating the quest that we allow you to terminate commitment to conduct the surveil- postmarket surveillance or modify lance in accordance with the approved your postmarket surveillance because plan, any applicable FDA regulations, you no longer market the device. We and any conditions of approval for your will make these decisions on a case-by- plan, such as reporting requirements; case basis, and you must continue to (c) Your approved postmarket sur- conduct the postmarket surveillance veillance plan, with documentation of unless we notify you that you may stop the date and reason for any deviation your surveillance study. from the plan; (d) All data collected and analyses Subpart F—Waivers and conducted in support of your postmarket surveillance plan; and Exemptions (e) Any other records that we require § 822.29 May I request a waiver of a to be maintained by regulation or by specific requirement of this part? order, such as copies of signed consent documents, evidence of Institutional You may request that we waive any Review Board review and approval, etc. specific requirement of this part. You may submit your request, with sup- § 822.32 What records are the inves- porting documentation, separately or tigators in my surveillance plan re- as a part of your postmarket surveil- quired to keep? lance submission to the address in Your investigator must keep copies § 822.8. of: § 822.30 May I request exemption from (a) All correspondence between inves- the requirement to conduct tigators, FDA, the manufacturer, and postmarket surveillance? the designated person, including re- You may request exemption from the quired reports. requirement to conduct postmarket (b) The approved postmarket surveil- surveillance for your device or any spe- lance plan, with documentation of the cific model of that device at any time. date and reason for any deviation from You must comply with the require- the plan. ments of this part unless and until we (c) All data collected and analyses grant an exemption for your device. conducted at that site for postmarket Your request for exemption must ex- surveillance. plain why you believe we should ex- (d) Any other records that we require empt the device or model from to be maintained by regulation or by postmarket surveillance. You should order. demonstrate why the surveillance question does not apply to your device § 822.33 How long must we keep the or does not need to be answered for the records? device for which you are requesting ex- You, the designated person, and your emption. Alternatively, you may pro- investigators must keep all records for

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a period of 2 years after we have ac- generally will redact information per- cepted your final report, unless we taining to individual subjects prior to specify otherwise. copying those records, unless there are extenuating circumstances. § 822.34 What must I do with the records if the sponsor of the plan or § 822.37 Under what circumstances an investigator in the plan would you inspect records identi- changes? fying subjects? If the sponsor of the plan or an inves- We can inspect and copy records tigator in the plan changes, you must identifying subjects under the same ensure that all records related to the circumstances that we can inspect any postmarket surveillance have been records relating to postmarket surveil- transferred to the new sponsor or in- lance. We are likely to be interested in vestigator and notify us within 10 such records if we have reason to be- working days of the effective date of lieve that required reports have not the change. You must provide the been submitted, or are incomplete, in- name, address, and telephone number accurate, false, or misleading. of the new sponsor or investigator, certify that all records have been trans- § 822.38 What reports must I submit to ferred, and provide the date of transfer. you? § 822.35 Can you inspect my manufac- You must submit interim and final turing site or other sites involved in reports as specified in your approved my postmarket surveillance plan? postmarket surveillance plan. In addition, we may ask you to submit addi- We can review your postmarket surveillance programs during regularly tional information when we believe scheduled inspections, inspections ini- that the information is necessary for tiated to investigate recalls or other the protection of the public health and similar actions, and inspections initi- implementation of the act. We will also ated specifically to review your state the reason or purpose for the re- postmarket surveillance plan. We may quest and how we will use the informa- also inspect any other person or site tion. involved in your postmarket surveillance, such as investigators or contrac- PART 830—UNIQUE DEVICE tors. Any person authorized to grant IDENTIFICATION access to a facility must permit authorized FDA employees to enter and Subpart A—General Provisions inspect any facility where the device is held or where records regarding 830.3 Definitions. postmarket surveillance are held. Subpart B—Requirements for a Unique § 822.36 Can you inspect and copy the Device Identifier records related to my postmarket Sec. surveillance plan? 830.10 Incorporation by reference. We may, at a reasonable time and in 830.20 Requirements for a unique device a reasonable manner, inspect and copy identifier. any records pertaining to the conduct 830.40 Use and discontinuation of a device of postmarket surveillance that are re- identifier. quired to be kept by this regulation. 830.50 Changes that require use of a new device identifier. You must be able to produce records 830.60 Relabeling of a device that is required and information required by this regu- to bear a unique device identifier. lation that are in the possession of others under contract with you to conduct Subpart C—FDA Accreditation of an the postmarket surveillance. Those Issuing Agency who have signed agreements or are under contract with you must also 830.100 FDA accreditation of an issuing agency. produce the records and information 830.110 Application for accreditation as an upon our request. This information issuing agency. must be produced within 72 hours of 830.120 Responsibilities of an FDA-accred- the initiation of the inspection. We ited issuing agency.

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830.130 Suspension or revocation of the ac- Expiration date means the date by creditation of an issuing agency. which the label of a device states the device must or should be used. Subpart D—FDA as an Issuing Agency FDA, we, or us means the Food and 830.200 When FDA will act as an issuing Drug Administration. agency. Federal Food, Drug, and Cosmetic Act 830.210 Eligibility for use of FDA as an means 21 U.S.C. 321 et seq., as amended. issuing agency. Finished device means any device or 830.220 Termination of FDA service as an accessory to any device that is suitable issuing agency. for use or capable of functioning. Global Unique Device Identification Subpart E—Global Unique Device Database (GUDID) means the database Identification Database that serves as a repository of information to facilitate the identification of 830.300 Devices subject to device identification data submission requirements. medical devices through their distribu- 830.310 Information required for unique de- tion and use. vice identification. Human cell, tissue, or cellular or tissue- 830.320 Submission of unique device identi- based product (HCT/P) regulated as a de- fication information. vice means an HCT/P as defined in 830.330 Times for submission of unique de- § 1271.3(d) of this chapter that does not vice identification information. meet the criteria in § 1271.10(a) and that 830.340 Voluntary submission of ancillary is also regulated as a device. device identification information. Issuing agency means an organization 830.350 Correction of information submitted accredited by FDA to operate a system to the Global Unique Device Identifica- for the issuance of unique device iden- tion Database. tifiers. 830.360 Records to be maintained by the labeler. Label has the meaning set forth in section 201(k) of the Federal Food, AUTHORITY: 21 U.S.C. 321, 331, 352, 353, 360, Drug, and Cosmetic Act. 360d, 360i, 360j, 371. Labeler means: SOURCE: 78 FR 55823, Sept. 24, 2013, unless (1) Any person who causes a label to otherwise noted. be applied to a device with the intent that the device will be commercially Subpart A—General Provisions distributed without any subsequent replacement or modification of the label; and SOURCE: 78 FR 55825, Sept. 24, 2013, unless (2) Any person who causes the label otherwise noted. of a device to be replaced or modified § 830.3 Definitions. with the intent that the device will be commercially distributed without any As used in this part: subsequent replacement or modifica- Automatic identification and data cap- tion of the label, except that the addi- ture (AIDC) means any technology that tion of the name of, and contact infor- conveys the unique device identifier or mation for, a person who distributes the device identifier of a device in a the device, without making any other form that can be entered into an elec- changes to the label, is not a modifica- tronic patient record or other com- tion for the purposes of determining puter system via an automated proc- whether a person is a labeler. ess. Lot or batch means one finished device Center Director means the Director of or more that consist of a single type, the Center for Devices and Radio- model, class, size, composition, or soft- logical Health or the Director of the ware version that are manufactured Center for Biologics Evaluation and under essentially the same conditions Research, depending on which Center and that are intended to have uniform has been assigned lead responsibility characteristics and quality within for the device. specified limits. Device package means a package that Shipping container means a container contains a fixed quantity of a par- used during the shipment or transpor- ticular version or model of a device. tation of devices, and whose contents

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may vary from one shipment to an- Management (HFA–305), Food and Drug other. Administration, 5630 Fishers Lane, rm. Small business means a medical device 1061, Rockville, MD 20852, 301–827–6860, manufacturer with 500 or fewer em- and is available from the source listed ployees, or a medical device relabeler in paragraph (b) of this section. Copies or repackager with 100 or fewer em- are also available for purchase from ployees. the American National Standards In- Specification means any requirement stitute (ANSI), mailing address: ANSI, with which a device must conform. Attn: Customer Service Department, 25 Unique device identifier (UDI) means West 43rd St., 4th floor, New York, NY an identifier that adequately identifies 10036, phone: 212–642–4980, and may be a device through its distribution and ordered online at http:// use by meeting the requirements of webstore.ansi.org/. The material is also § 830.20. A UDI is composed of: available for inspection at the National (1) A device identifier—a mandatory, Archives and Records Administration fixed portion of a UDI that identifies (NARA). For information on the avail- the specific version or model of a de- ability of this material at NARA, call vice and the labeler of that device; and 202–741–6030 or go to: http:// (2) A production identifier—a condi- www.archives.gov/federallregister/ tional, variable portion of a UDI that codeloflfederallregulations/ identifies one or more of the following ibrllocations.html. when included on the label of the de- (b) International Organization for vice: Standardization (ISO), mailing address: (i) The lot or batch within which a ISO, Attn: ISO Central Secretariat, 1, device was manufactured; ch. de la Voie-Creuse, Case postale 56, (ii) The serial number of a specific CH–1211 Geneva 20, Switzerland, phone device; (dialing from the United States): 011– (iii) The expiration date of a specific 41–22–749–0111, and may be ordered on- device; line at http://www.standardsinfo.net. (iv) The date a specific device was (1) ISO/IEC 646:1991(E), Information manufactured. technology—ISO 7-bit coded character (v) For an HCT/P regulated as a de- set for information interchange (third vice, the distinct identification code edition; December 15, 1991), into required by § 1271.290(c) of this chapter. §§ 830.20(c) and 830.100(b); Universal product code (UPC) means (2) ISO/IEC 15459–2:2006(E), Informa- the product identifier used to identify tion technology—Unique identifiers— an item sold at retail in the United Part 2: Registration procedures (second States. edition; March 1, 2006), into §§ 830.20(b) Version or model means all devices and 830.100(b); that have specifications, performance, (3) ISO/IEC 15459–4:2008(E), Informa- size, and composition, within limits set tion technology—Unique identifiers— by the labeler. Part 4: Individual items (second edition; July 15, 2008), into §§ 830.20(b) and Subpart B—Requirements for a 830.100(b); Unique Device Identifier (4) ISO/IEC 15459–6:2007(E), Informa- tion technology—Unique identifiers— § 830.10 Incorporation by reference. Part 6: Unique identifier for product (a) Certain material is incorporated groupings (first edition; June 15, 2007), by reference into this part with the ap- into §§ 830.20(b) and 830.100(b). proval of the Director of the Federal Register in accordance with 5 U.S.C. § 830.20 Requirements for a unique de- 552(a) and 1 CFR part 51. To enforce vice identifier. any edition other than that specified in A unique device identifier (UDI) this section, the Food and Drug Admin- must: istration must publish notice of change (a) Be issued under a system operated in the FEDERAL REGISTER and the ma- by FDA or an FDA-accredited issuing terial must be available to the public. agency; All approved material is available for (b) Conform to each of the following inspection at the Division of Dockets international standards:

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(1) ISO/IEC 15459–2, which is incor- § 830.60 Relabeling of a device that is porated by reference at § 830.10; required to bear a unique device (2) ISO/IEC 15459–4, which is incor- identifier. porated by reference at § 830.10; and If you relabel a device that is re- (3) ISO/IEC 15459–6, which is incor- quired to bear a unique device identi- porated by reference at § 830.10. fier (UDI), you must: (c) Use only characters and numbers (a) Assign a new device identifier to from the invariant character set of the device, and ISO/IEC 646, which is incorporated by (b) Keep a record showing the rela- reference at § 830.10. tionship of the prior device identifier to your new device identifier. [78 FR 55825, Sept. 24, 2013] [78 FR 55825, Sept. 24, 2013] § 830.40 Use and discontinuation of a device identifier. Subpart C—FDA Accreditation of (a) Only one device identifier from an Issuing Agency any particular system for the issuance § 830.100 FDA accreditation of an of unique device identifiers (UDIs) may issuing agency. be used to identify a particular version (a) Eligibility. A private organization or model of a device. A particular may apply for accreditation as an version or model may be identified by issuing agency. UDIs from two or more systems for the (b) Accreditation criteria. FDA may ac- issuance of UDIs. credit an organization as an issuing (b) A device identifier shall be used agency, if the system it will operate: to identify only one version or model. (1) Will employ unique device identi- (c) In the event that a version or fiers (UDIs) that meet the require- model of a device is discontinued, its ments of this part to adequately iden- device identifier may not be reassigned tify a device through its distribution to another device. If a discontinued and use; version or model is re-introduced and (2) Conforms to each of the following no changes have been made that would international standards: require the use of a new device identi- (i) ISO/IEC 15459–2, which is incor- fier, the device identifier that was pre- porated by reference at § 830.10; viously in use may be used to identify (ii) ISO/IEC 15459–4, which is incor- the device. porated by reference at § 830.10; (d) In the event that an issuing agen- (iii) ISO/IEC 15459–6, which is incor- cy relinquishes or does not renew its porated by reference at § 830.10. accreditation, you may continue to use (3) Uses only characters and numbers a previously issued UDI until such time from the invariant character set of ISO/IEC 646, which is incorporated by as § 830.50 requires you to assign a new reference at § 830.10. device identifier. (4) Will be available to all users ac- [78 FR 55825, Sept. 24, 2013] cording to a single set of consistent, fair, and reasonable terms and condi- § 830.50 Changes that require use of a tions. new device identifier. (5) Will protect against conflicts of (a) Whenever you make a change to a interest between the issuing agency device that is required to bear a unique (and its officers, employees, and other device identifier (UDI) on its label, and agents) and labelers (and their officers, the change results in a new version or employees, and other agents) seeking to use UDIs that may impede the appli- model, you must assign a new device cant’s ability to independently operate identifier to the new version or model. a fair and neutral identifier system. (b) Whenever you create a new device package, you must assign a new device § 830.110 Application for accreditation identifier to the new device package. as an issuing agency. [78 FR 55825, Sept. 24, 2013] (a) Application for initial accreditation. (1) An applicant seeking initial FDA

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accreditation as an issuing agency (vi) Fee schedules, if any, together shall notify FDA of its desire to be ac- with an explanation of any fee waivers credited by sending a notification by or reductions that are available; email to: [email protected], (vii) Detailed information regarding or by correspondence to: UDI Regu- any financial or other relationship be- latory Policy Support, Center for De- tween the applicant and any labeler(s) vices and Radiological Health, Food or governmental entity(ies); and and Drug Administration, 10903 New (viii) Other information required by Hampshire Ave., Bldg. 66, Rm. 3303, Sil- FDA to clarify the application for ac- ver Spring, MD 20993–0002. creditation. (2) FDA will provide the applicant (b) Application for renewal of accredita- with additional information to aid in tion. An accredited issuing agency that submission of an application for ap- intends to continue to serve as an proval as an issuing agency, together issuing agency beyond its current term with an email address for submission of shall apply to FDA for renewal or no- an application. tify FDA of its plans not to apply for (3) The applicant shall furnish to renewal in accordance with the fol- FDA, via email to the email address lowing procedures and schedule: provided in paragraph (a)(1) of this sec- (1) At least 9 months before the date tion, an application containing the fol- of expiration of its accreditation, an lowing information, materials, and issuing agency shall inform FDA, at supporting documentation: the address given in paragraph (a)(1) of (i) Name, address, and phone number this section, of its intent to seek re- of the applicant; newal. (ii) Detailed descriptions of any (2) FDA will notify the issuing agen- standards or criteria the applicant will cy of the relevant information, mate- apply to participating labelers; rials, and supporting documentation (iii) A detailed description of the that we will require the issuing agency guidelines that govern assignment of a to submit as part of the renewal proce- unique device identifier (UDI) to a de- dure. We will tailor these requirements vice; to reflect our experience with the (iv) A detailed description of the re- issuing agency during the current and view and decisionmaking process the any prior period of accreditation. We applicant will apply when determining will limit our request to the types of whether a particular labeler may use the information required by paragraph the applicant’s UDI system, including: (a)(3) of this section, and we will re- (A) Copies of the application forms, quire less information if experience guidelines, instructions, and other ma- shows that we need only a subset of terials the applicant will send to med- that information. ical device labelers who wish to use the (3) At least 6 months before the date applicant’s unique device identification of expiration of its accreditation, an system; issuing agency shall furnish to FDA, at (B) Policies and procedures for noti- the email address we provide, a copy of fying a labeler of deficiencies in its use a renewal application containing the of UDIs; information, materials, and supporting (C) Procedures for monitoring a la- documentation requested by FDA in beler’s correction of deficiencies in its accordance with paragraph (b)(2) of use of UDIs; this section. (D) Policies and procedures for sus- (4) Any issuing agency that does not pending or revoking a labeler’s use of plan to renew its accreditation shall so the applicant’s UDI system, including notify FDA at the address given in any appeals process. paragraph (a)(1) of this section at least (v) Description of the applicant’s 9 months before the expiration of the electronic data management system issuing agency’s term of accreditation with respect to its review and decision and shall include a description of its processes and the applicant’s ability to plans for allowing continued use of provide electronic data in a format UDIs issued prior to the expiration of compatible with FDA data systems; the current term of accreditation.

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(c) FDA action on an application for to serve as an FDA-accredited issuing initial or renewal accreditation. (1) FDA agency. will conduct a review and evaluation to (f) Term of accreditation. The initial determine whether the applicant meets term of accreditation for an issuing the requirements of this subpart and agency shall be for a period of 3 years. whether the UDI system proposed by An issuing agency’s term of accredita- the applicant will meet the require- tion may be periodically renewed for a ments of this subpart. period of 7 years. (2) Within 60 days of receipt of an ap- [78 FR 55825, Sept. 24, 2013, as amended at 81 plication for accreditation, FDA will FR 11429, Mar. 4, 2016] notify the applicant of any deficiencies in its application and will request cor- § 830.120 Responsibilities of an FDA- rection of those deficiencies within 60 accredited issuing agency. days. The applicant may request an ex- To maintain its accreditation, an tension if it needs additional time to issuing agency must: correct deficiencies in its application. (a) Operate a system for assignment If the deficiencies are not resolved to of unique device identifiers (UDIs) that FDA’s satisfaction within the specified meets the requirements of § 830.20; time period, the application for accred- (b) Make available information con- itation as an issuing agency may be de- cerning its system for the assignment nied. of UDIs; (3) FDA shall notify the applicant (c) Maintain a list of labelers that whether the application for accredita- use its system for the assignment of tion has been granted or denied. That UDIs and provide FDA a copy of such notification shall list any conditions of list in electronic form by December 31 approval or state the reasons for de- of each year; nial. (d) Upon request, provide FDA with (4) If FDA denies an application, we information concerning a labeler that will advise the applicant of the cir- is employing the issuing agency’s sys- cumstances under which a denied appli- tem for assignment of UDIs; and cation may be resubmitted. (e) Remain in compliance with the eligibility and accreditation criteria (5) If FDA does not reach a final deci- set forth in § 830.100. sion on a renewal application before the expiration of an issuing agency’s § 830.130 Suspension or revocation of current accreditation, the approval the accreditation of an issuing will be deemed extended until FDA agency. reaches a final decision on the applica- FDA may suspend or revoke the action. creditation of an issuing agency if FDA (d) Relinquishment of accreditation. If finds, after providing the issuing agen- an issuing agency decides to relinquish cy with notice and opportunity for an its accreditation before expiration of informal hearing in accordance with the current term of accreditation, it part 16 of this chapter, that the issuing shall submit a letter of such intent to agency or any officer, employee, or FDA, at the address provided in para- other agent of the issuing agency: graph (a)(1) of this section, at least 9 (a) Has been guilty of misrepresenta- months before relinquishing its accred- tion or failure to disclose required in- itation. formation in obtaining accreditation; (e) Notice of termination of accredita- (b) Has failed to fulfill the respon- tion. An issuing agency that does not sibilities outlined in § 830.120; apply for renewal of its accreditation, (c) Has failed to protect against con- is denied renewal of accreditation by flicts of interest that may impede the FDA, or relinquishes its accreditation issuing agency’s ability to independ- and duties before expiration of the cur- ently operate a fair and neutral identi- rent term of accreditation, shall notify fier system; all labelers that are using the issuing (d) In the operation of the issuing agency’s UDI system, in a manner and agency, has engaged in any anti- time period approved by FDA, of the competitive activity to restrain trade; date that the issuing agency will cease or

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(e) Has violated or aided and abetted Subpart E—Global Unique Device in the violation of any regulation Identification Database issued under section 510(e) or section 519(f) of the Federal Food, Drug, and Cosmetic Act. SOURCE: 78 FR 55826, Sept. 24, 2013, unless otherwise noted.

Subpart D—FDA as an Issuing § 830.300 Devices subject to device Agency identification data submission requirements. SOURCE: 78 FR 55826, Sept. 24, 2013, unless (a) In general. The labeler of a device otherwise noted. must provide the information required § 830.200 When FDA will act as an by this subpart for each version or issuing agency. model required to bear a unique device (a) During any period where there is identifier (UDI). no accredited issuing agency, FDA will (b) Voluntary submission of informa- act as an issuing agency. tion. If a labeler voluntarily includes a (b) If FDA determines that a signifi- UDI on the label of a device under cant number of small businesses would § 801.40, the labeler may also volun- be substantially and adversely affected tarily submit information concerning by the fees required by all accredited that device under this part. issuing agencies, FDA will act as an (c) Exclusions. FDA may reject or re- issuing agency. move any device identification data (c) FDA may, in its discretion, act as where: an issuing agency if we determine it is (1) The device identifier submitted necessary for us to do so to ensure the does not conform to § 830.20; continuity or the effectiveness of the (2) The information concerns a device system for the identification of medical devices. that is neither manufactured in the (d) FDA may, in its discretion, act as United States nor in interstate com- an issuing agency if we determine it is merce in the United States, appropriate for us to do so in order to (3) The information concerns a prod- facilitate or implement an alternative uct that FDA determines is not a de- granted under § 801.55 of this chapter. vice or a combination product that includes a device constituent part, § 830.210 Eligibility for use of FDA as (4) The information concerns a device an issuing agency. or a combination product that re- When FDA acts as an issuing agency, quires, but does not have, FDA pre- any labeler will be permitted to use market approval, licensure, or clear- FDA’s unique device identification sys- ance; tem, regardless of whether the labeler (5) A device that FDA has banned is considered a small business. under section 516 of the Federal Food, § 830.220 Termination of FDA service Drug, and Cosmetic Act; or as an issuing agency. (6) FDA has suspended the accredita- (a) FDA may end our services as an tion of the issuing agency that oper- issuing agency if we determine that the ates the system used by the labeler. conditions that prompted us to act no § 830.310 Information required for longer exist and that ending our serv- unique device identification. ices would not be likely to lead to a return of the conditions that prompted The contact for device identification us to act. designated under § 830.320(a) shall pro- (b) If FDA has ended our services as vide FDA with the following informa- an issuing agency, a labeler may con- tion concerning each version or model tinue to use a device identifier as- of a device required to bear a unique signed under FDA’s unique device iden- device identifier (UDI) on its label: tification system until such time as (a) Concerning the labeler: § 830.50 requires the use of a new device (1) The name of the labeler; identifier.

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(2) A telephone number or email ad- (10) The type of production identi- dress that will allow FDA to commu- fiers that appear on the label of the de- nicate with the contact for device iden- vice; tification designated under § 830.320(a); (11) The FDA premarket submission and number of a cleared or approved device, (3) The name of each issuing agency or a statement that FDA has by regula- whose system is used by the labeler to tion exempted the device from pre- assign UDIs used by the labeler. market notification; (b) Concerning each version or model of (12) The FDA listing number assigned a device with a UDI on its label: to the device; (1) The device identifier portion of (13) The Global Medical Device No- the UDI assigned to the version or menclature (GMDN) term or code for model; the device; (2) When reporting a substitution of a (14) The total number of individual new device identifier that will be used devices contained in the device pack- in lieu of a previously reported identi- age. fier, the device identifier that was previously assigned to the version or § 830.320 Submission of unique device model; identification information. (3) If § 801.45 of this chapter requires (a) Designation of contact for device the device to bear a UDI as a perma- identification. Each labeler must des- nent marking on the device itself, ei- ignate an individual to serve as the ther: point of contact with FDA on matters (i) A statement that the device iden- relating to the identification of med- tifier that appears as a permanent ical devices marketed by the labeler. marking on the device is identical to The contact for device information is that reported under paragraph (b)(1) of responsible for ensuring FDA is pro- this section, or vided with all information required by (ii) The device identifier portion of this part. The contact for device infor- the UDI that appears as a permanent mation may authorize an issuing agen- marking on the device; cy or any other person to provide infor- (4) The proprietary, trade, or brand mation to FDA on behalf of the labeler. name of the device as it appears on the (b) Information shall be submitted via label of the device; electronic means. All information re- (5) Any version or model number or quired by this subpart shall be sub- similar reference that appears on the mitted electronically to FDA’s Global label of the device; Unique Device Identification Database (6) If the device is labeled as sterile, (GUDID) in a format that we can proc- a statement to that effect; ess, review, and archive, unless the la- (7) If the device is labeled as con- beler has obtained a waiver from elec- taining natural rubber latex that con- tronic submission of unique device tacts humans, or is labeled as having identifier (UDI) data. packaging containing natural rubber (c) Waiver from electronic submission. latex that contacts humans, as de- (1) A labeler may request a waiver from scribed by §§ 801.437(b)(1), 801.437(b)(3), electronic submission of UDI data by and 801.437(f) of this chapter, a state- submitting a letter addressed to the ment to that effect; appropriate Center Director explaining (8) Whether a patient may be safely why electronic submission is not tech- exposed to magnetic resonance imag- nologically feasible; send the request ing, nuclear magnetic resonance imag- by email to: [email protected], or by cor- ing, or magnetic resonance tomog- respondence to: UDI Regulatory Policy raphy while using the device, or while Support, Center for Devices and Radio- the device is implanted in patient. logical Health, Food and Drug Admin- (9) If the device is available in more istration, Bldg. 66, Rm. 3303, 10903 New than one size, the size of the particular Hampshire Ave., Silver Spring, MD version or model, together with the 20993–0002. unit of measure, as it appears on the (2) If the establishment where the la- label of the device; beler is located has obtained a waiver

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from electronic submission of registra- will announce any change on the FDA tion and listing information under sec- Web site at http://www.fda.gov/udi/ at tion 510(p) of the Federal Food, Drug, least 60 days before making the change. and Cosmetic Act, the labeler is deemed to have a waiver from elec- § 830.350 Correction of information tronic submission of UDI data. submitted to the Global Unique De- vice Identification Database. (3) A labeler that has a waiver from electronic submission of UDI data must (a) If FDA becomes aware that any send a letter containing all of the in- information submitted to the Global formation required by § 830.310, as well Unique Device Identification Database as any ancillary information permitted (GUDID) appears to be incorrect or po- to be submitted under § 830.340 that the tentially misleading, we may notify labeler wishes to submit, within the the labeler of the specific information time permitted by § 830.330, addressed that appears to be incorrect, and re- to: UDI Regulatory Policy Support, quest that the labeler provide cor- Center for Devices and Radiological rected information or explain why the Health, Food and Drug Administration, information is correct. The labeler Bldg. 66, Rm. 3303, 10903 New Hampshire must provide corrected information or Ave., Silver Spring, MD 20993–0002. provide a satisfactory explanation of why the information is correct within § 830.330 Times for submission of 30 days of receipt of FDA’s notifica- unique device identification infor- tion. mation. (b) If the labeler does not respond to (a) The labeler shall submit to FDA FDA’s notification within 30 days of re- the information required by § 830.310 no ceipt, or if FDA determines, at any later than the date the label of the de- time, that any information in the vice must bear a unique device identi- GUDID is incorrect or could be mis- fier under § 801.20 of this chapter. leading, we may delete or correct the information. Any action taken by FDA (b) The labeler of a device shall sub- under this paragraph does not relieve mit to FDA an update to the informa- the labeler of its responsibility under tion required by § 830.310 whenever the paragraph (a) of this section to provide information changes. The updated in- corrected information or an expla- formation must be submitted no later nation of why the information pre- than the date a device is first labeled viously submitted is correct. with the changed information. If the information does not appear on the § 830.360 Records to be maintained by label of a device, the updated informa- the labeler. tion must be submitted within 10 busi- (a) Each labeler shall retain, and sub- ness days of the change. mit to FDA upon specific request, records showing all unique device iden- § 830.340 Voluntary submission of ancillary device identification infor- tifiers (UDIs) used to identify devices mation. that must bear a UDI on their label, and the particular version or model as- (a) You may not submit any informa- sociated with each device identifier. tion to the Global Unique Device Iden- These records must be retained for 3 tification Database (GUDID) other years from the date the labeler ceases than that specified by § 830.310, except to market the version or model. where FDA acts to permit the submis- (b) Compliance with this section does sion of specified additional types of in- not relieve the labeler of the need to formation, termed ancillary informa- comply with recordkeeping require- tion. ments of any other FDA regulation. (b) FDA will provide information through the FDA Web site at http:// www.fda.gov/udi/ concerning the types PART 860—MEDICAL DEVICE of ancillary information that may be CLASSIFICATION PROCEDURES submitted to the GUDID. (c) FDA may periodically change the Subpart A—General types of ancillary information that Sec. may be submitted to the GUDID. We 860.1 Scope.

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860.3 Definitions. participate in proceedings to classify 860.5 Confidentiality and use of data and in- and reclassify devices. This part also formation submitted in connection with describes the kind of data required for classification and reclassification. determination of the safety and effec- 860.7 Determination of safety and effectiveness. tiveness of a device, and the circumstances under which information Subpart B—Classification submitted to classification panels or to the Commissioner in connection with 860.84 Classification procedures for ‘‘old de- classification and reclassification pro- vices.’’ ceedings will be available to the public. 860.93 Classification of implants, life-supporting or life-sustaining devices. § 860.3 Definitions. 860.95 Exemptions from sections 510, 519, and 520(f) of the act. For the purposes of this part: (a) Act means the Federal Food, Subpart C—Reclassification Drug, and Cosmetic Act. (b) Commissioner means the Commis- 860.120 General. 860.123 Reclassification petition: Content sioner of Food and Drugs, Food and and form. Drug Administration, United States 860.125 Consultation with panels. Department of Health and Human 860.130 General procedures under section Services, or the Commissioner’s des- 513(e) of the act. ignee. 860.132 Procedures when the Commissioner (c) Class means one of the three cat- initiates a performance standard or pre- egories of regulatory control for med- market approval proceeding under sec- ical devices, defined below: tion 514(b) or 515(b) of the act. (1) Class I means the class of devices 860.134 Procedures for ‘‘new devices’’ under section 513(f) of the act and reclassifica- that are subject to only the general tion of certain devices. controls authorized by or under sec- 860.136 Procedures for transitional products tions 501 (adulteration), 502 (mis- under section 520(l) of the act. branding), 510 (registration), 516 AUTHORITY: 21 U.S.C. 360c, 360d, 360e, 360i, (banned devices), 518 (notification and 360j, 371, 374. other remedies), 519 (records and reports), and 520 (general provisions) of SOURCE: 43 FR 32993, July 28, 1978, unless the act. A device is in class I if (i) gen- otherwise noted. eral controls are sufficient to provide EDITORIAL NOTE: Nomenclature changes to reasonable assurance of the safety and part 860 appear at 73 FR 35341, June 23, 2008. effectiveness of the device, or (ii) there is insufficient information from which Subpart A—General to determine that general controls are sufficient to provide reasonable assur- § 860.1 Scope. ance of the safety and effectiveness of (a) This part implements sections 513, the device or to establish special con- 514(b), 515(b), and 520(l) of the act with trols to provide such assurance, but the respect to the classification and reclas- device is not life-supporting or life-sus- sification of devices intended for taining or for a use which is of human use. substanial importance in preventing (b) This part prescribes the criteria impairment of human health, and and procedures to be used by classifica- which does not present a potential un- tion panels in making their rec- reasonable risk of illness of injury. ommendations and by the Commis- (2) Class II means the class of devices sioner in making the Commissioner’s that is or eventually will be subject to determinations regarding the class of special controls. A device is in class II regulatory control (class I, class II, or if general controls alone are insuffi- class III) appropriate for particular de- cient to provide reasonable assurance vices. Supplementing the general Food of its safety and effectiveness and there and Drug Administration procedures is sufficient information to establish governing advisory committees (part 14 special controls, including the promul- of this chapter), this part also provides gation of performance standards, procedures for manufacturers, import- postmarket surveillance, patient reg- ers, and other interested persons to istries, development and dissemination

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of guidance documents (including guid- of a device and the answers are de- ance on the submission of clinical data signed to help the Commissioner deter- in premarket notification submissions mine the proper classification of the in accordance with section 510(k) of the device. act), recommendations, and other ap- (g) Supplemental data sheet means in- propriate actions as the Commissioner formation compiled by a classification deems necessary to provide such assur- panel or submitted in a petition for re- ance. For a device that is purported or classification, including: represented to be for use in supporting (1) A summary of the reasons for the or sustaining human life, the Commis- recommendation (or petition); sioner shall examine and identify the (2) A summary of the data upon special controls, if any, that are nec- which the recommendation (or peti- essary to provide adequate assurance of tion) is based; safety and effectiveness and describe (3) An identification of the risks to how such controls provide such assur- health (if any) presented by the device; ance. (4) To the extent practicable in the (3) Class III means the class of devices case of a class II or class III device, a for which premarket approval is or will recommendation for the assignment of be required in accordance with section a priority for the application of the re- 515 of the act. A device is in class III if quirements of performance standards insufficient information exists to de- or premarket approval; termine that general controls are sufficient to provide reasonable assurance (5) In the case of a class I device, a of its safety and effectiveness or that recommendation whether the device application of special controls de- should be exempted from any of the re- scribed in paragraph (c)(2) of this sec- quirements of registration, record- tion would provide such assurance and keeping and reporting, or good manu- if, in addition, the device is life-sup- facturing practice requirements of the porting or life-sustaining, or for a use quality system regulation; which is of substantial importance in (6) In the case of an implant or a life- preventing impairment of human supporting or life-sustaining device for health, or if the device presents a po- which classification in class III is not tential unreasonable risk of illness or recommended, a statement of the rea- injury. sons for not recommending that the de- (d) Implant means a device that is vice be classified in class III; placed into a surgically or naturally (7) Identification of any needed re- formed cavity of the human body. A de- strictions on the use of the device, e.g., vice is regarded as an implant for the whether the device requires special la- purpose of this part only if it is in- beling, should be banned, or should be tended to remain implanted continu- used only upon authorization of a prac- ously for a period of 30 days or more, titioner licensed by law to administer unless the Commissioner determines or use such device; and otherwise in order to protect human (8) Any known existing standards ap- health. plicable to the device, device compo- (e) Life-supporting or life-sustaining de- nents, or device materials. vice means a device that is essential to, (h) Classification panel means one of or that yields information that is es- the several advisory committees estab- sential to, the restoration or continu- lished by the Commissioner under sec- ation of a bodily function important to tion 513 of the act and part 14 of this the continuation of human life. chapter for the purpose of making rec- (f) Classification questionnaire means a ommendations to the Commissioner on specific series of questions prepared by the classification and reclassification the Commissioner for use as guidelines of devices and for other purposes pre- by classification panels preparing rec- scribed by the act or by the Commis- ommendations to the Commissioner re- sioner. garding classification and by peti- (i) Generic type of device means a tioners submitting petitions for reclas- grouping of devices that do not differ sification. The questions relate to the significantly in purpose, design, mate- safety and effectiveness characteristics rials, energy source, function, or any

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other feature related to safety and ef- mitted for that device that had been fectiveness, and for which similar regu- regarded as confidential under para- latory controls are sufficient to pro- graph (c)(1) of this section will be vide reasonable assurance of safety and available for public disclosure and effectiveness. placed on public display in the office of (j) Petition means a submission seek- the Division of Dockets Management, ing reclassification of a device in ac- Food and Drug Administration unless, cordance with § 860.123. within that 30-day period, the person who submitted the data demonstrates [43 FR 32993, July 28, 1978, as amended at 57 FR 58403, Dec. 10, 1992; 65 FR 56480, Sept. 19, that the data still fall within the ex- 2000] emption for trade secrets and confidential commercial information described § 860.5 Confidentiality and use of data in § 20.61 of this chapter. Safety and ef- and information submitted in con- fectiveness data submitted for a device nection with classification and re- that is classified into class III by regu- classification. lation in accordance with § 860.84 will (a) This section governs the avail- remain confidential and unavailable ability for public disclosure and the use for public disclosure so long as such by the Commissioner of data and infor- data have not been disclosed to the mation submitted to classification public as described in § 20.81 of this panels or to the Commissioner in con- chapter. nection with the classification or re- (3) Because device classification af- classification of devices under this fects generic types of devices, in mak- part. ing determinations under § 860.84 con- (b) In general, data and information cerning the initial classification of a submitted to classification panels in device, the classification panels and connection with the classification of the Commissioner may consider safety devices under § 860.84 will be available and effectiveness data developed for immediately for public disclosure upon another device in the same generic request. However, except as provided type, regardless of whether such data by the special rules in paragraph (c) of are regarded currently as confidential this section, this provision does not under paragraph (c)(1) of this section. apply to data and information exempt (d)(1) The fact of its existence and from public disclosure in accordance the contents of a petition for reclassi- with part 20 of this chapter: Such data fication filed in accordance with and information will be available only § 860.130 or § 860.132 are available for in accordance with part 20. public disclosure at the time the peti- (c)(1) Safety and effectiveness data tion is received by the Food and Drug submitted to classification panels or to Administration. the Commissioner in connection with (2) The fact of the existence of a peti- the classification of a device under tion for reclassification filed in accord- § 860.84, which have not been disclosed ance with § 860.134 or § 860.136 is avail- previously to the public, as described able for public disclosure at the time in § 20.81 of this chapter, shall be re- the petition is received by the Food garded as confidential if the device is and Drug Administration. The contents classified in to class III. Because the of such a petition are not available for classification of a device under § 860.84 public disclosure for the period of time may be ascertained only upon publica- following its receipt (not longer than 30 tion of a final regulation, all safety and days) during which the petition is re- effectiveness data that have not been viewed for any deficiencies preventing disclosed previously are not available the Commissioner from making a deci- for public disclosure unless and until sion on it. Once it is determined that the device is classified into class I or the petition contains no deficiencies II, in which case the procedure in para- preventing the Commissioner from graph (c)(2) of this section applies. making a decision on it, the petition (2) Thirty days after publication of a will be filed with the Division of Dock- final regulation under § 860.84 ets Management and its entire con- classifying a device into class I or class tents will be available for public disclo- II, safety and effectiveness data sub- sure and subject to consideration by

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classification panels and by the Com- making a decision on it. Accordingly, missioner in making a decision on the all data and information contained in petition. If, during this 30-day period of such petitions may be disclosed by the time, the petition is found to contain Commissioner and used as the basis for deficiencies that prevent the Commis- reclassification of a device from class sioner from making a decision on it, III to class II. the petitioner will be so notified and (f) For purposes of this section, safe- afforded an opportunity to correct the ty and effectiveness data include data deficiencies. and results derived from all studies and Thirty days after notice to the peti- tests of a device on animals and hu- tioner of deficiencies in the petition, mans and from all studies and tests of the contents of the petition will be the device itself intended to establish available for public disclosure unless, or determine its safety and effective- within that 30 days, the petitioner sub- ness. mits supplemental material intended to correct the deficiencies in the peti- § 860.7 Determination of safety and ef- tion. The Commissioner, in the Com- fectiveness. missioner’s discretion, may allow with- (a) The classification panels, in re- drawal of a deficient petition during viewing evidence concerning the safety the 30-day period provided for cor- and effectiveness of a device and in pre- recting deficiencies. Any supplemental paring advice to the Commissioner, and material submitted by the petitioner, the Commissioner, in making deter- together with the material in the origi- minations concerning the safety and nal petition, is considered as a new pe- effectiveness of a device, will apply the tition. The new petition is reviewed for rules in this section. deficiencies in the same manner as the (b) In determining the safety and ef- original petition, and the same proce- fectiveness of a device for purposes of dures for notification and correction of classification, establishment of per- deficiencies are followed. Once the pe- formance standards for class II devices, titioner has corrected the deficiencies, and premarket approval of class III de- the entire contents of the petition will vices, the Commissioner and the classi- be available for public disclosure and fication panels will consider the fol- subject to consideration by classifica- lowing, among other relevant factors: tion panels and by the Commissioner in (1) The persons for whose use the de- making a decision on the petition. De- vice is represented or intended; ficient petitions which have not been (2) The conditions of use for the de- corrected within 180 days after notifi- vice, including conditions of use pre- cation of deficiency will be returned to scribed, recommended, or suggested in the petitioner and will not be consid- the labeling or advertising of the de- ered further unless resubmitted. vice, and other intended conditions of (e) The Commissioner may not dis- use; close, or use as the basis for reclassi- (3) The probable benefit to health fication of a device from class III to from the use of the device weighed class II, any information reported to or against any probable injury or illness otherwise obtained by the Commis- from such use; and sioner under section 513, 514, 515, 516, (4) The reliability of the device. 518, 519, 520(f), 520(g), or 704 of the act (c)(1) Although the manufacturer that falls within the exemption de- may submit any form of evidence to scribed in § 20.61 of this chapter for the Food and Drug Administration in trade secrets and confidential commer- an attempt to substantiate the safety cial information. The exemption de- and effectiveness of a device, the agen- scribed in § 20.61 does not apply to data cy relies upon only valid scientific evi- or information contained in a petition dence to determine whether there is for reclassification submitted in ac- reasonable assurance that the device is cordance with § 860.130 or § 860.132, or in safe and effective. After considering a petition submitted in accordance the nature of the device and the rules with § 860.134 or § 860.136 that has been in this section, the Commissioner will determined to contain no deficiencies determine whether the evidence sub- that prevent the Commissioner from mitted or otherwise available to the

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Commissioner is valid scientific evi- and nonclinical investigations includ- dence for the purpose of determining ing in vitro studies. the safety or effectiveness of a par- (e)(1) There is reasonable assurance ticular device and whether the avail- that a device is effective when it can be able evidence, when taken as a whole, determined, based upon valid scientific is adequate to support a determination evidence, that in a significant portion that there is reasonable assurance that of the target population, the use of the the device is safe and effective for its device for its intended uses and condi- conditions of use. tions of use, when accompanied by ade- (2) Valid scientific evidence is evi- quate directions for use and warnings dence from well-controlled investiga- against unsafe use, will provide clini- tions, partially controlled studies, cally significant results. studies and objective trials without (2) The valid scientific evidence used matched controls, well-documented to determine the effectiveness of a de- case histories conducted by qualified vice shall consist principally of well- experts, and reports of significant controlled investigations, as defined in human experience with a marketed de- paragraph (f) of this section, unless the vice, from which it can fairly and re- Commissioner authorizes reliance upon sponsibly be concluded by qualified ex- other valid scientific evidence which perts that there is reasonable assur- the Commissioner has determined is ance of the safety and effectiveness of sufficient evidence from which to de- a device under its conditions of use. termine the effectiveness of a device, even in the absence of well-controlled The evidence required may vary ac- investigations. The Commissioner may cording to the characteristics of the make such a determination where the device, its conditions of use, the exist- requirement of well-controlled inves- ence and adequacy of warnings and tigations in paragraph (f) of this sec- other restrictions, and the extent of ex- tion is not reasonably applicable to the perience with its use. Isolated case re- device. ports, random experience, reports lack- (f) The following principles have been ing sufficient details to permit sci- developed over a period of years and entific evaluation, and unsubstantiated are recognized by the scientific com- opinions are not regarded as valid sci- munity as the essentials of a well-con- entific evidence to show safety or effec- trolled clinical investigation. They tiveness. Such information may be con- provide the basis for the Commis- sidered, however, in identifying a de- sioner’s determination whether there is vice the safety and effectiveness of reasonable assurance that a device is which is questionable. effective based upon well-controlled in- (d)(1) There is reasonable assurance vestigations and are also useful in as- that a device is safe when it can be de- sessing the weight to be given to other termined, based upon valid scientific valid scientific evidence permitted evidence, that the probable benefits to under this section. health from use of the device for its in- (1) The plan or protocol for the study tended uses and conditions of use, when and the report of the results of a well- accompanied by adequate directions controlled investigation shall include and warnings against unsafe use, out- the following: weigh any probable risks. The valid sci- (i) A clear statement of the objec- entific evidence used to determine the tives of the study; safety of a device shall adequately (ii) A method of selection of the sub- demonstrate the absence of unreason- jects that: able risk of illness or injury associated (a) Provides adequate assurance that with the use of the device for its in- the subjects are suitable for the pur- tended uses and conditions of use. poses of the study, provides diagnostic (2) Among the types of evidence that criteria of the condition to be treated may be required, when appropriate, to or diagnosed, provides confirmatory determine that there is reasonable as- laboratory tests where appropriate surance that a device is safe are inves- and, in the case of a device to prevent tigations using laboratory animals, in- a disease or condition, provides evi- vestigations involving human subjects, dence of susceptibility and exposure to

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the condition against which prophy- natural history of the disease or condi- laxis is desired; tion in comparable patients or popu- (b) Assigns the subjects to test lations who received no treatment or groups, if used, in such a way as to who followed an established effective minimize any possible bias; regimen (therapeutic, diagnostic, pro- (c) Assures comparability between phylactic). test groups and any control groups of (v) A summary of the methods of pertinent variables such as sex, sever- analysis and an evaluation of the data ity or duration of the disease, and use derived from the study, including any of therapy other than the test device; appropriate statistical methods uti- (iii) An explanation of the methods of lized. observation and recording of results (2) To insure the reliability of the re- utilized, including the variables meas- sults of an investigation, a well-con- ured, quantitation, assessment of any trolled investigation shall involve the subject’s response, and steps taken to use of a test device that is standardized minimize any possible bias of subjects in its composition or design and per- and observers; formance. (iv) A comparison of the results of (g)(1) It is the responsibility of each treatment or diagnosis with a control manufacturer and importer of a device in such a fashion as to permit quan- to assure that adequate, valid sci- titative evaluation. The precise nature entific evidence exists, and to furnish of the control must be specified and an such evidence to the Food and Drug explanation provided of the methods Administration to provide reasonable employed to minimize any possible assurance that the device is safe and bias of the observers and analysts of effective for its intended uses and con- the data. Level and methods of ‘‘blind- ditions of use. The failure of a manu- ing,’’ if appropriate and used, are to be facturer or importer of a device to documented. Generally, four types of present to the Food and Drug Adminis- comparisons are recognized: tration adequate, valid scientific evi- (a) No treatments. Where objective dence showing that there is reasonable measurements of effectiveness are assurance of the safety and effective- available and placebo effect is neg- ness of the device, if regulated by gen- ligible, comparison of the objective re- eral controls alone, or by general consults in comparable groups of treated trols and performance standards, may and untreated patients; support a determination that the de- (b) Placebo control. Where there may vice be classified into class III. be a placebo effect with the use of a de- (2) The Commissioner may require vice, comparison of the results of use of that a manufacturer, importer, or dis- the device with an ineffective device tributor make reports or provide other used under conditions designed to re- information bearing on the classifica- semble the conditions of use under in- tion of a device and indicating whether vestigation as far as possible; there is reasonable assurance of the (c) Active treatment control. Where an safety and effectiveness of the device effective regimen of therapy may be or whether it is adulterated or mis- used for comparison, e.g., the condition branded under the act. being treated is such that the use of a (3) A requirement for a report or placebo or the withholding of treat- other information under this paragraph ment would be inappropriate or con- will comply with section 519 of the act. trary to the interest of the patient; Accordingly, the requirement will (d) Historical control. In certain cir- state the reason or purpose for such re- cumstances, such as those involving quest; will describe the required report diseases with high and predictable mor- or information as clearly as possible; tality or signs and symptoms of pre- will not be imposed on a manufacturer, dictable duration or severity, or in the importer, or distributor of a classified case of prophylaxis where morbidity is device that has been exempted from predictable, the results of use of the de- such a requirement in accordance with vice may be compared quantitatively § 860.95; will prescribe the time for com- with prior experience historically de- pliance with the requirement; and will rived from the adequately documented prescribe the form and manner in

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which the report or information is to (1) Considers the factors set forth in be provided. § 860.7 relating to the determination of (4) Required information that has safety and effectiveness; been submitted previously to the Cen- (2) Determines the safety and effec- ter for Devices and Radiological tiveness of the device on the basis of Health, the Center for Biologics Eval- the types of scientific evidence set uation and Research, or the Center for forth in § 860.7; Drug Evaluation and Research, as ap- (3) Answers the questions in the clas- plicable, need not be resubmitted, but sification questionnaire applicable to may be incorporated by reference. the device being classified; (4) Completes a supplemental data [43 FR 32993, July 28, 1978, as amended at 53 sheet for the device; FR 11253, Apr. 6, 1988; 73 FR 49942, Aug. 25, 2008] (5) Provides, to the maximum extent practicable, an opportunity for interested persons to submit data and views Subpart B—Classification on the classification of the device in accordance with part 14 of this chapter. § 860.84 Classification procedures for (d) Based upon its review of evidence ‘‘old devices.’’ of the safety and effectiveness of the (a) This subpart sets forth the proce- device, and applying the definition of dures for the original classification of each class in § 860.3(c), the panel sub- a device that either was in commercial mits to the Commissioner a rec- distribution before May 28, 1976, or is ommendation regarding the classifica- substantially equivalent to a device tion of the device. The recommenda- that was in commercial distribution tion will include: before that date. Such a device will be (1) A summary of the reasons for the classified by regulation into either recommendation; class I (general controls), class II (spe- (2) A summary of the data upon cial controls) or class III (premarket which the recommendation is based, approval), depending upon the level of accompanied by references to the regulatory control required to provide sources containing such data; reasonable assurance of the safety and (3) An identification of the risks to effectiveness of the device (§ 860.3(c)). health (if any) presented by the device; This subpart does not apply to a device (4) In the case of a recommendation that is classified into class III by stat- for classification into class I, a rec- ute under section 513(f) of the act be- ommendation as to whether the device cause the Food and Drug Administra- should be exempted from the require- tion has determined that the device is ments of one or more of the following not ‘‘substantially equivalent’’ to any sections of the act: section 510 (reg- device subject to this subpart or under istration, product listing, and pre- section 520(l) (1) through (3) of the act market notification) section 519 because the device was regarded pre- (records and reports) and section 520(f) viously as a new drug. In classifying a (good manufacturing practice require- device under this section, the Food and ments of the quality system regula- Drug Administration will follow the tion) in accordance with § 860.95; procedures described in paragraphs (b) (5) In the case of a recommendation through (g) of this section. for classification into class II or class (b) The Commissioner refers the de- III, to the extent practicable, a rec- vice to the appropriate classification ommendation for the assignment to panel organized and operated in accord- the device of a priority for the applica- ance with section 513 (b) and (c) of the tion of a performance standard or a act and part 14 of this chapter. premarket approval requirement; (c) In order to make recommenda- (6) In the case of a recommendation tions to the Commissioner on the class for classification of an implant or a of regulatory control (class I, class II, life-supporting or life-sustaining device or class III) appropriate for the device, into class I or class II, a statement of the panel reviews the device for safety why premarket approval is not nec- and effectiveness. In so doing, the essary to provide reasonable assurance panel: of the safety and effectiveness of the

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device, accompanied by references to classification or reclassification of supporting documentation and data such a device into a class other than satisfying the requirements of § 860.7, class III, it shall set forth in its rec- and an identification of the risks to ommendation the reasons for so doing health, if any, presented by the device. together with references to supporting (e) A panel recommendation is re- documentation and data satisfying the garded as preliminary until the Com- requirements of § 860.7, and an identi- missioner has reviewed it, discussed it fication of the risks to health, if any, with the panel if appropriate, and pub- presented by the device. lished a proposed regulation classifying (b) The Commissioner will classify an the device. Preliminary panel rec- implant or life-supporting or life-sus- ommendations are filed in the Division taining device into class III unless the of Dockets Management’s office upon Commissioner determines that such receipt and are available to the public classification is not necessary to pro- upon request. vide reasonable assurance of the safety (f) The Commissioner publishes the and effectiveness of the device. If the panel’s recommendation in the FED- Commissioner proposes to classify or ERAL REGISTER, together with a pro- reclassify such a device into a class posed regulation classifying the device, other than class III, the regulation or and other devices of that generic type, order effecting such classification or and provides interested persons an op- reclassification will be accompanied by portunity to submit comments on the a full statement of the reasons for so recommendation and proposed regula- doing. A statement of the reasons for tion. not classifying or retaining the device (g) The Commissioner reviews the in class III may be in the form of con- comments and issues a final regulation currence with the reasons for the rec- classifying the device and other devices ommendation of the classification of that generic type. The regulation panel, together with supporting docu- will: mentation and data satisfying the re- (1) If classifying the device into class quirements of § 860.7 and an identifica- I, prescribe which, if any, of the re- tion of the risks to health, if any, pre- quirements of sections 510, 519, and sented by the device. 520(f) of the act will not apply to the device and state the reasons for mak- § 860.95 Exemptions from sections 510, ing the requirements inapplicable, in 519, and 520(f) of the act. accordance with § 860.95; (a) A panel recommendation to the (2) If classifying the device into class Commissioner that a device be classi- II or class III, at the discretion of the fied or reclassified into class I will in- Commissioner, establish priorities for clude a recommendation as to whether the application to the device of a per- the device should be exempted from formance standard or a premarket ap- some or all of the requirements of one proval requirement; or more of the following sections of the (3) If classifying an implant, or life- act: Section 510 (registration, product supporting or life-sustaining device, listing and premarket notification), comply with § 860.93(b). section 519 (records and reports), and [43 FR 32993, July 28, 1978, as amended at 57 section 520(f) (good manufacturing FR 58404, Dec. 10, 1992; 64 FR 404, Jan. 5, 1999] practice requirements of the quality system regulation). § 860.93 Classification of implants, life- (b) A regulation or an order supporting or life-sustaining de- classifying or reclassifying a device vices. into class I will specify which require- (a) The classification panel will rec- ments, if any, of sections 510, 519, and ommend classification into class III of 520(f) of the act the device is to be ex- any implant or life-supporting or life- empted from, together with the reasons sustaining device unless the panel de- for such exemption. termines that such classification is not (c) The Commissioner will grant ex- necessary to provide reasonable assur- emptions under this section only if the ance of the safety and effectiveness of Commissioner determines that the re- the device. If the panel recommends quirements from which the device is

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exempted are not necessary to provide requested that l device(s) be reclassi- reasonable assurance of the safety and fied from class III to a class II’’; effectiveness of the device. (3) A completed supplemental data sheet applicable to the device for which Subpart C—Reclassification reclassification is requested; (4) A completed classification ques- § 860.120 General. tionnaire applicable to the device for (a) Sections 513(e) and (f), 514(b), which reclassification is requested; 515(b), and 520(l) of the act provide for (5) A statement of the basis for dis- reclassification of a device and pre- agreement with the present classifica- scribe the procedures to be followed to tion status of the device; effect reclassification. The purposes of (6) A full statement of the reasons, subpart C are to: together with supporting data satis- (1) Set forth the requirements as to fying the requirements of § 860.7, why form and content of petitions for re- the device should not be classified into classification; its present classification and how the (2) Describe the circumstances in proposed classification will provide which each of the five statutory reclas- reasonable assurance of the safety and sification provisions applies; and effectiveness of the device; (3) Explain the procedure for reclassi- (7) Representative data and informa- fication prescribed in the five statu- tion known by the petitioner that are tory reclassification provisions. unfavorable to the petitioner’s posi- (b) The criteria for determining the tion; proper class for a device are set forth in § 860.3(c). The reclassification of any (8) If the petition is based upon new device within a generic type of device information under section 513(e), 514(b), causes the reclassification of all sub- or 515(b) of the act, a summary of the stantially equivalent devices within new information; that generic type. Accordingly, a peti- (9) Copies of source documents from tion for the reclassification of a spe- which new information used to support cific device will be considered a peti- the petition has been obtained (at- tion for reclassification of all substan- tached as appendices to the petition). tially equivalent devices within the (10) A financial certification or dis- same generic type. closure statement or both as required (c) Any interested person may submit by part 54 of this chapter. a petition for reclassification under (b) Each petition submitted pursuant section 513(e), 514(b), or 515(b). A manu- to this section shall be: facturer or importer may submit a pe- (1) For devices regulated by the Cen- tition for reclassification under section ter for Devices and Radiological 513(f) or 520(l). The Commissioner may Health, addressed to the Food and Drug initiate the reclassification of a device Administration, Center for Devices and classified into class III under sections Radiological Health, Regulations Staff, 513(f) and 520(l) of the act. 10903 New Hampshire Ave., Bldg. 66, [43 FR 32993, July 28, 1978, as amended at 57 Rm. 4438, Silver Spring, MD 20993–0002; FR 58404, Dec. 10, 1992] for devices regulated by the Center for Biologics Evaluation and Research, ad- § 860.123 Reclassification petition: dressed to the Food and Drug Adminis- Content and form. tration, Center for Biologics Evalua- (a) Unless otherwise provided in writ- tion and Research, Document Control ing by the Commissioner, any petition Center, 10903 New Hampshire Ave., for reclassification of a device, regard- Bldg. 71, Rm. G112, Silver Spring, MD less of the section of the act under 20993–0002; for devices regulated by the which it is filed, shall include the fol- Center for Drug Evaluation and Re- lowing: search, addressed to the Food and Drug (1) A specification of the type of de- Administration, Center for Drug Eval- vice for which reclassification is re- uation and Research, Central Docu- quested; ment Control Room, 5901–B (2) A statement of the action re- Ammendale Rd., Beltsville, MD 20705– quested by the petitioner, e.g., ‘‘It is 1266, as applicable.

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(2) Marked clearly with the section of § 860.130 General procedures under the act under which the petition is section 513(e) of the act. being submitted, i.e., ‘‘513(e),’’ ‘‘513(f),’’ (a) Section 513(e) of the act applies to ‘‘514(b),’’ ‘‘515(b),’’ or ‘‘520(l) Petition’’; reclassification proceedings under the (3) Bound in a volume or volumes, act based upon new information. where necessary; and (b) A proceeding to reclassify a de- (4) Submitted in an original and two vice under section 513(e) may be initi- copies. ated: (1) On the initiative of the Commis- [43 FR 32993, July 28, 1978, as amended at 49 sioner alone; FR 14505, Apr. 12, 1984; 53 FR 11253, Apr. 6, (2) On the initiative of the Commis- 1988; 55 FR 11169, Mar. 27, 1990; 63 FR 5254, sioner in response to a request for Feb. 2, 1998; 65 FR 17137, Mar. 31, 2000; 73 FR change in classification based upon 49942, Aug. 25, 2008; 75 FR 20916, Apr. 22, 2010; 79 FR 77388, Dec. 24, 2014] new information, under section 514(b) or 515(b) of the act (see § 860.132); or § 860.125 Consultation with panels. (3) In response to the petition of an interested person, based upon new in- (a) When the Commissioner is re- formation, filed in accordance with quired to refer a reclassification peti- § 860.123. tion to a classification panel for its (c) By regulation promulgated under recommendation under § 860.134, or is this section, the Commissioner may required, or chooses, to consult with a change the classification from class III panel concerning a reclassification pe- into: tition, such as under § 860.130, § 860.132, (1) Class II if the Commissioner de- or § 860.136, the Commissioner will dis- termines that special controls in addi- tribute a copy of the petition, or its tion to general controls would provide relevant portions, to each panel mem- reasonable assurance of the safety and ber and will consult with the panel in effectiveness of the device and there is one of the following ways: sufficient information to establish spe- (1) Consultation by telephone with at cial controls to provide assurance; or least a majority of current voting (2) Class I if the Commissioner deter- panel members and, when possible, mines that general controls would pro- nonvoting panel members; vide reasonable assurance of the safety (2) Consultation by mail with at least and effectiveness of the device. a majority of current voting panel (d) The rulemaking procedures in members and, when possible, nonvoting § 10.40 of this chapter apply to pro- panel members; and ceedings to reclassify a device under (3) Discussion at a panel meeting. section 513(e), except that the Commis- sioner may secure a recommendation (b) The method of consultation cho- with respect to a proposed reclassifica- sen by the Commissioner will depend tion from the classification panel to upon the importance and complexity of which the device was last referred. The the subject matter involved and the panel will consider a proposed reclassi- time available for action. When time fication submitted to it by the Com- and circumstances permit, the Com- missioner in accordance with the con- missioner will consult with a panel sultation procedures of § 860.125. Any through discussion at a panel meeting. recommendation submitted to the (c) When a petition is submitted Commissioner by the panel will be pub- under § 860.134 for a post-enactment, lished in the FEDERAL REGISTER when not substantially equivalent device the Commissioner promulgates a regu- (‘‘new device’’), in consulting with the lation under this section. panel the Commissioner will obtain a (e) Within 180 days after the filing of recommendation that includes the in- a petition for reclassification under formation described in § 860.84(d). In this section, the Commissioner, by consulting with a panel about a peti- order published in the FEDERAL REG- tion submitted under § 860.130, § 860.132, ISTER, will either deny the petition or or § 860.136, the Commissioner may or give notice of his intent to initiate a may not obtain a formal recommenda- change in the classification of the de- tion. vice.

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(f) If a device is reclassified under of this section, the Commissioner, by this section, the regulation effecting order published in the FEDERAL REG- the reclassification may revoke any ISTER, either denies the petition or special control or premarket approval gives notice of his intent to initiate a requirement that previously applied to change in classification in accordance the device but that is no longer appli- with § 860.130. cable because of the change in classification. § 860.134 Procedures for ‘‘new devices’’ (g) A regulation under this section under section 513(f) of the act and changing the classification of a device reclassification of certain devices. from class III to class II may provide (a) Section 513(f)(3) of the act applies that such classification will not take to proceedings for reclassification of a effect until the effective date of a spe- device currently in class III by oper- cial control for the device established ation of section 513(f)(1) of the act. This under section 514 of the act. category includes any device that is to [43 FR 32993, July 28, 1978, as amended at 57 be first introduced or delivered for in- FR 58404, Dec. 10, 1992] troduction into interstate commerce for commercial distribution after May § 860.132 Procedures when the Com- 28, 1976, unless: missioner initiates a performance (1) It is substantially equivalent to standard or premarket approval another device that was in commercial proceeding under section 514(b) or 515(b) of the act. distribution before that date and had not been regulated before that date as (a) Sections 514(b) and 515(b) of the a new drug; or act require the Commissioner to pro- (2) It is substantially equivalent to vide, by notice in the FEDERAL REG- another device that was not in com- ISTER, an opportunity for interested mercial distribution before such date parties to request a change in the clas- but which has been classified into class sification of a device based upon new I or class II; or information relevant to its classification when the Commissioner initiates a (3) The Commissioner has classified proceeding either to develop a perform- the device into class I or class II in re- ance standard for the device if in class sponse to a petition for reclassification II, or to promulgate a regulation re- under this section. quiring premarket approval for the de- The Commissioner determines whether vice if in class III. In either case, if the a device is ‘‘substantially equivalent’’ Commissioner agrees that the new infor purposes of the application of this formation warrants a change in classi- section. If a manufacturer or importer fication, the Commissioner will publish believes that a device is not ‘‘substan- in the FEDERAL REGISTER notice of the tially equivalent’’ but that it should Commissioner’s intent to initiate a not be in class III under the criteria in proceeding under section 513(e) of the § 860.3(c), the manufacturer or importer act and § 860.130 to effect such a change. may petition for reclassification under (b) The procedures for effecting a this section. A manufacturer or im- change in classification under sections porter who believes that a device is 514(b) and 515(b) of the act are as fol- ‘‘substantially equivalent’’ and wishes lows: to proceed to market the device shall (1) Within 15 days after publication of submit a premarket notification in ac- the Commissioner’s notice referred to cordance with part 807 of this chapter. in paragraph (a) of this section, an in- After considering a premarket notifica- terested person files a petition for re- tion, the Commissioner will determine classification in accordance with whether the device is ‘‘substantially § 860.123. equivalent’’ and will notify the manu- (2) The Commissioner consults with facturer or importer of such determina- the appropriate classification panel tion in accordance with part 807 of this with regard to the petition in accord- chapter. ance with § 860.125. (b) The procedures for effecting re- (3) Within 60 days after publication of classification under section 513(f) of the notice referred to in paragraph (a) the act are as follows:

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(1) The manufacturer or importer of § 860.95, relating to exemptions from the device petitions for reclassification certain requirements of the act. of the device in accordance with (7) Within a reasonable time after § 860.123. issuance of an order under this section, (2) Within 30 days after the petition the Commissioner announces the order is filed, the Commissioner notifies the by notice published in the FEDERAL petitioner of any deficiencies in the pe- REGISTER. tition that prevent the Commissioner from making a decision on it and al- [43 FR 32993, July 28, 1978, as amended at 57 FR 58404, Dec. 10, 1992; 73 FR 34860, June 19, lows the petitioner to supplement a de- 2008] ficient petition. Within 30 days after any supplemental material is received, § 860.136 Procedures for transitional the Commissioner notifies the peti- products under section 520(l) of the tioner whether the petition, as supple- act. mented, is adequate for review. (a) Section 520(l)(2) of the act applies (3) After determining that the peti- to reclassification proceedings initi- tion contains no deficiencies pre- ated by a manufacturer or importer for cluding a decision on it, the Commis- reclassification of a device currently in sioner may for good cause shown refer class III by operation of section the petition to the appropriate classi- 520(l)(1) of the act. This section applies fication panel for its review and rec- only to devices that the Food and Drug ommendation whether to approve or Administration regarded as ‘‘new deny the petition. drugs’’ before May 28, 1976. (4) Within 90 days after the date the petition is referred to the panel, fol- (b) The procedures for effecting re- lowing the review procedures set forth classification under section 520(l) are in § 860.84(c) for the original classifica- as follows: tion of an ‘‘old’’ device, the panel sub- (1) The manufacturer or importer of mits to the Commissioner its rec- the device files a petition for reclassi- ommendation containing the informa- fication of the device in accordance tion set forth in § 860.84(d). A panel rec- with § 860.123. ommendation is regarded as prelimi- (2) Within 30 days after the petition nary until the Commissioner has re- is filed, the Commissioner notifies the viewed it, discussed it with the panel, petitioner of any deficiencies in the pe- if appropriate, and developed a pro- tition that prevent the Commissioner posed reclassification order. Prelimi- from making a decision on it, allowing nary panel recommendations are filed the petitioner to supplement a defi- in the Division of Dockets Management cient petition. Within 30 days after any upon receipt and are available to the supplemental material is received, the public upon request. Commissioner notifies the petitioner (5) The panel recommendation is pub- whether the petition, as supplemented, lished in the FEDERAL REGISTER as is adequate for review. soon as practicable and interested per- (3) The Commissioner provides the sons are provided an opportunity to petitioner an opportunity for a regu- comment on the recommendation. latory hearing conducted in accordance (6) Within 90 days after the panel’s with part 16 of this chapter. recommendation is received (and no (4) The Commissioner consults with more than 210 days after the date the the appropriate classification panel petition was filed), the Commissioner with regard to the petition in accord- denies or approves the petition by ance with § 860.125. order in the form of a letter to the pe- (5) Within 180 days after the petition titioner. If the Commissioner approves is filed (where the Commissioner has the petition, the order will classify the determined it to be adequate for re- device into class I or class II in accord- view), the Commissioner, by order in ance with the criteria set forth in the form of a letter to the petitioner, § 860.3(c) and subject to the applicable either denies the petition or classifies requirements of § 860.93, relating to the the device into class I or class II in ac- classification of implants, life-sup- cordance with the criteria set forth in porting or life-sustaining devices, and § 860.3(c).

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(6) Within a reasonable time after risk or risks associated with such de- issuance of an order under this section, vice. the Commissioner announces the order (c) References in this part to regu- by notice published in the FEDERAL latory sections of the Code of Federal REGISTER. Regulations are to chapter I of title 21 unless otherwise noted. PART 861—PROCEDURES FOR PER- [45 FR 7484, Feb. 1, 1980, as amended at 45 FR FORMANCE STANDARDS DEVEL- 23686, Apr. 8, 1980; 57 FR 58404, Dec. 10, 1992] OPMENT § 861.5 Statement of policy. Subpart A—General In carrying out its duties under this Sec. section, the Food and Drug Adminis- 861.1 Purpose and scope. tration will, to the maximum extent 861.5 Statement of policy. practical: 861.7 Contents of standards. (a) Use personnel, facilities, and other technical support available in Subpart B—Procedures for Performance other Federal agencies; Standards Development and Publication (b) Consult with other Federal agen- 861.20 Summary of standards development cies concerned with standard setting process. and other nationally or internationally 861.24 Existing standard as a proposed recognized standard-setting entities; standard. and 861.30 Development of standards. (c) Invite participation, through con- 861.34 Amendment or revocation of a stand- ferences, workshops, or other means, ard. by representatives of scientific, profes- 861.36 Effective dates. sional, industry, or consumer organiza- 861.38 Standards advisory committees. tions who can make a significant con- AUTHORITY: 21 U.S.C. 351, 352, 360c, 360d, tribution. 360gg–360ss, 371, 374; 42 U.S.C. 262, 264.

SOURCE: 45 FR 7484, Feb. 1, 1980, unless oth- § 861.7 Contents of standards. erwise noted. Any performance standard established under this part will include such Subpart A—General provisions as the Food and Drug Ad- ministration determines are necessary § 861.1 Purpose and scope. to provide reasonable assurance of the (a) This part implements section 514 safety and effectiveness of the device of the Federal Food, Drug, and Cos- or devices for which it is established. metic Act (the act) with respect to the Where necessary to provide such assur- establishment, amendment, and rev- ance, a standard will address (but need ocation of performance standards ap- not be limited to): plicable to devices intended for human (a) Performance characteristics of use. the device; (b) The Food and Drug Administra- (b) The design, construction, compo- tion may determine that a performance nents, ingredients, and properties of standard, as described under special the device, and its compatibility with controls for class II devices in § 860.7(b) power systems and connections to such of this chapter, is necessary to provide systems; reasonable assurance of the safety and (c) The manufacturing processes and effectiveness of the device. Perform- quality control procedures applicable ance standards may be established for: to the device; (1) A class II device; (d) Testing of the device on either a (2) A class III device which, upon the sample or a 100-percent basis by the effective date of the standard, is reclas- manufacturer, or, if it is determined sified into class II; and that no other more practical means are (3) A class III device, as a condition available to the Food and Drug Admin- to premarket approval under section istration to assure the conformity of 515 of the act, to reduce or eliminate a the device to the standard, providing

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for testing by the Food and Drug Ad- ment, or revocation of any perform- ministration or a third person to en- ance standard for a device. sure that the device conforms to the (1) A notice of proposed rulemaking standard; for the establishment or amendment of (e) The publication of the results of a performance standard for a device each test or of certain tests of the de- will: vice to show that the device conforms (i) Set forth a finding, with sup- to the portions of the standard for porting justification, that the perform- which the test or tests were required; ance standard is appropriate and nec- (f) Manufacturers’ certification to essary to provide reasonable assurance purchasers or to the Food and Drug Ad- of the safety and effectiveness of the ministration that the device conforms device; to the applicable performance stand- (ii) Set forth proposed findings with ard; respect to the risk of illness or injury (g) Restrictions on the sale and dis- that the performance standard is in- tribution of the device, but only to the tended to reduce or eliminate; extent authorized under section 520(e) (iii) Invite interested persons to sub- of the act; mit to the Food and Drug Administra- (h) The use, and the form and con- tion, within 30 days of the publication tent, of labeling for the proper installa- of the notice, requests for changes in tion, maintenance, operation, and use the classification of the device pursu- of the device. Among the provisions ant to § 860.132 of this chapter, based on that may be required in the labeling new information relevant to the classi- are warnings; storage and transpor- fication; and tation information; expiration dates; (iv) Invite interested persons to sub- the date and place of manufacture; the mit an existing performance standard results that may be expected if the de- for the device, including a draft or pro- vice is used properly; the ranges of ac- posed performance standard, for con- curacy of diagnostic information; in- sideration by the Commissioner of structions regarding the proper care of, Food and Drugs. and the proper components, acces- (2) A notice of proposed rulemaking sories, or other equipment to be used for the revocation of a performance with the device; and statements con- standard will set forth a finding, with cerning the appropriate patient popu- supporting justification, that the per- lation, for example, a statement that formance standard is no longer nec- the device is considered safe and effec- essary to provide reasonable assurance tive only when used by, or in the treat- of the safety and effectiveness of a de- ment of, a patient who has been tested vice. by particular designated procedures (b) A notice under this section will and found to have an illness or condi- provide for a comment period of not tion for which use of the device is indi- less than 60 days. cated by a person skilled in the use of (c) If, after publication of a notice the device. under paragraph (a) of this section, FDA receives a request to change the Subpart B—Procedures for Per- classification of the device, FDA will, formance Standards Develop- within 60 days of the publication of the ment and Publication notice and after consultation with the appropriate panel under § 860.125 of this § 861.20 Summary of standards devel- chapter, either deny the request or give opment process. notice of its intent to initiate a change The procedure by which a perform- in the classification under § 860.130. ance standard for a device may be es- (d) If FDA initiates a rulemaking tablished, amended, or revoked is as proceeding under paragraph (a) of this follows: section, FDA will: (a) The Food and Drug Administra- (1) Complete the proceeding and es- tion (FDA) will publish in the FEDERAL tablish the performance standard for REGISTER a notice of proposed rule- the device in accordance with this part making for the establishment, amend- and § 10.40 of this chapter; or

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(2) Terminate the proceeding by pub- (b) Provide interested persons an op- lishing in the FEDERAL REGISTER a no- portunity to participate in the develop- tice announcing such termination and ment of the standard by accepting the reasons therefor and, unless the comments and, where appropriate, proceeding is terminated because the holding public meetings on issues re- device is a banned device, initiate a lating to development of the standard. proceeding in accordance with section Notice of the opportunity to partici- 513(e) of the act to reclassify the de- pate in the development of the stand- vice; or ard will be furnished in a manner rea- (3) Take other appropriate action. sonably calculated to reach the majority of persons interested in the devel- [57 FR 58404, Dec. 10, 1992] opment of the standard. This requirement shall be satisfied by publishing § 861.24 Existing standard as a pro- such a notice in the FEDERAL REG- posed standard. ISTER. Whenever it is appropriate, FDA (a) The Food and Drug Administra- will use the FEDERAL REGISTER to tion may accept an existing standard make announcements about the stand- or a proposed or draft standard if it in- ard development process of standard cludes: developers other than Federal agen- (1) A description of the procedures cies. used to develop the standard and a list (c) Maintain records disclosing the of the persons and organizations that course of development of the proposed participated in its development, to the standard, the comments and other in- extent that such information is avail- formation submitted by a person in able or reasonably obtainable; connection with such development (in- (2) An identification of the specific cluding comments and information re- portions of the existing standard that garding the need for a standard), and the person submitting the standard be- such other information as may be re- lieves are appropriate for adoption as, quired to evaluate the standard. or inclusion in, the proposed standard; [45 FR 7484, Feb. 1, 1980, as amended at 57 FR and 58405, Dec. 10, 1992] (3) A summary of the test data, or, if requested by the Food and Drug Ad- § 861.34 Amendment or revocation of a ministration, all such data or other in- standard. formation supporting the specific por- (a) The Food and Drug Administra- tions of the standard identified by the tion will provide for periodic evalua- person submitting the standard. tion of performance standards to deter- (b) The Food and Drug Administra- mine whether such standards should be tion will publish a notice in the FED- changed to reflect new medical, sci- ERAL REGISTER stating either that it entific, or other technological data. has accepted, or accepted with modi- (b) The Food and Drug Administra- fication, as a proposed standard, an ex- tion may, on its own initiative or upon isting standard or one that has been petition of an interested party, amend developed, or that an existing standard or revoke by regulation a standard es- is not acceptable, together with the tablished under this part. reasons therefor. (c) Any petition to amend or revoke a standard shall: [45 FR 7484, Feb. 1, 1980, as amended at 57 FR (1) Identify the specific device and 58405, Dec. 10, 1992] standard for which the amendment or revocation is sought; and § 861.30 Development of standards. (2) Be submitted in accordance with The Food and Drug Administration the requirements of § 10.30. (FDA), while engaged in the develop- (d) Proceedings to amend or revoke a ment of a proposed standard under this performance standard shall be con- section will: ducted in accordance with the rule- (a) Support its proposed performance making procedures of § 10.40. In addi- standard by such test data or other tion, a notice of proposed rulemaking documents or materials as may reason- to amend or revoke a standard shall set ably be required; forth proposed findings with respect to

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the degree of risk or illness to be elimi- selected in accordance with §§ 14.82 and nated or reduced and the benefit the 14.84, except that no member may be a public will derive from the proposed regular full-time FDA employee. Each amendment or revocation. advisory committee established under this section shall include as nonvoting § 861.36 Effective dates. members a representative of consumer (a) A regulation establishing, amend- interests and a representative of inter- ing, or revoking a performance stand- ests of the device manufacturing indus- ard will set forth the date upon which try. it will take effect. To the extent prac- (b) A proposed regulation to estab- tical, consistent with the public health lish, amend, or revoke a performance and safety, such effective date will be standard shall be referred to an advi- established so as to minimize economic sory committee for a report and rec- loss to, and disruption or dislocation ommendation with respect to any mat- of, domestic and international trade. ter involved in the proposed regulation (b) Except as provided in paragraph which requires the exercise of sci- (c) of this section, no regulation estab- entific judgment if: lishing, amending, or revoking a standard may take effect before 1 year after (1) The Food and Drug Administra- the date of its publication unless: tion determines that such referral is (1) The Food and Drug Administra- necessary or appropriate under the cir- tion determines that an earlier effec- cumstances; or tive date is necessary to protect the (2) Requested by an interested per- public health and safety; or son, in the form of a citizen petition in (2) The standard has been established accordance with § 10.30 of this chapter, for a device that, by the effective date which is made within the period proof the standard, has been reclassified vided for comment on the proposed reg- from class III to class II. ulation and which demonstrates good (c) The Food and Drug Administra- cause for referral. tion may declare a proposed regulation (c) When a proposed regulation is re- amending a standard effective on publi- ferred to an advisory committee, the cation in the FEDERAL REGISTER if it Food and Drug Administration will fur- determines that making the regulation nish the committee with the data and so effective is in the public interest. A information upon which the proposed proposed amendment of a performance regulation is based. After independ- standard made effective upon publica- ently reviewing the materials fur- tion may not prohibit the introduction nished by the Food and Drug Adminis- or delivery for introduction into inter- tration and any other available data state commerce of a device that con- and information, the advisory com- forms to the standard without the mittee shall, within 60 days of the re- change or changes provided in the pro- ferral, submit a report and rec- posed amendment until the effective ommendation on the proposed regula- date of any final action on the pro- tion, together with all underlying data posal. and information and a statement of the [45 FR 7484, Feb. 1, 1980, as amended at 57 FR reason or basis for the recommenda- 58405, Dec. 10, 1992] tion. A copy of the report and recommendation will be publicly dis- § 861.38 Standards advisory committees. played in the office of the Division of Dockets Management, Food and Drug (a) The Food and Drug Administra- Administration. tion will establish advisory commit- (d) Where appropriate, each proposed tees to which proposed regulations may regulation establishing a standard pub- be referred, and these committees shall lished in the FEDERAL REGISTER will consider such referrals in accordance include a call for nominations to the with this section and part 14 of this advisory committee for that particular chapter. Such advisory committees, which may not be classification panels, standard. shall be considered ad hoc advisory [45 FR 7484, Feb. 1, 1980, as amended at 57 FR committees. Their members shall be 58405, Dec. 10, 1992]

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PART 862—CLINICAL CHEMISTRY 862.1163 Cardiac allograft gene expression profiling test system. AND CLINICAL TOXICOLOGY 862.1165 Catecholamines (total) test system. DEVICES 862.1170 Chloride test system. 862.1175 Cholesterol (total) test system. Subpart A—General Provisions 862.1177 Cholylglycine test system. 862.1180 Chymotrypsin test system. Sec. 862.1185 Compound S (11-deoxycortisol) test 862.1 Scope. system. 862.2 Regulation of calibrators. 862.1187 Conjugated sulfolithocholic acid 862.3 Effective dates of requirement for pre- (SLCG) test system. market approval. 862.1190 Copper test system. 862.9 Limitations of exemptions from sec- 862.1195 Corticoids test system. tion 510(k) of the Federal Food, Drug, 862.1200 Corticosterone test system. and Cosmetic Act (the act). 862.1205 Cortisol (hydrocortisone and hydroxycorticosterone) test system. Subpart B—Clinical Chemistry Test Systems 862.1210 Creatine test system. 862.1215 Creatine phosphokinase/creatine ki- 862.1020 Acid phosphatase (total or pros- nase or isoenzymes test system. tatic) test system. 862.1225 Creatinine test system. 862.1025 Adrenocorticotropic hormone 862.1230 Cyclic AMP test system. (ACTH) test system. 862.1235 Cyclosporine test system. 862.1030 Alanine amino transferase (ALT/ 862.1240 Cystine test system. SGPT) test system. 862.1245 Dehydroepiandrosterone (free and 862.1035 Albumin test system. sulfate) test system. 862.1040 Aldolase test system. 862.1250 Desoxycorticosterone test system. 862.1045 Aldosterone test system. 862.1255 2,3-Diphosphoglyceric acid test sys- 862.1050 Alkaline phosphatase or isoenzymes tem. test system. 862.1260 Estradiol test system. 862.1055 Newborn screening test system for 862.1265 Estriol test system. amino acids, free carnitine, and 862.1270 Estrogens (total, in pregnancy) test acylcarnitines using tandem mass spec- system. trometry. 862.1275 Estrogens (total, nonpregnancy) 862.1060 Delta-aminolevulinic acid test sys- test system. tem. 862.1280 Estrone test system. 862.1065 Ammonia test system. 862.1285 Etiocholanolone test system. 862.1070 Amylase test system. 862.1290 Fatty acids test system. 862.1075 Androstenedione test system. 862.1295 Folic acid test system. 862.1080 Androsterone test system. 862.1300 Follicle-stimulating hormone test 862.1085 Angiotensin I and renin test sys- system. tem. 862.1305 Formiminoglutamic acid (FIGLU) 862.1090 Angiotensin converting enzyme test system. (A.C.E.) test system. 862.1310 Galactose test system. 862.1095 Ascorbic acid test system. 862.1315 Galactose-1-phosphate uridyl trans- 862.1100 Aspartate amino transferase (AST/ ferase test system. SGOT) test system. 862.1320 Gastric acidity test system. 862.1110 Bilirubin (total or direct) test sys- 862.1325 Gastrin test system. tem. 862.1330 Globulin test system. 862.1113 Bilirubin (total and unbound) in the 862.1335 Glucagon test system. neonate test system. 862.1340 Urinary glucose (nonquantitative) 862.1115 Urinary bilirubin and its conjugates test system. (nonquantitative) test system. 862.1345 Glucose test system. 862.1117 B-type natriuretic peptide test sys- 862.1350 Continuous glucose monitor sec- tem. ondary display. 862.1118 Biotinidase test system. 862.1360 Gamma-glutamyl transpeptidase 862.1120 Blood gases (PCO2PO2) and blood pH and isoenzymes test system. test system. 862.1365 Glutathione test system. 862.1130 Blood volume test system. 862.1370 Human growth hormone test sys- 862.1135 C-peptides of proinsulin test system. tem. 862.1373 Hemoglobin A1c test system. 862.1140 Calcitonin test system. 862.1375 Histidine test system. 862.1145 Calcium test system. 862.1377 Urinary homocystine (nonquantita- 862.1150 Calibrator. tive) test system. 862.1155 Human chorionic gonadotropin 862.1380 Hydroxybutyric dehydrogenase test (HCG) test system. system. 862.1160 Bicarbonate/carbon dioxide test 862.1385 17-Hydroxycorticosteroids (17- system. ketogenic steroids) test system.

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862.1390 5-Hydroxyindole acetic acid/sero- 862.1635 Total protein test system. tonin test system. 862.1640 Protein-bound iodine test system. 862.1395 17-Hydroxyprogesterone test sys- 862.1645 Urinary protein or albumin (non- tem. quantitative) test system. 862.1400 Hydroxyproline test system. 862.1650 Pyruvate kinase test system. 862.1405 Immunoreactive insulin test sys- 862.1655 Pyruvic acid test system. tem. 862.1660 Quality control material (assayed 862.1410 Iron (non-heme) test system. and unassayed). 862.1415 Iron-binding capacity test system. 862.1665 Sodium test system. 862.1420 Isocitric dehydrogenase test sys- 862.1670 Sorbitol dehydrogenase test system. tem. 862.1430 17-Ketosteroids test system. 862.1675 Blood specimen collection device. 862.1435 Ketones (nonquantitative) test sys- 862.1678 Tacrolimus test system. tem. 862.1680 Testosterone test system. 862.1440 Lactate dehydrogenase test system. 862.1685 Thyroxine-binding globulin test 862.1445 Lactate dehydrogenase isoenzymes system. test system. 862.1690 Thyroid-stimulating hormone test 862.1450 Lactic acid test system. system. 862.1455 Lecithin/sphingomyelin ratio in 862.1695 Free thyroxine test system. amniotic fluid test system. 862.1700 Total thyroxine test system. 862.1460 Leucine aminopeptidase test sys- 862.1705 Triglyceride test system. tem. 862.1710 Total triiodothyronine test system. 862.1465 Lipase test system. 862.1715 Triiodothyronine uptake test sys- 862.1470 Lipid (total) test system. tem. 862.1475 Lipoprotein test system. 862.1720 Triose phosphate isomerase test 862.1485 Luteinizing hormone test system. system. 862.1490 Lysozyme (muramidase) test sys- 862.1725 Trypsin test system. tem. 862.1730 Free tyrosine test system. 862.1495 Magnesium test system. 862.1770 Urea nitrogen test system. 862.1500 Malic dehydrogenase test system. 862.1775 Uric acid test system. 862.1505 Mucopolysaccharides (nonquantita- 862.1780 Urinary calculi (stones) test sys- tive) test system. tem. 862.1509 Methylmalonic acid (nonquantita- 862.1785 Urinary urobilinogen (nonquantitative) test system. tive) test system. 862.1510 Nitrite (nonquantitative) test sys- 862.1790 Uroporphyrin test system. tem. 862.1795 Vanilmandelic acid test system. 862.1515 Nitrogen (amino-nitrogen) test sys- 862.1805 Vitamin A test system. tem. 862.1810 Vitamin B12 test system. 862.1520 5′-Nucleotidase test system. 862.1815 Vitamin E test system. 862.1530 Plasma oncometry test system. 862.1820 Xylose test system. 862.1535 Ornithine carbamyl transferase test 862.1825 Vitamin D test system. system. 862.1540 Osmolality test system. Subpart C—Clinical Laboratory Instruments 862.1542 Oxalate test system. 862.1545 Parathyroid hormone test system. 862.2050 General purpose laboratory equip- 862.1550 Urinary pH (nonquantitative) test ment labeled or promoted for a specific system. medical use. 862.1555 Phenylalanine test system. 862.2100 Calculator/data processing module 862.1560 Urinary phenylketones (non- for clinical use. quantitative) test system. 862.2140 Centrifugal chemistry analyzer for 862.1565 6-Phosphogluconate dehydrogenase clinical use. test system. 862.2150 Continuous flow sequential mul- 862.1570 Phosphohexose isomerase test sys- tiple chemistry analyzer for clinical use. tem. 862.2160 Discrete photometric chemistry an- 862.1575 Phospholipid test system. alyzer for clinical use. 862.1580 Phosphorus (inorganic) test system. 862.2170 Micro chemistry analyzer for clin- 862.1585 Human placental lactogen test sys- ical use. tem. 862.2230 Chromatographic separation mate- 862.1590 Porphobilinogen test system. rial for clinical use. 862.1595 Porphyrins test system. 862.2250 Gas liquid chromatography system 862.1600 Potassium test system. for clinical use. 862.1605 Pregnanediol test system. 862.2260 High pressure liquid chroma- 862.1610 Pregnanetriol test system. tography system for clinical use. 862.1615 Pregnenolone test system. 862.2265 High throughput genomic sequence 862.1620 Progesterone test system. analyzer for clinical use. 862.1625 Prolactin (lactogen) test system. 862.2270 Thin-layer chromatography system 862.1630 Protein (fractionation) test system. for clinical use.

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862.2300 Colorimeter, photometer, or spec- 862.3640 Morphine test system. trophotometer for clinical use. 862.3645 Neuroleptic drugs radioreceptor 862.2310 Clinical sample concentrator. assay test system. 862.2320 Beta or gamma counter for clinical 862.3650 Opiate test system. use. 862.3660 Phenobarbital test system. 862.2400 Densitometer/scanner (integrating, 862.3670 Phenothiazine test system. reflectance, TLC, or radiochromatogram) 862.3680 Primidone test system. for clinical use. 862.2485 Electrophoresis apparatus for clin- 862.3700 Propoxyphene test system. ical use. 862.3750 Quinine test system. 862.2500 Enzyme analyzer for clinical use. 862.3830 Salicylate test system. 862.2540 Flame emission photometer for 862.3840 Sirolimus test system. clinical use. 862.3850 Sulfonamide test system. 862.2560 Fluorometer for clinical use. 862.3870 Cannabinoid test system. 862.2570 Instrumentation for clinical multi- 862.3880 Theophylline test system. plex test systems. 862.3900 Tobramycin test system. 862.2680 Microtitrator for clinical use. 862.3910 Tricyclic antidepressant drugs test 862.2700 Nephelometer for clinical use. system. 862.2720 Plasma oncometer for clinical use. 862.3950 Vancomycin test system. 862.2730 Osmometer for clinical use. 862.2750 Pipetting and diluting system for AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, clinical use. 360j, 360l, 371. 862.2800 Refractometer for clinical use. 862.2850 Atomic absorption spectrophotom- SOURCE: 52 FR 16122, May 1, 1987, unless eter for clinical use. otherwise noted. 862.2860 Mass spectrometer for clinical use. EDITORIAL NOTE: Nomenclature changes to 862.2900 Automated urinalysis system. part 862 appear at 73 FR 35341, June 23, 2008. 862.2920 Plasma viscometer for clinical use.

Subpart D—Clinical Toxicology Test Subpart A—General Provisions Systems § 862.1 Scope. 862.3030 Acetaminophen test system. 862.3035 Amikacin test system. (a) This part sets forth the classifica- 862.3040 Alcohol test system. tion of clinical chemistry and clinical 862.3050 Breath-alcohol test system. toxicology devices intended for human 862.3080 Breath nitric oxide test system. use that are in commercial distribu- 862.3100 Amphetamine test system. tion. 862.3110 Antimony test system. (b) The identification of a device in a 862.3120 Arsenic test system. regulation in this part is not a precise 862.3150 Barbiturate test system. 862.3170 Benzodiazepine test system. description of every device that is, or 862.3200 Clinical toxicology calibrator. will be, subject to the regulation. A 862.3220 Carbon monoxide test system. manufacturer who submits a pre- 862.3240 Cholinesterase test system. market notification submission for a 862.3250 Cocaine and cocaine metabolite test device under part 807 cannot show system. merely that the device is accurately 862.3270 Codeine test system. described by the section title and iden- 862.3280 Clinical toxicology control material. tification provisions of a regulation in 862.3300 Digitoxin test system. this part, but shall state why the de- 862.3320 Digoxin test system. vice is substantially equivalent to 862.3350 Diphenylhydantoin test system. other devices, as required in § 807.87. 862.3360 Drug metabolizing enzyme (c) References in this part to regu- genotyping system. latory sections of the Code of Federal 862.3380 Ethosuximide test system. Regulations are to chapter I of title 21 862.3450 Gentamicin test system. 862.3520 Kanamycin test system. unless otherwise noted. 862.3550 Lead test system. (d) Guidance documents referenced in 862.3555 Lidocaine test system. this part are available on the Internet 862.3560 Lithium test system. at http://www.fda.gov/MedicalDevices/ 862.3580 Lysergic acid diethylamide (LSD) DeviceRegulationandGuidance/ test system. GuidanceDocuments/default.htm. 862.3600 Mercury test system. 862.3610 Methamphetamine test system. [52 FR 16122, May 1, 1987, as amended at 67 862.3620 Methadone test system. FR 58329, Sept. 16, 2002; 78 FR 18233, Mar. 26, 862.3630 Methaqualone test system. 2013; 79 FR 50552, Aug. 25, 2014]

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§ 862.2 Regulation of calibrators. day of the 30th full calendar month Many devices classified in this part after the regulation that classifies the are intended to be used with a cali- device into class III is effective, which- brator. A calibrator has a reference ever is later. See section 501(f)(2)(B) of value assigned to it which serves as the the act. Accordingly, unless an effec- basis by which test results of patients tive date of the requirement for pre- are derived or calculated. The cali- market approval is shown in the regu- brator for a device may be (a) manufac- lation for a device classified into class tured and distributed separately from III in this part, the device may be com- the device with which it is intended to mercially distributed without FDA’s be used, (b) manufactured and distrib- issuance of an order approving a PMA uted as one of several device compo- or declaring completed a PDP for the nents, such as in a kit of reagents, or device. If FDA promulgates a regula- (c) built-in as an integral part of the tion under section 515(b) of the act re- device. Because of the central role that quiring premarket approval for a de- a calibrator plays in the measurement vice, section 501(f)(1)(A) of the act ap- process and the critical effect cali- plies to the device. brators have on accuracy of test re- (b) Any new, not substantially equiv- sults, elsewhere in this part, all three alent, device introduced into commer- of these types of calibrators (§§ 862.1150 cial distribution on or after May 28, and 862.3200 of this part) are classified 1976, including a device formerly mar- into class II, notwithstanding the clas- keted that has been substantially al- sification of the device with which it is tered, is classified by statute (section intended to be used. Thus, a device and 513(f) of the act) into class III without its calibrator may have different clas- any grace period and FDA must have sifications, even if the calibrator is issued an order approving a PMA or de- built into the device. claring completed a PDP for the device before the device is commercially dis- § 862.3 Effective dates of requirement tributed unless it is reclassified. If for premarket approval. FDA knows that a device being com- A device included in this part that is mercially distributed may be a ‘‘new’’ classified into class III (premarket ap- device as defined in this section be- proval) shall not be commercially dis- cause of any new intended use or other tributed after the date shown in the reasons, FDA may codify the statutory regulation classifying the device unless classification of the device into class the manufacturer has an approval III for such new use. Accordingly, the under section 515 of the act (unless an regulation for such a class III device exemption has been granted under sec- states that as of the enactment date of tion 520(g)(2) of the act). An approval the amendments, May 28, 1976, the de- under section 515 of the act consists of vice must have an approval under sec- FDA’s issuance of an order approving tion 515 of the act before commercial an application for premarket approval distribution. (PMA) for the device or declaring completed a product development protocol § 862.9 Limitations of exemptions from (PDP) for the device. section 510(k) of the Federal Food, (a) Before FDA requires that a device Drug, and Cosmetic Act (the act). commercially distributed before the The exemption from the requirement enactment date of the amendments, or of premarket notification (section a device that has been found substan- 510(k) of the act) for a generic type of tially equivalent to such a device, has class I or II device is only to the extent an approval under section 515 of the act that the device has existing or reason- FDA must promulgate a regulation ably foreseeable characteristics of under section 515(b) of the act requir- commercially distributed devices with- ing such approval, except as provided in that generic type or, in the case of in paragraph (b) of this section. Such a in vitro diagnostic devices, only to the regulation under section 515(b) of the extent that misdiagnosis as a result of act shall not be effective during the using the device would not be associ- grace period ending on the 90th day ated with high morbidity or mortality. after its promulgation or on the last Accordingly, manufacturers of any

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commercially distributed class I or II assay is intended for use in matrices device for which FDA has granted an other than serum or plasma; exemption from the requirement of (8) For noninvasive testing as defined premarket notification must still sub- in § 812.3(k) of this chapter; and mit a premarket notification to FDA (9) For near patient testing (point of before introducing or delivering for in- care). troduction into interstate commerce for commercial distribution the device [65 FR 2304, Jan. 14, 2000] when: (a) The device is intended for a use Subpart B—Clinical Chemistry Test different from the intended use of a le- Systems gally marketed device in that generic type of device; e.g., the device is in- § 862.1020 Acid phosphatase (total or tended for a different medical purpose, prostatic) test system. or the device is intended for lay use (a) Identification. An acid phosphatase where the former intended use was by health care professionals only; (total or prostatic) test system is a de- (b) The modified device operates vice intended to measure the activity using a different fundamental sci- of the acid phosphatase enzyme in plas- entific technology than a legally mar- ma and serum. keted device in that generic type of de- (b) Classification. Class II. vice; e.g., a surgical instrument cuts tissue with a laser beam rather than § 862.1025 Adrenocorticotropic hor- with a sharpened metal blade, or an in mone (ACTH) test system. vitro diagnostic device detects or iden- (a) Identification. An tifies infectious agents by using adrenocorticotropic hormone (ACTH) deoxyribonucleic acid (DNA) probe or test system is a device intended to nucleic acid hybridization technology measure adrenocorticotropic hormone rather than culture or immunoassay in plasma and serum. ACTH measure- technology; or ments are used in the differential diag- (c) The device is an in vitro device nosis and treatment of certain dis- that is intended: orders of the adrenal glands such as (1) For use in the diagnosis, moni- Cushing’s syndrome, adrenocortical in- toring, or screening of neoplastic dis- sufficiency, and the ectopic ACTH syn- eases with the exception of drome. immunohistochemical devices; (b) Class II. (2) For use in screening or diagnosis Classification. of familial or acquired genetic dis- § 862.1030 Alanine amino transferase orders, including inborn errors of me- (ALT/SGPT) test system. tabolism; (3) For measuring an analyte that (a) Identification. An alanine amino serves as a surrogate marker for transferase (ALT/SGPT) test system is screening, diagnosis, or monitoring a device intended to measure the activ- life-threatening diseases such as ac- ity of the enzyme alanine amino trans- quired immune deficiency syndrome ferase (ALT) (also known as a serum (AIDS), chronic or active hepatitis, tu- glutamic pyruvic transaminase or berculosis, or myocardial infarction or SGPT) in serum and plasma. Alanine to monitor therapy; amino transferase measurements are (4) For assessing the risk of cardio- used in the diagnosis and treatment of vascular diseases; certain liver diseases (e.g., viral hepa- (5) For use in diabetes management; titis and cirrhosis) and heart diseases. (6) For identifying or inferring the (b) Classification. Class I (general con- identity of a microorganism directly trols). The device is exempt from the from clinical material; premarket notification procedures in (7) For detection of antibodies to subpart E of part 807 of this chapter microorganisms other than subject to § 862.9. immunoglobulin G (IgG) or IgG assays when the results are not qualitative, or [52 FR 16122, May 1, 1987, as amended at 65 are used to determine immunity, or the FR 2305, Jan. 14, 2000]

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§ 862.1035 Albumin test system. § 862.1055 Newborn screening test system for amino acids, free carnitine, (a) Identification. An albumin test and acylcarnitines using tandem system is a device intended to measure mass spectrometry. the albumin concentration in serum and plasma. Albumin measurements (a) Identification. A newborn screen- are used in the diagnosis and treating test system for amino acids, free ment of numerous diseases involving carnitine, and acylcarnitines using primarily the liver or kidneys. tandem mass spectrometry is a device that consists of stable isotope internal (b) Classification. Class II. standards, control materials, extrac- § 862.1040 Aldolase test system. tion solutions, flow solvents, instrumentation, software packages, and (a) Identification. An aldolase test other reagents and materials. The de- system is a device intended to measure vice is intended for the measurement the activity of the enzyme aldolase in and evaluation of amino acids, free car- serum or plasma. Aldolase measure- nitine, and acylcarnitine concentra- ments are used in the diagnosis and tions from newborn whole blood filter treatment of the early stages of acute paper samples. The quantitative anal- hepatitis and for certain muscle dis- ysis of amino acids, free carnitine, and eases such as progressive Duchenne- acylcarnitines and their relationship type muscular dystrophy. with each other provides analyte con- (b) Classification. Class I (general concentration profiles that may aid in trols). The device is exempt from the screening newborns for one or more in- premarket notification procedures in born errors of amino acid, free carni- subpart E of part 807 of this chapter tine, and acyl-carnitine metabolism. subject to § 862.9. (b) Classification. Class II (special [52 FR 16122, May 1, 1987, as amended at 65 controls). The special control is FDA’s FR 2305, Jan. 14, 2000] guidance document entitled ‘‘Class II Special Controls Guidance Document: § 862.1045 Aldosterone test system. Newborn Screening Test Systems for Amino Acids, Free Carnitine, and (a) Identification. An aldosterone test Acylcarnitines Using Tandem Mass system is a device intended to measure Spectrometry.’’ See § 862.1(d) for the the hormone aldosterone in serum and availability of this guidance document. urine. Aldosterone measurements are used in the diagnosis and treatment of [69 FR 68255, Nov. 24, 2004] primary aldosteronism (a disorder caused by the excessive secretion of § 862.1060 Delta-aminolevulinic acid aldosterone by the adrenal gland), hy- test system. pertension caused by primary (a) Identification. A delta- aldosteronism, selective aminolevulinic acid test system is a hypoaldosteronism, edematous states, device intended to measure the level of and other conditions of electrolyte im- delta-aminolevulinic acid (a precursor balance. of porphyrin) in urine. Delta- (b) Classification. Class II. aminolevulinic acid measurements are used in the diagnosis and treatment of § 862.1050 Alkaline phosphatase or lead poisoning and certain porphyrias isoenzymes test system. (diseases affecting the liver, gastro- (a) Identification. An alkaline phos- intestinal, and nervous systems that phatase or isoenzymes test system is a are accompanied by increased urinary device intended to measure alkaline excretion of various heme compounds phosphatase or its isoenzymes (a group including delta-aminolevulinic acid). of enzymes with similar biological ac- (b) Classification. Class I (general con- tivity) in serum or plasma. Measure- trols). The device is exempt from pre- ments of alkaline phosphatase or its market notification procedures in sub- isoenzymes are used in the diagnosis part E of part 807 of this chapter sub- and treatment of liver, bone, parathy- ject to § 862.9. roid, and intestinal diseases. [52 FR 16122, May 1, 1987, as amended at 65 (b) Classification. Class II. FR 2305, Jan. 14, 2000]

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§ 862.1065 Ammonia test system. § 862.1085 Angiotensin I and renin test system. (a) Identification. An ammonia test system is a device intended to measure (a) Identification. An angiotensin I ammonia levels in blood, serum, and and renin test system is a device in- plasma, Ammonia measurements are tended to measure the level of used in the diagnosis and treatment of angiotensin I generated by renin in severe liver disorders, such as cir- plasma. Angiotensin I measurements rhosis, hepatitis, and Reye’s syndrome. are used in the diagnosis and treat- (b) Classification. Class I. ment of certain types of hypertension. (b) Classification. Class II. § 862.1070 Amylase test system. § 862.1090 Angiotensin converting en- (a) Identification. An amylase test zyme (A.C.E.) test system. system is a device intended to measure (a) Identification. An angiotensin con- the activity of the enzyme amylase in verting enzyme (A.C.E.) test system is serum and urine. Amylase measure- a device intended to measure the activ- ments are used primarily for the diag- ity of angiotensin converting enzyme nosis and treatment of pancreatitis (in- in serum and plasma. Measurements flammation of the pancreas). obtained by this device are used in the (b) Classification. Class II. diagnosis and treatment of diseases such as sarcoidosis, a disease charac- § 862.1075 Androstenedione test sys- terized by the formation of nodules in tem. the lungs, bones, and skin, and (a) Identification. An androstenedione Gaucher’s disease, a hereditary dis- test system is a device intended to order affecting the spleen. measure androstenedione (a substance (b) Classification. Class II. secreted by the testes, ovary, and adrenal glands) in serum. Adrostenedione § 862.1095 Ascorbic acid test system. measurements are used in the diag- (a) Identification. An ascorbic acid nosis and treatment of females with ex- test system is a device intended to cessive levels of androgen (male sex measure the level of ascorbic acid (vi- hormone) production. tamin C) in plasma, serum, and urine. (b) Classification. Class I (general con- Ascorbic acid measurements are used trols). The device is exempt from the in the diagnosis and treatment of premarket notification procedures in ascorbic acid dietary deficiencies. subpart E of part 807 of this chapter (b) Classification. Class I (general con- subject to § 862.9. trols). The device is exempt from the premarket notification procedures in [52 FR 16122, May 1, 1987, as amended at 65 subpart E of part 807 of this chapter FR 2305, Jan. 14, 2000] subject to § 862.9. § 862.1080 Androsterone test system. [52 FR 16122, May 1, 1987, as amended at 65 (a) Identification. An androsterone FR 2305, Jan. 14, 2000] test system is a device intended to § 862.1100 Aspartate amino transferase measure the hormone adrosterone in (AST/SGOT) test system. serum, plasma, and urine. Andros- terone measurements are used in the (a) Identification. An aspartate amino transferase (AST/SGOT) test system is diagnosis and treatment of gonadal and a device intended to measure the activ- adrenal diseases. ity of the enzyme aspartate amino (b) Classification. Class I (general con- transferase (AST) (also known as a trols). The device is exempt from the serum glutamic oxaloacetic transferase premarket notification procedures in or SGOT) in serum and plasma. subpart E of part 807 of this chapter Aspartate amino transferase measure- subject to § 862.9. ments are used in the diagnosis and [52 FR 16122, May 1, 1987, as amended at 65 treatment of certain types of liver and FR 2305, Jan. 14, 2000] heart disease. (b) Classification. Class II.

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§ 862.1110 Bilirubin (total or direct) II Special Control Guidance Document test system. for B-Type Natriuretic Peptide Pre- (a) Identification. A bilirubin (total or market Notifications; Final Guidance direct) test system is a device intended for Industry and FDA Reviewers.’’ to measure the levels of bilirubin (total [66 FR 12734, Feb. 28, 2001] or direct) in plasma or serum. Measure- ments of the levels of bilirubin, an or- § 862.1118 Biotinidase test system. ganic compound formed during the normal and abnormal distruction of red (a) Identification. The biotinidase test blood cells, if used in the diagnosis and system is an in vitro diagnostic device treatment of liver, hemolytic intended to measure the activity of the hematological, and metabolic dis- enzyme biotinidase in blood. Measure- orders, including hepatitis and gall ments of biotinidase are used in the bladder block. treatment and diagnosis of biotinidase (b) Classification. Class II. deficiency, an inborn error of metabolism in infants, characterized by the § 862.1113 Bilirubin (total and un- inability to utilize dietary protein bound) in the neonate test system. bound vitamin or to recycle endoge- (a) Identification. A bilirubin (total nous biotin. The deficiency may result and unbound) in the neonate test sys- in irreversible neurological impair- tem is a device intended to measure ment. the levels of bilirubin (total and un- (b) Classification. Class II (special bound) in the blood (serum) of newborn controls). The special control is sale, infants to aid in indicating the risk of distribution, and use in accordance bilirubin encephalopathy (kernicterus). with the prescription device require- (b) Classification. Class I. ments in § 801.109 of this chapter. [54 FR 30206, July 19, 1989] [65 FR 16521, Mar. 29, 2000]

§ 862.1115 Urinary bilirubin and its § 862.1120 Blood gases (PCO2, PO2) and conjugates (nonquantitative) test blood pH test system. system. (a) Identification. A blood gases (PCO2, (a) Identification. A urinary bilirubin PO2) and blood pH test system is a de- and its conjugates (nonquantitative) vice intended to measure certain gases test system is a device intended to in blood, serum, plasma or pH of blood, measure the levels of bilirubin con- serum, and plasma. Measurements of jugates in urine. Measurements of uri- blood gases (PCO2, PO2) and blood pH are nary bilirubin and its conjugates (non- used in the diagnosis and treatment of quantitative) are used in the diagnosis life-threatening acid-base disturbances. and treatment of certain liver diseases. (b) Classification. Class II. (b) Classification. Class I (general controls). The device is exempt from the § 862.1130 Blood volume test system. premarket notification procedures in subpart E of part 807 of this chapter (a) Identification. A blood volume test subject to § 862.9. system is a device intended to measure the circulating blood volume. Blood [52 FR 16122, May 1, 1987, as amended at 65 volume measurements are used in the FR 2305, Jan. 14, 2000] diagnosis and treatment of shock, hem- § 862.1117 B-type natriuretic peptide orrhage, and polycythemia vera (a dis- test system. ease characterized by an absolute increase in erythrocyte mass and total (a) Identification. The B-type blood volume). natriuretic peptide (BNP) test system (b) Classification. Class I (general con- is an in vitro diagnostic device in- trols). The device is exempt from the tended to measure BNP in whole blood premarket notification procedures in and plasma. Measurements of BNP are subpart E of part 807 of this chapter used as an aid in the diagnosis of patients with congestive heart failure. subject to § 862.9. (b) Classification. Class II (special [52 FR 16122, May 1, 1987, as amended at 65 controls). The special control is ‘‘Class FR 2305, Jan. 14, 2000]

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§ 862.1135 C-peptides of proinsulin test § 862.1155 Human chorionic system. gonadotropin (HCG) test system. (a) Identification. A C-peptides of (a) Human chorionic gonadotropin proinsulin test system is a device in- (HCG) test system intended for the early tended to measure C-peptides of detection of pregnancy—(1) Identification. proinsulin levels in serum, plasma, and A human chorionic gonadotropin (HCG) urine. Measurements of C-peptides of test system is a device intended for the proinsulin are used in the diagnosis early detection of pregnancy is intended to measure HCG, a placental and treatment of patients with abnor- hormone, in plasma or urine. mal insulin secretion, including diabe- (2) Classification. Class II. tes mellitus. (b) Human chorionic gonadotropin (b) Classification. Class I (general con- (HCG) test system intended for any uses trols). The device is exempt from the other than early detection of pregnancy— premarket notification procedures in (1) Identification. A human chorionic subpart E of part 807 of this chapter goadotropin (HCG) test system is a de- subject to § 862.9. vice intended for any uses other than early detection of pregnancy (such as [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] an aid in the diagnosis, prognosis, and management of treatment of persons § 862.1140 Calcitonin test system. with certain tumors or carcinomas) is intended to measure HCG, a placental (a) Identification. A calcitonin test hormone, in plasma or urine. system is a device intended to measure (2) Classification. Class III. the thyroid hormone calcitonin (3) Date PMA or notice of completion of (thyrocalcitonin) levels in plasma and a PDP is required. As of the enactment serum. Calcitonin measurements are date of the amendments, May 28, 1976, used in the diagnosis and treatment of an approval under section 515 of the act diseases involving the thyroid and is required before the device described parathyroid glands, including car- in paragraph (b)(1) may be commer- cinoma and hyperparathyroidism (ex- cially distributed. See § 862.3. cessive activity of the parathyroid gland). § 862.1160 Bicarbonate/carbon dioxide test system. (b) Classification. Class II. (a) Identification. A bicarbonate/car- § 862.1145 Calcium test system. bon dioxide test system is a device intended to measure bicarbonate/carbon (a) Identification. A calcium test sys- dioxide in plasma, serum, and whole tem is a device intended to measure blood. Bicarbonate/carbon dioxide the total calcium level in serum. Cal- measurements are used in the diag- cium measurements are used in the di- nosis and treatment of numerous po- agnosis and treatment of parathyroid tentially serious disorders associated disease, a variety of bone diseases, with changes in body acid-base bal- chronic renal disease and tetany (inter- ance. mittent muscular contractions or (b) Classification. Class II. spasms). (b) Classification. Class II. § 862.1163 Cardiac allograft gene expression profiling test system. § 862.1150 Calibrator. (a) Identification. A cardiac allograft (a) Identification. A calibrator is a de- gene expression profiling test system is vice intended for medical purposes for a device that measures the ribonucleic acid (RNA) expression level of multiple use in a test system to establish points genes and combines this information to of reference that are used in the deter- yield a signature (pattern, classifier, mination of values in the measurement index, score) to aid in the identifica- of substances in human specimens. (See tion of a low probability of acute cel- also § 862.2 in this part.) lular rejection (ACR) in heart trans- (b) Classification. Class II. plant recipients with stable allograft function.

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(b) Classification. Class II (special subpart E of part 807 of this chapter controls). The special control is FDA’s subject to § 862.9. guidance document entitled ‘‘Class II Special Controls Guidance Document: [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] Cardiac Allograft Gene Expression Profiling Test Systems.’’ See § 862.1(d) § 862.1177 Cholylglycine test system. for the availability of this guidance document. (a) Identification. A cholylglycine test system is a device intended to measure [74 FR 53885, Oct. 21, 2009] the bile acid cholylglycine in serum. Measurements obtained by this device § 862.1165 Catecholamines (total) test are used in the diagnosis and treat- system. ment of liver disorders, such as cir- (a) Identification. A catecholamines rhosis or obstructive liver disease. (total) test system is a device intended (b) Classification. Class II. to determine whether a group of similar compounds (epinephrine, § 862.1180 Chymotrypsin test system. norepinephrine, and dopamine) are present in urine and plasma. (a) Identification. A chymotrypsin Catecholamine determinations are test system is a device intended to used in the diagnosis and treatment of measure the activity of the enzyme adrenal medulla and hypertensive dis- chymotrypsin in blood and other body orders, and for catecholamine-secret- fluids and in feces. Chymotrypsin ing tumors (pheochromo-cytoma, neu- measurements are used in the diag- roblastoma, ganglioneuroma, and nosis and treatment of pancreatic exo- retinoblastoma). crine insufficiency. (b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to § 862.9. subject to § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] FR 2305, Jan. 14, 2000]

§ 862.1170 Chloride test system. § 862.1185 Compound S (11- (a) Identification. A chloride test sys- deoxycortisol) test system. tem is a device intended to measure (a) Identification. A compound S (11- the level of chloride in plasma, serum, dioxycortisol) test system is a device sweat, and urine. Chloride measure- intended to measure the level of comments are used in the diagnosis and pound S (11-dioxycortisol) in plasma. treatment of electrolyte and metabolic Compound S is a steroid intermediate disorders such as cystic fibrosis and di- in the biosynthesis of the adrenal hor- abetic acidosis. mone cortisol. Measurements of com- (b) Classification. Class II. pound S are used in the diagnosis and treatment of certain adrenal and pitui- § 862.1175 Cholesterol (total) test system. tary gland disorders resulting in clinical symptoms of masculinization and (a) Identification. A cholesterol (total) hypertension. test system is a device intended to (b) Classification. Class I (general con- measure cholesterol in plasma and trols). The device is exempt from the serum. Cholesterol measurements are premarket notification procedures in used in the diagnosis and treatment of subpart E of part 807 of this chapter disorders involving excess cholesterol subject to § 862.9. in the blood and lipid and lipoprotein metabolism disorders. [52 FR 16122, May 1, 1987, as amended at 65 (b) Classification. Class I (general con- FR 2305, Jan. 14, 2000] trols). The device is exempt from the premarket notification procedures in

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§ 862.1187 Conjugated sulfolithocholic plasma. Measurements of corticos- acid (SLCG) test system. terone are used in the diagnosis and (a) Identification. A conjugated treatment of adrenal disorders such as sulfolithocholic acid (SLCG) test sys- adrenal cortex disorders and blocks in tem is a device intended to measure cortisol synthesis. the bile acid SLCG in serum. Measure- (b) Classification. Class I (general con- ments obtained by this device are used trols). The device is exempt from the in the diagnosis and treatment of liver premarket notification procedures in disorders, such as cirrhosis or obstruc- subpart E of part 807 of this chapter tive liver disease. subject to § 862.9. (b) Classification. Class II. [52 FR 16122, May 1, 1987, as amended at 65 FR 2305, Jan. 14, 2000] § 862.1190 Copper test system. (a) Identification. A copper test sys- § 862.1205 Cortisol (hydrocortisone tem is a device intended to measure and hydroxycorticosterone) test copper levels in plasma, serum, and system. urine. Measurements of copper are used (a) Identification. A cortisol (hydro- in the diagnosis and treatment of ane- cortisone and hydroxycorticosterone) mia, infections, inflammations, and test system is a device intended to Wilson’s disease (a hereditary disease measure the cortisol hormones se- primarily of the liver and nervous sys- creted by the adrenal gland in plasma tem). Test results are also used in mon- and urine. Measurements of cortisol itoring patients with Hodgkin’s disease are used in the diagnosis and treat- (a disease primarily of the lymph sys- ment of disorders of the adrenal gland. tem). (b) Classification. Class II. (b) Classification. Class I (general controls). The device is exempt from the § 862.1210 Creatine test system. premarket notification procedures in (a) Identification. A creatine test sys- subpart E of part 807 of this chapter tem is a device intended to measure subject to the limitations in § 862.9. creatine (a substance synthesized in [52 FR 16122, May 1, 1987, as amended at 53 the liver and pancreas and found in bio- FR 21449, June 8, 1988; 66 FR 38787, July 25, logical fluids) in plasma, serum, and 2001] urine. Measurements of creatine are used in the diagnosis and treatment of § 862.1195 Corticoids test system. muscle diseases and endocrine dis- (a) Identification. A corticoids test orders including hyperthyroidism. system is a device intended to measure (b) Classification. Class I (general con- the levels of corticoids (hormones of trols). The device is exempt from the the adrenal cortex) in serum and p premarket notification procedures in lasma. Measurements of corticoids are subpart E of part 807 of this chapter used in the diagnosis and treatment of subject to the limitations in § 862.9. disorders of the cortex of the adrenal glands, especially those associated [52 FR 16122, May 1, 1987, as amended at 53 with hypertension and electrolyte dis- FR 21449, June 8, 1988; 66 FR 38787, July 25, 2001] turbances. (b) Classification. Class I (general con- § 862.1215 Creatine phosphokinase/cre- trols). The device is exempt from the atine kinase or isoenzymes test sys- premarket notification procedures in tem. subpart E of part 807 of this chapter (a) Identification. A creatine subject to § 862.9. phosphokinase/creatine kinase or [52 FR 16122, May 1, 1987, as amended at 65 isoenzymes test system is a device in- FR 2305, Jan. 14, 2000] tended to measure the activity of the enzyme creatine phosphokinase or its § 862.1200 Corticosterone test system. isoenzymes (a group of enzymes with (a) Identification. A corticosterone similar biological activity) in plasma test system is a device intended to and serum. Measurements of creatine measure corticosterone (a steroid se- phosphokinase and its isoenzymes are creted by the adrenal gland) levels in used in the diagnosis and treatment of

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myocardial infarction and muscle dis- agnosis of cystinuria (occurrence of eases such as progressive, Duchenne- cystine in urine). Patients with type muscular dystrophy. cystinuria frequently develop kidney (b) Classification. Class II. calculi (stones). (b) Classification. Class I (general con- § 862.1225 Creatinine test system. trols). The device is exempt from the (a) Identification. A creatinine test premarket notification procedures in system is a device intended to measure subpart E of part 807 of this chapter creatinine levels in plasma and urine. subject to § 862.9. Creatinine measurements are used in [52 FR 16122, May 1, 1987, as amended at 65 the diagnosis and treatment of renal FR 2305, Jan. 14, 2000] diseases, in monitoring renal dialysis, and as a calculation basis for meas- § 862.1245 Dehydroepiandrosterone uring other urine analytes. (free and sulfate) test system. (b) Classification. Class II. (a) Identification. A dehydroepiandrosterone (free and sul- § 862.1230 Cyclic AMP test system. fate) test system is a device intended (a) Identification. A cyclic AMP test to measure dehydroepiandrosterone system is a device intended to measure (DHEA) and its sulfate in urine, serum, the level of adenosine 3′, 5′- plasma, and amniotic fluid. monophosphate (cyclic AMP) in plas- Dehydroepiandrosterone measurements ma, urine, and other body fluids. Cyclic are used in the diagnosis and treat- AMP measurements are used in the di- ment of DHEA-secreting adrenal car- agnosis and treatment of endocrine dis- cinomas. orders, including hyperparathyroidism (b) Classification. Class I (general con- (overactivity of the parathyroid gland). trols). The device is exempt from the Cyclic AMP measurements may also be premarket notification procedures in used in the diagnosis and treatment of subpart E of part 807 of this chapter Graves’ disease (a disorder of the thy- subject to § 862.9. roid) and in the differentiation of [52 FR 16122, May 1, 1987, as amended at 65 causes of hypercalcemia (elevated lev- FR 2306, Jan. 14, 2000] els of serum calcium.) (b) Classification. Class II. § 862.1250 Desoxycorticosterone test system. § 862.1235 Cyclosporine test system. (a) Identification. A (a) Identification. A cyclosporine test desoxycorticosterone test system is a system is a device intended to quan- device intended to measure titatively determine cyclosporine con- desoxycorticosterone (DOC) in plasma centrations as an aid in the manage- and urine. DOC measurements are used ment of transplant patients receiving in the diagnosis and treatment of pa- therapy with this drug. This generic tients with hypermineralocorticoidism type of device includes immunoassays (excess retention of sodium and loss of and chromatographic assays for potassium) and other disorders of the cyclosporine. adrenal gland. (b) Classification. Class II (special (b) Classification. Class I (general con- controls). The special control is ‘‘Class trols). The device is exempt from the II Special Controls Guidance Docu- premarket notification procedures in ment: Cyclosporine and Tacrolimus As- subpart E of part 807 of this chapter says; Guidance for Industry and FDA.’’ subject to § 862.9. See § 862.1(d) for the availability of this guidance document. [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] [67 FR 58329, Sept. 16, 2002] § 862.1255 2,3-Diphosphoglyceric acid § 862.1240 Cystine test system. test system. (a) Identification. A cystine test sys- (a) Identification. A 2,3- tem is a device intended to measure diphosphoglyceric acid test system is a the amino acid cystine in urine. Cys- device intended to measure 2,3- tine measurements are used in the di- diphosphoglyceric acid (2,3-DPG) in

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erythrocytes (red blood cells). Meas- of total estrogens are used to aid in the urements of 2,3-diphosphoglyceric acid diagnosis and treatment of are used in the diagnosis and treat- fetoplacental distress in certain cases ment of blood disorders that affect the of high-risk pregnancy. delivery of oxygen by erythrocytes to (b) Classification. Class I (general con- tissues and in monitoring the quality trols). The device is exempt from the of stored blood. premarket notification procedures in (b) Classification. Class I (general con- subpart E of part 807 of this chapter trols). The device is exempt from the subject to § 862.9. premarket notification procedures in subpart E of part 807 of this chapter [52 FR 16122, May 1, 1987, as amended at 65 subject to the limitations in § 862.9. FR 2306, Jan. 14, 2000] [52 FR 16122, May 1, 1987, as amended at 53 § 862.1275 Estrogens (total, nonpreg- FR 21449, June 8, 1988; 66 FR 38787, July 25, nancy) test system. 2001] (a) Identification. As estrogens (total, § 862.1260 Estradiol test system. nonpregnancy) test system is a device (a) Identification. An estradiol test intended to measure the level of estro- system is a device intended to measure gens (total estrone, estradiol, and es- estradiol, an estrogenic steroid, in triol) in plasma, serum, and urine of plasma. Estradiol measurements are males and nonpregnant females. Meas- used in the diagnosis and treatment of urement of estrogens (total, nonpreg- various hormonal sexual disorders and nancy) is used in the diagnosis and in assessing placental function in com- treatment of numerous disorders, in- plicated pregnancy. cluding infertility, amenorrhea (ab- (b) Classification. Class I (general con- sence of menses) differentiation of pri- trols). The device is exempt from the mary and secondary ovarian malfunc- premarket notification procedures in tion, estrogen secreting testicular and subpart E of part 807 of this chapter ovarian tumors, and precocious pu- subject to § 862.9. berty in females. [52 FR 16122, May 1, 1987, as amended at 65 (b) Classification. Class I (general con- FR 2306, Jan. 14, 2000] trols). The device is exempt from the premarket notification procedures in § 862.1265 Estriol test system. subpart E of part 807 of this chapter (a) Identification. An estriol test sys- subject to § 862.9. tem is a device intended to measure es- [52 FR 16122, May 1, 1987, as amended at 65 triol, an estrogenic steroid, in plasma, FR 2306, Jan. 14, 2000] serum, and urine of pregnant females. Estriol measurements are used in the § 862.1280 Estrone test system. diagnosis and treatment of (a) Identification. An estrone test sys- fetoplacental distress in certain cases tem is a device intended to measure of high-risk pregnancy. estrone, an estrogenic steroid, in plas- (b) Classification. Class I (general con- ma. Estrone measurements are used in trols). The device is exempt from the premarket notification procedures in the diagnosis and treatment of numer- subpart E of part 807 of this chapter ous disorders, including infertility, subject to § 862.9. amenorrhea, differentiation of primary and secondary ovarian malfunction, es- [52 FR 16122, May 1, 1987, as amended at 65 trogen secreting testicular and ovarian FR 2306, Jan. 14, 2000] tumors, and precocious puberty in females. § 862.1270 Estrogens (total, in pregnancy) test system. (b) Classification. Class I (general controls). The device is exempt from the (a) Identification. As estrogens (total, premarket notification procedures in in pregnancy) test system is a device subpart E of part 807 of this chapter intended to measure total estrogens in subject to § 862.9. plasma, serum, and urine during pregnancy. The device primarily measures [52 FR 16122, May 1, 1987, as amended at 65 estrone plus estradiol. Measurements FR 2306, Jan. 14, 2000]

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§ 862.1285 Etiocholanolone test system. (b) Classification. Class I (general con- (a) Identification. An etiocholanolone trols). The device is exempt from the test system is a device intended to premarket notification procedures in measure etiocholanolone in serum and subpart E of part 807 of this chapter urine. Etiocholanolone is a metabolic subject to § 862.9. product of the hormone testosterone [52 FR 16122, May 1, 1987, as amended at 65 and is excreted in the urine. FR 2306, Jan. 14, 2000] Etiocholanolone measurements are used in the diagnosis and treatment of § 862.1305 Formiminoglutamic acid disorders of the testes and ovaries. (FIGLU) test system. (b) Classification. Class I (general con- (a) Identification. A trols). The device is exempt from the formiminoglutamic acid (FIGLU) test premarket notification procedures in system is a device intended to measure subpart E of part 807 of this chapter formiminolutamic acid in urine. subject to § 862.9. FIGLU measurements obtained by this [52 FR 16122, May 1, 1987, as amended at 65 device are used in the diagnosis of FR 2306, Jan. 14, 2000] anemias, such as pernicious anemia and congenital hemolytic anemia. § 862.1290 Fatty acids test system. (b) Classification. Class I (general con- (a) Identification. A fatty acids test trols). The device is exempt from the system is a device intended to measure premarket notification procedures in fatty acids in plasma and serum. Meas- subpart E of part 807 of this chapter urements of fatty acids are used in the subject to the limitations in § 862.9. diagnosis and treatment of various dis- [52 FR 16122, May 1, 1987, as amended at 53 orders of lipid metabolism. FR 21449, June 8, 1988; 66 FR 38787, July 25, (b) Classification. Class I (general con- 2001] trols). The device is exempt from the premarket notification procedures in § 862.1310 Galactose test system. subpart E of part 807 of this chapter (a) Identification. A galactose test subject to the limitations in § 862.9. system is a device intended to measure [52 FR 16122, May 1, 1987, as amended at 53 galactose in blood and urine. Galactose FR 21449, June 8, 1988; 66 FR 38787, July 25, measurements are used in the diag- 2001] nosis and treatment of the hereditary disease galactosemia (a disorder of ga- § 862.1295 Folic acid test system. lactose metabolism) in infants. (a) Identification. A folic acid test sys- (b) Classification. Class I. tem is a device intended to measure the vitamin folic acid in plasma and § 862.1315 Galactose-1-phosphate serum. Folic acid measurements are uridyl transferase test system. used in the diagnosis and treatment of (a) Identification. A galactose-1-phos- megaloblastic anemia, which is charac- phate uridyl transferase test system is terized by the presence of megaloblasts a device intended to measure the activ- (an abnormal red blood cell series) in ity of the enzyme galactose-1-phos- the bone marrow. phate uridyl transferase in (b) Classification. Class II. erythrocytes (red blood cells). Meas- [52 FR 16122, May 1, 1987; 53 FR 11645, Apr. 8, urements of galactose-1-phosphate 1988] uridyl transferase are used in the diagnosis and treatment of the hereditary § 862.1300 Follicle-stimulating hor- disease galactosemia (disorder of galac- mone test system. tose metabolism) in infants. (a) Identification. A follicle-stimu- (b) Classification. Class II. lating hormone test system is a device intended to measure follicle-stimu- § 862.1320 Gastric acidity test system. lating hormone (FSH) in plasma, (a) Identification. A gastric acidity serum, and urine. FSH measurements test system is a device intended to are used in the diagnosis and treat- measure the acidity of gastric fluid. ment of pituitary gland and gonadal Measurements of gastric acidity are disorders. used in the diagnosis and treatment of

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patients with peptic ulcer, Zollinger- cluding diabetes mellitus, hypo- Ellison syndrome (peptic ulcer due to glycemia, and hyperglycemia. gastrin-secreting tumor of the pan- (b) Classification. Class I (general con- creas), and related gastric disorders. trols). The device is exempt from the (b) Classification. Class I (general con- premarket notification procedures in trols). The device is exempt from the subpart E of part 807 of this chapter premarket notification procedures in subject to § 862.9. subpart E of part 807 of this chapter [52 FR 16122, May 1, 1987, as amended at 65 subject to the limitations in § 862.9. FR 2306, Jan. 14, 2000] [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38787, July 25, § 862.1340 Urinary glucose (non- 2001] quantitative) test system. (a) Identification. A urinary glucose § 862.1325 Gastrin test system. (nonquantitative) test system is a de- (a) Identification. A gastrin test sys- vice intended to measure glucosuria tem is a device intended to measure (glucose in urine). Urinary glucose the hormone gastrin in plasma and (nonquantitative) measurements are serum. Measurements of gastrin are used in the diagnosis and treatment of used in the diagnosis and treatment of carbohydrate metabolism disorders in- patients with ulcers, pernicious ane- cluding diabetes mellitus, hypo- mia, and the Zollinger-Ellison syn- glycemia, and hyperglycemia. drome (peptic ulcer due to a gastrin-se- (b) Classification. Class II. creting tumor of the pancreas). (b) Classification. Class I (general con- § 862.1345 Glucose test system. trols). The device is exempt from the (a) Identification. A glucose test sys- premarket notification procedures in tem is a device intended to measure subpart E of part 807 of this chapter glucose quantitatively in blood and subject to § 862.9. other body fluids. Glucose measure- [52 FR 16122, May 1, 1987, as amended at 65 ments are used in the diagnosis and FR 2306, Jan. 14, 2000] treatment of carbohydrate metabolism disorders including diabetes mellitus, § 862.1330 Globulin test system. neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet (a) Identification. A globulin test sys- cell carcinoma. tem is a device intended to measure globulins (proteins) in plasma and (b) Classification. Class II. serum. Measurements of globulin are § 862.1350 Continuous glucose monitor used in the diagnosis and treatment of secondary display. patients with numerous illnesses including severe liver and renal disease, (a) Identification. A continuous glu- multiple myeloma, and other disorders cose monitor secondary display is iden- of blood globulins. tified as a device intended to be used (b) Classification. Class I (general con- for passive real-time monitoring of trols). The device is exempt from the continuous glucose monitoring data. It premarket notification procedures in must not be capable of serving as a subpart E of part 807 of this chapter stand-alone primary display device. subject to § 862.9. The primary display device, which is not a part of the continuous glucose [52 FR 16122, May 1, 1987, as amended at 65 monitor secondary display, directly re- FR 2306, Jan. 14, 2000] ceives the glucose data (for example, it communicates directly with trans- § 862.1335 Glucagon test system. mitter) from the continuous glucose (a) Identification. A glucagon test sys- meter, which is not a part of the con- tem is a device intended to measure tinuous glucose monitor secondary dis- the pancreatic hormone glucagon in play, and is the primary means of view- plasma and serum. Glucagon measure- ing the continuous glucose monitor ments are used in the diagnosis and data and alerting the patient to a low treatment of patients with various dis- or high glucose value. A continuous orders of carbohydrate metabolism, in- glucose monitor secondary display can

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be used by caregivers of people with di- § 862.1365 Glutathione test system. abetes to monitor a person’s contin- (a) Identification. A glutathione test uous glucose monitoring data. A device system is a device intended to measure is not a continuous glucose monitor glutathione (the tripeptide of glycine, secondary display if the data from the cysteine, and glutamic acid) in primary display device is modified (for erythrocytes (red blood cells). Gluta- example, predicting future glucose val- thione measurements are used in the ues) or the patient can use the sec- diagnosis and treatment of certain ondary display in lieu of a primary dis- drug-induced hemolytic (erythrocyte play device (for example, the primary destroying) anemias due to an inher- display device is blinded or the pri- ited enzyme deficiency. mary display does not have to be near (b) Classification. Class I (general con- the person wearing the sensor and trols). The device is exempt from the transmitter). premarket notification procedures in (b) Classification. Class II (special subpart E of part 807 of this chapter controls). The special controls for this subject to the limitations in § 862.9 device are: [52 FR 16122, May 1, 1987, as amended at 53 (1) Devices being marketed must in- FR 21449, June 8, 1988; 66 FR 38787, July 25, clude appropriate measures to protect 2001] against unauthorized access to data and unauthorized modification of data. § 862.1370 Human growth hormone test system. (2) The labeling must prominently and conspicuously display a warning (a) Identification. A human growth that states ‘‘Dosing decisions should hormone test system is a device in- not be made based on this device. The tended to measure the levels of human user should follow instructions on the growth hormone in plasma. Human growth hormone measurements are continuous glucose monitoring sys- used in the diagnosis and treatment of tem.’’ disorders involving the anterior lobe of (3) The labeling for the device must the pituitary gland. include a statement that reads ‘‘This (b) Classification. Class I (general con- device is not intended to replace self- trols). The device is exempt from the monitoring practices as advised by a premarket notification procedures in physician.’’ subpart E of part 807 of this chapter [82 FR 13550, Mar. 14, 2017] subject to § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 § 862.1360 Gamma-glutamyl FR 2306, Jan. 14, 2000] transpeptidase and isoenzymes test system. § 862.1373 Hemoglobin A1c test system. (a) Identification. A gamma-glutamyl (a) Identification. A hemoglobin A1c transpeptidase and isoenzymes test test system is a device used to measure system is a device intended to measure the percentage concentration of hemo- the activity of the enzyme gamma- globin A1c in blood. Measurement of glutamyl transpeptidase (GGTP) in hemoglobin A1c is used as an aid in the plasma and serum. Gamma-glutamyl diagnosis of diabetes mellitus and as an transpeptidase and isoenzymes meas- aid in the identification of patients at urements are used in the diagnosis and risk for developing diabetes mellitus. treatment of liver diseases such as al- (b) Classification. Class II (special coholic cirrhosis and primary and sec- controls). The special controls for this ondary liver tumors. device are: (b) Classification. Class I (general con- (1) The device must have initial and annual standardization verification by trols). The device is exempt from the a certifying glycohemoglobin standard- premarket notification procedures in ization organization deemed acceptable subpart E of part 807 of this chapter by FDA. subject to § 862.9. (2) The premarket notification sub- [52 FR 16122, May 1, 1987, as amended at 65 mission must include performance FR 2306, Jan. 14, 2000] testing to evaluate precision, accuracy,

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linearity, and interference, including subpart E of part 807 of this chapter the following: subject to § 862.9. (i) Performance testing of device pre- [52 FR 16122, May 1, 1987, as amended at 65 cision must, at a minimum, use blood FR 2306, Jan. 14, 2000] samples with concentrations near 5.0 percent, 6.5 percent, 8.0 percent, and 12 § 862.1377 Urinary homocystine (non- percent hemoglobin A1c. This testing quantitative) test system. must evaluate precision over a min- (a) Identification. A urinary imum of 20 days using at least three homocystine (nonquantitative) test lots of the device and three instru- system is a device intended to identify ments, as applicable. homocystine (an analogue of the amino (ii) Performance testing of device ac- acid cystine) in urine. The identifica- curacy must include a minimum of 120 tion of urinary homocystine is used in blood samples that span the measuring the diagnosis and treatment of interval of the device and compare re- homocystinuria (homosystine in sults of the new device to results of a urine), a heritable metabolic disorder standardized test method. Results which may cause mental retardation. must demonstrate little or no bias (b) Classification. Class II. versus the standardized method. § 862.1380 Hydroxybutyric dehydro- (iii) Total error of the new device genase test system. must be evaluated using single measurements by the new device compared (a) Identification. A hydroxybutyric to results of the standardized test dehydrogenase test system is a device method, and this evaluation must dem- intended to measure the activity of the onstrate a total error less than or enzyme alpha-hydroxybutric dehydrogenase (HBD) in plasma or serum. HBD equal to 6 percent. measurements are used in the diag- (iv) Performance testing must dem- nosis and treatment of myocardial in- onstrate that there is little to no inter- farction, renal damage (such as rejec- ference from common hemoglobin tion of transplants), certain variants, including Hemoglobin C, He- hematological diseases (such as acute moglobin D, Hemoglobin E, Hemo- leukemias and megaloblastic anemias) globin A2, and Hemoglobin S. and, to a lesser degree, liver disease. (3) When assay interference from He- (b) Classification. Class I (general con- moglobin F or interference with other trols). The device is exempt from the hemoglobin variants with low fre- premarket notification procedures in quency in the population is observed, a subpart E of part 807 of this chapter warning statement must be placed in a subject to the limitations in § 862.9. black box and must appear in all labeling material for these devices describ- [52 FR 16122, May 1, 1987, as amended at 53 ing the interference and any affected FR 21449, June 8, 1988; 66 FR 38787, July 25, 2001] populations. [79 FR 50551, Aug. 25, 2014] § 862.1385 17-Hydroxycorticosteroids (17-ketogenic steroids) test system. § 862.1375 Histidine test system. (a) Identification. A 17-hydroxycorticosteroids (17-ketogenic steroids) (a) Identification. A histidine test sys- test system is a device intended to tem is a device intended to measure measure corticosteroids that possess a free histidine (an amino acid) in plas- dihydroxyacetone ma and urine. Histidine measurements are used in the diagnosis and treatment of hereditary histidinemia characterized by excess histidine in the blood and urine often resulting in mental retardation and disordered speech moiety on the steroid nucleus in urine. development. Corticosteroids with this chemical con- (b) Classification. Class I (general con- figuration include cortisol, cortisone trols). The device is exempt from the 11-desoxycortisol, premarket notification procedures in desoxycorticosterone, and their

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tetrahydroderivatives. This group of Hydroxyproline measurements are used hormones is synthesized by the adrenal in the diagnosis and treatment of var- gland. Measurements of 17-hydroxy- ious collagen (connective tissue) dis- corticosteroids (17-ketogenic steroids) eases, bone disease such as Paget’s dis- are used in the diagnosis and treat- ease, and endocrine disorders such as ment of various diseases of the adrenal hyperparathyroidism and hyper- or pituitary glands and gonadal dis- thyroidism. orders. (b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to § 862.9. subject to § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 [52 FR 16122, May 1, 1987; 52 FR 29468, Aug. 7, FR 2306, Jan. 14, 2000] 1987, as amended at 65 FR 2306, Jan. 14, 2000] § 862.1405 Immunoreactive insulin test § 862.1390 5-Hydroxyindole acetic acid/ system. serotonin test system. (a) Identification. An immunoreactive (a) Identification. A 5-hydroxyindole insulin test system is a device intended acetic acid/serotonin test system is a to measure immunoreactive insulin in device intended to measure 5- serum and plasma. Immunoreactive in- hydroxyindole acetic acid/serotonin in sulin measurements are used in the di- urine. Measurements of 5- agnosis and treatment of various car- hydroxyindole acetic acid/serotonin are bohydrate metabolism disorders, in- used in the diagnosis and treatment of cluding diabetes mellitus, and hypo- carcinoid tumors of endocrine tissue. glycemia. (b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to § 862.9. subject to § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 [52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000] FR 2306, Jan. 14, 2000]

§ 862.1395 17-Hydroxyprogesterone § 862.1410 Iron (non-heme) test system. test system. (a) Identification. An iron (non-heme) (a) Identification. A 17- test system is a device intended to hydroxyprogesterone test system is a measure iron (non-heme) in serum and device intended to measure 17- plasma. Iron (non-heme) measurements hydroxyprogesterone (a steroid) in are used in the diagnosis and treat- plasma and serum. Measurements of 17- ment of diseases such as iron defi- hydroxyprogesterone are used in the ciency anemia, hemochromatosis (a diagnosis and treatment of various dis- disease associated with widespread de- orders of the adrenal glands or the ova- posit in the tissues of two iron-con- ries. taining pigments, hemosiderin and (b) Classification. Class I (general con- hemofuscin, and characterized by pig- trols). The device is exempt from the mentation of the skin), and chronic premarket notification procedures in renal disease. subpart E of part 807 of this chapter (b) Classification. Class I. subject to § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 § 862.1415 Iron-binding capacity test FR 2306, Jan. 14, 2000] system. (a) Identification. An iron-binding ca- § 862.1400 Hydroxyproline test system. pacity test system is a device intended (a) Identification. A hydroxyproline to measure iron-binding capacity in test system is a device intended to serum. Iron-binding capacity measure- measure the amino acid ments are used in the diagnosis and hydroxyproline in urine. treatment of anemia.

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(b) Classification. Class I. ketogenic diets and patients with diabetes. § 862.1420 Isocitric dehydrogenase test (b) Classification. Class I (general con- system. trols). The device is exempt from the (a) Identification. An isocitric dehy- premarket notification procedures in drogenase test system is a device in- subpart E of part 807 of this chapter tended to measure the activity of the subject to § 862.9. enzyme isocitric dehydrogenase in serum and plasma. Isocitric dehydro- [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] genase measurements are used in the diagnosis and treatment of liver dis- § 862.1440 Lactate dehydrogenase test ease such as viral hepatitis, cirrhosis, system. or acute inflammation of the biliary tract; pulmonary disease such as pul- (a) Identification. A lactate dehydro- monary infarction (local arrest or sud- genase test system is a device intended den insufficiency of the blood supply to to measure the activity of the enzyme the lungs), and diseases associated with lactate dehydrogenase in serum. Lac- pregnancy. tate dehydrogenase measurements are (b) Classification. Class I (general con- used in the diagnosis and treatment of trols). The device is exempt from the liver diseases such as acute viral hepa- premarket notification procedures in titis, cirrhosis, and metastatic car- subpart E of part 807 of this chapter cinoma of the liver, cardiac diseases subject to the limitations in § 862.9. such as myocardial infarction, and tumors of the lung or kidneys. [52 FR 16122, May 1, 1987, as amended at 53 (b) Classification. Class II (special FR 21449, June 8, 1988; 66 FR 38788, July 25, controls). The device is exempt from 2001] the premarket notification procedures § 862.1430 17-Ketosteroids test system. in subpart E of part 807 of this chapter subject to § 862.9. (a) Identification. A 17-ketosteroids test system is a device intended to [52 FR 16122, May 1, 1987, as amended at 63 measure 17-ketosteroids in urine. Meas- FR 59225, Nov. 3, 1998] urements of 17-ketosteroids are used in the diagnosis and treatment of dis- § 862.1445 Lactate dehydrogenase orders of the adrenal cortex and gonads isoenzymes test system. and of other endocrine disorders, in- (a) Identification. A lactate dehydro- cluding hypertension, diabetes, and genase isoenzymes test system is a de- hypothyroidism. vice intended to measure the activity (b) Classification. Class I (general con- of lactate dehydrogenase isoenzymes (a trols). The device is exempt from the group of enzymes with similar biologi- premarket notification procedures in cal activity) in serum. Measurements subpart E of part 807 of this chapter of lactate dehydrogenase isoenzymes subject to § 862.9. are used in the diagnosis and treatment of liver diseases, such as viral [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] hepatitis, and myocardial infarction. (b) Classification. Class II. § 862.1435 Ketones (nonquantitative) test system. § 862.1450 Lactic acid test system. (a) Identification. A ketones (non- (a) Identification. A lactic acid test quantitative) test system is a device system is a device intended to measure intended to identify ketones in urine lactic acid in whole blood and plasma. and other body fluids. Identification of Lactic acid measurements that evalu- ketones is used in the diagnosis and ate the acid-base status are used in the treatment of acidosis (a condition diagnosis and treatment of lactic aci- characterized by abnormally high acid- dosis (abnormally high acidity of the ity of body fluids) or ketosis (a condi- blood). tion characterized by increased produc- (b) Classification. Class I (general con- tion of ketone bodies such as acetone) trols). The device is exempt from the and for monitoring patients on premarket notification procedures in

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subpart E of part 807 of this chapter in serum and plasma. Lipid (total) subject to § 862.9. measurements are used in the diagnosis and treatment of various diseases [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] involving lipid metabolism and atherosclerosis. § 862.1455 Lecithin/sphingomyelin (b) Classification. Class I (general con- ratio in amniotic fluid test system. trols). The device is exempt from the (a) Identification. A lecithin/ premarket notification procedures in sphingomyelin ratio in amniotic fluid subpart E of part 807 of this chapter test system is a device intended to subject to the limitations in § 862.9. measure the lecithin/sphingomyelin [52 FR 16122, May 1, 1987, as amended at 53 ratio in amniotic fluid. Lecithin and FR 21449, June 8, 1988; 66 FR 38788, July 25, sphingomyelin are phospholipids (fats 2001] or fat-like substances containing phosphorus). Measurements of the lecithin/ § 862.1475 Lipoprotein test system. sphingomyelin ratio in amniotic fluid (a) Identification. A lipoprotein test are used in evaluating fetal maturity. system is a device intended to measure (b) Classification. Class II. lipoprotein in serum and plasma. § 862.1460 Leucine aminopeptidase Lipoprotein measurements are used in test system. the diagnosis and treatment of lipid disorders (such as diabetes mellitus), (a) Identification. A leucine atherosclerosis, and various liver and aminopeptidase test system is a device renal diseases. intended to measure the activity of the enzyme leucine amino-peptidase in (b) Classification. Class I (general con- serum, plasma, and urine. Leucine trols). The device is exempt from the aminopeptidase measurements are used premarket notification procedures in in the diagnosis and treatment of liver subpart E of part 807 of this chapter diseases such as viral hepatitis and ob- subject to § 862.9. structive jaundice. [52 FR 16122, May 1, 1987, as amended at 65 (b) Classification. Class I (general con- FR 2307, Jan. 14, 2000] trols). The device is exempt from the premarket notification procedures in § 862.1485 Luteinizing hormone test subpart E of part 807 of this chapter system. subject to § 862.9. (a) Identification. A luteinizing hor- [52 FR 16122, May 1, 1987, as amended at 65 mone test system is a device intended FR 2307, Jan. 14, 2000] to measure luteinizing hormone in serum and urine. Luteinizing hormone § 862.1465 Lipase test system. measurements are used in the diag- (a) Identification. A lipase test system nosis and treatment of gonadal dys- is a device intended to measure the ac- function. tivity of the enzymes lipase in serum. (b) Classification. Class I (general con- Lipase measurements are used in diag- trols). The device is exempt from the nosis and treatment of diseases of the premarket notification procedures in pancreas such as acute pancreatitis subpart E of part 807 of this chapter and obstruction of the pancreatic duct. subject to § 862.9. (b) Classification. Class I (general con- [52 FR 16122, May 1, 1987, as amended at 65 trols). The device is exempt from the FR 2307, Jan. 14, 2000] premarket notification procedures in subpart E of part 807 of this chapter § 862.1490 Lysozyme (muramidase) test subject to § 862.9. system. [52 FR 16122, May 1, 1987, as amended at 65 (a) Identification. A lysozyme FR 2307, Jan. 14, 2000] (muramidase) test system is a device intended to measure the activity of the § 862.1470 Lipid (total) test system. bacteriolytic enzyme lysozyme (a) Identification. A lipid (total) test (muramidase) in serum, plasma, leu- system is a device intended to measure kocytes, and urine. Lysozyme measure- total lipids (fats or fat-like substances) ments are used in the diagnosis and

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treatment of monocytic leukemia and (b) Classification. Class I (general con- kidney disease. trols). The device is exempt from the (b) Classification. Class I (general con- premarket notification procedures in trols). The device is exempt from the subpart E of part 807 of this chapter premarket notification procedures in subject to § 862.9. subpart E of part 807 of this chapter subject to the limitations in § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, § 862.1509 Methylmalonic acid (non- 2001] quantitative) test system. § 862.1495 Magnesium test system. (a) Identification. A methylmalonic acid (nonquantitative) test system is a (a) Identification. A magnesium test device intended to identify system is a device intended to measure methylmalonic acid in urine. The iden- magnesium levels in serum and plas- tification of methylmalonic acid in ma. Magnesium measurements are used urine is used in the diagnosis and in the diagnosis and treatment of treatment of methylmalonic aciduria, hypomagnesemia (abnormally low plasma levels of magnesium) and a heritable metabolic disorder which, if hypermagnesemia (abnormally high untreated, may cause mental retarda- plasma levels of magnesium). tion. (b) Classification. Class I. (b) Classification. Class II.

§ 862.1500 Malic dehydrogenase test § 862.1510 Nitrite (nonquantitative) system. test system. (a) Identification. A malic dehydro- (a) Identification. A nitrite (non- genase test system is a device that is quantitative) test system is a device intended to measure the activity of the intended to identify nitrite in urine. enzyme malic dehydrogenase in serum Nitrite identification is used in the di- and plasma. Malic dehydrogenase agnosis and treatment of uninary tract measurements are used in the diag- infection of bacterial origin. nosis and treatment of muscle and (b) Classification. Class I (general con- liver diseases, myocardial infarctions, trols). The device is exempt from the cancer, and blood disorders such as premarket notification procedures in myelogenous (produced in the bone subpart E of part 807 of this chapter marrow) leukemia. subject to § 862.9. (b) Classification. Class I (general controls). The device is exempt from the [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] premarket notification procedures in subpart E of part 807 of this chapter § 862.1515 Nitrogen (amino-nitrogen) subject to § 862.9. test system. [52 FR 16122, May 1, 1987, as amended at 65 (a) Identification. A nitrogen (amino- FR 2307, Jan. 14, 2000] nitrogen) test system is a device intended to measure amino acid nitrogen § 862.1505 Mucopolysaccharides (nonquantitative) test system. levels in serum, plasma, and urine. Ni- trogen (amino-nitrogen) measurements (a) Identification. A are used in the diagnosis and treat- mucopolysaccharides (nonquantitative) ment of certain forms of severe liver test system is a device intended to disease and renal disorders. measure the levels of (b) Class I (general con- mucopolysaccharides in urine. Classification. Mucopolysaccharide measurements in trols). The device is exempt from the urine are used in the diagnosis and premarket notification procedures in treatment of various inheritable dis- subpart E of part 807 of this chapter orders that affect bone and connective subject to the limitations in § 862.9. tissues, such as Hurler’s, Hunter’s, [52 FR 16122, May 1, 1987, as amended at 53 Sanfilippo’s, Scheie’s Morquio’s and FR 21449, June 8, 1988; 66 FR 38788, July 25, Maroteaux-Lamy syndromes. 2001]

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§ 862.1520 5′-Nucleotidase test system. premarket notification procedures in (a) Identification. A 5′-nucleotidase subpart E of part 807 of this chapter test system is a device intended to subject to § 862.9. measure the activity of the enzyme 5′- [52 FR 16122, May 1, 1987, as amended at 65 nucleotidase in serum and plasma. FR 2307, Jan. 14, 2000] Measurements of 5′-nucleotidase are used in the diagnosis and treatment of § 862.1540 Osmolality test system. liver diseases and in the differentia- (a) Identification. An osmolality test tions between liver and bone diseases system is a device intended to measure in the presence of elevated serum alka- ionic and nonionic solute concentra- line phosphatase activity. tion in body fluids, such as serum and (b) Class I (general con- Classification. urine. Osmolality measurement is used trols). The device is exempt from the as an adjunct to other tests in the eval- premarket notification procedures in uation of a variety of diseases, includ- subpart E of part 807 of this chapter ing kidney diseases (e.g., chronic pro- subject to § 862.9. gressive renal failure), diabetes [52 FR 16122, May 1, 1987, as amended at 65 insipidus, other endocrine and meta- FR 2307, Jan. 14, 2000] bolic disorders, and fluid imbalances. (b) Classification. Class I (general con- § 862.1530 Plasma oncometry test system. trols). The device is exempt from the premarket notification procedures in (a) Identification. A plasma subpart E of part 807 of this chapter oncometry test system is a device in- subject to § 862.9. tended to measure plasma oncotic pressure. Plasma oncotic pressure is that [52 FR 16122, May 1, 1987, as amended at 65 portion of the total fluid pressure con- FR 2307, Jan. 14, 2000] tributed by proteins and other molecules too large to pass through a spec- § 862.1542 Oxalate test system. ified membrane. Measurements of plas- (a) Identification. An oxalate test sys- ma oncotic pressure are used in the di- tem is a device intended to measure agnosis and treatment of dehydration the concentration of oxalate in urine. and circulatory disorders related to Measurements of oxalate are used to low serum protein levels and increased aid in the diagnosis or treatment of capillary permeability, such as edema urinary stones or certain other meta- and shock. bolic disorders. (b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to § 862.9. subject to § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] § 862.1535 Ornithine carbamyl transferase test system. § 862.1545 Parathyroid hormone test system. (a) Identification. An ornithine carbamyl transferase test system is a (a) Identification. A parathyroid hor- device intended to measure the activ- mone test system is a device intended ity of the enzyme ornithine carbamyl to measure the levels of parathyroid transferase (OCT) in serum. Ornithine hormone in serum and plasma. Meas- carbamyl transferase measurements urements of parathyroid hormone lev- are used in the diagnosis and treat- els are used in the differential diag- ment of liver diseases, such as infec- nosis of hypercalcemia (abnormally tious hepatitis, acute cholecystitis (in- high levels of calcium in the blood) and flammation of the gall bladder), cir- hypocalcemia (abnormally low levels of rhosis, and liver metastases. calcium in the blood) resulting from (b) Classification. Class I (general con- disorders of calcium metabolism. trols). The device is exempt from the (b) Classification. Class II.

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§ 862.1550 Urinary pH (nonquantita- drogenase are used in the diagnosis and tive) test system. treatment of certain liver diseases (a) Identification. A urinary pH (non- (such as hepatitis) and anemias. quantitative) test system is a device (b) Classification. Class I (general con- intended to estimate the pH of urine. trols). The device is exempt from the Estimations of pH are used to evaluate premarket notification procedures in the acidity or alkalinity of urine as it subpart E of part 807 of this chapter relates to numerous renal and meta- subject to the limitations in § 862.9. bolic disorders and in the monitoring [52 FR 16122, May 1, 1987, as amended at 53 of patients with certain diets. FR 21449, June 8, 1988; 66 FR 38788, July 25, (b) Classification. Class I (general con- 2001] trols). The device is exempt from the premarket notification procedures in § 862.1570 Phosphohexose isomerase subpart E of part 807 of this chapter test system. subject to § 862.9. (a) Identification. A phosphohexose [52 FR 16122, May 1, 1987, as amended at 65 isomerase test system is a device in- FR 2307, Jan. 14, 2000] tended to measure the activity of the enzyme phosphohexose isomerase in § 862.1555 Phenylalanine test system. serum. Measurements of (a) Identification. A phenylalanine phosphohexose isomerase are used in test system is a device intended to the diagnosis and treatment of muscle measure free phenylalanine (an amino diseases such as muscular dystrophy, acid) in serum, plasma, and urine. liver diseases such as hepatitis or cir- Measurements of phenylalanine are rhosis, and metastatic carcinoma. used in the diagnosis and treatment of (b) Classification. Class I (general con- congenital phenylketonuria which, if trols). The device is exempt from the untreated, may cause mental retarda- premarket notification procedures in tion. subpart E of part 807 of this chapter (b) Classification. Class II. subject to § 862.9.

§ 862.1560 Urinary phenylketones [52 FR 16122, May 1, 1987, as amended at 65 (nonquantitative) test system. FR 2307, Jan. 14, 2000] (a) Identification. A urinary § 862.1575 Phospholipid test system. phenylketones (nonquantitative) test system is a device intended to identify (a) Identification. A phospholipid test phenylketones (such as phenylpyruvic system is a device intended to measure acid) in urine. The identification of phospholipids in serum and plasma. urinary phenylketones is used in the Measurements of phospholipids are diagnosis and treatment of congenital used in the diagnosis and treatment of phenylketonuria which, if untreated, disorders involving lipid (fat) metabo- may cause mental retardation. lism. (b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to § 862.9. subject to the limitations in § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 [52 FR 16122, May 1, 1987, as amended at 53 FR 2307, Jan. 14, 2000] FR 21449, June 8, 1988; 66 FR 38788, July 25, 2001] § 862.1565 6-Phosphogluconate dehydrogenase test system. § 862.1580 Phosphorus (inorganic) test (a) Identification. A 6- system. phosphogluconate dehydrogenase test (a) Identification. A phosphorus (inor- system is a device intended to measure ganic) test system is a device intended the activity of the enzyme 6- to measure inorganic phosphorus in phosphogluconate dehydrogenase (6 serum, plasma, and urine. Measure- PGD) in serum and erythrocytes. Meas- ments of phosphorus (inorganic) are urements of 6-phosphogluconate dehy- used in the diagnosis and treatment of

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various disorders, including parathy- diseases associated with disturbed por- roid gland and kidney diseases, and vi- phyrin metabolism), and other diseases tamin D imbalance. characterized by alterations in the (b) Classification. Class I. heme pathway. (b) Classification. Class I (general con- § 862.1585 Human placental lactogen trols). The device is exempt from the test system. premarket notification procedures in (a) Identification. A human placental subpart E of part 807 of this chapter lactogen test system is a device in- subject to § 862.9. tended to measure the hormone human placental lactogen (HPL), (also known [52 FR 16122, May 1, 1987, as amended at 65 as human chorionic FR 2308, Jan. 14, 2000] somatomammotrophin (HCS)), in ma- § 862.1600 Potassium test system. ternal serum and maternal plasma. Measurements of human placental (a) Identification. A potassium test lactogen are used in the diagnosis and system is a device intended to measure clinical management of high-risk preg- potassium in serum, plasma, and urine. nancies involving fetal distress associ- Measurements obtained by this device ated with placental insufficiency. are used to monitor electrolyte balance Measurements of HPL are also used in in the diagnosis and treatment of dis- pregnancies complicated by hyper- eases conditions characterized by low tension, proteinuria, edema, post-ma- or high blood potassium levels. turity, placental insufficiency, or pos- (b) Classification. Class II. sible miscarriage. (b) Classification. Class II. § 862.1605 Pregnanediol test system. (a) Identification. A pregnanediol test § 862.1590 Porphobilinogen test system. system is a device intended to measure pregnanediol (a major urinary meta- (a) Identification. A porphobilinogen bolic product of progesterone) in urine. test system is a device intended to Measurements obtained by this device measure porphobilinogen (one of the are used in the diagnosis and treat- derivatives of hemoglobin which can ment of disorders of the ovaries or pla- make the urine a red color) in urine. centa. Measurements obtained by this device (b) Classification. Class I (general con- are used in the diagnosis and treat- trols). The device is exempt from the ment of porphyrias (primarily inher- premarket notification procedures in ited diseases associated with disturbed subpart E of part 807 of this chapter porphyrine metabolism), lead poi- subject to § 862.9. soning, and other diseases characterized by alterations in the heme path- [52 FR 16122, May 1, 1987, as amended at 65 way. FR 2308, Jan. 14, 2000] (b) Classification. Class I (general controls). The device is exempt from the § 862.1610 Pregnanetriol test system. premarket notification procedures in (a) Identification. A pregnanetriol test subpart E of part 807 of this chapter system is a device intended to measure subject to § 862.9. pregnanetriol (a precursor in the biosynthesis of the adrenal hormone [52 FR 16122, May 1, 1987, as amended at 65 FR 2307, Jan. 14, 2000] cortisol) in urine. Measurements obtained by this device are used in the di- § 862.1595 Porphyrins test system. agnosis and treatment of congenital (a) Identification. A porphyrins test adrenal hyperplasia (congenital en- system is a device intended to measure largement of the adrenal gland). porphyrins (compounds formed during (b) Classification. Class I (general con- the biosynthesis of heme, a constituent trols). The device is exempt from the of hemoglobin, and related compounds) premarket notification procedures in in urine and feces. Measurements ob- subpart E of part 807 of this chapter tained by this device are used in the di- subject to § 862.9. agnosis and treatment of lead poi- [52 FR 16122, May 1, 1987, as amended at 65 soning, porphyrias (primarily inherited FR 2308, Jan. 14, 2000]

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§ 862.1615 Pregnenolone test system. urine, cerebrospinal fluid, and other (a) Identification. A pregnenolone test body fluids. Protein fractionations are system is a device intended to measure used as an aid in recognizing abnormal pregnenolone (a precursor in the bio- proteins in body fluids and genetic synthesis of the adrenal hormone variants of proteins produced in dis- cortisol and adrenal androgen) in eases with tissue destruction. serum and plasma. Measurements ob- (b) Classification. Class I (general contained by this device are used in the di- trols). The device is exempt from the agnosis and treatment of diseases of premarket notification procedures in the adrenal cortex or the gonads. subpart E of part 807 of this chapter (b) Classification. Class I (general con- subject to § 862.9. trols). The device is exempt from the [52 FR 16122, May 1, 1987, as amended at 65 premarket notification procedures in FR 2308, Jan. 14, 2000] subpart E of part 807 of this chapter subject to § 862.9. § 862.1635 Total protein test system. [52 FR 16122, May 1, 1987, as amended at 65 (a) Identification. A total protein test FR 2308, Jan. 14, 2000] system is a device intended to measure total protein(s) in serum or plasma. § 862.1620 Progesterone test system. Measurements obtained by this device (a) Identification. A progesterone test are used in the diagnosis and treat- system is a device intended to measure ment of a variety of diseases involving progesterone (a female hormone) in the liver, kidney, or bone marrow as serum and plasma. Measurements ob- well as other metabolic or nutritional tained by this device are used in the di- disorders. agnosis and treatment of disorders of (b) Classification. Class II (special the ovaries or placenta. controls). The device is exempt from (b) Classification. Class I (general con- the premarket notification procedures trols). The device is exempt from the in subpart E of part 807 of this chapter premarket notification procedures in subject to § 862.9. subpart E of part 807 of this chapter subject to § 862.9. [52 FR 16122, May 1, 1987, as amended at 63 FR 59225, Nov. 3, 1998] [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.1640 Protein-bound iodine test system. § 862.1625 Prolactin (lactogen) test system. (a) Identification. A protein-bound io- (a) Identification. A prolactin dine test system is a device intended to (lactogen) test system is a device in- measure protein-bound iodine in tended to measure the anterior pitui- serum. Measurements of protein-bound tary polypeptide hormone prolactin in iodine obtained by this device are used serum and plasma. Measurements ob- in the diagnosis and treatment of thy- tained by this device are used in the di- roid disorders. agnosis and treatment of disorders of (b) Classification. Class I (general con- the anterior pituitary gland or of the trols). The device is exempt from the hypothalamus portion of the brain. premarket notification procedures in (b) Classification. Class I (general con- subpart E of part 807 of this chapter trols). The device is exempt from the subject to the limitations in § 862.9. premarket notification procedures in [52 FR 16122, May 1, 1987, as amended at 53 subpart E of part 807 of this chapter FR 21449, June 8, 1988; 66 FR 38788, July 25, subject to § 862.9. 2001] [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.1645 Urinary protein or albumin (nonquantitative) test system. § 862.1630 Protein (fractionation) test (a) Identification. A urinary protein or system. albumin (nonquantitative) test system (a) Identification. A protein (fraction- is a device intended to identify pro- ation) test system is a device intended teins or albumin in urine. Identifica- to measure protein fractions in blood, tion of urinary protein or albumin

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(nonquantitative) is used in the diag- to detect systematic analytical devi- nosis and treatment of disease condi- ations that may arise from reagent or tions such as renal or heart diseases or analytical instrument variation. A thyroid disorders, which are character- quality control material (assayed and ized by proteinuria or albuminuria. unassayed) may be used for proficiency (b) Classification. Class I (general con- testing in interlaboratory surveys. trols). The device is exempt from the This generic type of device includes premarket notification procedures in controls (assayed and unassayed) for subpart E of part 807 of this chapter blood gases, electrolytes, enzymes, subject to § 862.9. multianalytes (all kinds), single (speci- [52 FR 16122, May 1, 1987, as amended at 65 fied) analytes, or urinalysis controls. FR 2308, Jan. 14, 2000] (b) Classification. Class I (general controls). Except when used in donor § 862.1650 Pyruvate kinase test system. screening tests, unassayed material is (a) Identification. A pyruvate kinase exempt from the premarket notifica- test system is a device intended to tion procedures in subpart E of part 807 measure the activity of the enzyme of this chapter subject to § 862.9. pyruvate kinase in erythrocytes (red blood cells). Measurements obtained by [52 FR 16122, May 1, 1987, as amended at 65 this device are used in the diagnosis FR 2308, Jan. 14, 2000] and treatment of various inherited anemias due to pyruvate kinase defi- § 862.1665 Sodium test system. ciency or of acute leukemias. (a) Identification. A sodium test sys- (b) Classification. Class I (general con- tem is a device intended to measure so- trols). The device is exempt from the dium in serum, plasma, and urine. premarket notification procedures in Measurements obtained by this device subpart E of part 807 of this chapter are used in the diagnosis and treat- subject to § 862.9. ment of aldosteronism (excessive secre- [52 FR 16122, May 1, 1987, as amended at 65 tion of the hormone aldosterone), dia- FR 2308, Jan. 14, 2000] betes insipidus (chronic excretion of large amounts of dilute urine, accom- § 862.1655 Pyruvic acid test system. panied by extreme thirst), adrenal hy- (a) Identification. A pyruvic acid test pertension, Addison’s disease (caused system is a device intended to measure by destruction of the adrenal glands), pyruvic acid (an intermediate com- dehydration, inappropriate antidiuretic pound in the metabolism of carbo- hormone secretion, or other diseases hydrate) in plasma. Measurements ob- involving electrolyte imbalance. tained by this device are used in the (b) Classification. Class II. evaluation of electrolyte metabolism and in the diagnosis and treatment of § 862.1670 Sorbitol dehydrogenase test acid-base and electrolyte disturbances system. or anoxia (the reduction of oxygen in (a) Identification. A sorbitol dehydro- body tissues). genase test system is a device intended (b) Classification. Class I (general con- to measure the activity of the enzyme trols). The device is exempt from the premarket notification procedures in sorbitol dehydrogenase in serum. Meas- subpart E of part 807 of this chapter urements obtained by this device are subject to § 862.9. used in the diagnosis and treatment of liver disorders such as cirrhosis or [52 FR 16122, May 1, 1987, as amended at 65 acute hepatitis. FR 2308, Jan. 14, 2000] (b) Classification. Class I (general con- § 862.1660 Quality control material (as- trols). The device is exempt from the sayed and unassayed). premarket notification procedures in (a) Identification. A quality control subpart E of part 807 of this chapter material (assayed and unassayed) for subject to the limitations in § 862.9. clinical chemistry is a device intended [52 FR 16122, May 1, 1987, as amended at 53 for medical purposes for use in a test FR 21449, June 8, 1988; 66 FR 38788, July 25, system to estimate test precision and 2001]

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§ 862.1675 Blood specimen collection tein which binds thyroxine, in serum device. and plasma. Measurements obtained by (a) Identification. A blood specimen this device are used in the diagnosis collection device is a device intended and treatment of thyroid diseases. for medical purposes to collect and to (b) Classification. Class II. handle blood specimens and to separate serum from nonserum (cellular) compo- § 862.1690 Thyroid stimulating hor- nents prior to further testing. This ge- mone test system. neric type device may include blood (a) Identification. A thyroid stimu- collection tubes, vials, systems, serum lating hormone test system is a device separators, blood collection trays, or intended to measure thyroid stimu- vacuum sample tubes. lating hormone, also known as thyrot- (b) Classification. Class II. rophin and thyrotrophic hormone, in serum and plasma. Measurements of § 862.1678 Tacrolimus test system. thyroid stimulating hormone produced (a) Identification. A tacrolimus test by the anterior pituitary are used in system is a device intended to quan- the diagnosis of thyroid or pituitary titatively determine tacrolimus con- disorders. centrations as an aid in the manage- (b) Classification. Class II. ment of transplant patients receiving therapy with this drug. This generic § 862.1695 Free thyroxine test system. type of device includes immunoassays (a) Identification. A free thyroxine and chromatographic assays for test system is a device intended to tacrolimus. measure free (not protein bound) (b) Classification. Class II (special thyroxine (thyroid hormone) in serum controls). The special control is ‘‘Class or plasma. Levels of free thyroxine in II Special Controls Guidance Docu- plasma are thought to reflect the ment: Cyclosporine and Tacrolimus As- amount of thyroxine hormone avail- says; Guidance for Industry and FDA.’’ able to the cells and may therefore de- See § 862.1(d) for the availability of this termine the clinical metabolic status guidance document. of thyroxine. Measurements obtained [67 FR 58329, Sept. 16, 2002] by this device are used in the diagnosis and treatment of thyroid diseases. § 862.1680 Testosterone test system. (b) Classification. Class II. (a) Identification. A testosterone test system is a device intended to measure § 862.1700 Total thyroxine test system. testosterone (a male sex hormone) in (a) Identification. A total thyroxine serum, plasma, and urine. Measure- test system is a device intended to ment of testosterone are used in the di- measure total (free and protein bound) agnosis and treatment of disorders in- thyroxine (thyroid hormone) in serum volving the male sex hormones and plasma. Measurements obtained by (androgens), including primary and sec- this device are used in the diagnosis ondary hypogonadism, delayed or pre- and treatment of thyroid diseases. cocious puberty, impotence in males (b) Classification. Class II. and, in females hirsutism (excessive hair) and virilization (masculinization) § 862.1705 Triglyceride test system. due to tumors, polycystic ovaries, and (a) Identification. A triglyceride test adrenogenital syndromes. system is a device intended to measure (b) Classification. Class I. triglyceride (neutral fat) in serum and [52 FR 16122, May 1, 1987; 53 FR 11645, Apr. 8, plasma. Measurements obtained by this 1988] device are used in the diagnosis and treatment of patients with diabetes § 862.1685 Thyroxine-binding globulin mellitus, nephrosis, liver obstruction, test system. other diseases involving lipid metabo- (a) Identification. A thyroxine-binding lism, or various endocrine disorders. globulin test system is a device in- (b) Classification. Class I (general con- tended to measure thyroxine (thyroid)- trols). The device is exempt from the binding globulin (TBG), a plasma pro- premarket notification procedures in

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subpart E of part 807 of this chapter agnosis and treatment of congenital subject to § 862.9. triose phosphate isomerase enzyme de- [52 FR 16122, May 1, 1987, as amended at 65 ficiency, which causes a type of hemo- FR 2308, Jan. 14, 2000] lytic anemia. (b) Classification. Class I (general con- § 862.1710 Total triiodothyronine test trols). The device is exempt from the system. premarket notification procedures in (a) Identification. A total subpart E of part 807 subject to the triiodothyronine test system is a de- limitations in § 862.9. vice intended to measure the hormone triiodothyronine in serum and plasma. [52 FR 16122, May 1, 1987, as amended at 53 FR 21449, June 8, 1988; 66 FR 38788, July 25, Measurements obtained by this device 2001] are used in the diagnosis and treatment of thyroid diseases such as hyper- § 862.1725 Trypsin test system. thyroidism. (b) Classification. Class II. This device (a) Identification. A trypsin test sys- is exempt from the premarket notifica- tem is a device intended to measure tion procedures in subpart E of part 807 the activity of trypsin (a pancreatic of this chapter subject to the limita- enzyme important in digestion for the tions in § 862.9. breakdown of proteins) in blood and other body fluids and in feces. Measure- [52 FR 16122, May 1, 1987, as amended at 65 ments obtained by this device are used FR 62286, Oct. 18, 2000] in the diagnosis and treatment of pan- § 862.1715 Triiodothyronine uptake creatic disease. test system. (b) Classification. Class I (general con- (a) Identification. A triiodothyronine trols). The device is exempt from the uptake test system is a device intended premarket notification procedures in to measure the total amount of binding subpart E of part 807 of this chapter sites available for binding thyroid hor- subject to § 862.9. mone on the thyroxine-binding pro- [52 FR 16122, May 1, 1987, as amended at 65 teins, thyroid-binding globulin, FR 2308, Jan. 14, 2000] thyroxine-binding prealbumin, and albumin of serum and plasma. The device § 862.1730 Free tyrosine test system. provides an indirect measurement of (a) Identification. A free tyrosine test thyrkoxine levels in serum and plasma. system is a device intended to measure Measurements of triiodothyronine up- free tyrosine (an amono acid) in serum take are used in the diagnosis and and urine. Measurements obtained by treatment of thyroid disorders. this device are used in the diagnosis (b) Classification. Class II. The device is exempt from the premarket notifica- and treatment of diseases such as con- tion procedures in subpart E of part 807 genital tyrosinemia (a disease that can of this chapter subject to the limita- cause liver/kidney disorders) and as an tions in § 862.9. adjunct to the measurement of phenylalanine in detecting congenital [52 FR 16122, May 1, 1987, as amended at 64 phenylketonuria (a disease that can FR 1124, Jan. 8, 1999] cause brain damage). § 862.1720 Triose phosphate isomerase (b) Classification. Class I. test system. § 862.1770 Urea nitrogen test system. (a) Identification. A triose phosphate isomerase test system is a device in- (a) Identification. A urea nitrogen test tended to measure the activity of the system is a device intended to measure enzyme triose phosphate isomerase in urea nitrogen (an end-product of nitro- erythrocytes (red blood cells). Triose gen metabolism) in whole blood, phosphate isomerase is an enzyme im- serum, plasma, and urine. Measure- portant in glycolysis (the energy-yield- ments obtained by this device are used ing conversion of glucose to lactic acid in the diagnosis and treatment of cer- in various tissues). Measurements obtain renal and metabolic diseases. tained by this device are used in the di- (b) Classification. Class II.

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§ 862.1775 Uric acid test system. eases characterized by alterations in the heme pathway. (a) Identification. A uric acid test sys- (b) Classification. Class I (general con- tem is a device intended to measure trols). The device is exempt from the uric acid in serum, plasma, and urine. premarket notification procedures in Measurements obtained by this device subpart E of part 807 of this chapter are used in the diagnosis and treat- subject to § 862.9. ment of numerous renal and metabolic disorders, including renal failure, gout, [52 FR 16122, May 1, 1987, as amended at 65 leukemia, psoriasis, starvation or FR 2308, Jan. 14, 2000] other wasting conditions, and of patients receiving cytotoxic drugs. § 862.1795 Vanilmandelic acid test system. (b) Classification. Class I. (a) Identification. A vanilmandelic § 862.1780 Urinary calculi (stones) test acid test system is a device intended to system. measure vanilmandelic acid in urine. Measurements of vanilmandelic acid (a) Identification. A urinary calculi obtained by this device are used in the (stones) test system is a device in- diagnosis and treatment of neuro- tended for the analysis of urinary blastoma, pheochromocytoma, and cer- calculi. Analysis of urinary calculi is tain hypertensive conditions. used in the diagnosis and treatment of (b) Classification. Class I (general con- calculi of the urinary tract. trols). The device is exempt from the (b) Classification. Class I (general con- premarket notification procedures in trols). The device is exempt from the subpart E of part 807 of this chapter premarket notification procedures in subject to § 862.9. subpart E of part 807 of this chapter subject to § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] § 862.1805 Vitamin A test system. (a) Identification. A vitamin A test § 862.1785 Urinary urobilinogen (nonquantitative) test system. system is a device intended to measure vitamin A in serum or plasma. Meas- (a) Identification. A urinary urobi- urements obtained by this device are linogen (nonquantitative) test system used in the diagnosis and treatment of is a device intended to detect and esti- vitamin A deficiency conditions, in- mate urobilinogen (a bile pigment deg- cluding night blindness, or skin, eye, or radation product of red cell hemo- intestinal disorders. globin) in urine. Estimations obtained (b) Classification. Class I (general con- by this device are used in the diagnosis trols). The device is exempt from the and treatment of liver diseases and he- premarket notification procedures in molytic (red cells) disorders. subpart E of part 807 of this chapter (b) Classification. Class I (general con- subject to § 862.9. trols). The device is exempt from the premarket notification procedures in [52 FR 16122, May 1, 1987, as amended at 65 FR 2308, Jan. 14, 2000] subpart E of part 807 of this chapter subject to § 862.9. § 862.1810 Vitamin B 12 test system.

[52 FR 16122, May 1, 1987, as amended at 65 (a) Identification. A vitamin B12 test FR 2308, Jan. 14, 2000] system is a device intended to measure vitamin B12 in serum, plasma, and § 862.1790 Uroporphyrin test system. urine. Measurements obtained by this (a) Identification. A uroporphyrin test device are used in the diagnosis and system is a device intended to measure treatment of anemias of gastro- uroporphyrin in urine. Measurements intestinal malabsorption. obtained by this device are used in the (b) Classification. Class II. diagnosis and treatment of porphyrias (primarily inherited diseases associ- § 862.1815 Vitamin E test system. ated with disturbed porphyrin metabo- (a) Identification. A vitamin E test lism), lead poisoning, and other dis- system is a device intended to measure

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vitamin E (tocopherol) in serum. Meas- Subpart C—Clinical Laboratory urements obtained by this device are Instruments used in the diagnosis and treatment of infants with vitamin E deficiency syn- § 862.2050 General purpose laboratory drome. equipment labeled or promoted for (b) Classification. Class I (general con- a specific medical use. trols). The device is exempt from the (a) Identification. General purpose premarket notification procedures in laboratory equipment labeled or pro- subpart E of part 807 subject to the moted for a specific medical use is a limitations in § 862.9. device that is intended to prepare or examine specimens from the human [52 FR 16122, May 1, 1987, as amended at 53 body and that is labeled or promoted FR 21449, June 8, 1988; 66 FR 38788, July 25, for a specific medical use. 2001] (b) Classification. Class I (general controls). The device is identified in para- § 862.1820 Xylose test system. graph (a) of this section and is exempt (a) Identification. A xylose test sys- from the premarket notification proce- tem is a device intended to measure dures in subpart E of part 807 of this xylose (a sugar) in serum, plasma, and chapter subject to the limitations in urine. Measurements obtained by this § 862.9. The device is also exempt from device are used in the diagnosis and the current good manufacturing prac- treatment of gastrointestinal mal- tice requirements of the quality sys- absorption syndrome (a group of dis- tem regulation in part 820 of this chap- orders in which there is subnormal ab- ter, with the exception of § 820.180, with sorption of dietary constituents and respect to general requirements con- thus excessive loss from the body of cerning records, and § 820.198, with re- the nonabsorbed substances). spect to complaint files. (b) Classification. Class I (general con- [52 FR 16122, May 1, 1987, as amended at 66 trols). The device is exempt from the FR 38788, July 25, 2001] premarket notification procedures in subpart E of part 807 of this chapter § 862.2100 Calculator/data processing module for clinical use. subject to § 862.9. (a) Identification. A calculator/data [52 FR 16122, May 1, 1987, as amended at 65 processing module for clinical use is an FR 2308, Jan. 14, 2000] electronic device intended to store, retrieve, and process laboratory data. § 862.1825 Vitamin D test system. (b) Classification. Class I (general con- (a) Identification. A vitamin D test trols). The device is exempt from the system is a device intended for use in premarket notification procedures in clinical laboratories for the quan- subpart E of part 807 of this chapter titative determination of 25- subject to the limitations in § 862.9. hydroxyvitamin D (25-OH-D) and other [52 FR 16122, May 1, 1987, as amended at 53 hydroxylated metabolites of vitamin D FR 21449, June 8, 1988; 66 FR 38788, July 25, in serum or plasma to be used in the 2001] assessment of vitamin D sufficiency. (b) Classification. Class II (special § 862.2140 Centrifugal chemistry ana- controls). Vitamin D test systems must lyzer for clinical use. comply with the following special con- (a) Identification. A centrifugal chem- trols: istry analyzer for clinical use is an (1) Labeling in conformance with 21 automatic device intended to cen- CFR 809.10 and trifugally mix a sample and a reagent (2) Compliance with existing stand- and spectrophotometrically measure ards of the National Committee on concentrations of the sample constituents. This device is intended for use in Clinical Laboratory Standards. conjunction with certain materials to [63 FR 40366, July 29, 1998] measure a variety of analytes. (b) Classification. Class I (general controls). The device is exempt from the

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premarket notification procedures in § 862.2170 Micro chemistry analyzer subpart E of part 807 of this chapter for clinical use. subject to § 862.9. (a) Identification. A micro chemistry [52 FR 16122, May 1, 1987, as amended at 65 analyzer for clinical use is a device in- FR 2308, Jan. 14, 2000] tended to duplicate manual analytical procedures by performing automati- § 862.2150 Continuous flow sequential cally various steps such as pipetting, multiple chemistry analyzer for preparing filtrates, heating, and meas- clinical use. uring color intensity. The distin- (a) Identification. A continuous flow guishing characteristic of the device is sequential multiple chemistry analyzer that it requires only micro volume for clinical use is a modular analytical samples obtainable from pediatric pa- instrument intended to simultaneously tients. This device is intended for use perform multiple chemical procedures in conjunction with certain materials using the principles of automated con- to measure a variety of analytes. tinuous flow systems. This device is in- (b) Classification. Class I (general con- tended for use in conjunction with cer- trols). The device is exempt from the tain materials to measure a variety of premarket notification procedures in analytes. subpart E of part 807 of this chapter subject to § 862.9. (b) Classification. Class I (general controls). The device is exempt from the [52 FR 16122, May 1, 1987, as amended at 65 premarket notification procedures in FR 2309, Jan. 14, 2000] subpart E of part 807 of this chapter subject to § 862.9. § 862.2230 Chromatographic separation material for clinical use. [52 FR 16122, May 1, 1987, as amended at 65 (a) Identification. A chromatographic FR 2308, Jan. 14, 2000] separation material for clinical use is a § 862.2160 Discrete photometric chem- device accessory (e.g., ion exchange istry analyzer for clinical use. absorbents, ion exchagne resins, and ion papers) intended for use in ion ex- (a) Identification. A discrete photo- change chromatography, a procedure in metric chemistry analyzer for clinical which a compound is separated from a use is a device intended to duplicate solution. manual analytical procedures by per- (b) Classification. Class I (general conforming automatically various steps trols). The device is exempt from the such as pipetting, preparing filtrates, premarket notification procedures in heating, and measuring color intensity. subpart E of part 807 of this chapter This device is intended for use in con- subject to the limitations in § 862.9. junction with certain materials to [52 FR 16122, May 1, 1987, as amended at 61 measure a variety of analytes. Dif- FR 1119, Jan. 16, 1996; 66 FR 38788, July 25, ferent models of the device incorporate 2001] various instrumentation such as micro analysis apparatus, double beam, sin- § 862.2250 Gas liquid chromatography gle, or dual channel photometers, and system for clinical use. bichromatic 2-wavelength (a) Identification. A gas liquid chro- photometers. Some models of the de- matography system for clinical use is a vice may include reagent-containing device intended to separate one or components that may also serve as re- more drugs or compounds from a mix- action units. ture. Each of the constituents in a va- (b) Classification. Class I (general con- porized mixture of compounds is sepa- trols). The device is exempt from the rated according to its vapor pressure. premarket notification procedures in The device may include accessories subpart E of part 807 of this chapter such as columns, gases, column sup- subject to § 862.9. ports, and liquid coating. (b) Classification. Class I (general con- [52 FR 16122, May 1, 1987, as amended at 65 trols). The device is exempt from the FR 2309, Jan. 14, 2000] premarket notification procedures in

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subpart E of part 807 of this chapter (ii) The type(s) of nucleic acids (e.g., subject to § 862.9. germline DNA, tumor DNA) validated [52 FR 16122, May 1, 1987, as amended at 65 with this instrument. FR 2309, Jan. 14, 2000] (iii) The type(s) of sequence variations (e.g. single nucleotide variants, § 862.2260 High pressure liquid chro- insertions, deletions) validated with matography system for clinical use. this instrument. (a) Identification. A high pressure liq- (iv) The type(s) of sequencing (e.g., uid chromatography system for clinical targeted sequencing) validated with use is a device intended to separate one this instrument. or more drugs or compounds from a so- (v) The appropriate read depth for lution by processing the mixture of the sensitivity claimed and validation compounds (solutes) through a column information supporting those claims. packed with materials of uniform size (vi) The nucleic acid extraction (stationary phase) under the influence method(s) validated for use with the in- of a high pressure liquid (mobile strument system. phase). Separation of the solutes oc- (vii) Limitations must specify the curs either by absorption, sieving, par- types of sequence variations that the tition, or selective affinity. instrument cannot detect with the (b) Classification. Class I (general con- claimed accuracy and precision (e.g., trols). The device is exempt from the insertions or deletions larger than a premarket notification procedures in subpart E of part 807 of this chapter certain size, translocations). subject to § 862.9. (viii) Performance characteristics of the instrument system must include: [52 FR 16122, May 1, 1987, as amended at 65 (A) Reproducibility data generated FR 2309, Jan. 14, 2000] using multiple instruments and mul- § 862.2265 High throughput genomic tiple operators, and at multiple sites. sequence analyzer for clinical use. Samples tested must include all claimed specimen types, nucleic acid (a) Identification. A high throughput types, sequence variation types, and genomic sequence analyzer for clinical use is an analytical instrument system types of sequencing. Variants queried intended to generate, measure and sort shall be located in varying sequence signals in order to analyze nucleic acid context (e.g., different chromosomes, sequences in a clinical sample. The de- GC-rich regions). Device results shall vice may include a signal reader unit; be compared to reference sequence data reagent handling, dedicated instrument with high confidence. control, and other hardware compo- (B) Accuracy data for all claimed nents; raw data storage mechanisms; specimen types and nucleic acid types data acquisition software; and software generated by testing a panel of well to process detected signals. characterized samples to query all (b) Classification. Class II (special claimed sequence variation types, controls). The special controls for this types of sequencing, and sequences lo- device are: cated in varying sequence context (e.g., (1) The labeling for the instrument different chromosomes, GC-rich re- system must reference legally mar- gions). The well-characterized sample keted pre-analytical and analytical re- panel shall include samples from at agents to be used with the instrument least two sources that have highly con- system and include or reference legally fident sequence based on well-validated marketed analytical software that in- sequencing methods. At least one ref- cludes sequence alignment and variant erence source shall have sequence gen- calling functions, to be used with the erated independently of the manufac- instrument system. turer with respect to technology and (2) The labeling for the instrument analysis. Percent agreement and per- system must include a description of cent disagreement with the reference the following information: sequences must be described for all re- (i) The specimen type(s) validated as gions queried by the instrument. an appropriate source of nucleic acid (C) If applicable, data describing en- for this instrument. dogenous or exogenous substances that

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may interfere with the instrument sys- (b) Classification. Class I (general con- tem. trols). The device is exempt from the (D) If applicable, data demonstrating premarket notification procedures in the ability of the system to consist- subpart E of part 807 of this chapter ently generate an accurate result for a subject to § 862.9. given sample across different indexing [52 FR 16122, May 1, 1987, as amended at 65 primer combinations. FR 2309, Jan. 14, 2000] (ix) The upper and lower limit of input nucleic acid that will achieve the § 862.2310 Clinical sample concen- claimed accuracy and reproducibility. trator. Data supporting such claims must also (a) Identification. A clinical sample be summarized. concentrator is a device intended to [82 FR 13552, Mar. 14, 2017] concentrate (by dialysis, evaporation, etc.) serum, urine, cerebrospinal fluid, § 862.2270 Thin-layer chromatography and other body fluids before the fluids system for clinical use. are analyzed. (b) Classification. Class I (general con- (a) Identification. A thin-layer chro- trols). The device is exempt from the matography (TLC) system for clinical premarket notification procedures in use is a device intended to separate one subpart E of part 807 of this chapter or more drugs or compounds from a subject to the limitations in § 862.9. mixture. The mixture of compounds is absorbed onto a stationary phase or [52 FR 16122, May 1, 1987, as amended at 60 thin layer of inert material (e.g., cel- FR 38899, July 28, 1995; 66 FR 38788, July 25, lulose, alumina, etc.) and eluted off by 2001] a moving solvent (moving phase) until § 862.2320 Beta or gamma counter for equilibrium occurs between the two clinical use. phases. (b) Classification. Class I (general con- (a) Identification. A beta or gamma trols). The device is exempt from the counter for clinical use is a device in- premarket notification procedures in tended to detect and count beta or subpart E of part 807 of this chapter gamma radiation emitted by clinical samples. Clinical samples are prepared subject to § 862.9. Particular compo- by addition of a radioactive reagent to nents of TLC systems, i.e., the thin- the sample. These measurements are layer chromatography apparatus, TLC useful in the diagnosis and treatment atomizer, TLC developing tanks, and of various disorders. TLC ultraviolet light, are exempt from (b) Classification. Class I (general con- the current good manufacturing prac- trols). The device is exempt from the tice requirements of the quality sys- premarket notification procedures in tem regulation in part 820 of this chap- subpart E of part 807 of this chapter ter, with the exception of § 820.180 of subject to the limitations in § 862.9. this chapter, with respect to general requirements concerning records, and [52 FR 16122, May 1, 1987, as amended at 60 § 820.198 of this chapter, with respect to FR 38900, July 28, 1995; 66 FR 38788, July 25, complaint files. 2001] [52 FR 16122, May 1, 1987, as amended at 65 § 862.2400 Densitometer/scanner (inte- FR 2309, Jan. 14, 2000] grating, reflectance, TLC, or radiochromatogram) for clinical § 862.2300 Colorimeter, photometer, or use. spectrophotometer for clinical use. (a) Identification. A densitometer/ (a) Identification. A colorimeter, a scanner (integrating, reflectance, thin- photometer, or a spectrophotometer layer chromatography, or for clinical use is an instrument in- radiochromatogram) for clinical use is tended to measure radiant energy device intended to measure the con- emitted, transmitted, absorbed, or re- centration of a substance on the sur- flected under controlled conditions. face of a film or other support media The device may include a by either a photocell measurement of monochromator to produce light of a the light transmission through a given specific wavelength. area of the medium or, in the case of

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the radiochromatogram scanner, by intended to measure the concentration measurement of the distribution of a of sodium, potassium, lithium, and specific radio-active element on a other metal ions in body fluids. Abnor- radiochromatogram. mal variations in the concentration of (b) Classification. Class I (general con- these substances in the body are indic- trols). The device is exempt from the ative of certain disorders (e.g., electro- premarket notification procedures in lyte imbalance and heavy metal intoxi- subpart E of part 807 of this chapter cation) and are, therefore, useful in di- subject to § 862.9. agnosis and treatment of those disorders. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000] (b) Classification. Class I (general controls). The device is exempt from the § 862.2485 Electrophoresis apparatus premarket notification procedures in for clinical use. subpart E of part 807 of this chapter (a) Identification. An electrophoresis subject to § 862.9. apparatus for clinical use is a device [52 FR 16122, May 1, 1987, as amended at 65 intended to separate molecules or par- FR 2309, Jan. 14, 2000] ticles, including plasma proteins, lipoproteins, enzymes, and § 862.2560 Fluorometer for clinical use. hemoglobulins on the basis of their net (a) Identification. A fluorometer for charge in specified buffered media. clinical use is a device intended to This device is used in conjunction with measure by fluorescence certain certain materials to measure a variety analytes. Fluorescence is the property of analytes as an aid in the diagnosis of certain substances of radiating, and treatment of certain disorders. when illuminated, a light of a different (b) Classification. Class I (general con- wavelength. This device is used in controls). The device is exempt from the junction with certain materials to premarket notification procedures in measure a variety of analytes. subpart E of part 807 of this chapter (b) Classification. Class I (general con- subject to the limitations in § 862.9. trols). The device is exempt from the [52 FR 16122, May 1, 1987, as amended at 60 premarket notification procedures in FR 38900, July 28, 1995; 66 FR 38788, July 25, subpart E of part 807 of this chapter 2001] subject to § 862.9.

§ 862.2500 Enzyme analyzer for clinical [52 FR 16122, May 1, 1987, as amended at 65 use. FR 2309, Jan. 14, 2000] (a) Identification. An enzyme analyzer § 862.2570 Instrumentation for clinical for clinical use is a device intended to multiplex test systems. measure enzymes in plasma or serum (a) Identification. Instrumentation for by nonkinetic or kinetic measurement clinical multiplex test systems is a de- of enzyme-catalyzed reactions. This device intended to measure and sort mul- vice is used in conjunction with certain tiple signals generated by an assay materials to measure a variety of en- from a clinical sample. This instru- zymes as an aid in the diagnosis and mentation is used with a specific assay treatment of certain enzyme-related to measure multiple similar analytes disorders. that establish a single indicator to aid (b) Classification. Class I (general con- in diagnosis. Such instrumentation trols). The device is exempt from the may be compatible with more than one premarket notification procedures in specific assay. The device includes a subpart E of part 807 of this chapter signal reader unit, and may also inte- subject to § 862.9. grate reagent handling, hybridization, [52 FR 16122, May 1, 1987, as amended at 65 washing, dedicated instrument control, FR 2309, Jan. 14, 2000] and other hardware components, as well as raw data storage mechanisms, § 862.2540 Flame emission photometer data acquisition software, and software for clinical use. to process detected signals. (a) Identification. A flame emission (b) Classification. Class II (special photometer for clinical use is a device controls). The special control is FDA’s

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guidance document entitled ‘‘Class II (b) Classification. Class I (general con- Special Controls Guidance Document: trols). The device is exempt from the Instrumentation for Clinical Multiplex premarket notification procedures in Test Systems.’’ See § 862.1(d) for the subpart E of part 807 of this chapter availability of this guidance document. subject to the limitations in § 862.9. [70 FR 11868, Mar. 10, 2005] [52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995; 66 FR 38788, July 25, § 862.2680 Microtitrator for clinical 2001] use. (a) Identification. A microtitrator for § 862.2730 Osmometer for clinical use. clinical use is a device intended for use (a) Identification. An osmometer for in micronanalysis to measure the con- clinical use is a device intended to centration of a substance by reacting it measure the osmotic pressure of body with a measure ‘‘micro’’ volume of a fluids. Osmotic pressure is the pressure known standardized solution. required to prevent the passage of a so- (b) Classification. Class I (general controls). The device is exempt from the lution with a lesser solute concentra- premarket notification procedures in tion into a solution with greater solute subpart E of part 807 of this chapter concentration when the two solutions subject to § 862.9. are separated by a semipermeable membrane. The concentration of a so- [52 FR 16122, May 1, 1987, as amended at 65 lution affects its osmotic pressure, FR 2309, Jan. 14, 2000] freezing point, and other § 862.2700 Nephelometer for clinical physiochemical properties. use. Osmometers determine osmotic pres- (a) Identification. A nephelometer for sure by methods such as the measure- clinical use is a device intended to esti- ment of the freezing point. Measure- mate the concentration of particles in ments obtained by this device are used a suspension by measuring their light in the diagnosis and treatment of body scattering properties (the deflection of fluid disorders. light rays by opaque particles in their (b) Classification. Class I (general con- path). The device is used in conjunc- trols). The device is exempt from the tion with certain materials to measure premarket notification procedures in the concentration of a variety of subpart E of part 807 of this chapter analytes. subject to § 862.9. (b) Classification. Class I (general con- [52 FR 16122, May 1, 1987, as amended at 65 trols). The device is exempt from the FR 2309, Jan. 14, 2000] premarket notification procedures in subpart E of part 807 of this chapter § 862.2750 Pipetting and diluting sys- subject to § 862.9. tem for clinical use. [52 FR 16122, May 1, 1987, as amended at 65 (a) Identification. A pipetting and di- FR 2309, Jan. 14, 2000] luting system for clinical use is a device intended to provide an accurately § 862.2720 Plasma oncometer for clin- measured volume of liquid at a speci- ical use. fied temperature for use in certain test (a) Identification. A plasma oncometer procedures. This generic type of device for clinical use is a device intended to system includes serial, manual, auto- measure plasma oncotic pressure, mated, and semi-automated dilutors, which is that portion of the total plas- pipettors, dispensers, and pipetting sta- ma osmotic pressure contributed by tions. protein and other molecules too large (b) Classification. Class I (general con- to pass through a specified trols). The device is exempt from the semipermeable membrane. Because premarket notification procedures in variations in plasma oncotic pressure subpart E of part 807 of this chapter are indications of certain disorders, subject to § 862.9. measurements of the variations are useful in the diagnosis and treatment [52 FR 16122, May 1, 1987, as amended at 65 of these disorders. FR 2309, Jan. 14, 2000]

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§ 862.2800 Refractometer for clinical (b) Classification. Class I (general con- use. trols). The device is exempt from the (a) Identification. A refractometer for premarket notification procedures in subpart E of part 807 of this chapter clinical use is a device intended to de- subject to § 862.9. termine the amount of solute in a solution by measuring the index of refrac- [52 FR 16122, May 1, 1987, as amended at 65 tion (the ratio of the velocity of light FR 2309, Jan. 14, 2000] in a vacuum to the velocity of light in the solution). The index of refraction is § 862.2900 Automated urinalysis sys- used to measure the concentration of tem. certain analytes (solutes), such a plas- (a) Identification. An automated uri- ma total proteins and urinary total nalysis system is a device intended to solids. Measurements obtained by this measure certain of the physical prop- device are used in the diagnosis and erties and chemical constituents of treatment of certain conditions. urine by procedures that duplicate (b) Classification. Class I (general con- manual urinalysis systems. This device trols). The device is exempt from the is used in conjunction with certain ma- premarket notification procedures in terials to measure a variety of urinary subpart E of part 807 of this chapter analytes. subject to the limitations in § 862.9. (b) Classification. Class I (general controls). The device is exempt from the [52 FR 16122, May 1, 1987, as amended at 60 premarket notification procedures in FR 38900, July 28, 1995; 66 FR 38788, July 25, subpart E of part 807 of this chapter 2001] subject to § 862.9. § 862.2850 Atomic absorption spectro- [52 FR 16122, May 1, 1987, as amended at 65 photometer for clinical use. FR 2309, Jan. 14, 2000] (a) Identification. An atomic absorption spectrophotometer for clinical use § 862.2920 Plasma viscometer for clinical use. is a device intended to identify and measure elements and metals (e.g., (a) Identification. A plasma viscom- lead and mercury) in human specimens. eter for clinical use is a device in- The metal elements are identified ac- tended to measure the viscosity of cording to the wavelength and inten- plasma by determining the time period sity of the light that is absorbed when required for the plasma to flow a meas- the specimen is converted to the atom- ured distance through a calibrated ic vapor phase. Measurements obtained glass tube. Measurements obtained by by this device are used in the diagnosis this device are used to monitor changes and treatment of certain conditions. in the amount of solids present in plas- (b) Classification. Class I (general con- ma in various disorders. trols). The device is exempt from the (b) Classification. Class I (general con- premarket notification procedures in trols). The device is exempt from the subpart E of part 807 of this chapter premarket notification procedures in subject to § 862.9. subpart E of part 807 of this chapter subject to the limitations in § 862.9. [52 FR 16122, May 1, 1987, as amended at 65 FR 2309, Jan. 14, 2000] [52 FR 16122, May 1, 1987, as amended at 60 FR 38900, July 28, 1995; 66 FR 38788, July 25, § 862.2860 Mass spectrometer for clin- 2001] ical use. (a) Identification. A mass spectrom- Subpart D—Clinical Toxicology eter for clinical use is a device in- Test Systems tended to identify inorganic or organic compounds (e.g., lead, mercury, and § 862.3030 Acetaminophen test system. drugs) in human specimens by ionizing (a) Identification. An acetaminophen the compound under investigation and test system is a device intended to separating the resulting ions by means measure acetaminophen, an analgestic of an electrical and magnetic field ac- and fever reducing drug, in serum. cording to their mass. Measurements obtained by this device

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are used in the diagnosis and treat- § 862.1(d) for the availability of this ment of acetaminophen overdose. guidance document. (b) Classification. Class II. [68 FR 40127, July 7, 2003]

§ 862.3035 Amikacin test system. § 862.3100 Amphetamine test system. (a) Identification. An amikacin test (a) Identification. An amphetamine system is a device intended to measure test system is a device intended to amikacin, an aminoglycoside anti- measure amphetamine, a central nerv- biotic drug, in serum and plasma. ous system stimulating drug, in plasma Measurements obtained by this device and urine. Measurements obtained by are used in the diagnosis and treat- this device are used in the diagnosis ment of amikacin overdose and in mon- and treatment of amphetamine use or itoring levels of amikacin to ensure ap- overdose and in monitoring levels of propriate therapy. amphetamine to ensure appropriate (b) Classification. Class II. therapy. (b) Classification. Class II. § 862.3040 Alcohol test system. (a) Identification. An alcohol test sys- § 862.3110 Antimony test system. tem is a device intented to measure al- (a) Identification. An antimony test cohol (e.g., ethanol, methanol, system is a device intended to measure isopropanol, etc.) in human body fluids antimony, a heavy metal, in urine, (e.g., serum, whole blood, and urine). blood, vomitus, and stomach contents. Measurements obtained by this device Measurements obtained by this device are used in the diagnosis and treat- are used in the diagnosis and treatment of alcohol intoxication and poi- ment of antimony poisoning. soning. (b) Classification. Class I. (b) Classification. Class II. § 862.3120 Arsenic test system. § 862.3050 Breath-alcohol test system. (a) Identification. An arsenic test sys- (a) Identification. A breath-alcohol tem is a device intended to measure ar- test system is a device intened to senic, a poisonous heavy metal, in measure alcohol in the human breath. urine, vomitus, stomach contents, Measurements obtained by this device nails, hair, and blood. Measurements are used in the diagnosis of alcohol in- obtained by this device are used in the toxication. diagnosis and treatment of arsenic poi- (b) Classification. Class I. soning. (b) Classification. Class I. § 862.3080 Breath nitric oxide test system. § 862.3150 Barbiturate test system. (a) Identification. A breath nitric (a) Identification. A barbiturate test oxide test system is a device intended system is a device intended to measure to measure fractional nitric oxide in barbiturates, a class of hypnotic and human breath. Measurement of sedative drugs, in serum, urine, and changes in fractional nitric oxide con- gastric contents. Measurements ob- centration in expired breath aids in tained by this device are used in the di- evaluating an asthma patient’s re- agnosis and treatment of barbiturate sponse to anti-inflammatory therapy, use or overdose and in monitoring lev- as an adjunct to established clinical els of barbiturate to ensure appropriate and laboratory assessments of asthma. therapy. A breath nitric oxide test system com- (b) Classification. Class II. bines chemiluminescence detection of nitric oxide with a pneumotachograph, § 862.3170 Benzodiazepine test system. display, and dedicated software. (a) Identification. A benzodiazepine (b) Classification. Class II (special test system is a device intended to controls). The special control is FDA’s measure any of the benzodiazepine guidance entitled ‘‘Class II Special compounds, sedative and hypnotic Controls Guidance Document: Breath drugs, in blood, plasma, and urine. The Nitric Oxide Test System.’’ See benzodiazepine compounds include

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chlordiazepoxide, diazepam, oxazepam, § 862.3250 Cocaine and cocaine me- chlorzepate, flurazepam, and tabolite test system. nitrazepam. Measurements obtained by (a) Identification. A cocaine and co- this device are used in the diagnosis caine metabolite test system is a de- and treatment of benzodiazepine use or vice intended to measure cocaine and a overdose and in monitoring levels of benzodiazepines to ensure appropriate cocaine metabolite (benzoylecgonine) therapy. in serum, plasma, and urine. Measure- (b) Classification. Class II. ments obtained by this device are used in the diagnosis and treatment of co- § 862.3200 Clinical toxicology cali- caine use or overdose. brator. (b) Classification. Class II. (a) Identification. A clinical toxi- § 862.3270 Codeine test system. cology calibrator is a device intended for medical purposes for use in a test (a) Identification. A codeine test sys- system to establish points of reference tem is a device intended to measure co- that are used in the determination of deine (a narcotic pain-relieving drug) values in the measurement of sub- in serum and urine. Measurements ob- stances in human specimens. A clinical tained by this device are used in the di- toxicology calibrator can be a mixture agnosis and treatment of codeine use of drugs or a specific material for a or overdose and in monitoring levels of particular drug (e.g., ethanol, lido- codeine to ensure appropriate therapy. caine, etc.). (See also § 862.2 in this (b) Classification. Class II. part.) (b) Classification. Class II. § 862.3280 Clinical toxicology control material. § 862.3220 Carbon monoxide test system. (a) Identification. A clinical toxicology control material is a device in- (a) Identification. A carbon monoxide tended to provide an estimation of the test system is a device intended to precision of a device test system and to measure carbon monoxide or detect and monitor systematic devi- carboxyhemoglobin (carbon monoxide ations from accuracy resulting from re- bound to the hemoglobin in the blood) agent or instrument defects. This ge- in blood. Measurements obtained by neric type of device includes various this device are used in the diagnosis and treatment of or confirmation of single, and multi-analyte control ma- carbon monoxide poisoning. terials. (b) Classification. Class I. (b) Classification. Class I (general controls). Except when used in donor § 862.3240 Cholinesterase test system. screening, unassayed material is exempt from the premarket notification (a) Identification. A cholinesterase procedures in subpart E of part 807 of test system is a device intended to measure cholinesterase (an enzyme this chapter subject to § 862.9. that catalyzes the hydrolysis of acetyl- [52 FR 16122, May 1, 1987, as amended at 65 choline to choline) in human speci- FR 2309, Jan. 14, 2000] mens. There are two principal types of cholinesterase in human tissues. True § 862.3300 Digitoxin test system. cholinesterase is present at nerve (a) Identification. A digitoxin test sys- endings and in erythrocytes (red blood tem is a device intended to measure cells) but is not present in plasma. digitoxin, a cardiovascular drug, in Pseudo cholinesterase is present in serum and plasma. Measurements ob- plasma and liver but is not present in tained by this device are used in the di- erythrocytes. Measurements obtained agnosis and treatment of digitoxin by this device are used in the diagnosis and treatment of cholinesterase inhibi- overdose and in monitoring levels of tion disorders (e.g., insecticide poi- digitoxin to ensure appropriate ther- soning and succinylcholine poisoning). apy. (b) Classification. Class I. (b) Classification. Class II.

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§ 862.3320 Digoxin test system. toring levels of ethosuximide to ensure appropriate therapy. (a) Identification. A digoxin test sys- (b) Classification. Class II. tem is a device intended to measure digoxin, a cardiovascular drug, in § 862.3450 Gentamicin test system. serum and plasma. Measurements obtained by this device are used in the di- (a) Identification. A gentamicin test agnosis and treatment of digoxin over- system is a device intended to measure dose and in monitoring levels of dig- gentamicin, an antibiotic drug, in human specimens. Measurements ob- oxin to ensure appropriate therapy. tained by this device are used in the di- (b) Classification. Class II. agnosis and treatment of gentamicin § 862.3350 Diphenylhydantoin test sys- overdose and in monitoring levels of tem. gentamicin to ensure appropriate therapy. (a) Identification. A diphenylhydan- (b) Classification. Class II. toin test system is a device intended to measure diphenylhydantoin, an § 862.3520 Kanamycin test system. antiepileptic drug, in human speci- (a) Identification. A kanamycin test mens. Measurements obtained by this system is a device intended to measure device are used in the diagnosis and kanamycin, an antibiotic drug, in plas- treatment of diphenylhydantoin over- ma and serum. Measurements obtained dose and in monitoring levels of di- by this device are used in the diagnosis phenylhydantoin to ensure appropriate and treatment of kanamycin overdose therapy. and in monitoring levels of kanamycin (b) Classification. Class II. to ensure appropriate therapy. § 862.3360 Drug metabolizing enzyme (b) Classification. Class II. genotyping system. § 862.3550 Lead test system. (a) Identification. A drug metabolizing (a) Identification. A lead test system enzyme genotyping system is a device is a device intended to measure lead, a intended for use in testing heavy metal, in blood and urine. Meas- deoxyribonucleic acid (DNA) extracted urements obtained by this device are from clinical samples to identify the used in the diagnosis and treatment of presence or absence of human lead poisoning. genotypic markers encoding a drug me- (b) Classification. Class II. tabolizing enzyme. This device is used as an aid in determining treatment § 862.3555 Lidocaine test system. choice and individualizing treatment (a) Identification. A lidocaine test sys- dose for therapeutics that are metabo- tem is a device intended to measure lized primarily by the specific enzyme lidocaine, an antiarrythmic and about which the system provides anticonvulsant drug, in serum and genotypic information. plasma. Measurements obtained by this (b) Classification. Class II (special device are used in the diagnosis and controls). The special control is FDA’s treatment of lidocaine overdose or in guidance document entitled ‘‘Class II monitoring levels of lidocaine to en- Special Controls Guidance Document: sure appropriate therapy. Drug Metabolizing Enzyme Genotyping (b) Classification. Class II. Test System.’’ See § 862.1(d) for the availability of this guidance document. § 862.3560 Lithium test system. [70 FR 11867, Mar. 10, 2005] (a) Identification. A lithium test system is a device intended to measure § 862.3380 Ethosuximide test system. lithium (from the drug lithium car- (a) Identification. An ethosuximide bonate) in serum or plasma. Measure- test system is a device intended to ments of lithium are used to assure measure ethosuximide, an antiepileptic that the proper drug dosage is adminis- drug, in human specimens. Measure- tered in the treatment of patients with ments obtained by this device are used mental disturbances, such as manic-de- in the diagnosis and treatment of pressive illness (bipolar disorder). ethosuximide overdose and in moni- (b) Classification. Class II.

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§ 862.3580 Lysergic acid diethylamide § 862.3640 Morphine test system. (LSD) test system. (a) Identification. A morphine test (a) Identification. A lysergic acid system is a device intended to measure diethylamide (LSD) test system is a morphine, an addictive narcotic pain- device intended to measure lysergic relieving drug, and its analogs in acid diethylamide, a hallucinogenic serum, urine, and gastric contents. drug, in serum, urine, and gastric con- Measurements obtained by this device tents. Measurements obtained by this are used in the diagnosis and treat- device are used in the diagnosis and ment of morphine use or overdose and treatment of LSD use or overdose. in monitoring levels of morphine and (b) Classification. Class II. its analogs to ensure appropriate therapy. § 862.3600 Mercury test system. (b) Classification. Class II. (a) Identification. A mercury test sys- § 862.3645 Neuroleptic drugs tem is a device intended to measure radioreceptor assay test system. mercury, a heavy metal, in human (a) Identification. A neuroleptic drugs specimens. Measurements obtained by radioceptor assay test system is a de- this device are used in the diagnosis vice intended to measure in serum or and treatment of mercury poisoning. plasma the dopamine receptor blocking (b) Classification. Class I. activity of neuroleptic drugs and their active metabolites. A neuroleptic drug § 862.3610 Methamphetamine test sys- has anti-psychotic action affecting tem. principally psychomotor activity, is (a) Identification. A methamphet- generally without hypnotic effects, and amine test system is a device intended is a tranquilizer. Measurements ob- to measure methamphetamine, a cen- tained by this device are used to aid in tral nervous system stimulating drug, determining whether a patient is tak- in serum, plasma, and urine. Measure- ing the prescribed dosage level of such ments obtained by this device are used drugs. in the diagnosis and treatment of (b) Classification. Class II. methamphetamine use or overdose. § 862.3650 Opiate test system. (b) Classification. Class II. (a) Identification. An opiate test sys- § 862.3620 Methadone test system. tem is a device intended to measure any of the addictive narcotic pain-re- (a) Identification. A methadone test lieving opiate drugs in blood, serum, system is a device intended to measure urine, gastric contents, and saliva. An methadone, an addictive narcotic pain- opiate is any natural or synthetic drug relieving drug, in serum and urine. that has morphine-like Measurements obtained by this device pharmocological actions. The opiates are used in the diagnosis and treat- include drugs such as morphine, mor- ment of methadone use or overdose and phine glucoronide, heroin, codeine, to determine compliance with regula- nalorphine, and meperedine. Measure- tions in methadone maintenance treatments obtained by this device are used ment. in the diagnosis and treatment of opi- (b) Classification. Class II. ate use or overdose and in monitoring the levels of opiate administration to § 862.3630 Methaqualone test system. ensure appropriate therapy. (a) Identification. A methaqualone (b) Classification. Class II. test system is a device intended to § 862.3660 Phenobarbital test system. measure methaqualone, a hypnotic and sedative drug, in urine. Measurements (a) Identification. A phenobarbitol obtained by this device are used in the test system is a device intended to diagnosis and treatment of methaqua- measure phenobarbital, an lone use or overdose. antiepileptic and sedative-hypnotic drug, in human specimens. Measure- (b) Classification. Class II. ments obtained by this device are used

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in the diagnosis and treatment of phe- § 862.3830 Salicylate test system. nobarbital use or overdose and in moni- (a) Identification. A salicylate test toring levels of phenobarbital to ensure system is a device intended to measure appropriate therapy. salicylates, a class of analgesic, anti- (b) Classification. Class II. pyretic and anti-inflammatory drugs that includes aspirin, in human speci- § 862.3670 Phenothiazine test system. mens. Measurements obtained by this (a) Identification. A phenothiazine device are used in diagnosis and treat- test system is a device intended to ment of salicylate overdose and in measure any of the drugs of the monitoring salicylate levels to ensure phenothiazine class in human speci- appropriate therapy. mens. Measurements obtained by this (b) Classification. Class II. device are used in the diagnosis and § 862.3840 Sirolimus test system. treatment of phenothiazine use or (a) Identification. A sirolimus test overdose. system is a device intended to quan- (b) Classification. Class II. titatively determine sirolimus concentrations in whole blood. Measure- § 862.3680 Primidone test system. ments are used as an aid in manage- (a) Identification. A primidone test ment of transplant patients receiving system is a device intended to measure therapy with sirolimus. primidone, an antiepileptic drug, in (b) Classification. Class II (special human specimens. Measurements ob- controls). The special control is FDA’s tained by this device are used in the di- guidance document entitled ‘‘Class II agnosis and treatment of primidone Special Controls Guidance Document: overdose and in monitoring levels of Sirolimus Test Systems.’’ See § 862.1(d) primidone to ensure appropriate ther- for the availability of this guidance apy. document. (b) Classification. Class II. [69 FR 58259, Sept. 30, 2004]

§ 862.3700 Propoxyphene test system. § 862.3850 Sulfonamide test system. (a) Identification. A propoxyphene (a) Identification. A sulfonamide test test system is a device intended to system is a device intended to measure measure propoxyphene, a pain-reliev- sulfonamides, any of the antibacterial ing drug, in serum, plasma, and urine. drugs derived from sulfanilamide, in Measurements obtained by this device human specimens. Measurements ob- are used in the diagnosis and treat- tained by this device are used in the diagnosis and treatment of sulfonamide ment of propoxyphene use or overdose overdose and in monitoring sul- or in monitoring levels of fonamide levels to ensure appropriate propoxyphene to ensure appropriate therapy. therapy. (b) Classification. Class I. (b) Classification. Class II. [52 FR 16122, May 1, 1987, as amended at 53 § 862.3750 Quinine test system. FR 21450, June 8, 1988; 65 FR 2310, Jan. 14, 2000] (a) Identification. A quinine test system is a device intended to measure § 862.3870 Cannabinoid test system. quinine, a fever-reducing and pain-re- (a) Identification. A cannabinoid test lieving drug intended in the treatment system is a device intended to measure of malaria, in serum and urine. Meas- any of the cannabinoids, hallucino- urements obtained by this device are genic compounds endogenous to mari- used in the diagnosis and treatment of huana, in serum, plasma, saliva, and quinine overdose and malaria. urine. Cannabinoid compounds include (b) Classification. Class I. delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and [52 FR 16122, May 1, 1987, as amended at 53 cannabichromene. Measurements ob- FR 21450, June 8, 1988; 65 FR 2310, Jan. 14, tained by this device are used in the di- 2000] agnosis and treatment of cannabinoid

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use or abuse and in monitoring levels PART 864—HEMATOLOGY AND of cannabinoids during clinical inves- PATHOLOGY DEVICES tigational use. (b) Classification. Class II. Subpart A—General Provisions § 862.3880 Theophylline test system. Sec. 864.1 Scope. (a) Identification. A theophylline test 864.3 Effective dates of requirement for pre- system is a device intended to measure market approval. theophylline (a drug used for stimula- 864.9 Limitations of exemptions from section of the muscles in the cardio- tion 510(k) of the Federal Food, Drug, vascular, respiratory, and central nerv- and Cosmetic Act (the act). ous systems) in serum and plasma. Subpart B—Biological Stains Measurements obtained by this device are used in the diagnosis and treat- 864.1850 Dye and chemical solution stains. ment of theophylline overdose or in 864.1860 Immunohistochemistry reagents monitoring levels of theophylline to and kits. 864.1870 Early growth response 1 (EGR1) ensure appropriate therapy. gene fluorescence in-situ hybridization (b) Classification. Class II. (FISH) test system for specimen characterization. § 862.3900 Tobramycin test system. Subpart C—Cell and Tissue Culture (a) Identification. A tobramycin test Products system is a device intended to measure tobramycin, an aminoglycoside anti- 864.2220 Synthetic cell and tissue culture biotic drug, in plasma and serum. media and components. Measurements obtained by this device 864.2240 Cell and tissue culture supplies and are used in the diagnosis and treat- equipment. ment of tobramycin overdose and in 864.2260 Chromosome culture kit. 864.2280 Cultured animal and human cells. monitoring levels of tobramycin to en- 864.2360 Mycoplasma detection media and sure appropriate therapy. components. (b) Classification. Class II. 864.2800 Animal and human sera. 864.2875 Balanced salt solutions or formula- § 862.3910 Tricyclic antidepressant tions. drugs test system. Subpart D—Pathology Instrumentation and (a) Identification. A tricyclic Accessories antidepressant drugs test system is a device intended to measure any of the 864.3010 Tissue processing equipment. tricyclic antidepressant drugs in 864.3250 Specimen transport and storage serum. The tricyclic antidepressant container. 864.3260 OTC test sample collection systems drugs include imipramine, for drugs of abuse testing. desipramine, amitriptyline, 864.3300 Cytocentrifuge. nortriptyline, protriptyline, and 864.3400 Device for sealing microsections. doxepin. Measurements obtained by 864.3600 Microscopes and accessories. this device are used in the diagnosis 864.3800 Automated slide stainer. and treatment of chronic depression to 864.3875 Automated tissue processor. ensure appropriate therapy. Subpart E—Specimen Preparation (b) Classification. Class II. Reagents § 862.3950 Vancomycin test system. 864.4010 General purpose reagent. 864.4020 Analyte specific reagents. (a) Identification. A vancomycin test 864.4400 Enzyme preparations. system is a device intended to measure vancomycin, an antibiotic drug, in Subpart F—Automated and Semi- serum. Measurements obtained by this Automated Hematology Devices device are used in the diagnosis and treatment of vancomycin overdose and 864.5200 Automated cell counter. 864.5220 Automated differential cell in monitoring the level of vancomycin counter. to ensure appropriate therapy. 864.5240 Automated blood cell diluting appa- (b) Classification. Class II. ratus.

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864.5260 Automated cell-locating device. 864.7735 Prothrombin-proconvertin test and 864.5300 Red cell indices device. thrombotest. 864.5350 Microsedimentation centrifuge. 864.7750 Prothrombin time test. 864.5400 Coagulation instrument. 864.7825 Sickle cell test. 864.5425 Multipurpose system for in vitro 864.7875 Thrombin time test. coagulation studies. 864.7900 Thromboplastin generation test. 864.5600 Automated hematocrit instrument. 864.7925 Partial thromboplastin time tests. 864.5620 Automated hemoglobin system. 864.5680 Automated heparin analyzer. Subpart I—Hematology Reagents 864.5700 Automated platelet aggregation system. 864.8100 Bothrops atrox reagent. 864.5800 Automated sedimentation rate de- 864.8150 Calibrator for cell indices. vice. 864.8165 Calibrator for hemoglobin or hem- 864.5850 Automated slide spinner. atocrit measurement. 864.5950 Blood volume measuring device. 864.8175 Calibrator for platelet counting. 864.8185 Calibrator for red cell and white Subpart G—Manual Hematology Devices cell counting. 864.6100 Bleeding time device. 864.8200 Blood cell diluent. 864.6150 Capillary blood collection tube. 864.8500 Lymphocyte separation medium. 864.6160 Manual blood cell counting device. 864.8540 Red cell lysing reagent. 864.6400 Hematocrit measuring device. 864.8625 Hematology quality control mix- 864.6550 Occult blood test. ture. 864.6600 Osmotic fragility test. 864.8950 Russell viper venom reagent. 864.6650 Platelet adhesion test. 864.6675 Platelet aggregometer. Subpart J—Products Used In Establishments 864.6700 Erythrocyte sedimentation rate That Manufacture Blood and Blood test. Products Subpart H—Hematology Kits and 864.9050 Blood bank supplies. Packages 864.9100 Empty container for the collection and processing of blood and blood compo- 864.7040 Adenosine triphosphate release nents. assay. 864.9125 Vacuum-assisted blood collection 864.7060 Antithrombin III assay. system. 864.7100 Red blood cell enzyme assay. 864.9145 Processing system for frozen blood. 864.7140 Activated whole blood clotting time 864.9160 Blood group substances of tests. nonhuman origin for in vitro diagnostic 864.7250 Erythropoietin assay. use. 864.7275 Euglobulin lysis time tests. 864.9175 Automated blood grouping and 864.7280 Factor V Leiden DNA mutation de- antibody test system. tection systems. 864.9185 Blood grouping view box. 864.7290 Factor deficiency test. 864.9195 Blood mixing devices and blood 864.7300 Fibrin monomer paracoagulation weighing devices. test. 864.9205 Blood and plasma warming device. 864.7320 Fibrinogen/fibrin degradation prod- 864.9225 Cell-freezing apparatus and re- ucts assay. agents for in vitro diagnostic use. 864.7340 Fibrinogen determination system. 864.7360 Erythrocytic glucose-6-phosphate 864.9245 Automated blood cell separator. dehydrogenase assay. 864.9275 Blood bank centrifuge for in vitro 864.7375 Glutathione reductase assay. diagnostic use. 864.9285 Automated cell-washing centrifuge 864.7400 Hemoglobin A2 assay. 864.7415 Abnormal hemoglobin assay. for immuno-hematology. 864.7425 Carboxyhemoglobin assay. 864.9300 Automated Coombs test systems. 864.7440 Electrophoretic hemoglobin anal- 864.9320 Copper sulfate solution for specific ysis system. gravity determinations. 864.7455 Fetal hemoglobin assay. 864.9400 Stabilized enzyme solution. 864.7470 Glycosylated hemoglobin assay. 864.9550 Lectins and protectins. 864.7490 Sulfhemoglobin assay. 864.9575 Environmental chamber for storage 864.7500 Whole blood hemoglobin assays. of platelet concentrate. 864.7525 Heparin assay. 864.9600 Potentiating media for in vitro di- 864.7660 Leukocyte alkaline phosphatase agnostic use. test. 864.9650 Quality control kit for blood bank- 864.7675 Leukocyte peroxidase test. ing reagents. 864.7695 Platelet factor 4 864.9700 Blood storage refrigerator and radioimmunoassay. blood storage freezer. 864.7720 Prothrombin consumption test. 864.9750 Heat-sealing device.

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864.9875 Transfer set. FDA’s issuance of an order approving an application for premarket approval Subpart K—Products Used In Establish- (PMA) for the device or declaring comments That Manufacture Human Cells, pleted a product development protocol Tissues, and Cellular and Tissue-Based (PDP) for the device. Products (HCT/Ps) (a) Before FDA requires that a device 864.9900 Cord blood processing system and commercially distributed before the storage container. enactment date of the amendments, or AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, a device that has been found substan- 360j, 371. tially equivalent to such a device, has EDITORIAL NOTE: Nomenclature changes to an approval under section 515 of the act part 864 appear at 73 FR 35341, June 23, 2008. FDA must promulgate a regulation under section 515(b) of the act requir- Subpart A—General Provisions ing such approval, except as provided in paragraph (b) of this section. Such a § 864.1 Scope. regulation under section 515(b) of the (a) This part sets forth the classifica- act shall not be effective during the tion of hematology and pathology de- grace period ending on the 90th day vices intended for human use that are after its promulgation or on the last in commercial distribution. day of the 30th full calendar month (b) The identification of a device in a after the regulation that classifies the regulation in this part is not a precise device into class III is effective, which- description of every device that is, or ever is later. See section 501(f)(2)(B) of will be, subject to the regulation. A the act. Accordingly, unless an effec- manufacturer who submits a pre- tive date of the requirement for premarket notification submission for a market approval is shown in the regu- device under part 807 may not show lation for a device classified into class merely that the device is accurately III in this part, the device may be com- described by the section title and iden- mercially distributed without FDA’s tification provisions of a regulation in issuance of an order approving a PMA this part, but shall state why the de- or declaring completed a PDP for the vice is substantially equivalent to device. If FDA promulgates a regula- other devices, as required by § 807.87. tion under section 515(b) of the act re- (c) References in this part to regu- quiring premarket approval for a de- latory sections of the Code of Federal vice, section 501(f)(1)(A) of the act ap- Regulations are to chapter I of title 21, plies to the device. unless otherwise noted. (d) Guidance documents referenced in (b) Any new, not substantially equiv- this part are available on the Internet alent, device introduced into commer- at http://www.fda.gov/MedicalDevices/ cial distribution on or after May 28, DeviceRegulationandGuidance/ 1976, including a device formerly mar- GuidanceDocuments/default.htm. keted that has been substantially altered, is classified by statute (section [52 FR 17732, May 11, 1987, as amended at 69 513(f) of the act) into class III without FR 12273, Mar. 16, 2004; 78 FR 18233, Mar. 26, any grace period and FDA must have 2013; 79 FR 50552, Aug. 25, 2014] issued an order approving a PMA or de- § 864.3 Effective dates of requirement claring completed a PDP for the device for premarket approval. before the device is commercially dis- A device included in this part that is tributed unless it is reclassified. If classified into class III (premarket ap- FDA knows that a device being com- proval) shall not be commercially dis- mercially distributed may be a ‘‘new’’ tributed after the date shown in the device as defined in this section be- regulation classifying the device unless cause of any new intended use or other the manufacturer has an approval reasons, FDA may codify the statutory under section 515 of the act (unless an classification of the device into class exemption has been granted under sec- III for such new use. Accordingly, the tion 520(g)(2) of the act). An approval regulation for such a class III device under section 515 of the act consists of states that as of the enactment date of

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the amendments, May 28, 1976, the de- (2) For use in screening or diagnosis vice must have an approval under sec- of familial or acquired genetic dis- tion 515 of the act before commercial orders, including inborn errors of me- distribution. tabolism; (3) For measuring an analyte that [52 FR 17732, May 11, 1987] serves as a surrogate marker for screening, diagnosis, or monitoring § 864.9 Limitations of exemptions from section 510(k) of the Federal Food, life-threatening diseases such as ac- Drug, and Cosmetic Act (the act). quired immune deficiency syndrome (AIDS), chronic or active hepatitis, tu- The exemption from the requirement berculosis, or myocardial infarction or of premarket notification (section to monitor therapy; 510(k) of the act) for a generic type of (4) For assessing the risk of cardio- class I or II device is only to the extent vascular diseases; that the device has existing or reason- (5) For use in diabetes management; ably foreseeable characteristics of (6) For identifying or inferring the commercially distributed devices with- identity of a microorganism directly in that generic type or, in the case of from clinical material; in vitro diagnostic devices, only to the (7) For detection of antibodies to extent that misdiagnosis as a result of microorganisms other than using the device would not be associ- immunoglobulin G (IgG) or IgG assays ated with high morbidity or mortality. when the results are not qualitative, or Accordingly, manufacturers of any are used to determine immunity, or the commercially distributed class I or II assay is intended for use in matrices device for which FDA has granted an other than serum or plasma; exemption from the requirement of (8) For noninvasive testing as defined premarket notification must still sub- in § 812.3(k) of this chapter; and mit a premarket notification to FDA (9) For near patient testing (point of before introducing or delivering for in- care). troduction into interstate commerce for commercial distribution the device [65 FR 2310, Jan. 14, 2000] when: (a) The device is intended for a use Subpart B—Biological Stains different from the intended use of a legally marketed device in that generic § 864.1850 Dye and chemical solution type of device; e.g., the device is in- stains. tended for a different medical purpose, (a) Identification. Dye and chemical or the device is intended for lay use solution stains for medical purposes where the former intended use was by are mixtures of synthetic or natural health care professionals only; dyes or nondye chemicals in solutions (b) The modified device operates used in staining cells and tissues for di- using a different fundamental sci- agnostic histopathology, entific technology than a legally mar- cytopathology, or hematology. keted device in that generic type of de- (b) Classification. Class I (general con- vice; e.g., a surgical instrument cuts trols). These devices are exempt from tissue with a laser beam rather than the premarket notification procedures with a sharpened metal blade, or an in in subpart E of part 807 of this chapter vitro diagnostic device detects or iden- subject to the limitations in § 864.9. tifies infectious agents by using These devices are also exempt from the deoxyribonucleic acid (DNA) probe or current good manufacturing practice nucleic acid hybridization technology requirements of the quality system rather than culture or immunoassay regulation in part 820 of this chapter, technology; or with the exception of § 820.180, with re- (c) The device is an in vitro device spect to general requirements con- that is intended: cerning records, and § 820.198, with re- (1) For use in the diagnosis, moni- spect to complaint files. toring, or screening of neoplastic dis- [45 FR 60583, Sept. 12, 1980, as amended at 54 eases with the exception of FR 25044, June 12, 1989; 66 FR 38789, July 25, immunohistochemical devices; 2001]

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§ 864.1860 Immunohistochemistry re- measurement of an analyte, such as agents and kits. hormone receptors in breast cancer. (3) Class III (premarket approval). (a) Identification. IHC’s intended for any use not de- Immunohistochemistry test systems scribed in paragraphs (b)(1) or (b)(2) of (IHC’s) are in vitro diagnostic devices this section. consisting of polyclonal or monoclonal (c) Date of PMA or notice of completion antibodies labeled with directions for of a PDP is required. As of May 28, 1976, use and performance claims, which an approval under section 515 of the may be packaged with ancillary re- Federal Food, Drug, and Cosmetic Act agents in kits. Their intended use is to is required for any device described in identify, by immunological techniques, paragraph (b)(3) of this section before antigens in tissues or cytologic speci- this device may be commercially dis- mens. Similar devices intended for use tributed. See § 864.3. with flow cytometry devices are not considered IHC’s. [63 FR 30142, June 3, 1998] (b) Classification of § 864.1870 Early growth response 1 immunohistochemistry devices. (1) Class I (EGR1) gene fluorescence in-situ (general controls). Except as described hybridization (FISH) test system for in paragraphs (b)(2) and (b)(3) of this specimen characterization. section, these devices are exempt from (a) Identification. An early growth re- the premarket notification require- sponse 1 (EGR1) gene fluorescence in- ments in part 807, subpart E of this situ hybridization (FISH) test system chapter. This exemption applies to for specimen characterization is a de- IHC’s that provide the pathologist with vice intended to detect the EGR1 probe adjunctive diagnostic information that target on chromosome 5q in bone mar- may be incorporated into the patholo- row specimens from patients with gist’s report, but that is not ordinarily acute myeloid leukemia (AML) or reported to the clinician as an inde- myelodysplastic syndrome (MDS). The pendent finding. These IHC’s are used assay results are intended to be inter- after the primary diagnosis of tumor preted only by a qualified pathologist (neoplasm) has been made by conven- or cytogeneticist. These devices do not tional histopathology using include automated systems that di- nonimmunologic histochemical stains, rectly report results without review such as hematoxylin and eosin. Exam- and interpretation by a qualified pa- ples of class I IHC’s are differentiation thologist or cytogeneticist. These de- markers that are used as adjunctive vices also do not include any device in- tests to subclassify tumors, such as tended for use to select patient ther- keratin. apy, predict patient response to ther- (2) Class II (special control, guidance apy, or to screen for disease as well as document: ‘‘FDA Guidance for Submis- any device with a claim for a par- sion of Immunohistochemistry Appli- ticular diagnosis, prognosis, moni- cations to the FDA,’’ Center for De- toring, or risk assessment. vices and Radiologic Health, 1998). (b) Classification. Class II (special These IHC’s are intended for the detec- controls). The special controls for this tion and/or measurement of certain device are: target analytes in order to provide (1) Premarket notification submis- prognostic or predictive data that are sions must also include the following not directly confirmed by routine information: histopathologic internal and external (i) A detailed description of all control specimens. These IHC’s provide probes included in the kit; the pathologist with information that (ii) Purpose of each probe; is ordinarily reported as independent (iii) Probe molecular specificity; diagnostic information to the ordering (iv) Probe specificity; clinician, and the claims associated (v) Probe limits; with these data are widely accepted (vi) Probe sensitivity; and supported by valid scientific evi- (vii) Specification of required ancil- dence. Examples of class II IHC’s are lary reagents, instrumentation, and those intended for semiquantitative equipment;

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(viii) Specification of the specimen studies, justification for the pre-speci- collection, processing, storage and fied acceptance criteria, and whether slide preparation methods; the pre-specified acceptance criteria (ix) Specification of the assay proce- were met. dure; (3) Your § 809.10 of this chapter com- (x) Specification of control elements pliant labeling must include: that are incorporated into the rec- (i) A warning that reads ‘‘The assay ommended testing procedures; results are intended to be interpreted (xi) Specification of risk mitigation only by a qualified pathologist or elements: Description of all additional cytogeneticist.’’ procedures, methods, and practices in- (ii) A warning that reads ‘‘This de- corporated into the directions for use vice is not for high-risk uses such as that mitigate risks associated with selecting therapy, predicting thera- testing; peutic response or disease screening.’’ (xii) Specification of the criteria for (iii) A warning that reads ‘‘The use of test result interpretation and report- this device for diagnosis, monitoring or ing; risk assessment has not been estab- (xiii) Device analytical sensitivity lished.’’ data; (xiv) Device analytical specificity [79 FR 52196, Sept. 3, 2014] data; (xv) Device reference limit data; Subpart C—Cell And Tissue (xvi) Device precision/reproducibility Culture Products data; (xvii) Device stability data to in- § 864.2220 Synthetic cell and tissue clude: culture media and components. (A) Real-time stability, (a) Identification. Synthetic cell and (B) Freeze-thaw stability, tissue culture media and components (C) Transport and temperature sta- are substances that are composed en- bility, tirely of defined components (e.g., (D) Post-hybridization signal sta- amino acids, vitamins, inorganic salts) bility, that are essential for the survival and (E) Photostability of probe, and development of cell lines of humans (xviii) Documentation that dem- and other animals. This does not in- onstrates the clinical validity of the clude tissue culture media for human device. The documentation must in- ex vivo tissue and cell culture proc- clude data from clinical studies, a min- essing applications as described in imum of two peer-reviewed published § 876.5885 of this chapter. literature references using the specific (b) Classification. Class I (general con- device seeking marketing clearance, or trols). The device is exempt from the both. Documentation for the clinical premarket notification procedures in studies and peer-reviewed published lit- subpart E of part 807 of this chapter erature references cited must include subject to the limitations in § 864.9. the following elements: (A) Documentation that the spon- [45 FR 60583, Sept. 12, 1980, as amended at 54 sor’s probe was used in the literature FR 25044, June 12, 1989; 66 FR 27024, May 16, reference, 2001; 66 FR 38789, July 25, 2001] (B) Number and type of specimens, (C) Target population studied, § 864.2240 Cell and tissue culture sup- (D) Upper reference limit, and plies and equipment. (E) Range of positive probe results. (a) Identification. Cell and tissue cul- (2) Your § 809.10(b)(12) of this chapter ture supplies and equipment are de- compliant labeling must include a vices that are used to examine, propa- statement summarizing the data iden- gate, nourish, or grow cells and tissue tified in paragraphs (b)(1)(xiii) through cultures. These include such articles as (xviii) of this section and a description slide culture chambers, perfusion and of the studies supporting the informa- roller apparatus, cell culture suspen- tion, including the pre-specified ac- sion systems, and tissue culture flasks, ceptance criteria for these performance disks, tubes, and roller bottles.

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(b) Classification. Class I (general con- detect and isolate mycoplasma trols). These devices are exempt from pleuropneumonia-like organisms the premarket notification procedures (PPLO), a common microbial contami- in subpart E of part 807 of this chapter nant in cell cultures. subject to the limitations in § 864.9. If (b) Classification. Class I (general con- the devices are not labeled or otherwise trols). These devices are exempt from represented as sterile, they are exempt the premarket notification procedures from the current good manufacturing in subpart E of part 807 of this chapter practice requirements of the quality subject to the limitations in § 864.9. system regulation in part 820 of this chapter, with the exception of § 820.180, [45 FR 60586, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 66 FR 38789, July 25, with respect to general requirements 2001] concerning records, and § 820.198, with respect to complaint files. § 864.2800 Animal and human sera. [45 FR 60584, Sept. 12, 1980, as amended at 54 (a) Identification. Animal and human FR 25044, June 12, 1989; 66 FR 38789, July 25, sera are biological products, obtained 2001] from the blood of humans or other animals, that provide the necessary § 864.2260 Chromosome culture kit. growth-promoting nutrients in a cell (a) Identification. A chromosome cul- culture system. ture kit is a device containing the nec- (b) Classification. Class I (general con- essary ingredients (e.g., Minimum Es- trols). These devices are exempt from sential Media (MEM) of McCoy’s 5A the premarket notification procedures culture media, phytohemagglutinin, in subpart E of part 807 of this chapter fetal calf serum, antibiotics, and hep- subject to the limitations in § 864.9. arin) used to culture tissues for diagnosis of congenital chromosome abnor- [45 FR 60586, Sept. 12, 1980, as amended at 54 malities. FR 25044, June 12, 1989; 66 FR 38789, July 25, (b) Classification. Class I (general con- 2001] trols). The device is exempt from the § 864.2875 Balanced salt solutions or premarket notification procedures in formulations. subpart E of part 807 of this chapter subject to the limitations in § 864.9. (a) Identification. A balanced salt solution or formulation is a defined mix- [45 FR 60585, Sept. 12, 1980, as amended at 54 ture of salts and glucose in a simple FR 25044, June 12, 1989; 66 FR 38789, July 25, medium. This device is included as a 2001] necessary component of most cell cul- § 864.2280 Cultured animal and human ture systems. This media component cells. controls for pH, osmotic pressure, energy source, and inorganic ions. (a) Identification. Cultured animal (b) Classification. Class I (general con- and human cells are in vitro cultivated trols). These devices are exempt from cell lines from the tissue of humans or the premarket notification procedures other animals which are used in var- in subpart E of part 807 of this chapter ious diagnostic procedures, particu- subject to the limitations in § 864.9. larly diagnostic virology and cytogenetic studies. [45 FR 60586, Sept. 12, 1980, as amended at 54 (b) Classification. Class I (general con- FR 25044, June 12, 1989; 66 FR 38789, July 25, trols). The device is exempt from the 2001] premarket notification procedures in subpart E of part 807 of this chapter Subpart D—Pathology subject to § 864.9. Instrumentation and Accessories [45 FR 60585, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000] § 864.3010 Tissue processing equipment. § 864.2360 Mycoplasma detection (a) Identification. Tissue processing media and components. equipment consists of devices used to (a) Identification. Mycoplasma detec- prepare human tissue specimens for dition media and components are used to agnostic histological examination by

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processing specimens through the var- § 864.3260 OTC test sample collection ious stages of decalcifying, infiltrating, systems for drugs of abuse testing. sectioning, and mounting on micro- (a) Identification. An over-the-counter scope slides. (b) Classification. Class I (general con- (OTC) test sample collection system trols). These devices are exempt from for drugs of abuse testing is a device the premarket notification procedures intended to: Collect biological speci- in subpart E of part 807 of this chapter mens (such as hair, urine, sweat, or sa- subject to the limitations in § 864.9. The liva), outside of a medical setting and devices are also exempt from the cur- not on order of a health care profes- rent good manufacturing practice re- sional (e.g., in the home, insurance, quirements of the quality system regu- sports, or workplace setting); maintain lation in part 820 of this chapter, with the integrity of such specimens during the exception of § 820.180, with respect storage and transport in order that the to general requirements concerning matter contained therein can be tested records, and § 820.198, with respect to in a laboratory for the presence of complaint files. drugs of abuse or their metabolites; [45 FR 60587, Sept. 12, 1980, as amended at 54 and provide access to test results and FR 25044, June 12, 1989; 66 FR 38789, July 25, counseling. This section does not apply 2001] to collection, transport, or laboratory testing of biological specimens for the § 864.3250 Specimen transport and storage container. presence of drugs of abuse or their metabolites that is performed to develop (a) Identification. A specimen trans- evidence for law enforcement purposes. port and storage container, which may (b) Classification. Class I (general con- be empty or prefilled, is a device intended to contain biological specimens, trols). The device is exempt from the body waste, or body exudate during premarket notification requirements storage and transport in order that the in part 807, subpart E of this chapter matter contained therein can be de- subject to the limitations in § 864.9 if it stroyed or used effectively for diag- is sold, distributed, and used in accord- nostic examination. If prefilled, the de- ance with the restrictions set forth in vice contains a fixative solution or § 809.40 of this chapter. If the device is other general purpose reagent to pre- not labeled or otherwise represented as serve the condition of a biological spec- sterile, it is exempt from the current imen added to the container. This sec- good manufacturing practice require- tion does not apply to specimen trans- ments of the quality system regulation port and storage containers that are in part 820 of this chapter, with the ex- intended for use as part of an over-the- ception of § 820.198 of this chapter with counter test sample collection system respect to complaint files. for drugs of abuse testing. (b) Classification. Class I (general con- [65 FR 18234, Apr. 7, 2000] trols). The device is exempt from the premarket notification procedures in § 864.3300 Cytocentrifuge. subpart E of part 807 of this chapter (a) Identification. A cytocentrifuge is subject to § 864.9. If the device is not la- a centrifuge used to concentrate cells beled or otherwise represented as ster- from biological cell suspensions (e.g., ile, it is exempt from the current good cerebrospinal fluid) and to deposit manufacturing practice requirements these cells on a glass microscope slide of the quality system regulation in for cytological examination. part 820 of this chapter, with the excep- (b) Classification. Class I (general con- tion of § 820.180 of this chapter, with re- trols). This device is exempt from the spect to general requirements con- premarket notification procedures in cerning records, and § 820.198 of this subpart E of part 807 of this chapter chapter, with respect to complaint files. subject to the limitations in § 864.9. [54 FR 47206, Nov. 13, 1989, as amended at 65 [45 FR 60588, Sept. 12, 1980, as amended at 54 FR 2310, Jan. 14, 2000; 65 FR 18234, Apr. 7, FR 25044, June 12, 1989; 66 FR 38789, July 25, 2000] 2001]

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§ 864.3400 Device for sealing microsec- concerning records, and § 820.198, with tions. respect to complaint files. (a) Identification. A device for sealing [45 FR 60590, Sept. 12, 1980, as amended at 54 microsections is an automated instru- FR 25044, June 12, 1989; 66 FR 38789, July 25, ment used to seal stained cells and 2001] microsections for histological and § 864.3800 Automated slide stainer. cytological examination. (b) Classification. Class I (general con- (a) Identification. An automated slide trols). This device is exempt from the stainer is a device used to stain his- premarket notification procedures in tology, cytology, and hematology subpart E of part 807 of this chapter slides for diagnosis. subject to the limitations in § 864.9. (b) Classification. Class I (general controls). This device is exempt from the [45 FR 60589, Sept. 12, 1980, as amended at 54 premarket notification procedures in FR 25044, June 12, 1989; 66 FR 38789, July 25, subpart E of part 807 of this chapter 2001] subject to the limitations in § 864.9. § 864.3600 Microscopes and acces- [45 FR 60591, Sept. 12, 1980, as amended at 54 sories. FR 25044, June 12, 1989; 66 FR 38789, July 25, 2001] (a) Identification. Microscopes and accessories are optical instruments used § 864.3875 Automated tissue processor. to enlarge images of specimens, prep- (a) Identification. An automated tis- arations, and cultures for medical pursue processor is an automated system poses. Variations of microscopes and used to process tissue specimens for ex- accessories (through a change in the amination through fixation, dehydra- light source) used for medical purposes tion, and infiltration. include the following: (b) Classification. Class I (general con- (1) Phase contrast microscopes, trols). This device is exempt from the which permit visualization of premarket notification procedures in unstained preparations by altering the subpart E of part 807 of this chapter phase relationship of light that passes subject to the limitations in § 864.9. around the object and through the ob- [45 FR 60591, Sept. 12, 1980, as amended at 54 ject. FR 25045, June 12, 1989; 66 FR 38789, July 25, (2) Fluorescense microscopes, which 2001] permit examination of specimens stained with fluorochromes that fluo- Subpart E—Specimen Preparation resce under ultraviolet light. Reagents (3) Inverted stage microscopes, which permit examination of tissue cultures § 864.4010 General purpose reagent. or other biological specimens con- (a) A general purpose reagent is a tained in bottles or tubes with the chemical reagent that has general lab- light source mounted above the speci- oratory application, that is used to col- men. lect, prepare, and examine specimens (b) Classification. Class I (general con- from the human body for diagnostic trols). These devices are exempt from purposes, and that is not labeled or the premarket notification procedures otherwise intended for a specific diag- in subpart E of part 807 of this chapter nostic application. It may be either an subject to the limitations in § 864.9. If individual substance, or multiple sub- the device is not labeled or otherwise stances reformulated, which, when represented as sterile, it is exempt combined with or used in conjunction from the current good manufacturing with an appropriate analyte specific re- practice requirements of the quality agent (ASR) and other general purpose system regulation in part 820 of this reagents, is part of a diagnostic test chapter, with the exception of § 820.180, procedure or system constituting a fin- with respect to general requirements ished in vitro diagnostic (IVD) test. General purpose reagents are appropriate for combining with one or more

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than one ASR in producing such sys- graphs (b)(2) and (b)(3) of this section, tems and include labware or disposable these devices are exempt from the pre- constituents of tests; but they do not market notification requirements in include laboratory machinery, auto- part 807, subpart E of this chapter. mated or powered systems. General (2) Class II (special controls/guidance purpose reagents include cytological documents), when the analyte is used preservatives, decalcifying reagents, in blood banking tests that have been fixative and adhesives, tissue proc- classified as class II devices (e.g., cer- essing reagents, isotonic solutions and tain cytomegalovirus serological and pH buffers. Reagents used in tests for treponema pallidum nontreponemal more than one individual chemical sub- test reagents). Guidance Documents: stance or ligand are general purpose reagents (e.g., Thermus aquaticus (TAQ) 1. ‘‘Specifications for Immunological Test- polymerase, substrates for enzyme ing for Infectious Disease; Approved Guide- line,’’ NCCLS Document I/LA18–A, December immunoassay (EIA)). 1994. (b) Classification. Class I (general con- 2. ‘‘Assessment of the Clinical Accuracy of trols). The device is exempt from the Laboratory Tests Using Receiver Operating premarket notification procedures in Characteristic (ROC) Plots; Tentative Guide- subpart E of part 807 of this chapter line,’’ NCCLS Document KGP10–T, December subject to the limitations in § 864.9. If 1993. the device is not labeled or otherwise 3. ‘‘Review Criteria for Assessment of In represented as sterile, it is exempt Vitro Diagnostic Devices for Direct Detec- from the current good manufacturing tion of Mycobacterium spp,’’ FDA, July 6, practice requirements of the quality 1993, and its ‘‘Attachment 1,’’ February 28, 1994. system regulation in part 820 of this 4. ‘‘Draft Review Criteria for Nucleic Acid chapter, with the exception of § 820.180, Amplification-Based In Vitro Diagnostic De- with respect to general requirements vices for Direct Detection of Infectious concerning records, and § 820.198, with Microorganisms,’’ FDA, July 6, 1993. respect to complaint files. 5. The Center for Biologics Evaluation and Research, FDA, ‘‘Points to Consider in the [45 FR 60592, Sept. 12, 1980, as amended at 54 Manufacture and Clinical Evaluation of In FR 25045, June 12, 1989; 62 FR 62260, Nov. 21, Vitro Tests to Detect Antibodies to the 1997; 66 FR 38789, July 25, 2001] Human Immunodeficiency Virus, Type I’’ (54 FR 48943, November 28, 1989). § 864.4020 Analyte specific reagents. (a) Identification. Analyte specific re- (3) Class III (premarket approval), agents (ASR’s) are antibodies, both when: polyclonal and monoclonal, specific re- (i) The analyte is intended as a com- ceptor proteins, ligands, nucleic acid ponent in a test intended for use in the sequences, and similar reagents which, diagnosis of a contagious condition through specific binding or chemical that is highly likely to result in a fatal reaction with substances in a speci- outcome and prompt, accurate diag- men, are intended for use in a diagnosis offers the opportunity to miti- nostic application for identification gate the public health impact of the and quantification of an individual condition (e.g., human immunochemical substance or ligand in bio- deficiency virus (HIV/AIDS)or tuber- logical specimens. ASR’s that other- culosis (TB)); or wise fall within this definition are not (ii) The analyte is intended as a com- within the scope of subpart E of this ponent in a test intended for use in part when they are sold to: donor screening for conditions for (1) In vitro diagnostic manufacturers; which FDA has recommended or re- or quired testing in order to safeguard the (2) Organizations that use the re- blood supply or establish the safe use agents to make tests for purposes other of blood and blood products (e.g., tests than providing diagnostic information for hepatitis or tests for identifying to patients and practitioners, e.g., fo- blood groups). rensic, academic, research, and other (c) Date of 510(k), or date of PMA or nonclinical laboratories. notice of completion of a product develop- (b) Classification. (1) Class I (general ment protocol is required. (1) controls). Except as described in para- Preamendments ASR’s; No effective

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date has been established for the re- (b) Classification. Class II (perform- quirement for premarket approval for ance standards). the device described in paragraph (b)(3) [45 FR 60593, Sept. 12, 1980] of this section. See § 864.3. (2) For postamendments ASR’s; No- § 864.5220 Automated differential cell vember 23, 1998. counter. (d) Restrictions. Restrictions on the (a) Identification. An automated dif- sale, distribution and use of ASR’s are ferential cell counter is a device used set forth in § 809.30 of this chapter. to identify one or more of the formed [62 FR 62260, Nov. 21, 1997] elements of the blood. The device may also have the capability to flag, count, § 864.4400 Enzyme preparations. or classify immature or abnormal hematopoietic cells of the blood, bone (a) Identification. Enzyme prepara- marrow, or other body fluids. These de- tions are products that are used in the vices may combine an electronic par- histopathology laboratory for the fol- ticle counting method, optical method, lowing purposes: or a flow cytometric method utilizing (1) To disaggregate tissues and cells monoclonal CD (cluster designation) already in established cultures for markers. The device includes accessory preparation into subsequent cultures CD markers. (e.g., trypsin); (b) Classification. Class II (special (2) To disaggregate fluid specimens controls). The special control for this for cytological examination (e.g., device is the FDA document entitled papain for gastric lavage or trypsin for ‘‘Class II Special Controls Guidance sputum liquefaction); Document: Premarket Notifications for (3) To aid in the selective staining of Automated Differential Cell Counters tissue specimens (e.g., diastase for gly- for Immature or Abnormal Blood Cells; cogen determination). Final Guidance for Industry and FDA.’’ (b) Classification. Class I (general con- [67 FR 1607, Jan. 14, 2002] trols). This device is exempt from the premarket notification procedures in § 864.5240 Automated blood cell dilut- subpart E of part 807 of this chapter ing apparatus. subject to the limitations in § 864.9. (a) Identification. An automated blood [45 FR 60592, Sept. 12, 1980, as amended at 54 cell diluting apparatus is a fully auto- FR 25045, June 12, 1989; 66 FR 38789, July 25, mated or semi-automated device used 2001] to make appropriate dilutions of a blood sample for further testing. Subpart F—Automated and Semi- (b) Classification. Class I (general con- Automated Hematology Devices trols). The device is exempt from the premarket notification procedures in § 864.5200 Automated cell counter. subpart E of part 807 of this chapter subject to § 864.9. (a) Identification. An automated cell counter is a fully-automated or semi- [45 FR 60596, Sept. 12, 1980, as amended at 65 automated device used to count red FR 2310, Jan. 14, 2000] blood cells, white blood cells, or blood § 864.5260 Automated cell-locating de- platelets using a sample of the pa- vice. tient’s peripheral blood (blood circulating in one of the body’s extremities, (a) Identification. An automated cell- such as the arm). These devices may locating device is a device used to lo- also measure hemoglobin or hemato- cate blood cells on a peripheral blood crit and may also calculate or measure smear, allowing the operator to iden- one or more of the red cell indices (the tify and classify each cell according to erythrocyte mean corpuscular volume, type. (Peripheral blood is blood circu- the mean corpuscular hemoglobin, or lating in one of the body’s extremities, the mean corpuscular hemoglobin con- such as the arm.) centration). These devices may use ei- (b) Classification. Class II (perform- ther an electronic particle counting ance standards). method or an optical counting method. [45 FR 60597, Sept. 12, 1980]

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§ 864.5300 Red cell indices device. § 864.5600 Automated hematocrit instrument. (a) Identification. A red cell indices device, usually part of a larger system, (a) Identification. An automated hem- calculates or directly measures the atocrit instrument is a fully auto- erythrocyte mean corpuscular volume mated or semi-automated device which (MCV), the mean corpuscular hemo- may or may not be part of a larger sys- globin (MCH), and the mean corpus- tem. This device measures the packed cular hemoglobin concentration red cell volume of a blood sample to distinguish normal from abnormal (MCHC). The red cell indices are used states, such as anemia and for the differential diagnosis of erythrocytosis (an increase in the num- anemias. ber of red cells). (b) Classification. Class II (perform- (b) Classification. Class II (performance standards). ance standards). [45 FR 60597, Sept. 12, 1980] [45 FR 60600, Sept. 12, 1980]

§ 864.5350 Microsedimentation cen- § 864.5620 Automated hemoglobin sys- trifuge. tem. (a) Identification. A microsedimenta- (a) Identification. An automated he- tion centrifuge is a device used to sedi- moglobin system is a fully automated ment red cells for the microsedimenta- or semi-automated device which may tion rate test. or may not be part of a larger system. (b) Classification. Class I (general con- The generic type of device consists of trols). This device is exempt from the the reagents, calibrators, controls, and premarket notification procedures in instrumentation used to determine the subpart E of part 807 of this chapter hemoglobin content of human blood. subject to the limitations in § 864.9. (b) Classification. Class II (performance standards). [45 FR 60598, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38789, July 25, [45 FR 60601, Sept. 12, 1980] 2001] § 864.5680 Automated heparin ana- § 864.5400 Coagulation instrument. lyzer. (a) Identification. A coagulation in- (a) Identification. An automated hep- strument is an automated or semiauto- arin analyzer is a device used to deter- mated device used to determine the mine the heparin level in a blood sam- onset of clot formation for in vitro co- ple by mixing the sample with protamine (a heparin-neutralizing sub- agulation studies. stance) and determining (b) Class II (perform- Classification. photometrically the onset of air-acti- ance standards). vated clotting. The analyzer also deter- [45 FR 60598, Sept. 12, 1980] mines the amount of protamine necessary to neutralize the heparin in the § 864.5425 Multipurpose system for in patient’s circulation. vitro coagulation studies. (b) Classification. Class II (special (a) Identification. A multipurpose sys- controls). tem for in vitro coagulation studies is [45 FR 60601, Sept. 12, 1980, as amended at 52 a device consisting of one automated or FR 17733, May 11, 1987; 58 FR 51571, Oct. 4, semiautomated instrument and its as- 1993] sociated reagents and controls. The system is used to perform a series of § 864.5700 Automated platelet aggregation system. coagulation studies and coagulation factor assays. (a) Identification. An automated (b) Classification. Class II (perform- platelet aggregation system is a device ance standards). used to determine changes in platelet shape and platelet aggregation fol- [45 FR 60599, Sept. 12, 1980] lowing the addition of an aggregating reagent to a platelet-rich plasma.

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(b) Classification. Class II (perform- Subpart G—Manual Hematology ance standards). Devices [45 FR 60602, Sept. 12, 1980] § 864.6100 Bleeding time device. § 864.5800 Automated sedimentation (a) Identification. A bleeding time de- rate device. vice is a device, usually employing two (a) Identification. An automated sedi- spring-loaded blades, that produces two mentation rate device is an instrument small incisions in the patient’s skin. The length of time required for the that measures automatically the bleeding to stop is a measure of the ef- erythrocyte sedimentation rate in fectiveness of the coagulation system, whole blood. Because an increased sedi- primarily the platelets. mentation rate indicates tissue dam- (b) Classification. Class II (special age or inflammation, the erythrocyte controls). The device is exempt from sedimentation rate device is useful in the premarket notification procedures monitoring treatment of a disease. in subpart E of part 807 of this chapter (b) Classification. Class I (general con- subject to § 864.9. trols). This device is exempt from the [45 FR 60604, Sept. 12, 1980, as amended at 63 premarket notification procedures in FR 59225, Nov. 3, 1998] subpart E of part 807 of this chapter subject to the limitations in § 864.9. § 864.6150 Capillary blood collection tube. [45 FR 60602, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38790, July 25, (a) Identification. A capillary blood 2001] collection tube is a plain or heparinized glass tube of very small di- § 864.5850 Automated slide spinner. ameter used to collect blood by capillary action. (a) Identification. An automated slide (b) Classification. Class I (general con- spinner is a device that prepares auto- trols). The device is exempt from the matically a blood film on a microscope premarket notification procedures in slide using a small amount of periph- subpart E of part 807 of this chapter eral blood (blood circulating in one of subject to § 864.9. the body’s extremities, such as the arm). [45 FR 60604, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 65 FR 2310, Jan. 14, (b) Classification. Class I (general con- 2000] trols). This device is exempt from the premarket notification procedures in § 864.6160 Manual blood cell counting subpart E of part 807 of this chapter device. subject to the limitations in § 864.9. (a) Identification. A manual blood cell [45 FR 60603, Sept. 12, 1980, as amended at 54 counting device is a device used to FR 25045, June 12, 1989; 66 FR 38790, July 25, count red blood cells, white blood cells, 2001] or blood platelets. (b) Classification. Class I (general con- § 864.5950 Blood volume measuring de- trols). This device is exempt from the vice. premarket notification procedures in subpart E of part 807 of this chapter (a) Identification. A blood volume subject to the limitations in § 864.9. measuring device is a manual, semi- automated, or automated system that [45 FR 60605, Sept. 12, 1980, as amended at 54 is used to calculate the red cell mass, FR 25045, June 12, 1989; 66 FR 38790, July 25, plasma volume, and total blood vol- 2001] ume. § 864.6400 Hematocrit measuring de- (b) Classification. Class II (perform- vice. ance standards). (a) Identification. A hematocrit meas- [45 FR 60603, Sept. 12, 1980] uring device is a system consisting of instruments, tubes, racks, and a sealer and a holder. The device is used to measure the packed red cell volume in

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blood to determine whether the pa- dition of an aggregating reagent to a tient’s total red cell volume is normal platelet rich plasma. or abnormal. Abnormal states include (b) Classification. Class II (perform- anemia (an abnormally low total red ance standards). cell volume) and erythrocytosis (an ab- [45 FR 60608, Sept. 12, 1980] normally high total red cell mass). The packed red cell volume is produced by § 864.6700 Erythrocyte sedimentation centrifuging a given volume of blood. rate test. (b) Classification. Class II (special (a) Identification. An erythrocyte controls). The device is exempt from sedimentation rate test is a device that the premarket notification procedures measures the length of time required in subpart E of part 807 of this chapter for the red cells in a blood sample to subject to § 864.9. fall a specified distance or a device [45 FR 60606, Sept. 12, 1980, as amended at 63 that measures the degree of sedimenta- FR 59225, Nov. 3, 1998] tion taking place in a given length of time. An increased rate indicates tis- § 864.6550 Occult blood test. sue damage or inflammation. (a) Identification. An occult blood test (b) Classification. Class I (general con- is a device used to detect occult blood trols). This device is exempt from the in urine or feces. (Occult blood is blood premarket notification procedures in present in such small quantities that it subpart E of part 807 of this chapter can be detected only by chemical tests subject to the limitations in § 864.9. of suspected material, or by micro- [45 FR 60608, Sept. 12, 1980, as amended at 54 scopic or spectroscopic examination.) FR 25045, June 12, 1989; 66 FR 38790, July 25, (b) Classification. Class II (perform- 2001] ance standards). [45 FR 60606, Sept. 12, 1980] Subpart H—Hematology Kits and Packages § 864.6600 Osmotic fragility test. § 864.7040 Adenosine triphosphate re- (a) Identification. An osmotic fragility lease assay. test is a device used to determine the (a) Identification. An adenosine resistance of red blood cells to hemol- triphosphate release assay is a device ysis (destruction) in varying con- that measures the release of adenosine centrations of hypotonic saline solu- triphosphate (ATP) from platelets fol- tions. lowing aggregation. This measurement (b) Classification. Class I (general con- is made on platelet-rich plasma using a trols). This device is exempt from the photometer and a luminescent firefly premarket notification procedures in extract. Simultaneous measurements subpart E of part 807 of this chapter of platelet aggregation and ATP re- subject to the limitations in § 864.9. lease are used to evaluate platelet [45 FR 60607, Sept. 12, 1980, as amended at 54 function disorders. FR 25045, June 12, 1989; 66 FR 38790, July 25, (b) Classification. Class I (general 2001] controls). § 864.6650 Platelet adhesion test. [45 FR 60609, Sept. 12, 1980] (a) Identification. A platelet adhesion § 864.7060 Antithrombin III assay. test is a device used to determine in vitro platelet function. (a) Identification. An antithrombin III assay is a device that is used to deter- (b) Classification. Class II (performance standards). mine the plasma level of antithrombin III (a substance which acts with the [45 FR 60608, Sept. 12, 1980] anticoagulant heparin to prevent coagulation). This determination is used § 864.6675 Platelet aggregometer. to monitor the administration of hep- (a) Identification. A platelet arin in the treatment of thrombosis. aggregometer is a device, used to de- The determination may also be used in termine changes in platelet shape and the diagnosis of thrombophilia (a con- platelet aggregation following the ad- genital deficiency of antithrombin III).

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(b) Classification. Class II (perform- (that fraction of the plasma responsible ance standards). for the formation of plasmin, a clot lysing enzyme). This test evaluates [45 FR 60609, Sept. 12, 1980] natural fibrinolysis (destruction of a § 864.7100 Red blood cell enzyme blood clot after bleeding has been ar- assay. rested). The test also will detect accelerated fibrinolysis. (a) Identification. Red blood cell en- (b) Classification. Class II (perform- zyme assay is a device used to measure ance standards). the activity in red blood cells of clinically important enzymatic reactions [45 FR 60612, Sept. 12, 1980] and their products, such as pyruvate kinase or 2,3-diphosphoglycerate. A red § 864.7280 Factor V Leiden DNA muta- blood cell enzyme assay is used to de- tion detection systems. termine the enzyme defects responsible (a) Identification. Factor V Leiden for a patient’s hereditary hemolytic deoxyribonucleic acid (DNA) mutation anemia. detection systems are devices that con- (b) Classification. Class II (perform- sist of different reagents and instru- ance standards). ments which include polymerase chain [45 FR 60610, Sept. 12, 1980] reaction (PCR) primers, hybridization matrices, thermal cyclers, imagers, § 864.7140 Activated whole blood clot- and software packages. The detection ting time tests. of the Factor V Leiden mutation aids (a) Identification. An activated whole in the diagnosis of patients with sus- blood clotting time tests is a device, pected thrombophilia. used to monitor heparin therapy for (b) Classification. Class II (special the treatment of venous thrombosis or controls). The special control is FDA’s pulmonary embolism by measuring the guidance entitled ‘‘Class II Special coagulation time of whole blood. Controls Guidance Document: Factor V (b) Classification. Class II (perform- Leiden DNA Mutation Detection Sys- ance standards). tems.’’ (See § 864.1(d) for the availability of this guidance document.) [45 FR 60611, Sept. 12, 1980] [69 FR 12273, Mar. 16, 2004] § 864.7250 Erythropoietin assay. § 864.7290 Factor deficiency test. (a) Identification. A erythropoietin assay is a device that measures the (a) Identification. A factor deficiency concentration of erythropoietin (an en- test is a device used to diagnose spe- zyme that regulates the production of cific coagulation defects, to monitor red blood cells) in serum or urine. This certain types of therapy, to detect co- assay provides diagnostic information agulation inhibitors, and to detect a for the evaluation of erythrocytosis carrier state (a person carrying both a (increased total red cell mass) and ane- recessive gene for a coagulation factor mia. deficiency such as hemophilia and the (b) Classification. Class II. The special corresponding normal gene). control for this device is FDA’s ‘‘Docu- (b) Classification. Class II (perform- ment for Special Controls for Erythro- ance standards). poietin Assay Premarket Notification [45 FR 60613, Sept. 12, 1980] (510(k)s).’’ [45 FR 60612, Sept. 12, 1980, as amended at 52 § 864.7300 Fibrin monomer FR 17733, May 11, 1987; 65 FR 17144, Mar. 31, paracoagulation test. 2000] (a) Identification. A fibrin monomer paracoagulation test is a device used to § 864.7275 Euglobulin lysis time tests. detect fibrin monomer in the diagnosis (a) Identification. A euglobulin lysis of disseminated intravascular coagula- time test is a device that measures the tion (nonlocalized clotting within a length of time required for the lysis blood vessel) or in the differential diag- (dissolution) of a clot formed from nosis between disseminated fibrinogen in the euglobulin fraction intravascular coagulation and primary

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fibrinolysis (dissolution of the fibrin in phate dehydrogenase deficiency. This a blood clot). generic device includes assays based on (b) Classification. Class II. The special fluorescence, electrophoresis, control for this device is FDA’s ‘‘In methemoglobin reduction, catalase in- Vitro Diagnostic Fibrin Monomer hibition, and ultraviolet kinetics. Paracoagulation Test.’’ (b) Classification. Class II (perform- [45 FR 60614, Sept. 12, 1980, as amended at 52 ance standards). FR 17733, May 11, 1987; 65 FR 17144, Mar. 31, [45 FR 60616, Sept. 12, 1980] 2000] § 864.7375 Glutathione reductase § 864.7320 Fibrinogen/fibrin degrada- assay. tion products assay. (a) Identification. A glutathione re- (a) Identification. A fibrinogen/fibrin ductase assay is a device used to deter- degradation products assay is a device mine the activity of the enzyme gluta- used to detect and measure fibrinogen thione reductase in serum, plasma, or degradation products and fibrin deg- erythrocytes by such techniques as flu- radation products (protein fragments orescence and photometry. The results produced by the enzymatic action of of this assay are used in the diagnosis plasmin on fibrinogen and fibrin) as an of liver disease, glutathione reductase aid in detecting the presence and de- deficiency, or riboflavin deficiency. gree of intravascular coagulation and (b) Classification. Class II (perform- fibrinolysis (the dissolution of the ance standards). fibrin in a blood clot) and in monitoring therapy for disseminated [45 FR 60616, Sept. 12, 1980] intravascular coagulation (nonlocalized clotting in the blood vessels). § 864.7400 Hemoglobin A 2 assay. (b) Classification. Class II (perform- (a) Identification. A hemoglobin A2 ance standards). assay is a device used to determine the [45 FR 60615, Sept. 12, 1980] hemoglobin A2 content of human blood. The measurement of hemoglobin A2 is § 864.7340 Fibrinogen determination used in the diagnosis of the system. thalassemias (hereditary hemolytic (a) Identification. A fibrinogen deter- anemias characterized by decreased mination system is a device that con- synthesis of one or more types of he- sists of the instruments, reagents, moglobin polypeptide chains). standards, and controls used to deter- (b) Classification. Class II (perform- mine the fibrinogen levels in dissemi- ance standards). nated intravascular coagulation (non- [45 FR 60617, Sept. 12, 1980] localized clotting within the blood vessels) and primary fibrinolysis (the dis- § 864.7415 Abnormal hemoglobin assay. solution of fibrin in a blood clot). (b) Classification. Class II (perform- (a) Identification. An abnormal hemo- ance standards). globin assay is a device consisting of the reagents, apparatus, instrumenta- [45 FR 60615, Sept. 12, 1980] tion, and controls necessary to isolate and identify abnormal genetically de- § 864.7360 Erythrocytic glucose-6-phos- termined hemoglobin types. phate dehydrogenase assay. (b) Classification. Class II (perform- (a) Identification. An erythrocytic ance standards). glucose-6-phosphate dehydrogenase assay is a device used to measure the [45 FR 60618, Sept. 12, 1980] activity of the enzyme glucose-6-phosphate dehydrogenase or of glucose-6- § 864.7425 Carboxyhemoglobin assay. phosphate dehydrogenase isoenzymes. (a) Identification. A The results of this assay are used in carboxyhemoglobin assay is a device the diagnosis and treatment of used to determine the nonspherocytic congenital hemolytic carboxyhemoglobin (the compound anemia or drug-induced hemolytic ane- formed when hemoglobin is exposed to mia associated with a glucose-6-phos- carbon monoxide) content of human

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blood as an aid in the diagnosis of car- a patient. Elevated levels of bon monoxide poisoning. This measure- glycosylated hemoglobin indicate un- ment may be made using methods such controlled diabetes in a patient. as spectroscopy, colorimetry, (b) Classification. Class II (perform- spectrophotometry, and gasometry. ance standards). (b) Classification. Class II (performance standards). [45 FR 60621, Sept. 12, 1980] [45 FR 60619, Sept. 12, 1980] § 864.7490 Sulfhemoglobin assay. § 864.7440 Electrophoretic hemoglobin (a) Identification. A sulfhemoglobin analysis system. assay is a device consisting of the re- (a) Identification. An electrophoretic agents, calibrators, controls, and in- hemoglobin analysis system is a device strumentation used to determine the that electrophoretically separates and sulfhemoglobin (a compound of sulfur identifies normal and abnormal hemo- and hemoglobin) content of human globin types as an aid in the diagnosis blood as an aid in the diagnosis of of anemia or erythrocytosis (increased sulfhemoglobinemia (presence of total red cell mass) due to a hemo- sulfhemoglobin in the blood due to globin abnormality. drug administration or exposure to a (b) Classification. Class II (perform- poison). This measurement may be ance standards). made using methods such as spectros- [45 FR 60620, Sept. 12, 1980] copy, colorimetry, spectrophotometry, or gasometry. § 864.7455 Fetal hemoglobin assay. (b) Classification. Class II (perform- (a) Identification. A fetal hemoglobin ance standards). assay is a device that is used to deter- [45 FR 60621, Sept. 12, 1980] mine the presence and distribution of fetal hemoglobin (hemoglobin F) in red § 864.7500 Whole blood hemoglobin as- cells or to measure the amount of fetal says. hemoglobin present. The assay may be (a) Identification. A whole blood he- used to detect fetal red cells in the ma- moglobin assay is a device consisting ternal circulation or to detect the ele- or reagents, calibrators, controls, or vated levels of fetal hemoglobin exhib- photometric or spectrophotometric in- ited in cases of hemoglobin abnormali- strumentation used to measure the he- ties such as thalassemia (a hereditary hemolytic anemia characterized by a moglobin content of whole blood for decreased synthesis of one or more the detection of anemia. This generic types of hemoglobin polypeptide device category does not include auto- chains). The hemoglobin determination mated hemoglobin systems. may be made by methods such as elec- (b) Classification. Class II (perform- trophoresis, alkali denaturation, col- ance standards). umn chromatography, or radial [45 FR 60622, Sept. 12, 1980] immunodiffusion. (b) Classification. Class II (perform- § 864.7525 Heparin assay. ance standards). (a) Identification. A heparin assay is a [45 FR 60620, Sept. 12, 1980] device used to determine the level of the anticoagulant heparin in the pa- § 864.7470 Glycosylated hemoglobin tient’s circulation. These assays are assay. quantitative clotting time procedures (a) Identification. A glycosylated he- using the effect of heparin on activated moglobin assay is a device used to coagulation factor X (Stuart factor) or measure the glycosylated hemoglobins procedures based on the neutralization (A1a, A1b, and A1c) in a patient’s blood of heparin by protamine sulfate (a pro- by a column chromatographic proce- tein that neutralizes heparin). dure. Measurement of glycosylated he- (b) Classification. Class II (perform- moglobin is used to assess the level of ance standards). control of a patient’s diabetes and to determine the proper insulin dosage for [45 FR 60623, Sept. 12, 1980]

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§ 864.7660 Leukocyte alkaline phos- may indicate a coagulation disorder, phatase test. such as myocardial infarction or coro- (a) Identification. A leukocyte alka- nary artery disease. line phosphatase test is a device used (b) Classification. Class II (perform- to identify the enzyme leukocyte alka- ance standards). line phosphatase in neutrophilic [45 FR 60625, Sept. 12, 1980; 46 FR 14890, Mar. granulocytes (granular leukocytes 3, 1981] stainable by neutral dyes). The cytochemical identification of alkaline § 864.7720 Prothrombin consumption phosphatase depends on the formation test. of blue granules in cells containing al- (a) Identification. A prothrombin con- kaline phosphatase. The results of this sumption tests is a device that meas- test are used to differentiate chronic ures the patient’s capacity to generate granulocytic leukemia (a malignant thromboplastin in the coagulation disease characterized by excessive process. The test also is an indirect in- overgrowth of granulocytes in the bone dicator of qualitative or quantitative marrow) and reactions that resemble platelet abnormalities. It is a screen- true leukemia, such as those occuring ing test for thrombocytopenia (de- in severe infections and polycythemia creased number of blood platelets) and (increased total red cell mass). hemophilia A and B. (b) Classification. Class I (general con- (b) Classification. Class II (perform- trols). This device is exempt from the ance standards). premarket notification procedures in subpart E of part 807 of this chapter [45 FR 60625, Sept. 12, 1980] subject to the limitations in § 864.9. § 864.7735 Prothrombin-proconvertin [45 FR 60623, Sept. 12, 1980, as amended at 59 test and thrombotest. FR 63007, Dec. 7, 1994; 66 FR 38790, July 25, (a) Identification. The prothrombin- 2001] proconvertin test and thrombotest are devices used in the regulation of cou- § 864.7675 Leukocyte peroxidase test. marin therapy (administration of a (a) Identification. A leukocyte peroxi- coumarin anticoagulant such as so- dase test is a device used to distinguish dium warfarin in the treatment of ve- certain myeloid cells derived from the nous thrombosis and pulmonary embo- bone marrow, i.e., neutrophils, lism) and as a diagnostic test in con- eosinophils, and monocytes, from junction with, or in place of, the Quick lymphoid cells of the lymphatic system prothrombin time test to detect coagu- and erythroid cells of the red blood cell lation disorders. series on the basis of their peroxidase (b) Classification. Class II (perform- activity as evidenced by staining. The ance standards). results of this test are used in the differential diagnosis of the leukemias. [45 FR 60626, Sept. 12, 1980] (b) Classification. Class I (general con- § 864.7750 Prothrombin time test. trols). This device is exempt from the premarket notification procedures in (a) Identification. A prothrombin time subpart E of part 807 of this chapter test is a device used as a general subject to the limitations in § 864.9. screening procedure for the detection of possible clotting factor deficiencies [45 FR 60624, Sept. 12, 1980, as amended at 59 in the extrinsic coagulation pathway, FR 63007, Dec. 7, 1994; 66 FR 38790, July 25, which involves the reaction between 2001] coagulation factors III and VII, and to § 864.7695 Platelet factor 4 monitor patients receiving coumarin radioimmunoassay. therapy (the administration of one of the coumarin anticoagulants in the (a) Identification. A platelet factor 4 treatment of venous thrombosis or pul- radioimmunoassay is a device used to monary embolism). measure the level of platelet factor 4, a (b) Classification. Class II (perform- protein released during platelet activa- ance standards). tion by radioimmunoassay. This device measures platelet activiation, which [45 FR 60626, Sept. 12, 1980]

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§ 864.7825 Sickle cell test. agulation (nonlocalized clotting in the (a) Identification. A sickle cell test is blood vessels) in patients receiving a device used to determine the sickle heparin therapy (the administration of cell hemoglobin content of human the anticoagulant heparin in the treat- blood to detect sickle cell trait or sick- ment of thrombosis) or as an aid in the le cell diseases. classification of dysfibrinogenemia (b) Classification. Class II (perform- (presence in the plasma of functionally ance standards). defective fibrinogen). (b) Classification. Class II (perform- [45 FR 60627, Sept. 12, 1980] ance standards). § 864.7875 Thrombin time test. [45 FR 60629, Sept. 12, 1980] (a) Identification. A thrombin time test is a device used to measure § 864.8150 Calibrator for cell indices. fibrinogen concentration and detect (a) Identification. A calibrator for cell fibrin or fibrinogen split products for indices is a device that approximates the evaluation of bleeding disorders. whole blood or certain blood cells and (b) Classification. Class II (perform- that is used to set an instrument in- ance standards). tended to measure mean cell volume (MCV), mean corpuscular hemoglobin [45 FR 60628, Sept. 12, 1980] (MCH), and mean corpuscular hemo- § 864.7900 Thromboplastin generation globin concentration (MCHC), or other test. cell indices. It is a suspension of particles or cells whose size, shape, con- (a) Identification. A thromboplastin generation test is a device used to de- centration, and other characteristics tect and identify coagulation factor de- have been precisely and accurately deficiencies and coagulation inhibitors. termined. (b) Classification. Class I (general con- (b) Classification. Class II (perform- trols). This device is exempt from the ance standards). premarket notification procedures in [45 FR 60631, Sept. 12, 1980] subpart E of part 807 of this chapter subject to the limitations in § 864.9. § 864.8165 Calibrator for hemoglobin or hematocrit measurement. [45 FR 60628, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38790, July 25, (a) Identification. A calibrator for he- 2001] moglobin or hematocrit measurement is a device that approximates whole § 864.7925 Partial thromboplastin time blood, red blood cells, or a hemoglobin tests. derivative and that is used to set in- (a) Identification. A partial thrombo- struments intended to measure hemo- plastin time test is a device used for globin, the hematocrit, or both. It is a primary screening for coagulation ab- material whose characteristics have normalities, for evaluation of the ef- been precisely and accurately deter- fect of therapy on procoagulant dis- mined. orders, and as an assay for coagulation (b) Classification. Class II (perform- factor deficiencies of the intrinsic co- ance standards). agulation pathway. (b) Classification. Class II (perform- [45 FR 60632, Sept. 12, 1980] ance standards). § 864.8175 Calibrator for platelet [45 FR 60629, Sept. 12, 1980] counting. (a) Identification. A calibrator for Subpart I—Hematology Reagents platelet counting is a device that resembles platelets in plasma or whole § 864.8100 Bothrops atrox reagent. blood and that is used to set a platelet (a) Identification. A Bothrops atrox counting instrument. It is a suspension reagent is a device made from snake of particles or cells whose size, shape venom and used to determine blood concentration, and other characteris- fibrinogen levels to aid in the evalua- tics have been precisely and accurately tion of disseminated intravascular co- determined.

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(b) Classification. Class II (perform- subpart E of part 807 of this chapter ance standards). subject to the limitations in § 864.9. [45 FR 60633, Sept. 12, 1980] [45 FR 60636, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38790, July 25, § 864.8185 Calibrator for red cell and 2001] white cell counting. (a) Identification. A calibrator for red § 864.8625 Hematology quality control mixture. cell and white cell counting is a device that resembles red or white blood cells (a) Identification. A hematology qual- and that is used to set instruments in- ity control mixture is a device used to tended to count red cells, white cells, ascertain the accuracy and precision of or both. It is a suspension of particles manual, semiautomated, and auto- or cells whose size, shape, concentra- mated determinations of cell param- tion, and other characteristics have eters such as white cell count (WBC), been precisely and accurately deter- red cell count (RBC), platelet count mined. (PLT), hemoglobin, hematocrit (HCT), (b) Classification. Class II (perform- mean corpuscular volume (MCV), mean ance standards). corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin con- [45 FR 60634, Sept. 12, 1980] centration (MCHC). § 864.8200 Blood cell diluent. (b) Classification. Class II (performance standards). (a) Identification. A blood cell diluent is a device used to dilute blood for fur- [45 FR 60637, Sept. 12, 1980] ther testing, such as blood cell counting. § 864.8950 Russell viper venom reagent. (b) Classification. Class I (general controls). This device is exempt from the (a) Identification. Russell viper venom premarket notification procedures in reagent is a device used to determine subpart E of part 807 of this chapter the cause of an increase in the pro- subject to the limitations in § 864.9. thrombin time. (b) Classification. Class I (general con- [45 FR 60635, Sept. 12, 1980, as amended at 54 trols). FR 25045, June 12, 1989; 66 FR 38790, July 25, 2001] [45 FR 60637, Sept. 12, 1980] § 864.8500 Lymphocyte separation medium. Subpart J—Products Used In Es- (a) Identification. A lymphocyte sepa- tablishments That Manufac- ration medium is a device used to iso- ture Blood and Blood Prod- late lymphocytes from whole blood. ucts (b) Classification. Class I (general controls). This device is exempt from the § 864.9050 Blood bank supplies. premarket notification procedures in (a) Identification. Blood bank supplies subpart E of part 807 of this chapter are general purpose devices intended subject to the limitations in § 864.9. for in vitro use in blood banking. This generic type of device includes prod- [45 FR 60636, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38790, July 25, ucts such as blood bank pipettes, blood 2001] grouping slides, blood typing tubes, blood typing racks, and cold packs for § 864.8540 Red cell lysing reagent. antisera reagents. The device does not (a) Identification. A red cell lysing re- include articles that are licensed by agent is a device used to lyse (destroy) the Center for Biologics Evaluation red blood cells for hemoglobin deter- and Research of the Food and Drug Ad- minations or aid in the counting of ministration. white blood cells. (b) Classification. Class I (general con- (b) Classification. Class I (general controls). trols). This device is exempt from the [45 FR 60638, Sept. 12, 1980, as amended at 53 premarket notification procedures in FR 11253, Apr. 6, 1988]

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§ 864.9100 Empty container for the col- clude materials that are licensed by lection and processing of blood and the Center for Biologics Evaluation blood components. and Research of the Food and Drug Ad- (a) Identification. An empty container ministration. for the collection and processing of (b) Classification. Class II (special blood and blood components is a device controls). The device is exempt from intended for medical purposes that is the premarket notification procedures an empty plastic bag or plastic or glass in subpart E of part 807 of this chapter bottle used to collect, store, or transfer subject to § 864.9. blood and blood components for further processing. [45 FR 60640, Sept. 12, 1980, as amended at 53 FR 11253, Apr. 6, 1988; 63 FR 59225, Nov. 3, (b) Classification. Class II (perform- 1998] ance standards). [45 FR 60638, Sept. 12, 1980] § 864.9175 Automated blood grouping and antibody test system. § 864.9125 Vacuum-assisted blood col- (a) Identification. An automated blood lection system. grouping and antibody test system is a (a) Identification. A vacuum-assisted device used to group erythrocytes (red blood collection system is a device in- blood cells) and to detect antibodies to tended for medical purposes that uses a blood group antigens. vacuum to draw blood for subsequent (b) Classification. Class II (perform- reinfusion. ance standards). (b) Classification. Class I (general controls). The manual device is exempt [45 FR 60641, Sept. 12, 1980] from the premarket notification procedures in subpart E of part 807 of this § 864.9185 Blood grouping view box. chapter subject to § 864.9. (a) Identification. A blood grouping [45 FR 60639, Sept. 12, 1980, as amended at 65 view box is a device with a glass or FR 2310, Jan. 14, 2000] plastic viewing surface, which may be illuminated and heated, that is used to § 864.9145 Processing system for fro- view cell reactions in antigen-antibody zen blood. testing. (a) Identification. A processing system (b) Classification. Class I (general con- for frozen blood is a device used to trols). The device is exempt from the glycerolize red blood cells prior to premarket notification procedures in freezing to minimize hemolysis (disrup- subpart E of part 807 of this chapter tion of the red cell membrane accom- subject to § 864.9. panied by the release of hemoglobin) due to freezing and thawing of red [45 FR 60641, Sept. 12, 1980, as amended at 65 blood cells and to deglycerolize and FR 2310, Jan. 14, 2000] wash thawed cells for subsequent re- § 864.9195 Blood mixing devices and infusion. blood weighing devices. (b) Classification. Class II (performance standards). (a) Identification. A blood mixing device is a device intended for medical [45 FR 60639, Sept. 12, 1980] purposes that is used to mix blood or blood components by agitation. A § 864.9160 Blood group substances of nonhuman origin for in vitro diag- blood weighing device is a device in- nostic use. tended for medical purposes that is used to weigh blood or blood compo- (a) Identification. Blood group sub- nents as they are collected. stances of nonhuman origin for in vitro diagnostic use are materials, such as (b) Classification. Class I (general con- blood group specific substances pre- trols). The manual device is exempt pared from nonhuman sources (e.g., from the premarket notification proce- pigs, cows, and horses) used to detect, dures in subpart E of part 807 of this identify, or neutralize antibodies to chapter subject to § 864.9. various human blood group antigens. [45 FR 60642, Sept. 12, 1980, as amended at 65 This generic type of device does not in- FR 2310, Jan. 14, 2000]

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§ 864.9205 Blood and plasma warming nents for transfusion or further manu- device. facturing use. (a) Nonelectromagnetic blood or plasma (b) Classification. Class II (special warming device—(1) Identification. A controls). The special control for this nonelectromagnetic blood and plasma device is a guidance for industry and warming device is a device that warms FDA staff entitled ‘‘Class II Special blood or plasma, by means other than Controls Guidance Document: Auto- electromagnetic radiation, prior to ad- mated Blood Cell Separator Device Op- ministration. erating by Centrifugal or Filtration (2) Classification. Class II (perform- Separation Principle.’’ ance standards). (b) Electromagnetic blood and plasma [72 FR 67644, Nov. 30, 2007] warming device—(1) Identification. An electromagnetic blood and plasma § 864.9275 Blood bank centrifuge for in vitro diagnostic use. warming device is a device that employs electromagnetic radiation (a) Identification. A blood bank cen- (radiowaves or microwaves) to warm a trifuge for in vitro diagnostic use is a bag or bottle of blood or plasma prior device used only to separate blood cells to administration. for further diagnostic testing. (2) Classfication. Class III (premarket (b) Classification. Class I (general con- approval). trols). The device is exempt from the (c) Date PMA or notice of completion of premarket notification procedures in a PDP is required. No effective date has subpart E of part 807 of this chapter been established of the requirement for subject to § 864.9. premarket approval for the device described in paragraph (b)(1). See § 864.3. [45 FR 60645, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000] [45 FR 60642, Sept. 12, 1980, as amended at 52 FR 17733, May 11, 1987] § 864.9285 Automated cell-washing centrifuge for immuno-hematology. § 864.9225 Cell-freezing apparatus and reagents for in vitro diagnostic use. (a) Identification. An automated cell- (a) Identification. Cell-freezing appa- washing centrifuge for immuno-hema- ratus and reagents for in vitro diag- tology is a device used to separate and nostic use are devices used to freeze prepare cells and sera for further in human red blood cells for in vitro diag- vitro diagnostic testing. nostic use. (b) Classification. Class II (perform- (b) Classification. Class I (general con- ance standards). trols). The device is exempt from the [45 FR 60646, Sept. 12, 1980] premarket notification procedures in subpart E of part 807 of this chapter § 864.9300 Automated Coombs test sys- subject to § 864.9. tems. [45 FR 60643, Sept. 12, 1980, as amended at 65 (a) Identification. An automated FR 2310, Jan. 14, 2000] Coombs test system is a device used to § 864.9245 Automated blood cell sepa- detect and identify antibodies in pa- rator. tient sera or antibodies bound to red cells. The Coombs test is used for the (a) Identification. An automated blood cell separator is a device that uses a diagnosis of hemolytic disease of the centrifugal or filtration separation newborn, and autoimmune hemolytic principle to automatically withdraw anemia. The test is also used in whole blood from a donor, separate the crossmatching and in investigating whole blood into blood components, transfusion reactions and drug-induced collect one or more of the blood compo- red cell sensitization. nents, and return to the donor the re- (b) Classification. Class II (perform- mainder of the whole blood and blood ance standards). components. The automated blood cell [45 FR 60646, Sept. 12, 1980] separator device is intended for routine collection of blood and blood compo-

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§ 864.9320 Copper sulfate solution for the premarket notification procedures specific gravity determinations. in subpart E of part 807 of this chapter (a) Identification. A copper sulfate so- subject to § 864.9. lution for specific gravity determina- [45 FR 60648, Sept. 12, 1980, as amended at 63 tions is a device used to determine FR 59226, Nov. 3, 1998] whether the hemoglobin content of a potential donor’s blood meets the re- § 864.9600 Potentiating media for in quired level (12.5 grams per 100 milli- vitro diagnostic use. liters of blood for women and 13.5 (a) Identification. Potentiating media grams per 100 milliliters of blood for for in vitro diagnostic use are media, men). such as bovine albumin, that are used (b) Classification. Class I (general con- to suspend red cells and to enhance cell trols). The device is exempt from the reactions for antigen-antibody testing. premarket notification procedures in (b) Classification. Class II (special subpart E of part 807 of this chapter controls). The device is exempt from subject to § 864.9. the premarket notification procedures in subpart E of part 807 of this chapter [45 FR 60647, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000] subject to § 864.9. [45 FR 60649, Sept. 12, 1980, as amended at 63 § 864.9400 Stabilized enzyme solution. FR 59226, Nov. 3, 1998] (a) Identification. A stabilized enzyme solution is a reagent intended for med- § 864.9650 Quality control kit for blood ical purposes that is used to enhance banking reagents. the reactivity of red blood cells with (a) Identification. A quality control certain antibodies, including anti- kit for blood banking reagents is a de- bodies that are not detectable by other vice that consists of sera, cells, buffers, techniques. These enzyme solutions in- and antibodies used to determine the clude papain, bromelin, ficin, and specificity, potency, and reactivity of trypsin. the cells and reagents used for blood (b) Classification. Class II (perform- banking. ance standards). (b) Classification. Class II (performance standards). [45 FR 60647, Sept. 12, 1980] [45 FR 60649, Sept. 12, 1980] § 864.9550 Lectins and protectins. (a) Identification. Lectins and § 864.9700 Blood storage refrigerator and blood storage freezer. protectins are proteins derived from plants and lower animals that cause (a) Identification. A blood storage re- cell agglutination in the presence of frigerator and a blood storage freezer certain antigens. These substances are are devices intended for medical pur- used to detect blood group antigens for poses that are used to preserve blood in vitro diagnostic purposes. and blood products by storing them at (b) Classification. Class II (special cold or freezing temperatures. controls). The device is exempt from (b) Classification. Class II (special the premarket notification procedures controls). The device is exempt from in subpart E of part 807 of this chapter the premarket notification procedures subject to § 864.9. in subpart E of part 807 of this chapter subject to § 864.9. [45 FR 60648, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998] [45 FR 60650, Sept. 12, 1980, as amended at 63 FR 59226, Nov. 3, 1998] § 864.9575 Environmental chamber for storage of platelet concentrate. § 864.9750 Heat-sealing device. (a) Identification. An environmental (a) Identification. A heat-sealing de- chamber for storage of platelet con- vice is a device intended for medical centrate is a device used to hold plate- purposes that uses heat to seal plastic let-rich plasma within a preselected bags containing blood or blood compo- temperature range. nents. (b) Classification. Class II (special (b) Classification. Class I (general con- controls). The device is exempt from trols). The device is exempt from the

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premarket notification procedures in Subpart B—Diagnostic Devices subpart E of part 807 of this chapter subject to § 864.9. 866.1620 Antimicrobial susceptibility test disc. [45 FR 60650, Sept. 12, 1980, as amended at 65 866.1640 Antimicrobial susceptibility test FR 2311, Jan. 14, 2000] powder. 866.1645 Fully automated short-term incu- § 864.9875 Transfer set. bation cycle antimicrobial susceptibility system. (a) Identification. A transfer set is a 866.1700 Culture medium for antimicrobial device intended for medical purposes susceptibility tests. that consists of a piece of tubing with suitable adaptors used to transfer Subpart C—Microbiology Devices blood or plasma from one container to 866.2050 Staphylococcal typing another. bacteriophage. (b) Classification. Class II (perform- 866.2120 Anaerobic chamber. ance standards). 866.2160 Coagulase plasma. 866.2170 Automated colony counter. [45 FR 60651, Sept. 12, 1980] 866.2180 Manual colony counter. 866.2300 Multipurpose culture medium. Subpart K—Products Used In Es- 866.2320 Differential culture medium. tablishments That Manufac- 866.2330 Enriched culture medium. 866.2350 Microbiological assay culture me- ture Human Cells, Tissues, and dium. Cellular and Tissue-Based 866.2360 Selective culture medium. Products (HCT/Ps) 866.2390 Transport culture medium. 866.2410 Culture medium for pathogenic § 864.9900 Cord blood processing sys- Neisseria spp. tem and storage container. 866.2420 Oxidase screening test for gonorrhea. (a) Identification. A cord blood proc- 866.2440 Automated medium dispensing and essing system and storage container is stacking device. a device intended for use in the proc- 866.2450 Supplement for culture media. essing and the storage of cord blood. 866.2480 Quality control kit for culture This device is a functionally closed media. processing system that includes con- 866.2500 Microtiter diluting and dispensing device. tainers, other soft goods, and a cen- 866.2540 Microbiological incubator. trifugation system for cord blood con- 866.2560 Microbial growth monitor. centration, and a final container for 866.2580 Gas-generating device. the cryopreservation and the storage of 866.2600 Wood’s fluorescent lamp. a cord blood product. 866.2660 Microorganism differentiation and (b) Classification. Class II (special identification device. controls). The special control for this 866.2850 Automated zone reader. 866.2900 Microbiological specimen collection device is FDA’s guidance document en- and transport device. titled ‘‘Class II Special Controls Guid- ance Document: Cord Blood Processing Subpart D—Serological Reagents System and Storage Container.’’ For the availability of this guidance docu- 866.3010 Acinetobacter calcoaceticus sero- ment, see § 864.1(d). logical reagents. 866.3020 Adenovirus serological reagents. [72 FR 4638, Feb. 1, 2007] 866.3035 Arizona spp. serological reagents. 866.3040 Aspergillus spp. serological reagents. 866.3050 Beta-glucan serological assays. PART 866—IMMUNOLOGY AND 866.3060 Blastomyces dermatitidis serological MICROBIOLOGY DEVICES reagents. 866.3065 Bordetella spp. serological reagents. Subpart A—General Provisions 866.3085 Brucella spp. serological reagents. 866.3110 Campylobacter fetus serological re- Sec. agents. 866.1 Scope. 866.3120 Chlamydia serological reagents. 866.3 Effective dates of requirement for pre- 866.3125 Citrobacter spp. serological reagents. market approval. 866.3130 Clostridium difficile toxin gene am- 866.9 Limitations of exemptions from sec- plification assay. tion 510(k) of the Federal Food, Drug, 866.3135 Coccidioides immitis serological re- and Cosmetic Act (the act). agents.

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866.3140 Corynebacterium spp. serological re- 866.3380 Mumps virus serological reagents. agents. 866.3390 Neisseria spp. direct serological test 866.3145 Coxsackievirus serological re- reagents. agents. 866.3395 Norovirus serological reagents. 866.3165 Cryptococcus neoformans serological 866.3400 Parainfluenza virus serological re- reagents. agents. 866.3175 Cytomegalovirus serological re- 866.3402 Plasmodium species antigen detec- agents. tion assays. 866.3200 Echinococcus spp. serological reagents. 866.3405 Poliovirus serological reagents. 866.3205 Echovirus serological reagents. 866.3410 Proteus spp. (Weil-Felix) serological 866.3210 Endotoxin assay. reagents. 866.3220 Entamoeba histolytica serological re- 866.3415 Pseudomonas spp. serological reagents. agents. 866.3225 Enterovirus nucleic acid assay. 866.3460 Rabiesvirus immunofluorescent re- 866.3235 Epstein-Barr virus serological reagents. agents. 866.3470 Reovirus serological reagents. 866.3240 Equine encephalomyelitis virus se- 866.3480 Respiratory syncytial virus sero- rological reagents. logical reagents. 866.3250 Erysipelothrix rhusiopathiae sero- 866.3490 Rhinovirus serological reagents. logical reagents. 866.3500 Rickettsia serological reagents. 866.3255 Escherichia coli serological reagents. 866.3270 Flavobacterium spp. serological re- 866.3510 Rubella virus serological reagents. agents. 866.3520 Rubeola (measles) virus serological 866.3280 Francisella tularensis serological re- reagents. agents. 866.3550 Salmonella spp. serological reagents. 866.3290 Gonococcal antibody test (GAT). 866.3600 Schistosoma spp. serological re- 866.3300 Haemophilus spp. serological reagents. agents. 866.3630 Serratia spp. serological reagents. 866.3305 Herpes simplex virus serological as- 866.3660 Shigella spp. serological reagents. says. 866.3680 Sporothrix schenckii serological re- 866.3310 Hepatitis A virus (HAV) serological agents. assays. 866.3700 Staphylococcus aureus serological re- 866.3320 Histoplasma capsulatum serological agents. reagents. 866.3720 Streptococcus spp. exoenzyme re- 866.3328 Influenza virus antigen detection agents. test system. 866.3330 Influenza virus serological re- 866.3740 Streptococcus spp. serological reagents. agents. 866.3332 Reagents for detection of specific 866.3780 Toxoplasma gondii serological re- novel influenza A viruses. agents. 866.3336 John Cunningham Virus serological 866.3820 Treponema pallidum nontreponemal reagents. test reagents. 866.3340 Klebsiella spp. serological reagents. 866.3830 Treponema pallidum treponemal test 866.3350 Leptospira spp. serological reagents. reagents. 866.3355 Listeria spp. serological reagents. 866.3850 Trichinella spiralis serological re- 866.3360 Lymphocytic choriomeningitis agents. virus serological reagents. 866.3860 Trichomonas vaginalis nucleic acid 866.3365 Multiplex nucleic acid assay for assay. identification of microorganisms and re- 866.3870 Trypanosoma spp. serological resistance markers from positive blood cul- agents. tures. 866.3900 Varicella-zoster virus serological 866.3370 Mycobacterium tuberculosis reagents. immunofluorescent reagents. 866.3930 Vibrio cholerae serological reagents. 866.3372 Nucleic acid-based in vitro diag- 866.3940 West Nile virus serological re- nostic devices for the detection of agents. Mycobacterium tuberculosis complex in respiratory specimens. 866.3945 Dengue virus serological reagents. 866.3373 Nucleic acid-based in vitro diag- 866.3946 Dengue virus nucleic acid amplifi- nostic devices for the detection of cation test reagents. Mycobacterium tuberculosis complex 866.3950 In vitro human immunodeficiency (MTB-complex) and the genetic virus (HIV) drug resistance genotype mutations associated with MTB-complex assay. antibiotic resistance in respiratory 866.3980 Respiratory viral panel multiplex specimens. nucleic acid assay. 866.3375 Mycoplasma spp. serological re- 866.3990 Gastrointestinal microorganism agents. multiplex nucleic acid-based assay.

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Subpart E—Immunology Laboratory 866.5350 Fibrinopeptide A immunological Equipment and Reagents test system. 866.5360 Cohn fraction IV immunological 866.4070 RNA Preanalytical Systems. test system. 866.4100 Complement reagent. 866.5370 Cohn fraction V immunological test 866.4500 Immunoelectrophoresis equipment. system. 866.4520 Immunofluorometer equipment. 866.5380 Free secretory component immuno- 866.4540 Immunonephelometer equipment. logical test system. 866.4600 Ouchterlony agar plate. 866.5400 Alpha-globulin immunological test 866.4700 Automated fluorescence in situ hy- system. bridization (FISH) enumeration systems. 866.5420 Alpha-1-glycoproteins immuno- 866.4800 Radial immunodiffusion plate. logical test system. 866.4830 Rocket immunoelectrophoresis 866.5425 Alpha-2-glycoproteins immuno- equipment. logical test system. 866.4900 Support gel. 866.5430 Beta-2-glycoprotein I immunological test system. Subpart F—Immunological Test Systems 866.5440 Beta-2-glycoprotein III immunological test system. 866.5040 Albumin immunological test sys- 866.5460 Haptoglobin immunological test tem. system. 866.5060 Prealbumin immunological test 866.5470 Hemoglobin immunological test system. system. 866.5065 Human allotypic marker immuno- 866.5490 Hemopexin immunological test sys- logical test system. tem. 866.5080 Alpha-1-antichymotrypsin immuno- 866.5500 Hypersensitivity pneumonitis logical test system. immunological test system. 866.5510 Immunoglobulins A, G, M, D, and E 866.5090 Antimitochondrial antibody immunological test system. immunological test system. 866.5520 Immunoglobulin G (Fab fragment 866.5100 Antinuclear antibody immuno- specific) immunological test system. logical test system. 866.5530 Immunoglobulin G (Fc fragment 866.5110 Antiparietal antibody immuno- specific) immunological test system. logical test system. 866.5540 Immunoglobulin G (Fd fragment 866.5120 Antismooth muscle antibody specific) immunological test system. immunological test system. 866.5550 Immunoglobulin (light chain spe- 866.5130 Alpha-1-antitrypsin immunological cific) immunological test system. test system. 866.5560 Lactic dehydrogenase immuno- 866.5150 Bence-Jones proteins logical test system. immunological test system. 866.5570 Lactoferrin immunological test sys- 866.5160 Beta-globulin immunological test tem. system. 866.5580 Alpha-1-lipoprotein immunological 866.5170 Breast milk immunological test test system. system. 866.5590 Lipoprotein X immunological test 866.5180 Fecal calprotectin immunological system. test system. 866.5600 Low-density lipoprotein immuno- 866.5200 Carbonic anhydrase B and C logical test system. immunological test system. 866.5620 Alpha-2-macroglobulin immuno- 866.5210 Ceruloplasmin immunological test logical test system. system. 866.5630 Beta-2-microglobulin immuno- 866.5220 Cohn fraction II immunological test logical test system. system. 866.5640 Infectious mononucleosis immuno- 866.5230 Colostrum immunological test sys- logical test system. tem. 866.5660 Multiple autoantibodies immuno- 866.5240 Complement components immunological test system. logical test system. 866.5680 Myoglobin immunological test sys- 866.5250 Complement C1 inhibitor (inact- tem. ivator) immunological test system. 866.5700 Whole human plasma or serum 866.5260 Complement C3b inactivator immunological test system. immunological test system. 866.5715 Plasminogen immunological test 866.5270 C-reactive protein immunological system. test system. 866.5735 Prothrombin immunological test 866.5320 Properidin factor B immunological system. test system. 866.5750 Radioallergosorbent (RAST) 866.5330 Factor XIII, A, S, immunological immunological test system. test system. 866.5760 Tryptase test system. 866.5340 Ferritin immunological test sys- 866.5765 Retinol-binding protein immuno- tem. logical test system.

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866.5775 Rheumatoid factor immunological vice is substantially equivalent to test system. other devices, as required by § 807.87. 866.5785 Anti-Saccharomyces cerevisiae (S. (c) To avoid duplicative listings, an cerevisiae) antibody (ASCA) test systems. immunology and microbiology device 866.5800 Seminal fluid (sperm) immunological test system. that has two or more types of uses 866.5820 Systemic lupus erythematosus (e.g., used both as a diagnostic device immunological test system. and as a microbiology device) is listed 866.5860 Total spinal fluid immunological only in one subpart. test system. (d) References in this part to regu- 866.5870 Thyroid autoantibody immuno- latory sections of the Code of Federal logical test system. Regulations are to chapter I of title 21, 866.5880 Transferrin immunological test system. unless otherwise noted. 866.5890 Inter-alpha trypsin inhibitor (e) Guidance documents referenced in immunological test system. this part are available on the Internet 866.5900 Cystic fibrosis transmembrane con- at http://www.fda.gov/MedicalDevices/ ductance regulator (CFTR) gene muta- DeviceRegulationandGuidance/ tion detection system. GuidanceDocuments/default.htm. 866.5910 Quality control material for cystic fibrosis nucleic acid assays. [52 FR 17733, May 11, 1987, as amended at 68 866.5940 Autosomal recessive carrier screen- FR 5827, Feb. 5, 2003; 79 FR 50552, Aug. 25, ing gene mutation detection system. 2014]

Subpart G—Tumor Associated Antigen § 866.3 Effective dates of requirement Immunological Test Systems for premarket approval. 866.6010 Tumor associated antigen A device included in this part that is immunological test system. classified into class III (Premarket ap- 866.6020 Immunomagnetic circulating can- proval) shall not be commercially dis- cer cell selection and enumeration sys- tributed after the date shown in the tem. regulation classifying the device unless 866.6030 AFP-L3% immunological test sys- the manufacturer has an approval tem. under section 515 of the act (unless an 866.6040 Gene expression profiling test system for breast cancer prognosis. exemption has been granted under sec- 866.6050 Ovarian adnexal mass assessment tion 520(g)(2) of the act). An approval score test system. under section 515 of the act consists of FDA’s issuance of an order approving AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. an application for premarket approval (PMA) for the device or declaring com- SOURCE: 47 FR 50823, Nov. 9, 1982, unless pleted a product development protocol otherwise noted. (PDP) for the device. EDITORIAL NOTE: Nomenclature changes to (a) Before FDA requires that a device part 866 appear at 73 FR 35341, June 23, 2008. commercially distributed before the enactment date of the amendments, or Subpart A—General Provisions a device that has been found substantially equivalent to such a device, has § 866.1 Scope. an approval under section 515 of the act (a) This part sets forth the classifica- FDA must promulgate a regulation tion of immunology and microbiology under section 515(b) of the act requir- devices intended for human use that ing such approval, except as provided are in commercial distribution. in paragraphs (b) and (c) of this sec- (b) The indentification of a device in tion. Such a regulation under section a regulation in this part is not a pre- 515(b) of the act shall not be effective cise description of every device that is, during the grace period ending on the or will be, subject to the regulation. A 90th day after its promulgation or on manufacturer who submits a pre- the last day of the 30th full calendar market notification submission for a month after the regulation that classi- device under part 807 may not show fies the device into class III is effec- merely that the device is accurately tive, whichever is later. See section described by the section title and iden- 501(f)(2)(B) of the act. Accordingly, un- tification provisions of a regulation in less an effective date of the require- this part, but shall state why the de- ment for premarket approval is shown

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in the regulation for a device classified that the device has existing or reason- into class III in this part, the device ably foreseeable characteristics of may be commercially distributed with- commercially distributed devices without FDA’s issuance of an order approv- in that generic type or, in the case of ing a PMA or declaring completed a in vitro diagnostic devices, only to the PDP for the device. If FDA promul- extent that misdiagnosis as a result of gates a regulation under section 515(b) using the device would not be associ- of the act requiring premarket ap- ated with high morbidity or mortality. proval for a device, section 501(f)(1)(A) Accordingly, manufacturers of any of the act applies to the device. commercially distributed class I or II (b) Any new, not substantially equiv- device for which FDA has granted an alent, device introduced into commer- exemption from the requirement of cial distribution on or after May 28, premarket notification must still sub- 1976, including a device formerly mar- mit a premarket notification to FDA keted that has been substantially al- before introducing or delivering for in- tered, is classified by statute (section troduction into interstate commerce 513(f) of the act) into class III without for commercial distribution the device any grace period and FDA must have when: issued an order approving a PMA or de- (a) The device is intended for a use claring completed a PDP for the device different from the intended use of a le- before the device is commercially dis- gally marketed device in that generic tributed unless it is reclassified. If type of device; e.g., the device is in- FDA knows that a device being com- tended for a different medical purpose, mercially distributed may be a ‘‘new’’ or the device is intended for lay use device as defined in this section be- where the former intended use was by cause of any new intended use or other health care professionals only; reasons, FDA may codify the statutory (b) The modified device operates classification of the device into class using a different fundamental sci- III for such new use. Accordingly, the entific technology than a legally mar- regulation for such a class III device keted device in that generic type of de- states that as of the enactment date of vice; e.g., a surgical instrument cuts the amendments, May 28, 1976, the de- tissue with a laser beam rather than vice must have an approval under sec- with a sharpened metal blade, or an in tion 515 of the act before commercial vitro diagnostic device detects or iden- distribution. tifies infectious agents by using (c) A device identified in a regulation deoxyribonucleic acid (DNA) probe or in this part that is classified into class nucleic acid hybridization technology III and that is subject to the transi- rather than culture or immunoassay tional provisions of section 520(l) of the technology; or act is automatically classified by stat- (c) The device is an in vitro device ute into class III and must have an ap- that is intended: proval under section 515 of the act be- (1) For use in the diagnosis, moni- fore being commercially distributed. toring, or screening of neoplastic dis- Accordingly, the regulation for such a eases with the exception of class III transitional device states that immunohistochemical devices; as of the enactment date of the amend- (2) For use in screening or diagnosis ments, May 28, 1976, the device must of familial or acquired genetic dis- have an approval under section 515 of orders, including inborn errors of me- the act before commercial distribution. tabolism; [52 FR 17733, May 11, 1987; 52 FR 22577, June (3) For measuring an analyte that 12, 1987] serves as a surrogate marker for screening, diagnosis, or monitoring § 866.9 Limitations of exemptions from life-threatening diseases such as ac- section 510(k) of the Federal Food, quired immune deficiency syndrome Drug, and Cosmetic Act (the act). (AIDS), chronic or active hepatitis, tu- The exemption from the requirement berculosis, or myocardial infarction or of premarket notification (section to monitor therapy; 510(k) of the act) for a generic type of (4) For assessing the risk of cardio- class I or II device is only to the extent vascular diseases;

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(5) For use in diabetes management; microbial agent of choice in the treat- (6) For identifying or inferring the ment of bacterial diseases. identity of a microorganism directly (b) Classification. Class II (perform- from clinical material; ance standards). (7) For detection of antibodies to microorganisms other than § 866.1645 Fully automated short-term immunoglobulin G (IgG) or IgG assays incubation cycle antimicrobial sus- when the results are not qualitative, or ceptibility system. are used to determine immunity, or the (a) Identification. A fully automated assay is intended for use in matrices short-term incubation cycle anti- other than serum or plasma; microbial susceptibility system is a de- (8) For noninvasive testing as defined vice that incorporates concentrations in § 812.3(k) of this chapter; and of antimicrobial agents into a system (9) For near patient testing (point of for the purpose of determining in vitro care). susceptibility of bacterial pathogens isolated from clinical specimens. Test [65 FR 2311, Jan. 14, 2000] results obtained from short-term (less than 16 hours) incubation are used to Subpart B—Diagnostic Devices determine the antimicrobial agent of choice to treat bacterial diseases. § 866.1620 Antimicrobial susceptibility (b) Classification. Class II (special test disc. controls). The special control for this (a) Identification. An antimicrobial device is FDA’s guidance document en- susceptibility test disc is a device that titled ‘‘Class II Special Controls Guid- consists of antimicrobic-impregnated ance Document: Antimicrobial Suscep- paper discs used to measure by a disc- tibility Test (AST) Systems; Guidance agar diffusion technique or a disc-broth for Industry and FDA.’’ elution technique the in vitro susceptibility of most clinically important bac- [68 FR 5827, Feb. 5, 2003] terial pathogens to antimicrobial § 866.1700 Culture medium for anti- agents. In the disc-agar diffusion tech- microbial susceptibility tests. nique, bacterial susceptibility is ascertained by directly measuring the (a) Identification. A culture medium magnitude of a zone of bacterial inhibi- for antimicrobial susceptibility tests is tion around the disc on an agar sur- a device intended for medical purposes face. The disc-broth elution technique that consists of any medium capable of is associated with an automated rapid supporting the growth of many of the susceptibility test system and employs bacterial pathogens that are subject to a fluid medium in which susceptibility antimicrobial susceptibility tests. The is ascertained by photometrically medium should be free of components measuring changes in bacterial growth known to be antagonistic to the com- resulting when antimicrobial material mon agents for which susceptibility is eluted from the disc into the fluid tests are performed in the treatment of medium. Test results are used to deter- disease. mine the antimicrobial agent of choice (b) Classification. Class II (perform- in the treatment of bacterial diseases. ance standards). (b) Classification. Class II (performance standards). Subpart C—Microbiology Devices § 866.1640 Antimicrobial susceptibility § 866.2050 Staphylococcal typing test powder. bacteriophage. (a) Identification. An antimicrobial (a) Identification. A staphylococcal susceptibility test powder is a device typing bacteriophage is a device con- that consists of an antimicrobial drug sisting of a bacterial virus intended for powder packaged in vials in specified medical purposes to identify patho- amounts and intended for use in clin- genic staphylococcal bacteria through ical laboratories for determining in use of the bacteria’s susceptibility to vitro susceptibility of bacterial patho- destruction by the virus. Test results gens to these therapeutic agents. Test are used principally for the collection results are used to determine the anti- of epidemiological information.

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(b) Classification. Class I (general con- § 866.2170 Automated colony counter. trols). The device is exempt from the (a) Identification. An automated col- premarket notification procedures in ony counter is a mechanical device in- subpart E of part 807 of this chapter tended for medical purposes to deter- subject to the limitations in § 866.9. mine the number of bacterial colonies [47 FR 50823, Nov. 9, 1982, as amended at 54 present on a bacteriological culture FR 25045, June 12, 1989; 66 FR 38790, July 25, medium contained in a petri plate. The 2001] number of colonies counted is used in the diagnosis of disease as a measure of § 866.2120 Anaerobic chamber. the degree of bacterial infection. (a) Identification. An anaerobic cham- (b) Classification. Class I (general con- ber is a device intended for medical trols). The device is exempt from the purposes to maintain an anaerobic (ox- premarket notification procedures in ygen free) environment. It is used to subpart E of part 807 of this chapter isolate and cultivate anaerobic micro- subject to the limitations in § 866.9. organisms. [47 FR 50823, Nov. 9, 1982, as amended at 54 (b) Classification. Class I (general con- FR 25045, June 12, 1989; 66 FR 38790, July 25, trols). The device is exempt from the 2001] premarket notification procedures in subpart E of part 807 of this chapter § 866.2180 Manual colony counter. subject to the limitations in § 866.9. The (a) Identification. A manual colony device is also exempt from the good counter is a device intended for med- manufacturing practice requirements ical purposes that consists of a printed of the quality system regulation in grid system superimposed on an illumi- part 820 of this chapter, with the excep- nated screen. Petri plates containing tion of § 820.180, with respect to general bacterial colonies to be counted are requirements concerning records, and placed on the screen for better viewing § 820.198, with respect to complaint and ease of counting. The number of files. colonies counted is used in the diagnosis of disease as a measure of the de- [47 FR 50823, Nov. 9, 1982, as amended at 66 gree of bacterial infection. FR 38790, July 25, 2001] (b) Classification. Class I (general con- § 866.2160 Coagulase plasma. trols). The device is exempt from the premarket notification procedures in (a) Identification. Coagulase plasma is subpart E of part 807 of this chapter a device that consists of freeze-dried subject to the limitations in § 866.9. The animal or human plasma that is in- device is also exempt from the good tended for medical purposes to perform manufacturing practice requirements coagulase tests primarily on staphy- of the quality system regulation in lococcal bacteria. When reconstituted, part 820 of this chapter, with the excep- the fluid plasma is clotted by the action of § 820.180, with respect to general tion of the enzyme coagulase which is requirements concerning records, and produced by pathogenic staphylococci. § 820.198, with respect to complaint Test results are used primarily as an files. aid in the diagnosis of disease caused by pathogenic bacteria belonging to [47 FR 50823, Nov. 9, 1982, as amended at 66 FR 38790, July 25, 2001] the genus Staphylococcus and provide epidemiological information on disease § 866.2300 Multipurpose culture me- caused by these microorganisms. dium. (b) Classification. Class I (general con- (a) Identification. A multipurpose cul- trols). The device is exempt from the ture medium is a device that consists premarket notification procedures in primarily of liquid or solid biological subpart E of part 807 of this chapter materials intended for medical pur- subject to the limitations in § 866.9. poses for the cultivation and identi- [47 FR 50823, Nov. 9, 1982, as amended at 61 fication of several types of pathogenic FR 1119, Jan. 16, 1996; 66 FR 38790, July 25, microorganisms without the need of 2001] additional nutritional supplements.

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Test results aid in the diagnosis of dis- (b) Classification. Class I (general con- ease and also provide epidemiological trols). The device is exempt from the information on diseases caused by premarket notification procedures in these microorganisms. subpart E of part 807 of this chapter (b) Classification. Class I (general con- subject to the limitations in § 866.9. trols). The device is exempt from the [47 FR 50823, Nov. 9, 1982, as amended at 54 premarket notification procedures in FR 25046, June 12, 1989; 66 FR 38791, July 25, subpart E of part 807 of this chapter 2001] subject to the limitations in § 866.9. [47 FR 50823, Nov. 9, 1982, as amended at 54 § 866.2350 Microbiological assay cul- FR 25046, June 12, 1989; 66 FR 38790, July 25, ture medium. 2001] (a) Identification. A microbiological assay culture medium is a device that § 866.2320 Differential culture me- consists primarily of liquid or solid bi- dium. ological materials intended for medical (a) Identification. A differential cul- purposes to cultivate selected test ture medium is a device that consists microorganisms in order to measure by primarily of liquid biological materials microbiological procedures the con- intended for medical purposes to cul- centration in a patient’s serum of cer- tivate and identify different types of tain substances, such as amino acids, pathogenic microorganisms. The iden- antimicrobial agents, and vitamins. tification of these microorganisms is The concentration of these substances accomplished by the addition of a spe- is measured by their ability to promote cific biochemical component(s) to the or inhibit the growth of the test orga- medium. Microorganisms are identified nism in the innoculated medium. Test by a visible change (e.g., a color results aid in the diagnosis of disease change) in a specific biochemical com- resulting from either deficient or ex- ponent(s) which indicates that specific cessive amounts of these substances in metabolic reactions have occurred. a patient’s serum. Tests results may Test results aid in the diagnosis of dis- also be used to monitor the effects of ease and also provide epidemiological the administration of certain anti- information on diseases caused by microbial drugs. these microorganisms. (b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to the limitations in § 866.9. subject to the limitations in § 866.9. [47 FR 50823, Nov. 9, 1982, as amended at 54 [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 FR 38791, July 25, FR 25046, June 12, 1989; 66 FR 38790, July 25, 2001] 2001] § 866.2360 Selective culture medium. § 866.2330 Enriched culture medium. (a) Identification. A selective culture (a) Identification. An enriched culture medium is a device that consists pri- medium is a device that consists primarily of liquid or solid biological ma- marily of liquid or solid biological materials intended for medical purposes terials intended for medical purposes to cultivate and identify certain patho- to cultivate and identify fastidious genic microorganisms. The device con- microorganisms (those having complex tains one or more components that nutritional requirements). The device suppress the growth of certain micro- consists of a relatively simple basal organisms while either promoting or medium enriched by the addition of not affecting the growth of other such nutritional components as blood, microorganisms. The device aids in the blood serum, vitamins, and extracts of diagnosis of disease caused by patho- plant or animal tissues. The device is genic microorganisms and also pro- used in the diagnosis of disease caused vides epidemiological information on by pathogenic microorganisms and also these diseases. provides epidemiological information (b) Classification. Class I (general con- on these diseases. trols). The device is exempt from the

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premarket notification procedures in tive organisms other than Neisseria subpart E of part 807 of this chapter gonorrhoeae are present in the urethral subject to the limitations in § 866.9. discharge of males, the identification [47 FR 50823, Nov. 9, 1982, as amended at 54 of cytochrome oxidase with this device FR 25046, June 12, 1989; 66 FR 38791, July 25, indicates presumptive infection of the 2001] patient with the causative agent of gonorrhea. § 866.2390 Transport culture medium. (b) Classification. Class III (premarket (a) Identification. A transport culture approval) (transitional device). medium is a device that consists of a (c) Date PMA or notice of completion of semisolid, usually non-nutrient, me- a PDP is required. As of May 28, 1976, an dium that maintains the viability of approval under section 515 of the act is suspected pathogens contained in pa- required before this device may be tient specimens while in transit from commercially distributed. See § 866.3. the specimen collection area to the [47 FR 50823, Nov. 9, 1982, as amended at 52 laboratory. The device aids in the diag- FR 17734, May 11, 1987] nosis of disease caused by pathogenic microorganisms and also provides epi- § 866.2440 Automated medium dis- demiological information on these dispensing and stacking device. eases. (a) Identification. An automated me- (b) Classification. Class I (general con- dium dispensing and stacking device is trols). a device intended for medical purposes § 866.2410 Culture medium for patho- to dispense a microbiological culture genic Neisseria spp. medium into petri dishes and then mechanically stack the petri dishes. (a) Identification. A culture medium (b) Classification. Class I (general con- for pathogenic Neisseria spp. is a device trols). The device is exempt from the that consists primarily of liquid or premarket notification procedures in solid biological materials used to cul- subpart E of part 807 of this chapter tivate and identify pathogenic Neisseria subject to the limitations in § 866.9. The spp. The identification aids in the diag- device is also exempt from the good nosis of disease caused by bacteria be- manufacturing practice requirements longing to the genus Neisseria, such as of the quality system regulation in epidemic cerebrospinal meningitis, part 820 of this chapter, with the excep- other meningococcal disease, and gon- tion of § 820.180, with respect to general orrhea, and also provides epidemiolog- requirements concerning records, and ical information on these microorga- § 820.198, with respect to complaint nisms. files. (b) Classification. Class II (performance standards). [47 FR 50823, Nov. 9, 1982, as amended at 66 FR 38791, July 25, 2001] § 866.2420 Oxidase screening test for gonorrhea. § 866.2450 Supplement for culture (a) Identification. An oxidase screen- media. ing test for gonorrhea is an in vitro de- (a) Identification. A supplement for vice that consists of the articles in- culture media is a device, such as a vi- tended to identify by chemical reac- tamin or sugar mixture, that is added tion, cytochrome oxidase, an oxidizing to a solid or liquid basal culture me- enzyme that is associated with certain dium to produce a desired formulation bacteria including Neisseria and that is intended for medical pur- gonorrhoeae. A sample of a male’s poses to enhance the growth of fas- urethral discharge is obtained on a tidious microorganisms (those having swab which is placed into a wetting complex nutritional requirements). agent containing an ingredient that This device aids in the diagnosis of dis- will react with cytochrome oxidase. eases caused by pathogenic microorga- When cytochrome oxidase is present, nisms. the swab turns a dark purple color (b) Classification. Class I (general con- within 3 minutes. Because it is un- trols). The device is exempt from the likely that cytochrome oxidase-posi- premarket notification procedures in

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subpart E of part 807 of this chapter (b) Classification. Class I (general con- subject to the limitations in § 866.9. trols). The device is exempt from the premarket notification procedures in [47 FR 50823, Nov. 9, 1982, as amended at 54 subpart E of part 807 of this chapter FR 25046, June 12, 1989; 66 FR 38791, July 25, 2001] subject to the limitations in § 866.9. The device is also exempt from the good § 866.2480 Quality control kit for cul- manufacturing practice requirements ture media. of the quality system regulation in part 820 of this chapter, with the excep- (a) Identification. A quality control tion of § 820.180, with respect to general kit for culture media is a device that requirements concerning records, and consists of paper discs (or other suit- § 820.198, with respect to complaint able materials), each impregnated with files. a specified, freeze-dried, viable microorganism, intended for medical pur- [47 FR 50823, Nov. 9, 1982, as amended at 66 poses to determine if a given culture FR 38791, July 25, 2001] medium is able to support the growth of that microorganism. The device aids § 866.2560 Microbial growth monitor. in the diagnosis of disease caused by (a) Identification. A microbial growth pathogenic microorganisms and also monitor is a device intended for med- provides epidemiological information ical purposes that measures the con- on these diseases. centration of bacteria suspended in a (b) Classification. Class I (general con- liquid medium by measuring changes trols). The device is exempt from the in light scattering properties, optical premarket notification procedures in density, electrical impedance, or by subpart E of part 807 of this chapter making direct bacterial counts. The subject to the limitations in § 866.9. device aids in the diagnosis of disease caused by pathogenic microorganisms. [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 FR 38791, July 25, (b) Classification. Class I. With the ex- 2001] ception of automated blood culturing system devices that are used in testing § 866.2500 Microtiter diluting and dis- for bacteria, fungi, and other micro- pensing device. organisms in blood and other normally (a) Identification. A microtiter dilut- sterile body fluids, this device is ex- ing and dispensing device is a mechan- empt from the premarket notification ical device intended for medical pur- procedures in subpart E of part 807 of poses to dispense or serially dilute very this chapter. small quantities of biological or chem- [47 FR 50823, Nov. 9, 1982, as amended at 60 ical reagents for use in various diag- FR 38482, July 27, 1995] nostic procedures. (b) Classification. Class I (general con- § 866.2580 Gas-generating device. trols). The device is exempt from the (a) Identification. A gas-generating premarket notification procedures in device is a device intended for medical subpart E of part 807 of this chapter purposes that produces predetermined subject to the limitations in § 866.9. amounts of selected gases to be used in [47 FR 50823, Nov. 9, 1982, as amended at 54 a closed chamber in order to establish FR 25046, June 12, 1989; 66 FR 38791, July 25, suitable atmospheric conditions for 2001] cultivation of microorganisms with special atmospheric requirements. The § 866.2540 Microbiological incubator. device aids in the diagnosis of disease. (a) Identification. A microbiological (b) Classification. Class I (general con- incubator is a device with various trols). The device is exempt from the chambers or water-filled compartments premarket notification procedures in in which controlled environmental con- subpart E of part 807 of this chapter ditions, particularly temperature, are subject to the limitations in § 866.9. maintained. It is intended for medical [47 FR 50823, Nov. 9, 1982, as amended at 54 purposes to cultivate microorganisms FR 25046, June 12, 1989; 66 FR 38791, July 25, and aid in the diagnosis of disease. 2001]

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§ 866.2600 Wood’s fluorescent lamp. (b) Classification. Class I (general con- (a) Identification. A Wood’s fluores- trols). cent lamp is a device intended for med- § 866.2900 Microbiological specimen ical purposes to detect fluorescent ma- collection and transport device. terials (e.g., fluorescein pigment pro- (a) Identification. A microbiological duced by certain microorganisms) as specimen collection and transport de- an aid in the identification of these vice is a specimen collecting chamber microorganisms. The device aids in the intended for medical purposes to pre- diagnosis of disease. serve the viability or integrity of (b) Classification. Class I (general con- microorganisms in specimens during trols). The device is exempt from the storage of specimens after their collec- premarket notification procedures in tion and during their transport from subpart E of part 807 of this chapter the collecting area to the laboratory. subject to the limitations in § 866.9. The The device may be labeled or otherwise device is also exempt from the good represented as sterile. The device aids manufacturing practice requirements in the diagnosis of disease caused by of the quality system regulation in pathogenic microorganisms. part 820 of this chapter, with the excep- (b) Classification. Class I (general con- tion of § 820.180, with respect to general trols). requirements concerning records, and § 820.198, with respect to complaint files. Subpart D—Serological Reagents [47 FR 50823, Nov. 9, 1982, as amended at 66 § 866.3010 Acinetobacter calcoaceticus FR 38791, July 25, 2001] serological reagents. (a) Identification. Acinetobacter § 866.2660 Microorganism differentia- calcoaceticus serological reagents are tion and identification device. devices that consist of Acinetobacter (a) Identification. A microorganism calcoaceticus antigens and antisera used differentiation and identification de- to identify this bacterium from cul- vice is a device intended for medical tured isolates derived from clinical purposes that consists of one or more specimens. The identification aids in components, such as differential cul- the diagnosis of disease caused by the ture media, biochemical reagents, and bacterium Acinetobacter calcoaceticus paper discs or paper strips impregnated and provides epidemiological informa- with test reagents, that are usually tion on disease caused by this micro- contained in individual compartments organism. This organism becomes and used to differentiate and identify pathogenic in patients with burns or selected microorganisms. The device with immunologic deficiency, and in- aids in the diagnosis of disease. fection can result in sepsis (blood poi- (b) Classification. Class I (general con- soning). trols). The device is exempt from the (b) Classification. Class I (general con- premarket notification procedures in trols). The device is exempt from the subpart E of part 807 of this chapter premarket notification procedures in subject to § 866.9. subpart E of part 807 of this chapter [47 FR 50823, Nov. 9, 1982, as amended at 65 subject to the limitations in § 866.9. FR 2311, Jan. 14, 2000] [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 FR 38791, July 25, § 866.2850 Automated zone reader. 2001] (a) Identification. An automated zone reader is a mechanical device intended § 866.3020 Adenovirus serological re- for medical purposes to measure zone agents. diameters of microbial growth inhibi- (a) Identification. Adenovirus sero- tion (or exhibition), such as those ob- logical reagents are devices that con- served on the surface of certain culture sist of antigens and antisera used in se- media used in disc-agar diffusion anti- rological tests to identify antibodies to microbial susceptibility tests. The de- adenovirus in serum. Additionally, vice aids in decisionmaking respecting some of these reagents consist of the treatment of disease. adenovirus antisera conjugated with a

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fluorescent dye and are used to identify (b) Classification. Class I (general con- adenoviruses directly from clinical trols). The device is exempt from the specimens. The identification aids in premarket notification procedures in the diagnosis of disease caused by subpart E of part 807 of this chapter adenoviruses and provides epidemiolog- subject to § 866.9. ical information on these diseases. Adenovirus infections may cause phar- [47 FR 50823, Nov. 9, 1982, as amended at 65 yngitis (inflammation of the throat), FR 2311, Jan. 14, 2000] acute respiratory diseases, and certain external diseases of the eye (e.g., con- § 866.3050 Beta-glucan serological as- junctivitis). says. (b) Classification. Class I (general con- (a) Identification. Beta-glucan sero- trols). The device is exempt from the logical assays are devices that consist premarket notification procedures in of antigens or proteases used in sero- subpart E of part 807 of this chapter logical assays. The device is intended subject to the limitations in § 866.9. for use for the presumptive diagnosis of [47 FR 50823, Nov. 9, 1982, as amended at 54 fungal infection. The assay is indicated FR 25046, June 12, 1989; 66 FR 38791, July 25, for use in patients with symptoms of, 2001] or medical conditions predisposing the patient to invasive fungal infection. § 866.3035 Arizona spp. serological reagents. The device can be used as an aid in the diagnosis of deep seated mycoses and (a) Identification. Arizona spp. sero- fungemias. logical reagents are devices that con- (b) Classification. Class II (special sist of antisera and antigens used to identify Arizona spp. in cultured iso- controls). The special control is FDA’s lates derived from clinical specimens. guidance document entitled ‘‘Class II The identification aids in the diagnosis Special Controls Guidance Document: of disease caused by bacteria belonging Serological Assays for the Detection of to the genus Arizona and provides epi- Beta-Glucan.’’ See § 866.1(e) for the demiological information on diseases availability of this guidance document. caused by these microorganisms. Ari- [69 FR 56936, Sept. 23, 2004] zona spp. can cause gastroenteritis (food poisoning) and sepsis (blood poi- § 866.3060 Blastomyces dermatitidis se- soning). rological reagents. (b) Classification. Class I (general controls). The device is exempt from the (a) Identification. Blastomyces premarket notification procedures in dermatitidis serological reagents are de- subpart E of part 807 of this chapter vices that consist of antigens and subject to the limitations in § 866.9. antisera used in serological tests to identify antibodies to Blastomyces [47 FR 50823, Nov. 9, 1982, as amended at 54 determatitidis in serum. The identifica- FR 25046, June 12, 1989; 66 FR 38791, July 25, 2001] tion aids in the diagnosis of blastomycosis caused by the fungus § 866.3040 Aspergillus spp. serological Blastomyces dermatitidis. Blastomycosis reagents. is a chronic granulomatous (tumor- (a) Identification. Aspergillus spp. sero- like) disease, which may be limited to logical reagents are devices that con- the skin or lung or may be widely dis- sist of antigens and antisera used in seminated in the body resulting in le- various serological tests to identify sions of the bones, liver, spleen, and antibodies to Aspergillus spp. in serum. kidneys. The identification aids in the diagnosis (b) Classification. Class II (special of aspergillosis caused by fungi belong- controls). The device is exempt from ing to the genus Aspergillus. the premarket notification procedures Aspergillosis is a disease marked by in- in subpart E of part 807 of this chapter flammatory granulomatous (tumor- subject to § 866.9. like) lessions in the skin, ear, eyeball cavity, nasal sinuses, lungs, and occa- [47 FR 50823, Nov. 9, 1982, as amended at 63 sionally the bones. FR 59226, Nov. 3, 1998]

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§ 866.3065 Bordetella spp. serological § 866.3110 Campylobacter fetus sero- reagents. logical reagents. (a) Identification. Bordetella spp. sero- (a) Identification. Campylobacter fetus logical reagents are devices that con- serological reagents are devices that sist of antigens and antisera, including consist of antisera conjugated with a antisera conjugated with a fluorescent fluorescent dye used to identify dye, used in serological tests to iden- Campylobacter fetus from clinical speci- tify Bordetella spp. from cultured iso- mens or cultured isolates derived from lates or directly from clinical speci- clinical specimens. The identification mens. The identification aids in the di- aids in the diagnosis of diseases caused agnosis of diseases caused by bacteria by this bacterium and provides epide- belonging to the genus Bordetella and miological information on these dis- provides epidemiological information eases. Campylobacter fetus is a frequent on these diseases. Bordetella spp. cause cause of abortion in sheep and cattle whooping cough (Bordetella pertussis) and is sometimes responsible for endo- and other similiarly contagious and carditis (inflammation of certain membranes of the heart) and enteritis (in- acute respiratory infections character- flammation of the intestines) in hu- ized by pneumonitis (inflammation of mans. the lungs). (b) Classification. Class I (general con- (b) Classification. Class I (general controls). trols). The device is exempt from the premarket notification procedures in § 866.3120 Chlamydia serological re- subpart E of part 807 of this chapter agents. subject to the limitations in § 866.9. (a) Identification. Chlamydia sero- [47 FR 50823, Nov. 9, 1982, as amended at 54 logical reagents are devices that con- FR 25046, June 12, 1989; 66 FR 38791, July 25, sist of antigens and antisera used in se- 2001] rological tests to identify antibodies to chlamydia in serum. Additionally, § 866.3085 Brucella spp. serological re- some of these reagents consist of agents. chlamydia antisera conjugated with a (a) Identification. Brucella spp. sero- fluorescent dye used to identify logical reagents are devices that con- chlamydia directly from clinical speci- sist of antigens and antisera used for mens or cultured isolates derived from serological identification of Brucella clinical specimens. The identification spp. from cultured isolates derived aids in the diagnosis of disease caused from clinical specimens or to identify by bacteria belonging to the genus antibodies to Brucella spp. in serum. Chlamydia and provides epidemiolog- Additionally, some of these reagents ical information on these diseases. consist of antisera conjugated with a Chlamydia are the causative agents of fluorescent dye (immunofluorescent re- psittacosis (a form of pneumonia), agents) used to identify Brucella spp. lymphogranuloma venereum (a vene- directly from clinical specimens or cul- real disease), and trachoma (a chronic tured isolates derived from clinical disease of the eye and eyelid). specimens. The identification aids in (b) Classification. Class I (general con- the diagnosis of brucellosis (e.g., undu- trols). lant fever, Malta fever) caused by bac- § 866.3125 Citrobacter spp. serological teria belonging to the genus Brucella reagents. and provides epidemiological informa- (a) Identification. Citrobacter spp. sero- tion on diseases caused by these micro- logical reagents are devices that con- organisms. sist of antigens and antisera used in se- (b) Classification. Class II (special rological tests to identify Citrobacter controls). The device is exempt from spp. from cultured isolates derived the premarket notification procedures from clinical specimens. The identi- in subpart E of part 807 of this chapter fication aids in the diagnosis of disease subject to § 866.9. caused by bacteria belonging to the [47 FR 50823, Nov. 9, 1982, as amended at 63 genus Citrobacter and provides epide- FR 59226, Nov. 3, 1998] miological information on diseases

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caused by these microorganisms. in subpart E of part 807 of this chapter Citrobacter spp. have occasionally been subject to § 866.9. associated with urinary tract infec- [47 FR 50823, Nov. 9, 1982, as amended at 63 tions. FR 59226, Nov. 3, 1998] (b) Classification. Class I (general controls). The device is exempt from the § 866.3140 Corynebacterium spp. sero- premarket notification procedures in logical reagents. subpart E of part 807 of this chapter (a) Identification. Corynebacterium spp. subject to the limitations in § 866.9. serological reagents are devices that [47 FR 50823, Nov. 9, 1982, as amended at 54 consist of antisera conjugated with a FR 25046, June 12, 1989; 66 FR 38791, July 25, fluorescent dye used to identify 2001] Corynebacterium spp. from clinical specimens. The identification aids in § 866.3130 Clostridium difficile toxin the diagnosis of disease caused by bac- gene amplification assay. teria belonging to the genus (a) Identification. A Clostridium Corynebacterium and provides epidemio- difficile toxin gene amplification assay logical information on diseases caused is a device that consists of reagents for by these microorganisms. The principal the amplification and detection of tar- human pathogen of this genus, get sequences in Clostridium difficile Corynebacterium diphtheriae, causes toxin genes in fecal specimens from pa- diphtheria. However, many other types tients suspected of having Clostridium of corynebacteria form part of the nor- difficile infection (CDI). The detection mal flora of the human respiratory of clostridial toxin genes, in conjunc- tract, other mucus membranes, and tion with other laboratory tests, aids skin, and are either nonpathogenic or in the clinical laboratory diagnosis of have an uncertain role. CDI caused by Clostridium difficile. (b) Classification. Class I (general con- (b) Classification. Class II (special trols). The device is exempt from the controls). The special controls are set premarket notification procedures in subpart E of part 807 of this chapter forth in FDA’s guideline document en- subject to § 866.9. titled: ‘‘Class II Special Controls Guideline: Toxin Gene Amplification [47 FR 50823, Nov. 9, 1982, as amended at 65 Assays for the Detection of Clostridium FR 2311, Jan. 14, 2000] difficile; Guideline for Industry and Food and Drug Administration Staff.’’ § 866.3145 Coxsackievirus serological reagents. See § 866.1(e) for information on obtaining this document. (a) Identification. Coxsackievirus serological reagents are devices that con- [80 FR 51939, Aug. 27, 2015] sist of antigens and antisera used in serological tests to identify antibodies to § 866.3135 Coccidioides immitis sero- coxsackievirus in serum. Additionally, logical reagents. some of these reagents consist of (a) Identification. Coccidioides immitis coxsackievirus antisera conjugated serological reagents are devices that with a fluorescent dye that are used to consist of antigens and antisera used in identify coxsackievirus from clinical serological tests to identify antibodies specimens or from tissue culture iso- to Coccidioides immitis in serum. The lates derived from clinical specimens. identification aids in the diagnosis of The identification aids in the diagnosis coccidioidomycosis caused by a fungus of coxsackievirus infections and pro- belonging to the genus Coccidioides and vides epidemiological information on provides epidemiological information diseases caused by these viruses. on diseases caused by this microorga- Coxsackieviruses produce a variety of nism. An infection with Coccidioides infections, including common colds, immitis produces symptoms varying in meningitis (inflammation of brain and severity from those accompanying the spinal cord membranes), herpangina common cold to those of influenza. (brief fever accompanied by ulcerated (b) Classification. Class II (special lesions of the throat), and controls). The device is exempt from myopericarditis (inflammation of heart the premarket notification procedures tissue).

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(b) Classification. Class I (general con- been associated with acquired hemo- trols). The device is exempt from the lytic anemia, acute and chronic hepa- premarket notification procedures in titis, and an infectious mononucleosis- subpart E of part 807 of this chapter like syndrome. subject to § 866.9. (b) Classification. Class II (perform- [47 FR 50823, Nov. 9, 1982, as amended at 65 ance standards). FR 2311, Jan. 14, 2000] § 866.3200 Echinococcus spp. sero- § 866.3165 Cryptococcus neoformans se- logical reagents. rological reagents. (a) Identification. Echinococcus spp. se- (a) Identification. Cryptococcus rological reagents are devices that con- neoformans serological reagents are de- sist of Echinococcus spp. antigens and vices that consist of antigens used in antisera used in serological tests to serological tests to identify antibodies identify antibodies to Echinococcus spp. to Cryptococcus neoformans in serum. Additionally, some of these reagents in serum. The identification aids in the consist of antisera conjugated with a diagnosis of echinococcosis, caused by fluorescent dye (immunofluorescent re- parasitic tapeworms belonging to the agents) and are used to identify genus Echinococcus and provides epide- Cryptococcus neoformans directly from miological information on this disease. clinical specimens or from cultured Echinococcosis is characterized by the isolates derived from clinical speci- development of cysts in the liver, lung, mens. The identification aids in the di- kidneys, and other organs formed by agnosis of cryptococcosis and provides the larva of the infecting organisms. epidemiological information on this (b) Classification. Class I (general con- type of disease. Cryptococcosis infec- trols). The device is exempt from the tions are found most often as chronic premarket notification procedures in meningitis (inflammation of brain subpart E of part 807 of this chapter membranes) and, if not treated, are subject to § 866.9. usually fatal. (b) Classification. Class II (special [47 FR 50823, Nov. 9, 1982, as amended at 65 controls). The device is exempt from FR 2311, Jan. 14, 2000] the premarket notification procedures in subpart E of part 807 of this chapter § 866.3205 Echovirus serological re- subject to § 866.9. agents. [47 FR 50823, Nov. 9, 1982, as amended at 63 (a) Identification. Echovirus sero- FR 59226, Nov. 3, 1998] logical reagents are devices that consist of antigens and antisera used in se- § 866.3175 Cytomegalovirus serological rological tests to identify antibodies to reagents. echovirus in serum. Additionally, some (a) Identification. Cytomegalovirus se- of these reagents consist of echovirus rological reagents are devices that con- antisera conjugated with a fluorescent sist of antigens and antisera used in se- dye used to identify echoviruses from rological tests to identify antibodies to clinical specimens or from tissue cul- cytomegalovirus in serum. The identi- ture isolates derived from clinical fication aids in the diagnosis of dis- specimens. The identification aids in eases caused by cytomegaloviruses the diagnosis of echovirus infections (principally cytomegalic inclusion dis- and provides epidemiological informa- ease) and provides epidemiological in- tion on diseases caused by these vi- formation on these diseases. Cytomegalic inclusion disease is a gen- ruses. Echoviruses cause illnesses such eralized infection of infants and is as meningitis (inflammation of the caused by intrauterine or early post- brain and spinal cord membranes), feb- natal infection with the virus. The dis- rile illnesses (accompanied by fever) ease may cause severe congenital ab- with or without rash, and the common normalities, such as microcephaly (ab- cold. normal smallness of the head), motor (b) Classification. Class I (general con- disability, and mental retardation. trols). The device is exempt from the Cytomegalovirus infection has also premarket notification procedures in

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subpart E of part 807 of this chapter § 866.3225 Enterovirus nucleic acid subject to the limitations in § 866.9. assay. [47 FR 50823, Nov. 9, 1982, as amended at 54 (a) Identification. An enterovirus nu- FR 25046, June 12, 1989; 66 FR 38791, July 25, cleic acid assay is a device that con- 2001] sists of primers, probes, enzymes, and controls for the amplification and de- § 866.3210 Endotoxin assay. tection of enterovirus ribonucleic acid (a) Identification. An endotoxin assay (RNA) in cerebrospinal fluid (CSF) is a device that uses serological tech- from individuals who have signs and niques in whole blood. The device is in- symptoms consistent with meningitis tended for use in conjunction with or meningoencephalitis. The detection other laboratory findings and clinical of enterovirus RNA, in conjunction assessment of the patient to aid in the with other laboratory tests, aids in the risk assessment of critically ill pa- clinical laboratory diagnosis of viral tients for progression to severe sepsis. meningitis caused by enterovirus. (b) Classification. Class II (special (b) Classification. Class II (special controls). The special control for this controls). The special control is FDA’s device is the FDA guidance entitled guidance document entitled ‘‘Class II ‘‘Class II Special Controls Guidance Special Controls Guidance Document: Nucleic Acid Amplification Assay for Document: Endotoxin Assay.’’ See the Detection of Enterovirus RNA.’’ § 866.1(e) for the availability of this See § 866.1(e) for the availability of this guidance document. guidance document. [68 FR 62008, Oct. 31, 2003. Redesignated at 70 [74 FR 8, Jan. 2, 2009] FR 53069, Sept. 7, 2005]

§ 866.3220 Entamoeba histolytica sero- § 866.3235 Epstein-Barr virus serological reagents. logical reagents. (a) Identification. Entamoeba (a) Identification. Epstein-Barr virus serological reagents are devices that histolytica serological reagents are de- consist of antigens and antisera used in vices that consist of antigens and serological tests to identify antibodies antisera used in serological tests to to Epstein-Barr virus in serum. The identify antibodies to Entamoeba identification aids in the diagnosis of histolytica in serum. Additionally, some Epstein-Barr virus infections and proof these reagents consist of antisera vides epidemiological information on conjugated with a fluorescent dye diseases caused by these viruses. Ep- (immunofluorescent reagents) used to stein-Barr viruses are thought to cause identify Entamoeba histolytica directly infectious mononucleosis and have from clinical specimens. The identi- been associated with Burkitt’s fication aids in the diagnosis of amebi- lymphoma (a tumor of the jaw in Afri- asis caused by the microscopic proto- can children and young adults) and zoan parasite Entamoeba histolytica and postnasal carcinoma (cancer). provides epidemiological information (b) Classification. Class I (general con- on diseases caused by this parasite. trols). The parasite may invade the skin, liver, intestines, lungs, and diaphragm, § 866.3240 Equine encephalomyelitis causing disease conditions such as in- virus serological reagents. dolent ulcers, an amebic hepatitis, (a) Identification. Equine amebic dysentery, and pulmonary le- encephalomyelitis virus serological re- sions. agents are devices that consist of anti- (b) Classification. Class II (special gens and antisera used in serological controls). The device is exempt from tests to identify antobodies to equine the premarket notification procedures encephalomyelitis virus in serum. The in subpart E of part 807 of this chapter identification aids in the diagnosis of subject to § 866.9. diseases caused by equine [47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, encephalomyelitis viruses and provides 1982, as amended at 63 FR 59226, Nov. 3, 1998] epidemiological information on these

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viruses. Equine encephalomyelitis vi- microorganisms found in the intestinal ruses are transmitted to humans by tract in humans and is usually non- the bite of insects, such as mosquitos pathogenic, those strains which are and ticks, and may cause encephalitis pathogenic may cause urinary tract in- (inflammation of the brain), rash, fections or epidemic diarrheal disease, acute arthritis, or hepatitis. especially in children. (b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to § 866.9. subject to the limitations in § 866.9. [47 FR 50823, Nov. 9, 1982, as amended at 65 [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 2311, Jan. 14, 2000] FR 25046, June 12, 1989; 66 FR 38791, July 25, 2001] § 866.3250 Erysipelothrix rhusiopathiae serological reagents. § 866.3270 Flavobacterium spp. sero- (a) Identification. Erysipelothrix logical reagents. rhusiopathiae serological reagents are (a) Identification. Flavobacterium spp. devices that consist of antigens and serological reagents are devices that antisera used in serological tests to consist of antigens and antisera used in identify Erysipelothrix rhusiopathiae serological tests to identify from cultured isolates derived from Flavobacteriuim spp. from cultured iso- clinical specimens. The identification lates derived from clinical specimens. aids in the diagnosis of disease caused The identification aids in the diagnosis by this bacterium belonging to the of disease caused by bacteria belonging genus Erysipelothrix. This organism is to the genus Flavobacterium and pro- responsible for a variety of inflamma- vides epidemiological information on tions of the skin following skin abra- diseases caused by these microorga- sions from contact with fish, shellfish, nisms. Most members of this genus are or poultry. found in soil and water and, under cer- (b) Classification. Class I (general contain conditions, may become patho- trols). The device is exempt from the genic to humans. Flavobacterium premarket notification procedures in meningosepticum is highly virulent for subpart E of part 807 of this chapter the newborn, in whom it may cause subject to the limitations in § 866.9. epidemics of septicemia (blood poisoning) and meningitis (inflammation [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25046, June 12, 1989; 66 FR 38791, July 25, of the membranes of the brain) and is 2001] usually attributable to contaminated hospital equipment. § 866.3255 Escherichia coli serological (b) Classification. Class I (general con- reagents. trols). The device is exempt from the (a) Identification. Escherichia coli sero- premarket notification procedures in logical reagents are devices that con- subpart E of part 807 of this chapter sist of antigens and antisera used in se- subject to the limitations in § 866.9. rological tests to identify Escherichia [47 FR 50823, Nov. 9, 1982, as amended at 54 coli from cultured isolates derived from FR 25046, June 12, 1989; 66 FR 38792, July 25, clinical specimens. Additionally, some 2001] of these reagents consist of Escherichia coli antisera conjugated with a fluores- § 866.3280 Francisella tularensis sero- cent dye used to identify Escherichia logical reagents. coli directly from clinical specimens or (a) Identification. Francisella tularensis cultured isolates derived from clinical serological reagents are devices that specimens. The identification aids in consist of antigens and antisera used in the diagnosis of diseases caused by this serological tests to identify antibodies bacterium belonging to the genus Esch- to Francisella tularensis in serum or to erichia, and provides epidemiological identify Francisella tularensis in cul- information on diseases caused by this tured isolates derived from clinical microorganism. Although Escherichia specimens. Additionally, some of these coli constitutes the greater part of the reagents consist of antisera conjugated

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with a fluorescent dye specimens. The identification aids in (immunofluorescent reagents) used to the diagnosis of diseases caused by bac- identify Francisella tularensis directly teria belonging to the genus from clinical specimens. The identi- Haemophilus and provides epidemiolog- fication aids in the diagnosis of tula- ical information on diseases cause by remia caused by Francisella tularensis these microorganisms. Diseases most and provides epidemiological informa- often caused by Haemophilus spp. in- tion on this disease. Tularemia is a clude pneumonia, pharyngitis, sinus- desease principally of rodents, but may itis, vaginitis, chancroid venereal dis- be transmitted to humans through ease, and a contagious form of conjunc- handling of infected animals, animal tivitis (inflammation of eyelid mem- products, or by the bites of fleas and branes). ticks. The disease takes on several (b) Classification. Class II (special forms depending upon the site of infec- controls). The device is exempt from tion, such as skin lesions, lymph node the premarket notification procedures enlargements, or pulmonary infection. in subpart E of part 807 of this chapter (b) Classification. Class II (special subject to § 866.9. controls). The device is exempt from [47 FR 50823, Nov. 9, 1982, as amended at 63 the premarket notification procedures FR 59226, Nov. 3, 1998] in subpart E of part 807 of this chapter subject to § 866.9. § 866.3305 Herpes simplex virus sero- [47 FR 50823, Nov. 9, 1982, as amended at 63 logical assays. FR 59226, Nov. 3, 1998] (a) Identification. Herpes simplex virus serological assays are devices § 866.3290 Gonococcal antibody test that consist of antigens and antisera (GAT). used in various serological tests to (a) Identification. A gonococcal anti- identify antibodies to herpes simplex body test (GAT) is an in vitro device virus in serum. Additionally, some of that consists of the reagents intended the assays consist of herpes simplex to identify by immunochemical tech- virus antisera conjugated with a fluo- niques, such as latex agglutination, in- rescent dye (immunofluorescent as- direct fluorescent antibody, or says) used to identify herpes simplex radioimmunoassay, antibodies to virus directly from clinical specimens Neisseria gonorrhoeae in sera of asymp- or tissue culture isolates derived from tomatic females at low risk of infec- clinical specimens. The identification tion. Identification of antibodies with aids in the diagnosis of diseases caused this device may indicate past or by herpes simplex viruses and provides present infection of the patient with epidemiological information on these Neisseria gonorrhoeae. diseases. Herpes simplex viral infec- (b) Classification. Class III (premarket tions range from common and mild le- approval) (transitional device). sions of the skin and mucous mem- (c) Date PMA or notice of completion of branes to a severe form of encephalitis a PDP is required. As of May 28, 1976, an (inflammation of the brain). Neonatal approval under section 515 of the act is herpes virus infections range from a required before this device may be mild infection to a severe generalized commercially distributed. See § 866.3. disease with a fatal outcome. [47 FR 50823, Nov. 9, 1982, as amended at 52 (b) Classification. Class II (special FR 17734, May 11, 1987] controls). The device is classified as class II (special controls). The special § 866.3300 Haemophilus spp. sero- control for the device is FDA’s revised logical reagents. guidance document entitled ‘‘Class II (a) Identification. Haemophilus spp. se- Special Controls Guidance Document: rological reagents are devices that con- Herpes Simplex Virus Types 1 and 2 Se- sist of antigens and antisera, including rological Assays.’’ For availability of antisera conjugated with a fluorescent the guidance revised document, see dye, that are used in serological tests § 866.1(e). to identify Haemophilus spp. directly [72 FR 15830, Apr. 3, 2007, as amended at 74 from clinical specimens or tissue cul- FR 42775, Aug. 25, 2009; 76 FR 48717, Aug. 9, ture isolates derived from clinical 2011]

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§ 866.3310 Hepatitis A virus (HAV) se- in subpart E of part 807 of this chapter rological assays. subject to § 866.9. (a) Identification. HAV serological as- [47 FR 50823, Nov. 9, 1982, as amended at 63 says are devices that consist of anti- FR 59227, Nov. 3, 1998] gens and antisera for the detection of hepatitis A virus-specific IgM, IgG, or § 866.3328 Influenza virus antigen de- total antibodies (IgM and IgG), in tection test system. human serum or plasma. These devices (a) Identification. An influenza virus are used for testing specimens from in- antigen detection test system is a de- dividuals who have signs and symp- vice intended for the qualitative detec- toms consistent with acute hepatitis to tion of influenza viral antigens directly determine if an individual has been from clinical specimens in patients previously infected with HAV, or as an with signs and symptoms of res- aid to identify HAV-susceptible indi- piratory infection. The test aids in the viduals. The detection of these anti- diagnosis of influenza infection and bodies aids in the clinical laboratory provides epidemiological information diagnosis of an acute or past infection on influenza. Due to the propensity of by HAV in conjunction with other clin- the virus to mutate, new strains ical laboratory findings. These devices emerge over time which may poten- are not intended for screening blood or tially affect the performance of these solid or soft tissue donors. devices. Because influenza is highly (b) Classification. Class II (special contagious and may lead to an acute controls). The special control is ‘‘Guidance for Industry and FDA Staff: respiratory tract infection causing se- Class II Special Controls Guidance vere illness and even death, the accu- Document: Hepatitis A Virus Sero- racy of these devices has serious public logical Assays.’’ See § 866.1(e) for the health implications. availability of this guidance document. (b) Classification. Class II (special controls). The special controls for this [71 FR 6679, Feb. 9, 2006] device are: (1) The device’s sensitivity and speci- § 866.3320 Histoplasma capsulatum serological reagents. ficity performance characteristics or positive percent agreement and nega- (a) Identification. Histoplasma tive percent agreement, for each speci- capsulatum serological reagents are de- men type claimed in the intended use vices that consist of antigens and of the device, must meet one of the fol- antisera used in serological tests to lowing two minimum clinical perform- identify antibodies to Histoplasma ance criteria: capsulatum in serum. Additionally, some of these reagents consist of (i) For devices evaluated as compared Histoplasma capsulatum antisera con- to an FDA-cleared nucleic acid based- jugated with a fluorescent dye test or other currently appropriate and (immunofluorescent reagents) used to FDA accepted comparator method identify Histoplasma capsulatum from other than correctly performed viral clinical specimens or cultured isolates culture method: derived from clinical specimens. The (A) The positive percent agreement identification aids in the diagnosis of estimate for the device when testing histoplasmosis caused by this fungus for influenza A and influenza B must be belonging to the genus Histoplasma and at the point estimate of at least 80 per- provides epidemiological information cent with a lower bound of the 95 per- on the diseases caused by this fungus. cent confidence interval that is greater Histoplasmosis usually is a mild and than or equal to 70 percent. often asymptomatic respiratory infec- (B) The negative percent agreement tion, but in a small number of infected estimate for the device when testing individuals the lesions may spread to for influenza A and influenza B must be practically all tissues and organs. at the point estimate of at least 95 per- (b) Classification. Class II (special cent with a lower bound of the 95 per- controls). The device is exempt from cent confidence interval that is greater the premarket notification procedures than or equal to 90 percent.

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(ii) For devices evaluated as com- device received marketing authoriza- pared to correctly performed viral cul- tion from FDA must be included. The ture method as the comparator meth- results must be presented as part of the od: device’s labeling in a tabular format, (A) The sensitivity estimate for the which includes the detailed informa- device when testing for influenza A tion for each virus tested as described must be at the point estimate of at in the certificate of authentication, ei- least 90 percent with a lower bound of ther by: the 95 percent confidence interval that (A) Placing the results directly in the is greater than or equal to 80 percent. device’s § 809.10(b) of this chapter com- The sensitivity estimate for the device pliant labeling that physically accom- when testing for influenza B must be at panies the device in a separate section the point estimate of at least 80 per- of the labeling where the analytical re- cent with a lower bound of the 95 per- activity testing data can be found; or cent confidence interval that is greater (B) In the device’s label or in other than or equal to 70 percent. labeling that physically accompanies (B) The specificity estimate for the the device, prominently providing a device when testing for influenza A and hyperlink to the manufacturer’s public influenza B must be at the point esti- Web site where the analytical reac- mate of at least 95 percent with a lower tivity testing data can be found. The bound of the 95 percent confidence in- manufacturer’s home page, as well as terval that is greater than or equal to the primary part of the manufacturer’s 90 percent. Web site that discusses the device, (2) When performing testing to dem- must provide a prominently placed onstrate the device meets the require- hyperlink to the Web page containing ments in paragraph (b)(1) of this sec- this information and must allow unre- tion, a currently appropriate and FDA stricted viewing access. accepted comparator method must be (4) If one of the actions listed at sec- used to establish assay performance in tion 564(b)(1)(A)–(D) of the Federal clinical studies. (3) Annual analytical reactivity test- Food, Drug, and Cosmetic Act occurs ing of the device must be performed with respect to an influenza viral with contemporary influenza strains. strain, or if the Secretary of Health This annual analytical reactivity test- and Human Services (HHS) determines, ing must meet the following criteria: under section 319(a) of the Public (i) The appropriate strains to be test- Health Service Act, that a disease or ed will be identified by FDA in con- disorder presents a public health emer- sultation with the Centers for Disease gency, or that a public health emer- Control and Prevention (CDC) and gency otherwise exists, with respect to sourced from CDC or an FDA-des- an influenza viral strain: ignated source. If the annual strains (i) Within 30 days from the date that are not available from CDC, FDA will FDA notifies manufacturers that char- identify an alternative source for ob- acterized viral samples are available taining the requisite strains. for test evaluation, the manufacturer (ii) The testing must be conducted must have testing performed on the de- according to a standardized protocol vice with those viral samples in accord- considered and determined by FDA to ance with a standardized protocol con- be acceptable and appropriate. sidered and determined by FDA to be (iii) By July 31 of each calendar year, acceptable and appropriate. The proce- the results of the last 3 years of annual dure and location of testing may de- analytical reactivity testing must be pend on the nature of the emerging included as part of the device’s label- virus. ing. If a device has not been on the (ii) Within 60 days from the date that market long enough for 3 years of an- FDA notifies manufacturers that char- nual analytical reactivity testing to acterized viral samples are available have been conducted since the device for test evaluation and continuing received marketing authorization from until 3 years from that date, the re- FDA, then the results of every annual sults of the influenza emergency ana- analytical reactivity testing since the lytical reactivity testing, including the

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detailed information for the virus test- caused by specific novel influenza A vi- ed as described in the certificate of au- ruses in patients with clinical risk of thentication, must be included as part infection with these viruses, and also of the device’s labeling in a tabular for- aids in the presumptive laboratory mat, either by: identification of specific novel influ- (A) Placing the results directly in the enza A viruses to provide epidemiolog- device’s § 809.10(b) of this chapter com- ical information on influenza. These pliant labeling that physically accom- reagents include primers, probes, and panies the device in a separate section specific influenza A virus controls. of the labeling where analytical reactivity testing data can be found, but (b) Classification. Class II (special separate from the annual analytical re- controls). The special controls are: activity testing results; or (1) FDA’s guidance document entitled (B) In a section of the device’s label ‘‘Class II Special Controls Guidance or in other labeling that physically ac- Document: Reagents for Detection of companies the device, prominently pro- Specific Novel Influenza A Viruses.’’ viding a hyperlink to the manufactur- See § 866.1(e) for information on obtain- er’s public Web site where the analyt- ing this document. ical reactivity testing data can be (2) The distribution of these devices found. The manufacturer’s home page, is limited to laboratories with experi- as well as the primary part of the man- enced personnel who have training in ufacturer’s Web site that discusses the standardized molecular testing proce- device, must provide a prominently dures and expertise in viral diagnosis, placed hyperlink to the Web page con- and appropriate biosafety equipment taining this information and must and containment. allow unrestricted viewing access. [71 FR 14379, Mar. 22, 2006] [82 FR 3618, Jan. 12, 2017]

§ 866.3330 Influenza virus serological § 866.3336 John Cunningham Virus se- reagents. rological reagents. (a) Identification. Influenza virus sero- (a) Identification. John Cunningham logical reagents are devices that con- Virus serological reagents are devices sist of antigens and antisera used in se- that consist of antigens and antisera rological tests to identify antibodies to used in serological assays to identify influenza in serum. The identification antibodies to John Cunningham Virus aids in the diagnosis of influenza (flu) in serum and plasma. The identifica- and provides epidemiological information aids in the risk stratification for tion on influenza. Influenza is an acute the development of progressive respiratory tract disease, which is multifocal leukoencephalopathy in often epidemic. multiple sclerosis and Crohn’s disease (b) Classification. Class I (general con- patients undergoing natalizumab ther- trols). The device is exempt from the apy. These devices are for adjunctive premarket notification procedures in use, in the context of other clinical subpart E of part 807 of this chapter subject to the limitations in § 866.9. risk factors for the development of progressive multifocal leukoenceph- [47 FR 50823, Nov. 9, 1982, as amended at 54 alopathy. FR 25047, June 12, 1989; 66 FR 38792, July 25, (b) Classification. Class II (special 2001] controls). The special control for this § 866.3332 Reagents for detection of device is the FDA guideline document specific novel influenza A viruses. entitled ‘‘Class II Special Controls (a) Identification. Reagents for detec- Guideline: John Cunningham Virus Se- tion of specific novel influenza A vi- rological Reagents.’’ For availability ruses are devices that are intended for of the guideline document, see use in a nucleic acid amplification test § 866.1(e). to directly detect specific virus RNA in [79 FR 3740, Jan. 23, 2014] human respiratory specimens or viral cultures. Detection of specific virus RNA aids in the diagnosis of influenza

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§ 866.3340 Klebsiella spp. serological § 866.3355 Listeria spp. serological re- reagents. agents. (a) Identification. Klebsiella spp. sero- (a) Identification. Listeria spp. serological reagents are devices that con- logical reagents are devices that consist of antigens and antisera, including sist of antigens and antisera used in se- antisera conjugated with a fluorescent rological tests to identify Listeria spp. dye (immunofluorescent reagents), from cultured isolates derived from that are used in serological tests to clinical specimens. Additionally, some identify Klebsiella spp. from cultured of these reagents consist of Listeria spp. isolates derived from clinical speci- antisera conjugated with a fluorescent mens. The identification aids in the di- dye (immunofluorescent reagents) used agnosis of diseases caused by bacteria to identify Listeria spp. directly from belonging to the genus Klebsiella and clinical specimens. The identification provides epidemiological information aids in the diagnosis of listeriosis, a on these diseases. These organisms can disease caused by bacteria belonging to cause serious urinary tract and pul- the genus Listeria, and provides epide- monary infections, particularly in hos- miological information on diseases pitalized patients. caused by these microorganisms. Lis- (b) Classification. Class I (general con- teria monocytogenes, the most common trols). The device is exempt from the human pathogen of this genus, causes premarket notification procedures in meningitis (inflammation of the brain subpart E of part 807 of this chapter membranes) and meningoencephalitis subject to the limitations in § 866.9. (inflammation of the brain and brain membranes) and is often fatal if un- [47 FR 50823, Nov. 9, 1982, as amended at 54 treated. A second form of human FR 25047, June 12, 1989; 66 FR 38792, July 25, listeriosis is an intrauterine infection 2001] in pregnant women that results in a high mortality rate for infants before § 866.3350 Leptospira spp. serological or after birth. reagents. (b) Classification. Class I (general con- (a) Identification. Leptospira spp. sero- trols). The device is exempt from the logical reagents are devices that con- premarket notification procedures in sist of antigens and antisera used in se- subpart E of part 807 of this chapter rological tests to identify antibodies to subject to § 866.9. Leptospira spp. in serum or identify Leptospira spp. from cultured isolates [47 FR 50823, Nov. 9, 1982, as amended at 65 derived from clinical specimens. Addi- FR 2311, Jan. 14, 2000] tionally, some of these antisera are § 866.3360 Lymphocytic choriomenin- conjugated with a fluorescent dye gitis virus serological reagents. (immunofluorescent reagents) and used to identify Leptospira spp. directly (a) Identification. Lymphocytic cho- from clinical specimens. The identi- riomeningitis virus serological re- fication aids in the diagnosis of lepto- agents are devices that consist of anti- spirosis caused by bacteria belonging gens and antisera used in serological to the genus Leptospira and provides ep- tests to identify antibodies to idemiological information on this dis- lymphocytic choriomeningitis virus in ease. Leptospira infections range from serum. The identification aids in the diagnosis of lymphocytic choriomenin- mild fever-producing illnesses to severe gitis virus infections and provides epi- liver and kidney involvement pro- demiological information on diseases ducing hemorrhage and dysfunction of caused by these viruses. Lymphocytic these organs. choriomeningitis viruses usually cause (b) Classification. Class II (special a mild cerebral meningitis (inflamma- controls). The device is exempt from tion of membranes that envelop the the premarket notification procedures brain) and occasionally a mild pneu- in subpart E of part 807 of this chapter monia, but in rare instances may subject to § 866.9. produce severe and even fatal illnesses [47 FR 50823, Nov. 9, 1982, as amended at 63 due to complications from cerebral FR 59227, Nov. 3, 1998] meningitis and pneumonia.

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(b) Classification. Class I (general con- crosis (destruction), usually occurring trols). The device is exempt from the in the lung. premarket notification procedures in (b) Classification. Class I (general con- subpart E of part 807 of this chapter trols). subject to § 866.9. § 866.3372 Nucleic acid-based in vitro [47 FR 50823, Nov. 9, 1982, as amended at 65 diagnostic devices for the detection FR 2311, Jan. 14, 2000] of Mycobacterium tuberculosis complex in respiratory specimens. § 866.3365 Multiplex nucleic acid assay (a) Identification. Nucleic acid-based for identification of microorganisms and resistance markers from in vitro diagnostic devices for the de- positive blood cultures. tection of Mycobacterium tuberculosis complex in respiratory specimens are (a) Identification. A multiplex nucleic qualitative nucleic acid-based in vitro acid assay for identification of micro- diagnostic devices intended to detect organisms and resistance markers from Mycobacterium tuberculosis complex nu- positive blood cultures is a qualitative cleic acids extracted from human resin vitro device intended to simulta- piratory specimens. These devices are neously detect and identify microorga- non-multiplexed and intended to be nism nucleic acids from blood cultures used as an aid in the diagnosis of pul- that test positive by Gram stain or monary tuberculosis when used in con- other microbiological stains. The de- junction with clinical and other labora- vice detects specific nucleic acid se- tory findings. These devices do not in- quences for microorganism identifica- clude devices intended to detect the tion as well as for antimicrobial resist- presence of organism mutations associ- ance. This device aids in the diagnosis ated with drug resistance. Respiratory of bloodstream infections when used in specimens may include sputum (in- conjunction with other clinical and duced or expectorated), bronchial laboratory findings. However, the de- specimens (e.g., bronchoalveolar lavage vice does not replace traditional meth- or bronchial aspirate), or tracheal aspi- ods for culture and susceptibility test- rates. ing. (b) Classification. Class II (special (b) Classification. Class II (special controls). The special control for this controls). The special control for this device is the FDA document entitled device is FDA’s guideline document en- ‘‘Class II Special Controls Guideline: titled ‘‘Class II Special Controls Guide- Nucleic Acid-Based In Vitro Diagnostic line: Multiplex Nucleic Acid Assay for Devices for the Detection of Identification of Microorganisms and Mycobacterium tuberculosis Complex in Resistance Markers from Positive Respiratory Specimens.’’ For avail- Blood Cultures.’’ For availability of ability of the guideline document, see the guideline document, see § 866.1(e). § 866.1(e). [80 FR 30154, May 27, 2015] [79 FR 31027, May 30, 2014]

§ 866.3370 Mycobacterium tuberculosis § 866.3373 Nucleic acid-based in vitro immunofluorescent reagents. diagnostic devices for the detection of Mycobacterium tuberculosis com- (a) Identification. Mycobacterium tu- plex (MTB-complex) and the genetic berculosis immunofluorescent reagents mutations associated with MTB- are devices that consist of antisera complex antibiotic resistance in conjugated with a fluorescent dye used respiratory specimens. to identify Mycobacterium tuberculosis (a) Identification. Nucleic acid-based directly from clinical specimens. The in vitro diagnostic devices for the de- identification aids in the diagnosis of tection of Mycobacterium tuberculosis tuberculosis and provides epidemiolog- complex (MTB-complex) and the ge- ical information on this disease. netic mutations associated with MTB- Mycobacterium tuberculosis is the com- complex antibiotic resistance in res- mon causative organism in human tu- piratory specimens are qualitative nu- berculosis, a chronic infectious disease cleic acid-based devices that detect the characterized by formation of tubercles presence of MTB-complex-associated (small rounded nodules) and tissue ne- nucleic acid sequences in respiratory

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samples. These devices are intended to information indicating the potential aid in the diagnosis of pulmonary tu- for non-specific binding (e.g., BLAST berculosis and the selection of an ini- search). tial treatment regimen when used in (v) In demonstrating device perform- conjunction with clinical findings and ance you must perform: other laboratory results. These devices (A) Pre-analytical studies that evalu- do not provide confirmation of anti- ate: biotic susceptibility since other mech- (1) Frozen samples. If there is use of anisms of resistance may exist that any frozen samples in the device per- may be associated with a lack of clin- formance studies, or if there is a device ical response to treatment other than claim for the use of frozen samples for those detected by the device. testing, the effect of freezing samples (b) Classification. Class II (special controls). The special controls for this prior to testing and the effect of mul- device are: tiple freeze/thaw cycles on both anti- (1) The FDA document entitled biotic susceptible and antibiotic resist- ‘‘Class II Special Controls Guideline: ant strains of MTB-complex. Nucleic Acid-Based In Vitro Diagnostic (2) Nucleic acid extraction methods. Ex- Devices for the Detection of traction methods must parallel those Mycobacterium tuberculosis Complex and used in devices for the detection of Genetic Mutations Associated with An- MTB-complex nucleic acid and confirm tibiotic Resistance in Respiratory that the detection of the genetic Specimens,’’ which addresses the miti- mutations associated with antibiotic gation of risks specific to the detection resistance is not affected. of MTB-complex. For availability of (B) Analytical studies that analyze: the document, see § 866.1(e). (1) Limit of Detection. Limit of Detec- (2) The following items, which ad- tion must be determined in the most dress the mitigation of risks specific to challenging matrix (e.g., sputum) the detection of the genetic mutations claimed for use with the device. The associated with antibiotic resistance of Limit of Detection must be determined MTB-complex: using both antibiotic susceptible and (i) The device must include an exter- antibiotic resistant strains of MTB- nal positive assay control as appro- complex. The antibiotic resistant priate. Acceptable positive assay con- strains must be those with well charac- trols include MTB-complex isolates terized genetic mutations associated containing one or more antibiotic-re- with antibiotic resistance. sistance associated target sequences (2) Analytical Reactivity (Inclusivity). detected by the device. Testing must be conducted to evaluate (ii) The device must include internal the ability of the device to detect ge- controls as appropriate. An acceptable netic mutations associated with anti- internal control may include human biotic resistance in a diversity of MTB- nucleic acid co-extracted with MTB- complex strains. Isolates used in test- complex containing nucleic acid se- ing must be well characterized. Isolate quences associated with antibiotic resistance and primers amplifying human strain characterization must be determined using standardized reference housekeeping genes (e.g., RNaseP, b- actin). methods recognized by a reputable sci- (iii) The device’s intended use must entific body and appropriate to the include a description of the scope of strain lineage. antibiotic resistance targeted by the (3) Within-Laboratory (Repeatability) assay, i.e., the specific drugs and/or Precision Testing. Within-laboratory drug classes. precision studies, if appropriate, must (iv) The specific performance charac- include at least one antibiotic resist- teristics section of the device’s label- ant and one antibiotic susceptible ing must include information regarding strain of MTB-complex. the specificity of the assay (4) Between Laboratory Reproducibility oligonucleotides for detecting Testing. The protocol for the reproduc- mutations associated with antibiotic ibility study may vary slightly depend- resistance of MTB-complex, and any ing on the assay format; however, the

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panel must include at least one anti- § 866.3380 Mumps virus serological re- biotic resistant and one antibiotic sus- agents. ceptible strain of MTB-complex. (a) Identification. Mumps virus sero- (C) Clinical Studies. Clinical per- logical reagents consist of antigens and formance of the device must be estab- antisera used in serological tests to lished by conducting prospective clin- identify antibodies to mumps virus in ical studies that include subjects with serum. Additionally, some of these re- culture confirmed active tuberculosis. agents consist of antisera conjugated Studies must attempt to enroll sub- with a fluorescent dye jects at risk for antibiotic-resistant (immunofluorescent reagents) used in MTB-complex; however, it may be nec- serological tests to identify mumps vi- essary to include supplemental anti- ruses from tissue culture isolates de- biotic resistant retrospective and con- rived from clinical specimens. The trived samples. Clinical studies must identification aids in the diagnosis of compare device results to both mumps and provides epidemiological phenotypic drug susceptibility testing information on mumps. Mumps is an and genotypic reference methods. The acute contagious disease, particularly genotypic reference method must be a in children, characterized by an en- polymerase chain reaction based meth- largement of one or both of the parotid od that uses primers different from glands (glands situated near the ear), those in the experimental device and although other organs may also be in- confirmed by bidirectional sequencing. volved. (b) Classification. Class I (general con- [79 FR 63036, Oct. 22, 2014] trols). The device is exempt from the premarket notification procedures in § 866.3375 Mycoplasma spp. serological reagents. subpart E of part 807 of this chapter subject to § 866.9. (a) Identification. Mycoplasma spp. serological reagents are devices that con- [47 FR 50823, Nov. 9, 1982, as amended at 65 sist of antigens and antisera used in se- FR 2311, Jan. 14, 2000] rological tests to identify antibodies to § 866.3390 Neisseria spp. direct sero- Mycoplasma spp. in serum. Addition- logical test reagents. ally, some of these reagents consist of Mycoplasma spp. antisera conjugated (a) Identification. Neisseria spp. direct with a fluorescent dye serological test reagents are devices (immunofluorescent reagents) used to that consist of antigens and antisera identify Mycoplasma spp. directly from used in serological tests to identify clinical specimens. The identification Neisseria spp. from cultured isolates. aids in the diagnosis of disease caused Additionally, some of these reagents by bacteria belonging to the genus consist of Neisseria spp. antisera con- Mycoplasma and provides epidemiolog- jugated with a fluorescent dye ical information on diseases caused by (immunofluorescent reagents) which these microorganisms. Mycoplasma spp. may be used to detect the presence of are associated with inflammatory con- Neisseria spp. directly from clinical ditions of the urinary and respiratory specimens. The identification aids in tracts, the genitals, and the mouth. the diagnosis of disease caused by bac- The effects in humans of infection with teria belonging to the genus Neisseria, such as epidemic cerebrospinal menin- Mycoplasma pneumoniae range from gitis, meningococcal disease, and gon- inapparent infection to mild or severe orrhea, and also provides epidemiolog- upper respiratory disease, ear infec- ical information on diseases caused by tion, and bronchial pneumonia. these microorganisms. The device does (b) Classification. Class I (general con- not include products for the detection trols). The device is exempt from the of gonorrhea in humans by indirect premarket notification procedures in methods, such as detection of anti- subpart E of part 807 of this chapter bodies or of oxidase produced by gono- subject to § 866.9. coccal organisms. [47 FR 50823, Nov. 9, 1982, as amended at 65 (b) Classification. Class II (perform- FR 2311, Jan. 14, 2000] ance standards).

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§ 866.3395 Norovirus serological re- (HRP2) specific antigens, and pan ma- agents. larial antigens in human whole blood. (a) Identification. Norovirus sero- These devices are used for testing logical reagents are devices that con- specimens from individuals who have sist of antigens and antisera used in se- signs and symptoms consistent with rological tests to detect the presence of malaria infection. The detection of norovirus antigens in fecal samples. these antigens aids in the clinical lab- These devices aid in the diagnosis of oratory diagnosis of malaria caused by norovirus infection in the setting of an the four malaria species capable of in- individual patient with symptoms of fecting humans: Plasmodium falciparum, acute gastroenteritis when the indi- Plasmodium vivax, Plasmodium ovale, vidual patient is epidemiologically and Plasmodium malariae, and aids in linked to other patients with symp- the differential diagnosis of Plasmodium toms of acute gastroenteritis and/or falciparum infections from other less aid in the identification of norovirus as virulent Plasmodium species. The device the etiology of an outbreak of acute is intended for use in conjunction with gastroenteritis in the setting of other clinical laboratory findings. epidemiologically linked patients with (b) Classification. Class II (special symptoms of acute gastroenteritis. controls). The special control is FDA’s (b) Classification. Class II (special guidance document entitled ‘‘Class II controls). The special control is FDA’s guidance document entitled ‘‘Class II Special Controls Guidance Document: Special Controls Guidance Document: Plasmodium species Antigen Detection Norovirus Serological Reagents.’’ See Assays.’’ See § 866.1(e) for the avail- § 866.1(e) for the availability of this ability of this guidance document. guidance document. [73 FR 29054, May 20, 2008] [76 FR 14274, Mar. 9, 2012] § 866.3405 Poliovirus serological re- § 866.3400 Parainfluenza virus sero- agents. logical reagents. (a) Identification. Poliovirus sero- (a) Identification. Parainfluenza virus logical reagents are devices that con- serological reagents are devices that sist of antigens and antisera used in se- consist of antigens and antisera used in rological tests to identify antibodies to serological tests to identify antibodies poliovirus in serum. Additionally, some to parainfluenza virus in serum. The of these reagents consist of poliovirus identification aids in the diagnosis of antisera conjugated with a fluorescent parainfluenza virus infections and pro- dye (immunofluorescent reagents) used vides epidemiological information on to identify polioviruses from clinical diseases caused by these viruses. specimens or from tissue culture iso- Parainfluenza viruses cause a variety lates derived from clinical specimens. of respiratory illnesses ranging from The identification aids in the diagnosis the common cold to pneumonia. (b) Classification. Class I (general con- of poliomyelitis (polio) and provides trols). The device is exempt from the epidemiological information on this premarket notification procedures in disease. Poliomyelitis is an acute in- subpart E of part 807 of this chapter fectious disease which in its serious subject to the limitations in § 866.9. form affects the central nervous system resulting in atrophy (wasting [47 FR 50823, Nov. 9, 1982, as amended at 54 away) of groups of muscles, ending in FR 25047, June 12, 1989; 66 FR 38792, July 25, 2001] contraction and permanent deformity. (b) Classification. Class I (general con- § 866.3402 Plasmodium species antigen trols). The device is exempt from the detection assays. premarket notification procedures in (a) Identification. A Plasmodium spe- subpart E of part 807 of this chapter cies antigen detection assay is a device subject to § 866.9. that employs antibodies for the detec- [47 FR 50823, Nov. 9, 1982, as amended at 65 tion of specific malaria parasite anti- FR 2312, Jan. 14, 2000] gens, including histidine-rich protein-2

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§ 866.3410 Proteus spp. (Weil-Felix) se- in subpart E of part 807 of this chapter rological reagents. subject to § 866.9. (a) Identification. Proteus spp. (Weil- [47 FR 50823, Nov. 9, 1982, as amended at 63 Felix) serological reagents are devices FR 59227, Nov. 3, 1998] that consist of antigens and antisera, § 866.3460 Rabiesvirus immuno- including antisera conjugated with a fluorescent reagents. fluorescent dye (immunofluorescent re- (a) Identification. Rabiesvirus agents), derived from the bacterium immunofluorescent reagents are de- Proteus vulgaris used in agglutination vices that consist of rabiesvirus tests (a specific type of antigen-anti- antisera conjugated with a fluorescent body reaction) for the detection of dye used to identify rabiesvirus in antibodies to rickettsia (virus-like bac- specimens taken from suspected rabid teria) in serum. Test results aid in the animals. The identification aids in the diagnosis of diseases caused by bacteria diagnosis of rabies in patients exposed belonging to the genus Rickettsiae and by animal bites and provides epidemio- provide epidemiological information on logical information on rabies. Rabies is these diseases. Rickettsia are generally an acute infectious disease of the cen- transmitted by arthropods (e.g., ticks tral nervous system which, if and mosquitoes) and produce infections undiagnosed, may be fatal. The disease in humans characterized by rash and is commonly transmitted to humans by fever (e.g., typhus fever, spotted fever, a bite from a rabid animal. Q fever, and trench fever). (b) Classification. Class II (perform- (b) Classification. Class I (general con- ance standards). trols). The device is exempt from the § 866.3470 Reovirus serological re- premarket notification procedures in agents. subpart E of part 807 of this chapter (a) Identification. Reovirus serological subject to the limitations in § 866.9. reagents are devices that consist of [47 FR 50823, Nov. 9, 1982, as amended at 54 antigens and antisera used in sero- FR 25047, June 12, 1989; 66 FR 38792, July 25, logical tests to identify antibodies to 2001] reovirus in serum. The identification aids in the diagnosis of reovirus infec- § 866.3415 Pseudomonas spp. sero- tions and provides epidemiological in- logical reagents. formation on diseases caused by these (a) Identification. Pseudomonas spp. se- viruses. Reoviruses are thought to rological reagents are devices that con- cause only mild respiratory and gastro- sist of antigens and antisera, including intestinal illnesses. (b) Classification. Class I (general con- antisera conjugated with a fluorescent trols). The device is exempt from the dye (immunofluorescent reagents), premarket notification procedures in used to identify Pseudomonas spp. from subpart E of part 807 of this chapter clinical specimens or from cultured subject to the limitations in § 866.9. isolates derived from clinical specimens. The identification aids in the di- [47 FR 50823, Nov. 9, 1982, as amended at 54 agnosis of disease caused by bacteria FR 25047, June 12, 1989; 66 FR 38792, July 25, 2001] belonging to the genus Pseudomonas. Pseudomonas aeruginosa is a major § 866.3480 Respiratory syncytial virus cause of hospital-acquired infections, serological reagents. and has been associated with urinary (a) Identification. Respiratory tract infections, eye infections, burn syncytial virus serological reagents are and wound infections, blood poisoning, devices that consist of antigens and abscesses, and meningitis (inflamma- antisera used in serological tests to tion of brain membranes). Pseudomonas identify antibodies to respiratory pseudomallei causes melioidosis, a syncytial virus in serum. Additionally, chronic pneumonia. some of these reagents consist of res- (b) Classification. Class II (special piratory syncytial virus antisera con- controls). The device is exempt from jugated with a fluorescent dye the premarket notification procedures (immunofluorescent reagents) and used

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to identify respiratory syncytial vi- mosquitoes) and produce infections in ruses from clinical specimens or from humans characterized by rash and tissue culture isolates derived from fever (e.g., typhus fever, spotted fever, clinical specimens. The identification Q fever, and trench fever). aids in the diagnosis of respiratory (b) Classification. Class I (general con- syncytial virus infections and provides trols). The device is exempt from the epidemiological information on dis- premarket notification procedures in eases caused by these viruses. Res- subpart E of part 807 of this chapter piratory syncytial viruses cause a subject to § 866.9. number of respiratory tract infections, including the common cold, pharyn- [47 FR 50823, Nov. 9, 1982, as amended at 65 gitis, and infantile bronchopneumonia. FR 2312, Jan. 14, 2000] (b) Classification. Class I (general controls). The device is exempt from the § 866.3510 Rubella virus serological re- premarket notification procedures in agents. subpart E of part 807 of this chapter (a) Identification. Rubella virus sero- subject to § 866.9. logical reagents are devices that con- [47 FR 50823, Nov. 9, 1982, as amended at 65 sist of antigens and antisera used in se- FR 2312, Jan. 14, 2000] rological tests to identify antibodies to rubella virus in serum. The identifica- § 866.3490 Rhinovirus serological re- tion aids in the diagnosis of rubella agents. (German measles) or confirmation of a (a) Identification. Rhinovirus sero- person’s immune status from past in- logical reagents are devices that con- fections or immunizations and provides sist of antigens and antisera used in se- epidemiological information on Ger- rological tests to identify antibodies to man measles. Newborns infected in the rhinovirus in serum. The identification aids in the diagnosis of rhinovirus in- uterus with rubella virus may be born fections and provides epidemiological with multiple congenital defects (ru- information on diseases caused by bella syndrome). these viruses. Rhinoviruses cause com- (b) Classification. Class II. The special mon colds. controls for this device are: (b) Classification. Class I (general con- (1) National Committee for Clinical trols). The device is exempt from the Laboratory Standards’: premarket notification procedures in (i) 1/LA6 ‘‘Detection and Quantita- subpart E of part 807 of this chapter tion of Rubella IgG Antibody: Evalua- subject to the limitations in § 866.9. tion and Performance Criteria for Mul- [47 FR 50823, Nov. 9, 1982, as amended at 54 tiple Component Test Products, FR 25047, June 12, 1989; 66 FR 38792, July 25, Speciment Handling, and Use of the 2001] Test Products in the Clinical Labora- tory, October 1997,’’ § 866.3500 Rickettsia serological reagents. (ii) 1/LA18 ‘‘Specifications for Immunological Testing for Infectious (a) Identification. Rickettsia sero- Diseases, December 1994,’’ logical reagents are devices that consist of antigens and antisera used in se- (iii) D13 ‘‘Agglutination Characteris- rological tests to identify antibodies to tics, Methodology, Limitations, and rickettsia in serum. Additionally, some Clinical Validation, October 1993,’’ of these reagents consist of rickettsial (iv) EP5 ‘‘Evaluation of Precision antisera conjugated with a fluorescent Performance of Clinical Chemistry De- dye (immunofluorescent reagents) used vices, February 1999,’’ and to identify rickettsia directly from (v) EP10 ‘‘Preliminary Evaluation of clinical specimens. The identification the Linearity of Quantitive Clinical aids in the diagnosis of diseases caused Laboratory Methods, May 1998,’’ by virus-like bacteria belonging to the (2) Centers for Disease Control’s: genus Rickettsiae and provides epide- (i) Low Titer Rubella Standard, miological information on these dis- (ii) Reference Panel of Well Charac- eases. Rickettsia are generally trans- terized Rubella Sera, and mitted by arthropods (e.g., ticks and

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(3) World Health Organization’s in subpart E of part 807 of this chapter International Rubella Standard. subject to § 866.9. [47 FR 50823, Nov. 9, 1982, as amended at 52 [47 FR 50823, Nov. 9, 1982, as amended at 63 FR 17734, May 11, 1987; 65 FR 17144, Mar. 31, FR 59227, Nov. 3, 1998] 2000] § 866.3600 Schistosoma spp. serological § 866.3520 Rubeola (measles) virus se- reagents. rological reagents. (a) Identification. Schistosoma spp. se- (a) Identification. Rubeola (measles) rological reagents are devices that con- virus serological reagents are devices sist of antigens and antisera used in se- that consist of antigens and antisera rological tests to identify antibodies to used in serological tests to identify Schistosoma spp. in serum. The identi- antibodies to rubeola virus in serum. fication aids in the diagnosis of schis- The identification aids in the diagnosis tosomiasis caused by parasitic of measles and provides epidemiolog- flatworms of the genus Schistosoma. ical information on the disease. Mea- Schistosomiasis is characterized by a sles is an acute, highly infectious dis- variety of acute and chronic infections. ease of the respiratory and Acute infection is marked by fever, al- reticuloendothelial tissues, particu- lergic symptoms, and diarrhea. Chronic larly in children, characterized by a effects are usually severe and are confluent and blotchy rash. caused by fibrous degeneration of tissue around deposited eggs of the para- (b) Classification. Class I (general con- site in the liver, lungs, and central trols). The device is exempt from the nervous system. Schistosomes can also premarket notification procedures in cause schistosome dermatitis (e.g., subpart E of part 807 of this chapter swimmer’s itch), a skin disease marked subject to the limitations in § 866.9. by intense itching. [47 FR 50823, Nov. 9, 1982, as amended at 54 (b) Classification. Class I (general con- FR 25047, June 12, 1989; 66 FR 38792, July 25, trols). The device is exempt from the 2001] premarket notification procedures in subpart E of part 807 of this chapter § 866.3550 Salmonella spp. serological subject to § 866.9. reagents. [47 FR 50823, Nov. 9, 1982, as amended at 65 (a) Identification. Salmonella spp. sero- FR 2312, Jan. 14, 2000] logical reagents are devices that consist of antigens and antisera used in se- § 866.3630 Serratia spp. serological re- rological tests to identify Salmonella agents. spp. from cultured isolates derived (a) Identification. Serratia spp. sero- from clinical specimens. Additionally, logical reagents are devices that con- some of these reagents consist of sist of antigens and antisera used in se- antisera conjugated with a fluorescent rological tests to identify Serratia spp. dye (immunofluorescent reagents) used from cultured isolates. The identifica- to identify Salmonella spp. directly tion aids in the diagnosis of disease from clinical specimens or cultured caused by bacteria belonging to the isolates derived from clinical speci- genus Serratia and provides epidemio- mens. The identification aids in the di- logical information on these diseases. agnosis of salmonellosis caused by bac- Serratia spp. are occasionally associ- teria belonging to the genus Salmonella ated with gastroenteritis (food poi- and provides epidemiological informa- soning) and wound infections. tion on this disease. Salmonellosis is (b) Classification. Class I (general con- characterized by high grade fever (‘‘en- trols). The device is exempt from the teric fever’’), severe diarrhea, and premarket notification procedures in cramps. subpart E of part 807 of this chapter (b) Classification. Class II (special subject to the limitations in § 866.9. controls). The device is exempt from [47 FR 50823, Nov. 9, 1982, as amended at 54 the premarket notification procedures FR 25047, June 12, 1989; 66 FR 38792, July 25, 2001]

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§ 866.3660 Shigella spp. serological re- logical information on these diseases. agents. Certain strains of Staphylococcus aureus (a) Identification. Shigella spp. sero- produce an enterotoxin while growing logical reagents are devices that con- in meat, dairy, or bakery products. sist of antigens and antisera, including After ingestion, this enterotoxin is ab- antisera conjugated with a fluorescent sorbed in the gut and causes destruc- dye (immunofluorescent reagents), tion of the intestinal lining used in serological tests to identify (gastroenteritis). Shigella spp. from cultured isolates. (b) Classification. Class I (general con- The identification aids in the diagnosis trols). The device is exempt from the of shigellosis caused by bacteria be- premarket notification procedures in longing to the genus Shigella and pro- subpart E of part 807 of this chapter vides epidemiological information on subject to the limitations in § 866.9. this disease. Shigellosis is character- [47 FR 50823, Nov. 9, 1982, as amended at 54 ized by abdominal pain, cramps, diar- FR 25047, June 12, 1989; 66 FR 38792, July 25, rhea, and fever. 2001] (b) Classification. Class II (special controls). The device is exempt from § 866.3720 Streptococcus spp. exo- the premarket notification procedures enzyme reagents. in subpart E of part 807 of this chapter (a) Identification. Streptococcus spp. subject to § 866.9. exoenzyme reagents are devices used to [47 FR 50823, Nov. 9, 1982, as amended at 63 identify antibodies to Streptococcus spp. FR 59227, Nov. 3, 1998] exoenzyme in serum. The identification aids in the diagnosis of disease § 866.3680 Sporothrix schenckii sero- caused by bacteria belonging to the logical reagents. genus Streptococcus and provides epide- (a) Identification. Sporothrix schenckii miological information on these dis- serological reagents are devices that eases. Pathogenic streptococci are as- consist of antigens and antisera used in sociated with infections, such as sore serological tests to identify antibodies throat, impetigo (an infection charac- to Sporothrix schenckii in serum. The terized by small pustules on the skin), identification aids in the diagnosis of urinary tract infections, rheumatic sporothrichosis caused by a fungus be- fever, and kidney disease. longing to the genus Sporothrix and (b) Classification. Class I (general con- provides epidemiological information trols). The device is exempt from the on this disease. Sporothrichosis is a premarket notification procedures in chronic tumorlike infection primarily subpart E of part 807 of this chapter of the skin. subject to the limitations in § 866.9. (b) Classification. Class I (general con- [47 FR 50823, Nov. 9, 1982, as amended at 61 trols). The device is exempt from the FR 1119, Jan. 16, 1996; 66 FR 38792, July 25, premarket notification procedures in 2001] subpart E of part 807 of this chapter subject to § 866.9. § 866.3740 Streptococcus spp. serological reagents. [47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000] (a) Identification. Streptococcus spp. serological reagents are devices that § 866.3700 Staphylococcus aureus sero- consist of antigens and antisera (ex- logical reagents. cluding streptococcal exoenzyme re- (a) Identification. Staphylococcus agents made from enzymes secreted by aureus serological reagents are devices streptococci) used in serological tests that consist of antigens and antisera to identify Streptococcus spp. from cul- used in serological tests to identify tured isolates derived from clinical enterotoxin (toxin affecting the intes- specimens. The identification aids in tine) producing staphylococci from cul- the diagnosis of diseases caused by bac- tured isolates. The identification aids teria belonging to the genus Strepto- in the diagnosis of disease caused by coccus and provides epidemiological in- this bacterium belonging to the genus formation on these diseases. Patho- Staphylococcus and provides epidemio- genic streptococci are associated with

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infections, such as sore throat, impe- (b) Classification. Class II (perform- tigo (an infection characterized by ance standards). small pustules on the skin), urinary tract infections, rheumatic fever, and § 866.3830 Treponema pallidum tre- kidney disease. ponemal test reagents. (b) Classification. Class I (general con- (a) Identification. Treponema pallidum trols). The device is exempt from the treponemal test reagents are devices premarket notification procedures in that consist of the antigens, antisera subpart E of part 807 of this chapter and all control reagents (standardized subject to § 866.9. reagents with which test results are compared) which are derived from [47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000] treponemal sources and that are used in the fluorescent treponemal antibody § 866.3780 Toxoplasma gondii sero- absorption test (FTA-ABS), the logical reagents. Treponema pallidum immobilization test (a) Identification. Toxoplasma gondii (T.P.I.), and other treponemal tests serological reagents are devices that used to identify antibodies to consist of antigens and antisera used in Treponema pallidum directly from in- serological tests to identify antibodies fecting treponemal organisms in to Toxoplasma gondii in serum. Addi- serum. The identification aids in the tionally, some of these reagents consist diagnosis of syphilis caused by bacteria of antisera conjugated with a fluores- belonging to the genus Treponema and cent dye (immunofluorescent reagents) provides epidemiological information used to identify Toxoplasma gondii from on syphilis. clinical specimens. The identification (b) Classification. Class II (perform- aids in the diagnosis of toxoplasmosis ance standards). caused by the parasitic protozoan § 866.3850 Trichinella spiralis sero- Toxoplasma gondii and provides epide- logical reagents. miological information on this disease. Congenital toxoplasmosis is character- (a) Identification. Trichinella spiralis ized by lesions of the central nervous serological reagents are devices that system, which if undetected and un- consist of antigens and antisera used in treated may lead to brain defects, serological tests to identify antibodies blindness, and death of an unborn to Trichinella spiralis in serum. The fetus. The disease is characterized in identification aids in the diagnosis of children by inflammation of the brain trichinosis caused by parasitic and spinal cord. roundworms belonging to the genus (b) Classification. Class II (perform- Trichinella and provides epidemiolog- ance standards). ical information on trichinosis. Trichi- nosis is caused by ingestion of under- § 866.3820 Treponema pallidum non- cooked, infested meat, especially pork, treponemal test reagents. and characterized by fever, muscle (a) Identification. Treponema pallidum weakness, and diarrhea. nontreponemal test reagents are de- (b) Classification. Class I (general con- vices that consist of antigens derived trols). The device is exempt from the from nontreponemal sources (sources premarket notification procedures in not directly associated with subpart E of part 807 of this chapter treponemal organisms) and control subject to § 866.9. sera (standardized sera with which test [47 FR 50823, Nov. 9, 1982, as amended at 65 results are compared) used in sero- FR 2312, Jan. 14, 2000] logical tests to identify reagin, an antibody-like agent, which is produced § 866.3860 Trichomonas vaginalis nu- from the reaction of treponema micro- cleic acid assay. organisms with body tissues. The iden- (a) Identification. A Trichomonas tification aids in the diagnosis of vaginalis nucleic acid assay is a device syphilis caused by microorganisms be- that consists of primers, probes, en- longing to the genus Treponema and zymes, and controls for the amplifi- provides epidemiological information cation and detection of trichomonas on syphilis. nucleic acids in endocervical swabs,

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vaginal swabs, and female urine speci- dren. Zoster (shingles) is the recurrent mens, from women symptomatic for form of the disease, occurring in adults vaginitis, cervicitis, or urethritis and/ who were previously infected with or to aid in the diagnosis of trichomo- varicella-zoster viruses. Zoster is the niasis in asymptomatic women. The de- response (characterized by a rash) of tection of trichomonas nucleic acids, the partially immune host to a reac- in conjunction with other laboratory tivation of varicella viruses present in tests, aids in the clinical laboratory di- latent form in the patient’s body. agnosis of trichomoniasis caused by (b) Classification. Class II (perform- Trichomonas vaginalis. ance standards). (b) Classification. Class II (special controls). The special controls are set § 866.3930 Vibrio cholerae serological forth in FDA’s guideline document en- reagents. titled: ‘‘Class II Special Controls (a) Identification. Vibrio cholerae sero- Guideline: Nucleic Acid Amplification logical reagents are devices that are Assays for the Detection of used in the agglutination (an antigen- Trichomonas vaginalis; Guideline for In- antibody clumping reaction) test to dustry and Food and Drug Administra- identify Vibrio cholerae from cultured tion Staff.’’ See § 866.1(e) for informa- isolates derived from clinical speci- tion on obtaining this document. mens. The identification aids in the di- [80 FR 46192, Aug. 4, 2015] agnosis of cholera caused by the bacterium Vibrio cholerae and provides epi- § 866.3870 Trypanosoma spp. sero- demiological information on cholera. logical reagents. Cholera is an acute infectious disease (a) Identification. Trypanosoma spp. characterized by severe diarrhea with serological reagents are devices that extreme fluid and electrolyte (salts) consist of antigens and antisera used in depletion, and by vomiting, muscle serological tests to identify antibodies cramps, and prostration. If untreated, to Trypanosoma spp. in serum. The the severe dehydration may lead to identification aids in the diagnosis of shock, renal failure, cardiovascular trypanosomiasis, a disease caused by collapse, and death. parasitic protozoans belonging to the (b) Classification. Class II (special genus Trypanosoma. Trypanosomiasis controls). The device is exempt from in adults is a chronic disease charac- the premarket notification procedures terized by fever, chills, headache, and in subpart E of part 807 of this chapter vomiting. Central nervous system in- subject to § 866.9. volvement produces typical sleeping sickness syndrome: physical exhaus- [47 FR 50823, Nov. 9, 1982, as amended at 63 tion, inability to eat, tissue wasting, FR 59227, Nov. 3, 1998] and eventual death. Chagas disease, an acute form of trypanosomiasis in chil- § 866.3940 West Nile virus serological reagents. dren, most seriously affects the central nervous system and heart muscle. (a) Identification. West Nile virus se- (b) Classification. Class I (general con- rological reagents are devices that controls). sist of antigens and antisera for the detection of anti-West Nile virus IgM § 866.3900 Varicella-zoster virus sero- antibodies, in human serum, from indi- logical reagents. viduals who have signs and symptoms (a) Identification. Varicella-zoster consistent with viral meningitis/en- virus serological reagents are devices cephalitis. The detection aids in the that consist of antigens and antisera clinical laboratory diagnosis of viral used in serological tests to identify meningitis/encephalitis caused by West antibodies to varicella-zoster in serum. Nile virus. The identification aids in the diagnosis (b) Classification. Class II (special of diseases caused by varicella-zoster controls). The special control is FDA’s viruses and provides epidemiological guidance entitled ‘‘Class II Special information on these diseases. Controls Guidance Document: Sero- Varicella (chicken pox) is a mild, high- logical Reagents for the Laboratory Di- ly infectious disease, chiefly of chil- agnosis of West Nile Virus.’’ See

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§ 866.1(e) for the availability of this software for predicting drug resistance/ guidance document. susceptibility based on results obtained with these primers and probes. It is in- [68 FR 61745, Oct. 30, 2003] tended for use in detecting HIV § 866.3945 Dengue virus serological re- genomic mutations that confer resist- agents. ance to specific antiretroviral drugs, as an aid in monitoring and treating HIV (a) Identification. Dengue virus sero- infection. logical reagents are devices that con- (b) Classification. Class II (special sist of antigens and antibodies for the controls). The special control for this detection of dengue virus and dengue device is FDA’s guidance document en- antibodies in individuals who have titled ‘‘Class II Special Controls Guid- signs and symptoms of dengue fever or ance Document: In Vitro HIV Drug Re- dengue hemorrhagic fever. The detec- sistance Genotype Assay.’’ See § 866.1(e) tion aids in the clinical laboratory di- for the availability of this guidance agnosis of dengue fever or dengue hem- document. orrhagic fever caused by dengue virus. (b) Classification. Class II (special [72 FR 44382, Aug. 8, 2007] controls). The special control is FDA’s guideline entitled ‘‘Class II Special § 866.3980 Respiratory viral panel mul- Controls Guideline: Dengue Virus Sero- tiplex nucleic acid assay. logical Reagents.’’ For availability of (a) Identification. A respiratory viral the guideline document, see § 866.1(e). panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device [79 FR 31023, May 30, 2014] intended to simultaneously detect and § 866.3946 Dengue virus nucleic acid identify multiple viral nucleic acids ex- amplification test reagents. tracted from human respiratory specimens or viral culture. The detection (a) Identification. Dengue virus nu- and identification of a specific viral cleic acid amplification test reagents nucleic acid from individuals exhib- are devices that consist of primers, iting signs and symptoms of res- probes, enzymes, and controls for the piratory infection aids in the diagnosis amplification and detection of dengue of respiratory viral infection when used virus serotypes 1, 2, 3, or 4 from viral in conjunction with other clinical and ribonucleic acid (RNA) in human serum laboratory findings. The device is in- and plasma from individuals who have tended for detection and identification signs and symptoms consistent with of a combination of the following vi- dengue (mild or severe). The identifica- ruses: tion of dengue virus serotypes 1, 2, 3, or (1) Influenza A and Influenza B; 4 in human serum and plasma (sodium (2) Influenza A subtype H1 and Influ- citrate) collected from human patients enza A subtype H3; with dengue provides epidemiologic in- (3) Respiratory Syncytial Virus formation for surveillance of circu- subtype A and Respiratory Syncytial lating dengue viruses. Virus subtype B; (b) Classification. Class II (special (4) Parainfluenza 1, Parainfluenza 2, controls). The special control is FDA’s and Parainfluenza 3 virus; guideline entitled ‘‘Class II Special (5) Human Metapneumovirus; Controls Guideline: Dengue Virus Nu- (6) Rhinovirus; and cleic Acid Amplification Test Re- (7) Adenovirus. agents.’’ For availability of the guide- (b) Classification. Class II (special line document, see § 866.1(e). controls). The special controls are: [79 FR 53609, Sept. 10, 2014] (1) FDA’s guidance document entitled ‘‘Class II Special Controls Guidance § 866.3950 In vitro human immuno- Document: Respiratory Viral Panel deficiency virus (HIV) drug resist- Multiplex Nucleic Acid Assay;’’ ance genotype assay. (2) For a device that detects and (a) Identification. The in vitro HIV identifies Human Metapneumovirus, drug resistance genotype assay is a de- FDA’s guidance document entitled vice that consists of nucleic acid rea- ‘‘Class II Special Controls Guidance gent primers and probes together with Document: Testing for Human

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Metapneumovirus (hMPV) Using Nu- Subpart E—Immunology Labora- cleic Acid Assays;’’ and tory Equipment and Re- (3) For a device that detects and dif- agents ferentiates Influenza A subtype H1 and subtype H3, FDA’s guidance document § 866.4070 RNA Preanalytical Systems. entitled ‘‘Class II Special Controls (a) Identification. RNA Preanalytical Guidance Document: Testing for Detec- Systems are devices intended to col- tion and Differentiation of Influenza A lect, store, and transport patient speci- Virus Subtypes Using Multiplex Nu- mens, and stabilize intracellular RNA cleic Acid Assays.’’ See § 866.1(e) for the from the specimens, for subsequent iso- availability of these guidance docu- lation and purification of the ments. intracellular RNA for RT–PCR used in [74 FR 52138, Oct. 9, 2009] in vitro molecular diagnostic testing. (b) Classification. Class II (special § 866.3990 Gastrointestinal microorga- controls). The special control is FDA’s nism multiplex nucleic acid-based guidance document entitled ‘‘Class II assay. Special Controls Guidance Document: RNA Preanalytical Systems (RNA Col- (a) Identification. A gastrointestinal lection, Stabilization and Purification microorganism multiplex nucleic acid- System for RT–PCR Used in Molecular based assay is a qualitative in vitro di- Diagnostic Testing).’’ See § 866.1(e) for agnostic device intended to simulta- the availability of this guidance docu- neously detect and identify multiple ment. gastrointestinal microbial nucleic acids extracted from human stool [70 FR 49863, Aug. 25, 2005] specimens. The device detects specific § 866.4100 Complement reagent. nucleic acid sequences for organism identification as well as for deter- (a) Identification. A complement rea- mining the presence of toxin genes. gent is a device that consists of com- The detection and identification of a plement, a naturally occurring serum specific gastrointestinal microbial nu- protein from any warm-blooded animal cleic acid from individuals exhibiting such as guinea pigs, that may be in- signs and symptoms of gastrointestinal cluded as a component part of sero- infection aids in the diagnosis of gas- logical test kits used in the diagnosis of disease. trointestinal infection when used in (b) Classification. Class I (general con- conjunction with clinical evaluation trols). The device is exempt from the and other laboratory findings. A gas- premarket notification procedures in trointestinal microorganism multiplex subpart E of part 807 of this chapter nucleic acid-based assay also aids in subject to the limitations in § 866.9. the detection and identification of acute gastroenteritis in the context of [47 FR 50823, Nov. 9, 2001, as amended at 66 outbreaks. FR 38792, July 25, 2001] (b) Classification. Class II (special § 866.4500 Immunoelectrophoresis controls). The special controls are set equipment. forth in FDA’s guideline document en- (a) Identification. titled: ‘‘Class II Special Controls Immunoelectrophoresis equipment for Guideline: Gastrointestinal Microorga- clinical use with its electrical power nism Multiplex Nucleic Acid-Based As- supply is a device used for separating says for Detection and Identification of protein molecules. Microorganisms and Toxin Genes from Immunoelectrophoresis is a procedure Human Stool Specimens.’’ For avail- in which a complex protein mixture is ability of the guideline document, see placed in an agar gel and the various § 866.1(e). proteins are separated on the basis of [80 FR 67314, Nov. 2, 2015] their relative mobilities under the influence of an electric current. The separated proteins are then permitted to diffuse through the agar toward a

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multispecific antiserum, allowing pre- ergy into electrical energy. The cipitation and visualization of the sep- amount of electrical energy registers arate complexes. on a readout system such as a digital (b) Classification. Class I (general con- voltmeter or a recording chart. This trols). The device is exempt from the electrical readout is called the light- premarket notification procedures in scattering value and is used to measure subpart E of part 807 of this chapter the concentration of antigen-antibody subject to the limitations in § 866.9. complexes. This generic type of device includes devices with various kinds of [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 FR 38792, July 25, light sources, such as laser equipment. 2001] (b) Classification. Class I (general controls). The device is exempt from the § 866.4520 Immunofluorometer equip- premarket notification procedures in ment. subpart E of part 807 of this chapter (a) Identification. Immunofluorometer subject to the limitations in § 866.9. equipment for clinical use with its [47 FR 50823, Nov. 9, 1982, as amended at 54 electrical power supply is a device used FR 25047, June 12, 1989; 66 FR 38792, July 25, to measure the fluorescence of 2001] fluorochrome-labeled antigen-antibody complexes. The concentration of these § 866.4600 Ouchterlony agar plate. complexes may be measured by means (a) Identification. An ouchterlony of reflected light. A beam of light is agar plate for clinical use is a device passed through a solution in which a containing an agar gel used to examine fluorochrome has been selectively at- antigen-antibody reactions. In tached to serum protein antibody mol- immunodiffusion, antibodies and anti- ecules in suspension. The amount of gens migrate toward each other light emitted by the fluorochrome through gel which originally contained label is detected by a photodetector, neither of these reagents. As the re- which converts light energy into elec- agents come in contact with each trical energy. The amount of electrical other, they combine to form a precipi- energy registers on a readout system tate that is trapped in the gel matrix such as a digital voltmeter or a record- and is immobilized. ing chart. This electrical readout is (b) Classification. Class I (general con- called the fluorescence value and is trols). The device is exempt from the used to measure the concentration of premarket notification procedures in antigen-antibody complexes. subpart E of part 807 of this chapter (b) Classification. Class I (general con- subject to the limitations in § 866.9. trols). The device is exempt from the premarket notification procedures in [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 FR 38792, July 25, subpart E of part 807 of this chapter 2001] subject to the limitations in § 866.9. [47 FR 50823, Nov. 9, 1982, as amended at 54 § 866.4700 Automated fluorescence in FR 25047, June 12, 1989; 66 FR 38792, July 25, situ hybridization (FISH) enumera- 2001] tion systems. (a) Identification. An automated FISH § 866.4540 Immunonephelometer enumeration system is a device that equipment. consists of an automated scanning mi- (a) Identification. croscope, image analysis system, and Immunonephelometer equipment for customized software applications for clinical use with its electrical power FISH assays. This device is intended supply is a device that measures light for in vitro diagnostic use with FISH scattering from antigen-antibody com- assays as an aid in the detection, plexes. The concentration of these counting and classification of cells complexes may be measured by means based on recognition of cellular color, of reflected light. A beam of light size, and shape, and in the detection passed through a solution is scattered and enumeration of FISH signals in by the particles in suspension. The interphase nuclei of formalin-fixed, amount of light is detected by a paraffin-embedded human tissue speci- photodetector, which converts light en- mens.

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(b) Classification. Class II (special § 866.4900 Support gel. controls). The special control is FDA’s (a) Identification. A support gel for guidance document entitled ‘‘Class II clinical use is a device that consists of Special Controls Guidance Document: an agar or agarose preparation that is Automated Fluorescence in situ Hy- used while measuring various kinds of, bridization (FISH) Enumeration Sys- or parts of, protein molecules by var- tems.’’ See § 866.1(e) for the availability ious immunochemical techniques, such of this guidance document. as immunoelectrophoresis, [70 FR 14534, Mar. 23, 2005] immunodiffusion, or chromatography. (b) Classification. Class I (general con- § 866.4800 Radial immunodiffusion trols). The device is exempt from the plate. premarket notification procedures in (a) Identification. A radial subpart E of part 807 of this chapter immunodiffusion plate for clinical use subject to the limitations in § 866.9. is a device that consists of a plastic [47 FR 50823, Nov. 9, 1982, as amended at 54 plate to which agar gel containing FR 25047, June 12, 1989; 66 FR 38792, July 25, antiserum is added. In radial 2001] immunodiffusion, antigens migrate through gel which originally contains Subpart F—Immunological Test specific antibodies. As the reagents Systems come in contact with each other, they combine to form a precipitate that is § 866.5040 Albumin immunological test trapped in the gel matrix and immo- system. bilized. (a) Identification. An albumin (b) Classification. Class I (general con- immunological test system is a device trols). The device is exempt from the that consists of the reagents used to premarket notification procedures in measure by immunochemical tech- subpart E of part 807 of this chapter niques the albumin (a plasma protein) subject to the limitations in § 866.9. in serum and other body fluids. Meas- [47 FR 50823, Nov. 9, 1982, as amended at 66 urement of albumin aids in the diag- FR 38792, July 25, 2001] nosis of kidney and intestinal diseases. (b) Classification. Class II (special § 866.4830 Rocket immunoelectro- controls). The device is exempt from phoresis equipment. the premarket notification procedures (a) Identification. Rocket in subpart E of part 807 of this chapter immunoelectrophoresis equipment for subject to § 866.9. clinical use is a device used to perform [47 FR 50823, Nov. 9, 1982, as amended at 63 a specific test on proteins by using a FR 59227, Nov. 3, 1998] procedure called rocket immunoelectrophoresis. In this proce- § 866.5060 Prealbumin immunological dure, an electric current causes the test system. protein in solution to migrate through (a) Identification. A prealbumin agar gel containing specific antisera. immunological test system is a device The protein precipitates with the that consists of the reagents used to antisera in a rocket-shaped pattern, measure by immunochemical tech- giving the name to the device. The niques the prealbumin (a plasma pro- height of the peak (or the area under tein) in serum and other body fluids. the peak) is proportional to the con- Measurement of prealbumin levels in centration of the protein. serum may aid in the assessment of the (b) Classification. Class I (general con- patient’s nutritional status. trols). The device is exempt from the (b) Classification. Class I (general con- premarket notification procedures in trols). The device is exempt from the subpart E of part 807 of this chapter premarket notification procedures in subject to the limitations in § 866.9. subpart E of part 807 of this chapter subject to § 866.9. [47 FR 50823, Nov. 9, 1982, as amended at 54 FR 25047, June 12, 1989; 66 FR 38792, July 25, [47 FR 50823, Nov. 9, 1982, as amended at 65 2001] FR 2312, Jan. 14, 2000]

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§ 866.5065 Human allotypic marker used to measure by immunochemical immunological test system. techniques the autoimmune antibodies (a) Identification. A human allotypic in serum, other body fluids, and tissues marker immunological test system is a that react with cellular nuclear con- device that consists of the reagents stituents (molecules present in the nu- used to identify by immunochemical cleus of a cell, such as ribonucleic acid, techniques the inherited human pro- deoxyribonucleic acid, or nuclear protein allotypic markers (such as nGm, teins). The measurements aid in the di- nA2 m, and Km allotypes) in serum and agnosis of systemic lupus other body fluids. The identification erythematosus (a multisystem auto- may be used while studying population immune disease in which antibodies at- genetics. tack the victim’s own tissues), hepa- (b) Classification. Class I (general con- titis (a liver disease), rheumatoid ar- trols). The device is exempt from the thritis, Sjo¨ gren’s syndrome (arthritis premarket notification procedures in with inflammation of the eye, eyelid, subpart E of part 807 of this chapter and salivary glands), and systemic scle- subject to § 866.9. rosis (chronic hardening and shrinking [47 FR 50823, Nov. 9, 1982, as amended at 65 of many body tissues). FR 2312, Jan. 14, 2000] (b) Classification. Class II (performance standards). § 866.5080 Alpha-1-antichymotrypsin immunological test system. § 866.5110 Antiparietal antibody (a) Identification. An alpha-1- immunological test system. antichymotrypsin immunological test (a) Identification. An antiparietal system is a device that consists of the antibody immunological test system is reagents used to measure by a device that consists of the reagents immunochemical techniques alpha-1- used to measure by immunochemical antichymotrypsin (a protein) in serum, techniques the specific antibody for other body fluids, and tissues. Alpha-1- gastric parietal cells in serum and antichymotrypsin helps protect tissues other body fluids. Gastric parietal cells against proteolytic (protein-splitting) are those cells located in the stomach enzymes released during infection. that produce a protein that enables vi- (b) Classification. Class II (perform- tamin B12 to be absorbed by the body. ance standards). The measurements aid in the diagnosis of vitamin B deficiency (or pernicious § 866.5090 Antimitochondrial antibody 12 immunological test system. anemia), atrophic gastritis (inflammation of the stomach), and autoimmune (a) An Identification. connective tissue diseases (diseases re- antimitochondrial antibody sulting when the body produces anti- immunological test system is a device bodies against its own tissues). that consists of the reagents used to measure by immunochemical tech- (b) Classification. Class II (perform- niques the antimitochondrial anti- ance standards). bodies in human serum. The measurements aid in the diagnosis of diseases § 866.5120 Antismooth muscle antibody immunological test system. that produce a spectrum of autoantibodies (antibodies produced (a) Identification. An antismooth mus- against the body’s own tissue), such as cle antibody immunological test sys- primary biliary cirrhosis (degeneration tem is a device that consists of the re- of liver tissue) and chronic active hepa- agents used to measure by titis (inflammation of the liver). immunochemical techniques the (b) Classification. Class II (perform- antismooth muscle antibodies (anti- ance standards). bodies to nonstriated, involuntary muscle) in serum. The measurements § 866.5100 Antinuclear antibody aid in the diagnosis of chronic hepa- immunological test system. titis (inflammation of the liver) and (a) Identification. An antinuclear autoimmune connective tissue diseases antibody immunological test system is (diseases resulting from antibodies pro- a device that consists of the reagents duced against the body’s own tissues).

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(b) Classification Class II (perform- § 866.5160 Beta-globulin immunolog- ance standards). ical test system. (a) Identification. A beta-globulin § 866.5130 Alpha-1-antitrypsin immunological test system. immunological test system is a device that consists of reagents used to meas- (a) Identification. An alpha-1- ure by immunochemical techniques antitrypsin immunological test system beta globulins (serum protein) in serum is a device that consists of the reagents and other body fluids. Beta-globulin used to measure by immunochemical proteins include beta-lipoprotein, techniques the alpha-1-antitrypsin (a transferrin, glycoproteins, and com- plasma protein) in serum, other body plement, and are rarely associated with fluids, and tissues. The measurements specific pathologic disorders. aid in the diagnosis of several condi- (b) Classification. Class I (general con- tions including juvenile and adult cir- trols). The device is exempt from the rhosis of the liver. In addition, alpha-1- premarket notification procedures in antitrypsin deficiency has been associ- subpart E of part 807 of this chapter ated with pulmonary emphysema. subject to § 866.9. (b) Classification. Class II (performance standards). [47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2312, Jan. 14, 2000] § 866.5150 Bence-Jones proteins immunological test system. § 866.5170 Breast milk immunological test system. (a) Identification. A Bence-Jones pro- (a) Identification. A breast milk teins immunological test system is a immunological test system is a device device that consists of the reagents that consists of the reagents used to used to measure by immunochemical measure by immunochemical tech- techniques the Bence-Jones proteins in niques the breast milk proteins. urine and plasma. Immunoglobulin (b) Classification. Class I (general con- molecules normally consist of pairs of trols). The device is exempt from the polypeptide chains (subunits) of un- premarket notification procedures in equal size (light chains and heavy subpart E of part 807 of this chapter chains) bound together by several di- subject to the limitations in § 866.9. sulfide bridges. In some cancerous conditions, there is a proliferation of one [47 FR 50823, Nov. 9, 1982, as amended at 59 plasma cell (antibody-producing cell) FR 63007, Dec. 7, 1994; 66 FR 38793, July 25, with excess production of light chains 2001] of one specific kind (monoclonal light § 866.5180 Fecal calprotectin chains). These free homogeneous light immunological test system. chains not associated with an immunoglobulin molecule can be found (a) Identification. A fecal calprotectin in urine and plasma, and have been immunological test system is an in called Bence-Jones proteins. Measure- vitro diagnostic device that consists of ment of Bence-Jones proteins and de- reagents used to quantitatively meas- termination that they are monoclonal ure, by immunochemical techniques, aid in the diagnosis of multiple fecal calprotectin in human stool specimens. The device is intended for myeloma (malignant proliferation of in vitro diagnostic use as an aid in the di- plasma cells), Waldenstrom’s agnosis of inflammatory bowel diseases macroglobulinemia (increased produc- (IBD), specifically Crohn’s disease and tion of large immunoglobulins by ulcerative colitis, and as an aid in dif- spleen and bone marrow cells), leu- ferentiation of IBD from irritable kemia (cancer of the blood-forming or- bowel syndrome. gans), and lymphoma (cancer of the (b) Classification. Class II (special lymphoid tissue). controls). The special control for these (b) Classification. Class II (perform- devices is FDA’s guidance document ance standards). entitled ‘‘Class II Special Controls Guidance Document: Fecal

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Calprotectin Immunological Test Sys- (b) Classification. Class I (general con- tems.’’ For the availability of this trols). The device is exempt from the guidance document, see § 866.1(e). premarket notification procedures in subpart E of part 807 of this chapter [71 FR 42598, July 27, 2006] subject to the limitations in § 866.9. § 866.5200 Carbonic anhydrase B and [47 FR 50823, Nov. 9, 1982, as amended at 59 C immunological test system. FR 63007, Dec. 7, 1994; 66 FR 38793, July 25, (a) Identification. A carbonic anhy- 2001] drase B and C immunological test system is a device that consists of the re- § 866.5230 Colostrum immunological test system. agents used to measure by immunochemical techniques specific (a) Identification. A colostrum carbonic anhydrase protein molecules immunological test system is a device in serum and other body fluids. Meas- that consists of the reagents used to urements of carbonic anhydrase B and measure by immunochemical tech- C aid in the diagnosis of abnormal he- niques the specific proteins in colos- moglobin metabolism. trum. Colostrum is a substance ex- (b) Classification. Class I (general con- creted by the mammary glands during trols). The device is exempt from the pregnancy and until production of premarket notification procedures in breast milk begins 1 to 5 days after subpart E of part 807 of this chapter childbirth. subject to § 866.9. (b) Classification. Class I (general controls). The device is exempt from the [47 FR 50823, Nov. 9, 1982, as amended at 65 premarket notification procedures in FR 2312, Jan. 14, 2000] subpart E of part 807 of this chapter § 866.5210 Ceruloplasmin immunolog- subject to the limitations in § 866.9. ical test system. [47 FR 50823, Nov. 9, 1982, as amended at 59 (a) Identification. A ceruloplasmin FR 63007, Dec. 7, 1994; 66 FR 38793, July 25, immunological test system is a device 2001] that consists of the reagents used to § 866.5240 Complement components measure by immunochemical tech- immunological test system. niques the ceruloplasmin (copper- transporting serum protein) in serum, (a) Identification. A complement com- other body fluids, or tissues. Measure- ponents immunological test system is ments of ceruloplasmin aid in the diag- a device that consists of the reagents nosis of copper metabolism disorders. used to measure by immunochemical (b) Classification. Class II (perform- techniques complement components ance standards). C1q, C1r, C1s, C2, C3, C4, C5, C6, C7, C8, and C9, in serum, other body fluids, and tis- § 866.5220 Cohn fraction II immunolog- sues. Complement is a group of serum ical test system. proteins which destroy infectious (a) Identification. A Cohn fraction II agents. Measurements of these proteins immunological test system is a device aids in the diagnosis of immunologic that consists of the reagents that con- disorders, especially those associated tain or are used to measure that frac- with deficiencies of complement com- tion of plasma containing protein ponents. gamma globulins, predominantly of the (b) Classification. Class II (perform- IgG class. The device may be used as a ance standards). coprecipitant in radioimmunoassay [47 FR 50823, Nov. 9, 1982, as amended at 53 methods, as raw material for the puri- FR 11253, Apr. 6, 1988] fication of IgG subclasses, and to reduce nonspecific adsorption of plasma § 866.5250 Complement C 2 inhibitor proteins in immunoassay techniques. (inactivator) immunological test Measurement of these proteins aids in system. the diagnosis of any disease concerned (a) Identification. A complement C1 with abnormal levels of IgG gamma inhibitor (inactivator) immunological globulins such as agammaglobulinemia test system is a device that consists of or multiple myeloma. the reagents used to measure by

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immunochemical techniques the com- classical pathway of activation of complement C1 inhibitor (a plasma protein) plement (a group of plasma proteins in serum. Complement C1 inhibitor oc- which cause the destruction of cells curs normally in plasma and blocks the which are foreign to the body). Meas- action of the C1 component of com- urement of properdin factor B aids in plement (a group of serum proteins the diagnosis of several kidney dis- which destroy infectious agents). Meas- eases, e.g., chronic glomerulonephritis urement of complement C1 inhibitor (inflammation of the glomeruli of the aids in the diagnosis of hereditary kidney), lupus nephritis (kidney dis- angioneurotic edema (increased blood ease associated with a multisystem vessel permeability causing swelling of autoimmune disease, systemic lupus tissues) and a rare form of angioedema erythematosus), as well as several skin associated with lymphoma (lymph node diseases, e.g., dermititis herpetiformis cancer). (presence of vesicles on the skin that (b) Classification. Class II (perform- burn and itch), and pemphigus vulgaris ance standards). (large vesicles on the skin). Other diseases in which the alternate pathway § 866.5260 Complement C3b inactivator immunological test system. of complement activation has been im- plicated include rheumatoid arthritis, (a) Identification. A complement C3b sickle cell anemia, and gram-negative inactivator immunological test system bacteremia. is a device that consists of the reagents (b) Classification. Class II (special used to measure by immunochemical controls). The device is exempt from techniques the complement C 3b the premarket notification procedures inactivator (a plasma protein) in in subpart E of part 807 of this chapter serum. Complement is a group of serum subject to § 866.9. proteins that destroy infectious agents. Measurement of complement C3b [47 FR 50823, Nov. 9, 1982, as amended at 63 inactivator aids in the diagnosis of in- FR 59227, Nov. 3, 1998] herited antibody dysfunction. (b) Classification. Class II (perform- § 866.5330 Factor XIII, A, S, immuno- ance standards). logical test system. (a) Identification. A factor XIII, A, S, § 866.5270 C-reactive protein immuno- immunological test system is a device logical test system. that consists of the reagents used to (a) Identification. A C-reactive protein measure by immunochemical tech- immunological test system is a device niques the factor XIII (a bloodclotting that consists of the reagents used to factor), in platelets (A) or serum (S). measure by immunochemical tech- Measurements of factor XIII, A, S, aid niques the C-reactive protein in serum in the diagnosis and treatment of cer- and other body fluids. Measurement of tain bleeding disorders resulting from a C-reactive protein aids in evaluation of deficiency of this factor. the amount of injury to body tissues. (b) Classification. Class I (general con- (b) Classification. Class II (perform- trols). The device is exempt from the ance standards). premarket notification procedures in subpart E of part 807 of this chapter § 866.5320 Properdin factor B immunological test system. subject to § 866.9. This exemption does not apply to factor deficiency tests (a) Identification. A properdin factor classified under § 864.7290 of this chap- B immunological test system is a deter. vice that consists of the reagents used to measure by immunochemical tech- [47 FR 50823, Nov. 9, 1982, as amended at 65 niques properdin factor B in serum and FR 2312, Jan. 14, 2000] other body fluids. The deposition of properdin factor B in body tissues or a § 866.5340 Ferritin immunological test corresponding depression in the system. amount of properdin factor B in serum (a) Identification. A ferritin and other body fluids is evidence of the immunological test system is a device involvement of the alternative to the that consists of the reagents used to

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measure by immunochemical tech- This test aids in the diagnosis of dis- niques the ferritin (an iron-storing pro- eases where albumin levels may be de- tein) in serum and other body fluids. pressed, e.g., nephrosis (disease of the Measurements of ferritin aid in the di- kidney), proteinuria (protein in the agnosis of diseases affecting iron me- urine), gastroenteropathy (disease of tabolism, such as hemochromatosis the stomach and small intestine), rheu- (iron overload) and iron deficiency matoid arthritis, and viral hepatitis. amemia. (b) Classification. Class I (general con- (b) Classification. Class II (perform- trols). The device is exempt from the ance standards). premarket notification procedures in subpart E of part 807 of this chapter § 866.5350 Fibrinopeptide A immuno- subject to the limitations in § 866.9. logical test system. (a) Identification. A fibrinopeptide A [47 FR 50823, Nov. 9, 1982, as amended at 59 immunological test system is a device FR 63007, Dec. 7, 1994; 66 FR 38793, July 25, that consists of the reagents used to 2001] measure by immunochemical tech- § 866.5380 Free secretory component niques the fibrinopeptide A (a blood- immunological test system. clotting factor) in plasma and other body fluids. Measurement of (a) Identification. A free secretory fibrinopeptide A may aid in the diag- component immunological test system nosis and treatment of certain blood- is a device that consists of the reagents clotting disorders. used to measure by immunochemical (b) Classification. Class II (perform- techniques free secretory component ance standards). (normally a portion of the secretory IgA antibody molecule) in body fluids. § 866.5360 Cohn fraction IV immuno- Measurement of free secretory compo- logical test system. nent (protein molecules) aids in the di- (a) Identification. A Cohn fraction IV agnosis or repetitive lung infections immunological test system is a device and other hypogammaglobulinemic that consists of or measures that frac- conditions (low antibody levels). tion of plasma proteins, predominantly (b) Classification. Class II (special alpha- and beta- globulins, used as a controls). The device is exempt from raw material for the production of pure the premarket notification procedures alpha- or beta- globulins. Measurement in subpart E of part 807 of this chapter of specific alpha- or beta- globulins aids subject to § 866.9. in the diagnosis of many diseases, such as Wilson’s disease (an inherited dis- [47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998] ease affecting the liver and brain), Tangier’s disease (absence of alpha-1- § 866.5400 Alpha-globulin immuno- lipoprotein), malnutrition, iron defi- logical test system. ciency anemia, red blood cell disorders, and kidney disease. (a) Identification. An alpha-globulin (b) Classification. Class I (general con- immunological test system is a device trols). The device is exempt from the that consists of the reagents used to premarket notification procedures in measure by immunochemical tech- subpart E of part 807 of this chapter niques the alpha-globulin (a serum pro- subject to the limitations in § 866.9. tein) in serum and other body fluids. Measurement of alpha-globulin may [47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, aid in the diagnosis of inflammatory 1982, as amended at 59 FR 63007, Dec. 7, 1994; lesions, infections, severe burns, and a 66 FR 38793, July 25, 2001] variety of other conditions. § 866.5370 Cohn fraction V immuno- (b) Classification. Class I (general con- logical test system. trols). The device is exempt from the (a) Identification. A Cohn fraction V premarket notification procedures in immunological test system is a device subpart E of part 807 of this chapter that consists of or measures that frac- subject to § 866.9. tion of plasma containing predomi- [47 FR 50823, Nov. 9, 1982, as amended at 65 nantly albumin (a plasma protein). FR 2312, Jan. 14, 2000]

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§ 866.5420 Alpha-1-glycoproteins the diagnosis of an inherited deficiency immunological test system. of this serum protein. (a) Identification. An alpha-1- (b) Classification. Class I (general con- glycoproteins immunological test sys- trols). The device is exempt from the tem is a device that consists of the re- premarket notification procedures in agents used to measure by subpart E of part 807 of this chapter immunochemical techniques alpha-1- subject to § 866.9. glycoproteins (a group of plasma pro- [47 FR 50823, Nov. 9, 1982, as amended at 65 teins found in the alpha-1 group when FR 2312, Jan. 14, 2000] subjected to electrophoresis) in serum and other body fluids. Measurement of § 866.5440 Beta-2-glycoprotein III specific alpha-1-glycoproteins may aid immunological test system. in the diagnosis of collagen (connective (a) Identification. A beta-2- tissue) disorders, tuberculosis, infec- glycoprotein III immunological test tions, extensive malignancy, and diabe- system is a device that consists of the tes. reagents used to measure by (b) Classification. Class I (general con- immunochemical techniques the beta-2- trols). The device is exempt from the glycoprotein III (a serum protein) in premarket notification procedures in subpart E of part 807 of this chapter serum and other body fluids. Measure- subject to § 866.9. ment of beta-2-glycoprotein III aids in the diagnosis of an inherited deficiency [47 FR 50823, Nov. 9, 1982, as amended at 65 of this serum protein and a variety of FR 2312, Jan. 14, 2000] other conditions. (b) Classification. Class I (general con- § 866.5425 Alpha-2-glycoproteins immunological test system. trols). The device is exempt from the premarket notification procedures in (a) Identification. An alpha-2- subpart E of part 807 of this chapter glycoproteins immunolgical test sys- subject to § 866.9. tem is a device that consists of the reagents used to measure by [47 FR 50823, Nov. 9, 1982, as amended at 65 immunochemical techniques the alpha- FR 2312, Jan. 14, 2000] 2-glycoproteins (a group of plasma proteins found in the alpha-2 group when § 866.5460 Haptoglobin immunological subjected to electrophoresis) in serum test system. and other body fluids. Measurement of (a) Identification. A haptoglobin alpha-2-glycoproteins aids in the diag- immunological test system is a device nosis of some cancers and genetically that consists of the reagents used to inherited deficiencies of these plasma measure by immunochemical tech- proteins. niques the haptoglobin (a protein that (b) Classification. Class I (general con- binds hemoglobin, the oxygen-carrying trols). The device is exempt from the pigment in red blood cells) in serum. premarket notification procedures in Measurement of haptoglobin may aid subpart E of part 807 of this chapter in the diagnosis of hemolytic diseases subject to § 866.9. (diseases in which the red blood cells [47 FR 50823, Nov. 9, 1982, as amended at 65 rupture and release hemoglobin) re- FR 2312, Jan. 14, 2000] lated to the formation of hemoglobin- haptoglobin complexes and certain kid- § 866.5430 Beta-2-glycoprotein I ney diseases. immunological test system. (b) Classification. Class II (special (a) Identification. A beta-2- controls). The device is exempt from glycoprotein I immunological test sys- the premarket notification procedures tem is a device that consists of the rein subpart E of part 807 of this chapter agents used to measure by subject to § 866.9. immunochemical techniques the beta-2- glycoprotein I (a serum protein) in [47 FR 50823, Nov. 9, 1982, as amended at 63 serum and other body fluids. Measure- FR 59227, Nov. 3, 1998] ment of beta-2-glycoprotein I aids in

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§ 866.5470 Hemoglobin immunological sensitivity pneumonitis). Measurement test system. of these immunoglobulin G antibodies (a) Indentification. A hemoglobin aids in the diagnosis of hyper- immunological test system is a device sensitivity pneumonitis and other al- that consists of the reagents used to lergic respiratory disorders. measure by immunochemical tech- (b) Classification. Class II (perform- niques the different types of free hemo- ance standards). globin (the oxygen-carrying pigment in red blood cells) in blood, urine, plasma, § 866.5510 Immunoglobulins A, G, M, D, or other body fluids. Measurements of and E immunological test system. free hemoglobin aid in the diagnosis of (a) Identification. An various hematologic disorders, such as immunoglobulins A, G, M, D, and E sickle cell anemia, Fanconi’s anemia (a immunological test system is a device rare inherited disease), aplastic anemia that consists of the reagents used to (bone marrow does not produce enough measure by immunochemical tech- blood cells), and leukemia (cancer of the blood-forming organs). niques the immunoglobulins A, G, M, (b) Classification. Class II (perform- D, an E (serum antibodies) in serum. ance standards). Measurement of these immunoglobulins aids in the diagnosis § 866.5490 Hemopexin immunological of abnormal protein metabolism and test system. the body’s lack of ability to resist in- (a) Indentification. A hemopexin fectious agents. immunological test system is a device (b) Classification. Class II (perform- that consists of the reagents used to ance standards). measure by immunochemical techniques the hemopexin (a serum protein § 866.5520 Immunoglobulin G (Fab that binds heme, a component of hemo- fragment specific) immunological globin) in serum. Measurement of test system. hemopexin aids in the diagnosis of var- (a) Identification. An immunoglobulin ious hematologic disorders, such as he- G (Fab fragment specific) molytic anemia (anemia due to short- immunological test system is a device ened in vivo survival of mature red that consists of the reagents used to blood cells and inability of the bone marrow to compensate for their de- measure by immunochemical tech- creased life span) and sickle cell ane- niques the Fab antigen-binding frag- mia. ment resulting from breakdown of (b) Classification. Class II (special immunoglobulin G antibodies in urine, controls). The device is exempt from serum, and other body fluids. Measure- the premarket notification procedures ment of Fab fragments of in subpart E of part 807 of this chapter immunoglobulin G aids in the diag- subject to § 866.9. nosis of lymphoproliferative disorders, such as multiple myeloma (tumor of [47 FR 50823, Nov. 9, 1982, as amended at 63 FR 59227, Nov. 3, 1998] bone marrow cells), Waldenstrom’s macroglobulinemia (increased § 866.5500 Hypersensitivity pneumo- immunoglobulin production by the nitis immunological test system. spleen and bone marrow cells), and (a) Identification. A hypersensitivity lymphoma (tumor of the lymphoid tis- pneumonitis immunological test sys- sues). tem is a device that consists of the re- (b) Classification. Class I (general con- agents used to measure by trols). The device is exempt from the immunochemical techniques the premarket notification procedures in immunoglobulin antibodies in serum subpart E of part 807 of this chapter which react specifically with organic subject to the limitations in § 866.9. dust derived from fungal or animal protein sources. When these antibodies [47 FR 50823, Nov. 9, 1982, as amended at 61 react with such dusts in the lung, im- FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, mune complexes precipitate and trig- 2001] ger an inflammatory reaction (hyper-

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§ 866.5530 Immunoglobulin G (Fc frag- kappa and lambda types of light chain ment specific) immunological test portions of immunoglobulin molecules system. in serum, other body fluids, and tis- (a) Identification. An immunoglobulin sues. In some disease states, an excess G (Fc fragment specific) of light chains are produced by the immunological test system is a device antibody-forming cells. These free that consists of the reagents used to light chains, unassociated with gamma measure by immunochemical tech- globulin molecules, can be found in a niques the Fc (carbohydrate con- patient’s body fluids and tissues. Meas- taining) fragment of immunoglobulin urement of the various amounts of the G (resulting from breakdown of different types of light chains aids in immunoglobulin G antibodies) in urine, the diagnosis of multiple myeloma serum, and other body fluids. Measure- (cancer of antibody-forming cells), ment of immunoglobulin G Fc frag- lymphocytic neoplasms (cancer of ments aids in the diagnosis of plasma lymphoid tissue), Waldenstrom’s cell antibody-forming abnormalities, macroglobulinemia (increased produc- e.g., gamma heavy chain disease. tion of large immunoglobulins), and (b) Classification. Class I (general con- connective tissue diseases such as trols). The device is exempt from the rheumatoid arthritis or systemic lupus premarket notification procedures in erythematosus. subpart E of part 807 of this chapter (b) Classification. Class II (perform- subject to the limitations in § 866.9. ance standards). [47 FR 50823, Nov. 9, 1982, as amended at 61 § 866.5560 Lactic dehydrogenase FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, immunological test system. 2001] (a) Identification. A lactic dehydro- § 866.5540 Immunoglobulin G (Fd frag- genase immunological test system is a ment specific) immunological test device that consists of the reagents system. used to measure by immunochemical (a) Identification. An immunoglobulin techniques the activity of the lactic G (Fd fragment specific) dehydrogenase enzyme in serum. In- immunological test system is a device creased levels of lactic dehydrogenase that consists of the reagents used to are found in a variety of conditions, in- measure by immunochemical tech- cluding megaloblastic anemia (de- niques the amino terminal (antigen- crease in the number of mature red binding) end (Fd fragment) of the blood cells), myocardial infarction heavy chain (a subunit) of the (heart disease), and some forms of leu- immunoglobulin antibody molecule in kemia (cancer of the blood-forming or- serum. Measurement of gans). However, the diagnostic useful- immunoglobulin G Fd fragments aids ness of this device is limited because of in the diagnosis of plasma antibody- the many conditions known to cause forming cell abnormalities. increased lactic dehydrogenase levels. (b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to the limitations in § 866.9. subject to § 866.9. [47 FR 50823, Nov. 9, 1982, as amended at 59 [47 FR 50823, Nov. 9, 1982, as amended at 65 FR 63007, Dec. 7, 1994; 66 FR 38793, July 25, FR 2312, Jan. 14, 2000] 2001] § 866.5570 Lactoferrin immunological § 866.5550 Immunoglobulin (light test system. chain specific) immunological test (a) Identification. A lactoferrin system. immunological test system is a device (a) Identification. An immunoglobulin that consists of the reagents used to (light chain specific) immunological measure by immunochemical tech- test system is a device that consists of niques the lactoferrin (an iron-binding the reagents used to measure by protein with the ability to inhibit the immunochemical techniques both growth of bacteria) in serum, breast

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milk, other body fluids, and tissues. (b) Classification. Class II (perform- Measurement of lactoferrin may aid in ance standards). the diagnosis of an inherited deficiency of this protein. § 866.5620 Alpha-2-macroglobulin (b) Classification. Class I (general con- immunological test system. trols). The device is exempt from the (a) Identification. An alpha-2- premarket notification procedures in macroglobulin immunological test sys- subpart E of part 807 of this chapter tem is a device that consists of the re- subject to § 866.9. agents used to measure by [47 FR 50823, Nov. 9, 1982, as amended at 65 immunochemical techniques the alpha- FR 2312, Jan. 14, 2000] 2-macroglobulin (a serum protein) in plasma. Measurement of alpha-2- § 866.5580 Alpha-1-lipoprotein macroglobulin may aid in the diagnosis immunological test system. of blood-clotting or clot lysis disorders. (a) Identification. An alpha-1- (b) Classification. Class II (perform- lipoprotein immunological test system ance standards). is a device that consists of the reagents used to measure by immunochemical § 866.5630 Beta-2-microglobulin techniques the alpha-1-lipoprotein immunological test system. (high-density lipoprotein) in serum and (a) Identification. A beta-2-microglob- plasma. Measurement of alpha-1- ulin immunological test system is a de- lipoprotein may aid in the diagnosis of vice that consists of the reagents used Tangier disease (a hereditary disorder to measure by immunochemical tech- of fat metabolism). niques beta-2-microglobulin (a protein (b) Classification. Class II (perform- molecule) in serum, urine, and other ance standards). body fluids. Measurement of beta-2- microglobulin aids in the diagnosis of § 866.5590 Lipoprotein X immunological test system. active rheumatoid arthritis and kidney disease. (a) Identification. A lipoprotein X (b) Classification. Class II (perform- immunological test system is a device ance standards). that consists of the reagents used to measure by immunochemical tech- § 866.5640 Infectious mononucleosis niques lipoprotein X (a high-density immunological test system. lipoprotein) in serum and other body fluids. Measurement of lipoprotein X (a) Identification. An infectious mono- aids in the diagnosis of obstructive nucleosis immunological test system is liver disease. a device that consists of the reagents (b) Classification. Class I (general con- used to measure by immunochemical trols). The device is exempt from the techniques heterophile antibodies fre- premarket notification procedures in quently associated with infectious subpart E of part 807 of this chapter mononucleosis in serum, plasma, and subject to § 866.9. other body fluids. Measurements of these antibodies aid in the diagnosis of [47 FR 50823, Nov. 9, 1982, as amended at 65 infectious mononucleosis. FR 2313, Jan. 14, 2000] (b) Classification. Class II (perform- § 866.5600 Low-density lipoprotein ance standards). immunological test system. [47 FR 50823, Nov. 9, 1982; 47 FR 56846, Dec. 21, (a) Identification. A low-density 1982] lipoprotein immunological test system is a device that consists of the reagents § 866.5660 Multiple autoantibodies used to measure by immunochemical immunological test system. techniques the low-density lipoprotein (a) Identification. A multiple in serum and other body fluids. Meas- autoantibodies immunological test sys- urement of low-density lipoprotein in tem is a device that consists of the re- serum may aid in the diagnosis of dis- agents used to measure by orders of lipid (fat) metabolism and immunochemical techniques the help to identify young persons at risk autoantibodies (antibodies produced from cardiovascular diseases. against the body’s own tissues) in

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serum and other body fluids. Measure- the diagnosis of fibrinolytic (blood- ment of multiple autoantibodies aids clotting) disorders. in the diagnosis of autoimmune dis- (b) Classification. Class I (general con- orders (disease produced when the trols). The device is exempt from the body’s own tissues are injured by premarket notification procedures in autoantibodies). subpart E of part 807 of this chapter (b) Classification. Class II (perform- subject to § 866.9. ance standards). [47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2313, Jan. 14, 2000] § 866.5680 Myoglobin immunological test system. § 866.5735 Prothrombin immunological (a) Identification. A myoglobin test system. immunological test system is a device (a) Identification. A prothrombin that consists of the reagents used to immunological test system is a device measure by immunochemical tech- that consists of the reagents used to niques the myoglobin (an oxygen stor- measure by immunochemical tech- age protein found in muscle) in serum niques the prothrombin (clotting factor and other body fluids. Measurement of II) in serum. Measurements of the myoglobin aids in the rapid diagnosis amount of antigenically competent of heart or renal disease. (ability to react with protein anti- (b) Classification. Class II (perform- bodies) prothrombin aid in the diag- ance standards). nosis of blood-clotting disorders. (b) Classification. Class I (general con- § 866.5700 Whole human plasma or trols). The device is exempt from the serum immunological test system. premarket notification procedures in (a) Identification. A whole human subpart E of part 807 of this chapter plasma or serum immunological test subject to § 866.9. This exemption does system is a device that consists of re- not apply to multipurpose systems for agents used to measure by in vitro coagulation studies classified immunochemical techniques the pro- under § 864.5425 of this chapter or proteins in plasma or serum. Measure- thrombin time tests classified under ments of proteins in plasma or serum § 864.7750 of this chapter. aid in the diagnosis of any disease con- [47 FR 50823, Nov. 9, 1982, as amended at 65 cerned with abnormal levels of plasma FR 2313, Jan. 14, 2000] or serum proteins, e.g., agammaglobulinemia, allergies, multiple myeloma, § 866.5750 Radioallergosorbent (RAST) rheumatoid vasculitis, or hereditary immunological test system. angioneurotic edema. (a) Identification. A (b) Classification. Class I (general con- radioallergosorbent immunological trols). The device is exempt from the test system is a device that consists of premarket notification procedures in the reagents used to measure by subpart E of part 807 of this chapter immunochemical techniques the aller- subject to the limitations in § 866.9. gen antibodies (antibodies which cause [47 FR 50823, Nov. 9, 1982, as amended at 59 an allergic reaction) specific for a FR 63007, Dec. 7, 1994; 66 FR 38793, July 25, given allergen. Measurement of specific 2001] allergen antibodies may aid in the diagnosis of asthma, allergies, and other § 866.5715 Plasminogen immunological pulmonary disorders. test system. (b) Classification. Class II (perform- (a) Identification. A plasminogen ance standards). immunological test system is a device that consists of the reagents used to § 866.5760 Tryptase test system. measure by immunochemical tech- (a) Identification. A tryptase test sys- niques the plasminogen (an inactive tem is a device that aids in the diag- substance from which plasmin, a blood- nosis of systemic mastocytosis. It is in- clotting factor, is formed) in serum, tended for in vitro diagnostic use as an other body fluids, and tissues. Measure- aid in the clinical diagnosis of patients ment of plasminogen levels may aid in with a suspicion of systemic

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mastocytosis in conjunction with other (b) Classification. Class II (special clinical and laboratory findings. controls). The special control is FDA’s (b) Classification. Class II (special ‘‘Guidance for Industry and FDA Re- controls). The special control is FDA’s viewers: Class II Special Control Guid- guideline entitled ‘‘Class II Special ance Document for Anti-Saccharomyces Controls Guideline: Tryptase Test Sys- cerevisiae (S. cerevisiae) Antibody tem as an Aid in the Diagnosis of Sys- (ASCA) Premarket Notifications.’’ temic Mastocytosis.’’ For availability of the document, see § 866.1(e). [65 FR 70307, Nov. 22, 2000] [79 FR 56010, Sept. 18, 2014] § 866.5800 Seminal fluid (sperm) immunological test system. § 866.5765 Retinol-binding protein immunological test system. (a) Identification. A seminal fluid (sperm) immunological test system is a (a) Identification. A retinol-binding protein immunological test system is a device that consists of the reagents device that consists of the reagents used for legal purposes to identify and used to measure by immunochemical differentiate animal and human semen. techniques the retinol-binding protein The test results may be used as court that binds and transports vitamin A in evidence in alleged instances of rape serum and urine. Measurement of this and other sex-related crimes. protein may aid in the diagnosis of kid- (b) Classification. Class I (general con- ney disease and in monitoring patients trols). The device is exempt from the with kidney transplants. premarket notification procedures in (b) Classification. Class I (general con- subpart E of part 807 of this chapter trols). The device is exempt from the subject to the limitations in § 866.9. premarket notification procedures in [54 FR 25047, June 12, 1989, as amended at 66 subpart E of part 807 of this chapter FR 38793, July 25, 2001] subject to § 866.9. [47 FR 50823, Nov. 9, 1982, as amended at 65 § 866.5820 Systemic lupus erythema- FR 2313, Jan. 14, 2000] tosus immunological test system. (a) Identification. A systemic lupus § 866.5775 Rheumatoid factor immuno- erythematosus (SLE) immunological logical test system. test system is a device that consists of (a) Identification. A rheumatoid factor the reagents used to measure by immunological test system is a device immunochemical techniques the auto- that consists of the reagents used to immune antibodies in serum and other measure by immunochemical tech- body fluids that react with cellular nu- niques the rheumatoid factor (anti- clear double-stranded deoxyribonucleic bodies to immunoglobulins) in serum, acid (DNA) or other nuclear constitu- other body fluids, and tissues. Measure- ents that are specifically diagnostic of ment of rheumatoid factor may aid in SLE. Measurement of nuclear double- the diagnosis of rheumatoid arthritis. stranded DNA antibodies aids in the di- (b) Classification. Class II (perform- agnosis of SLE (a multisystem auto- ance standards). immune disease in which tissues are § 866.5785 Anti-Saccharomyces attacked by the person’s own anti- cerevisiae (S. cerevisiae) antibody bodies). (ASCA) test systems. (b) Classification. Class II (perform- (a) Identification. The Anti-Saccharo- ance standards). myces cerevisiae (S. cerevisiae) antibody (ASCA) test system is an in vitro diag- § 866.5860 Total spinal fluid immuno- nostic device that consists of the re- logical test system. agents used to measure, by (a) Identification. A total spinal fluid immunochemical techniques, anti- immunological test system is a device bodies to S. cerevisiae (baker’s or brew- that consists of the reagents used to er’s yeast) in human serum or plasma. measure by immunochemical tech- Detection of S. cerevisiae antibodies niques the total protein in cerebro- may aid in the diagnosis of Crohn’s dis- spinal fluid. Measurement of spinal ease. fluid proteins may aid in the diagnosis

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of multiple sclerosis and other diseases may aid in the diagnosis of acute bac- of the nervous system. terial infection and inflammation. (b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to the limitations in § 866.9. subject to § 866.9. [47 FR 50823, Nov. 9, 1982, as amended at 61 [47 FR 50823, Nov. 9, 1982, as amended at 53 FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, FR 11253, Apr. 6, 1988; 65 FR 2313, Jan. 14, 2001] 2000] § 866.5870 Thyroid autoantibody immunological test system. § 866.5900 Cystic fibrosis transmembrane conductance regu- (a) Identification. A thyroid lator (CFTR) gene mutation detec- autoantibody immunological test sys- tion system. tem is a device that consists of the re- (a) Identification. The CFTR gene mu- agents used to measure by tation detection system is a device immunochemical techniques the thy- used to simultaneously detect and roid autoantibodies (antibodies pro- identify a panel of mutations and duced against the body’s own tissues). variants in the CFTR gene. It is in- Measurement of thyroid autoantibodies tended as an aid in confirmatory diag- may aid in the diagnosis of certain thyroid disorders, such as Hashimoto’s dis- nostic testing of individuals with sus- ease (chronic lymphocytic thyroiditis), pected cystic fibrosis (CF), carrier nontoxic goiter (enlargement of thy- identification, and newborn screening. roid gland), Grave’s disease (enlarge- This device is not intended for stand- ment of the thyroid gland with protru- alone diagnostic purposes, prenatal di- sion of the eyeballs), and cancer of the agnostic, pre-implantation, or popu- thyroid. lation screening. (b) Classification. Class II (perform- (b) Classification. Class II (special ance standards). controls). The special control is FDA’s guidance document entitled ‘‘Class II § 866.5880 Transferrin immunological Special Controls Guidance Document: test system. CFTR Gene Mutation Detection Sys- (a) Identification. A transferrin tem.’’ See § 866.1(e) for the availability immunological test system is a device of this guidance document. that consists of the reagents used to [70 FR 61738, Oct. 26, 2005] measure by immunochemical techniques the transferrin (an iron-binding § 866.5910 Quality control material for and transporting serum protein) in cystic fibrosis nucleic acid assays. serum, plasma, and other body fluids. Measurement of transferrin levels aids (a) Identification. Quality control main the diagnosis of malnutrition, acute terial for cystic fibrosis nucleic acid inflammation, infection, and red blood assays. A quality control material for cell disorders, such as iron deficiency cystic fibrosis nucleic acid assays is a anemia. device intended to help monitor reli- (b) Classification. Class II (perform- ability of a test system by detecting ance standards). analytical deviations such as those that may arise from reagent or instru- § 866.5890 Inter-alpha trypsin inhib- ment variation in genetic testing. This itor immunological test system. type of device includes recombinant, (a) Identification. An inter-alpha synthetic, and cell line-based DNA con- trypsin inhibitor immunological test trols. system is a device that consists of the (b) Classification. Class II (special reagents used to measure by controls). The special control is FDA’s immunochemical techniques the inter- guidance document entitled ‘‘Class II alpha trypsin inhibitor (a protein) in Special Controls Guidance Document: serum and other body fluids. Measure- Quality Control Material for Cystic Fi- ment of inter-alpha trypsin inhibitor brosis Nucleic Acid Assays.’’ See

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§ 866.1(e) for the availability of this changes to the device that could sig- guidance document. nificantly affect safety or effectiveness [72 FR 1176, Jan. 10, 2007] would require new data or information in support of such changes, which § 866.5940 Autosomal recessive carrier would also have to be posted on the screening gene mutation detection manufacturer’s Web site. The informa- system. tion must include: (a) Identification. Autosomal reces- (i) A detailed device description in- sive carrier screening gene mutation cluding: detection system is a qualitative in (A) Gene (or list of the genes if more vitro molecular diagnostic system used than one) and variants the test detects for genotyping of clinically relevant (using standardized nomenclature, variants in genomic DNA isolated from Human Genome Organization (HUGO) human specimens intended for pre- nomenclature, and coordinates). scription use or over-the-counter use. (B) Scientifically established clinical The device is intended for autosomal validity of each variant detected and recessive disease carrier screening in reported by the test, which must be adults of reproductive age. The device well-established in peer-reviewed jour- is not intended for copy number vari- nal articles, authoritative summaries ation, cytogenetic, or biochemical test- of the literature such as Genetics ing. Home Reference (http://ghr.nlm.nih.gov/ (b) Classification. Class II (special ), GeneReviews (http:// controls). Autosomal recessive carrier www.ncbi.nlm.nih.gov/books/NBK1116/), screening gene mutation detection sys- or similar summaries of valid scientific tem must comply with the following evidence, and/or professional society special controls: recommendations, including: (1) If the device is offered over-the- (1) Genotype-phenotype information counter, the device manufacturer must for the reported mutations. provide information to a potential pur- (2) Relevant American College of chaser or actual test report recipient Medical Genetics (ACMG) or American about how to obtain access to a board- Congress of Obstetricians and Gyne- certified clinical molecular geneticist cologists (ACOG) guideline recom- or equivalent to assist in pre- and post- mending testing of the specific gene(s) test counseling. and variants the test detects and rec- (2) The device must use a collection ommended populations, if available. If device that is FDA cleared, approved, not available, a statement stating that or classified as 510(k) exempt, with an professional guidelines currently do indication for in vitro diagnostic use in not recommend testing for this specific DNA testing. gene(s) and variants. (3) The device’s labeling must include a prominent hyperlink to the manufac- (3) Table of expected prevalence of turer’s public Web site where the man- carrier status in major ethnic and ra- ufacturer shall make the information cial populations and the general popu- identified in this section publicly lation. available. The manufacturer’s home (C) The specimen type (e.g., saliva, page, as well as the primary part of the whole blood), matrix, and volume. manufacturer’s Web site that discusses (D) Assay steps and technology used. the device, must provide a prominently (E) Specification of required ancil- placed hyperlink to the Web page con- lary reagents, instrumentation, and taining this information and must equipment. allow unrestricted viewing access. If (F) Specification of the specimen col- the device can be purchased from the lection, processing, storage, and prepa- Web site or testing using the device ration methods. can be ordered from the Web site, the (G) Specification of risk mitigation same information must be found on the elements and description of all addi- Web page for ordering the device or tional procedures, methods, and prac- provided in a prominently placed and tices incorporated into the directions publicly accessible hyperlink on the for use that mitigate risks associated Web page for ordering the device. Any with testing.

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(H) Information pertaining to the fidence interval. Clinical specimens probability of test failure (e.g., failed must include both homozygous wild quality control) based on data from type and heterozygous genotypes. The clinical samples, description of sce- number of clinical specimens for each narios in which a test can fail (i.e., low variant reported that must be included sample volume, low DNA concentra- in the accuracy study must be based on tion, etc.), how customers will be noti- the variant prevalence. Common fied, and followup actions to be taken. variants (greater than 0.1 percent allele (I) Specification of the criteria for frequency in ethnically relevant popu- test result interpretation and report- lation) must have at least 20 unique ing. heterozygous clinical specimens tested. (ii) Information that demonstrates Rare variants (less than or equal to 0.1 the performance characteristics of the percent allele frequency in ethnically device, including: relevant population) shall have at least (A) Accuracy (method comparison) of three unique mutant heterozygous study results for each claimed speci- specimens tested. Any no calls (i.e., ab- men type. sence of a result) or invalid calls (e.g., (1) Accuracy of the device shall be failed quality control) in the study evaluated with fresh clinical specimens must be included in accuracy study re- collected and processed in a manner sults and reported separately. Variants consistent with the device’s instruc- that have a point estimate for PPA or tions for use. If this is impractical, NPA of less than 99 percent (incorrect fresh clinical samples may be sub- test results as compared to stituted or supplemented with archived bidirectional sequencing or other clinical samples. Archived samples methods identified as appropriate by shall have been collected previously in FDA) must not be incorporated into accordance with the device’s instructions for use, stored appropriately, and test claims and reports. Accuracy randomly selected. In some instances, measures generated from clinical speci- use of contrived samples or human cell mens versus contrived samples or cell line samples may also be appropriate; lines must be presented separately. Re- the contrived or human cell line sam- sults must be summarized and pre- ples shall mimic clinical specimens as sented in tabular format, by sample much as is feasible and provide an un- and by genotype. Point estimate of biased evaluation of the device’s accu- PPA should be calculated as the num- racy. ber of positive results divided by the (2) Accuracy must be evaluated as number of specimens known to harbor compared to bidirectional sequencing variants (mutations) without ‘‘no or other methods identified as appro- calls’’ or invalid calls. The point esti- priate by FDA. Performance criteria mate of NPA should be calculated as for both the comparator method and the number of negative results divided device must be predefined and appro- by the number of wild type specimens priate to the test’s intended use. De- tested without ‘‘no calls’’ or invalid tailed appropriate study protocols calls, for each variant that is being re- must be provided. ported. Point estimates should be cal- (3) Information provided shall in- culated along with 95 percent two-sided clude the number and type of speci- confidence intervals. mens, broken down by clinically rel- (4) Information shall be reported on evant variants, that were compared to the clinical positive predictive value bidirectional sequencing or other (PPV) and negative predictive value methods identified as appropriate by (NPV) for carrier status (and where FDA. The accuracy, defined as positive possible, for each variant) in each pop- percent agreement (PPA) and negative ulation. Specifically, to calculate PPV percent agreement (NPA), must be and NPV, estimate test coverage (TC) measured; accuracy point estimates and the percent of persons with vari- must be greater than 99 percent (both ant(s) included in the device among all per reported variant and overall) and carriers: PPV = (PPA * TC * π)/(PPA * uncertainty of the point estimate must TC * π + (1 ¥ NPA) * (1 ¥ π)) and NPV be presented using the 95 percent con- = (NPA * (1 ¥ π))/(NPA *(1 ¥ π) + (1 ¥

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PPA*TC) * π) where PPA and NPA de- the study must be provided as a part of scribed either in paragraph the precision (reproducibility) study (b)(3)(ii)(A)(4)(i) or in paragraph results. (b)(3)(ii)(A)(4)(ii) of this section and π is (C) Analytical specificity data: Data prevalence of carriers in the population must be generated evaluating the ef- (pre-test risk to be a carrier for the dis- fect on test performance of potential ease). endogenous and exogenous interfering (i) For the point estimates of PPA substances relevant to the specimen and NPA less than 100 percent, use the type, evaluation of cross-reactivity of calculated estimates in the PPV and known cross-reactive alleles and NPV calculations. pseudogenes, and assessment of cross- (ii) Point estimates of 100 percent contamination. may have high uncertainty. If these (D) Analytical sensitivity data: Data variants are measured using highly must be generated demonstrating the multiplexed technology, calculate the minimum amount of DNA that will en- random error rate for the overall de- able the test to perform accurately in vice and incorporate that rate in the 95 percent of runs. estimation of the PPA and NPA as cal- (E) Device stability data: The manu- culated previously. Then use these cal- facturer must establish upper and culated estimates in the PPV and NPV lower limits of input nucleic acid and calculations. This type of accuracy sample stability that will achieve the study is helpful in determining that claimed accuracy and reproducibility. there is no systematic error in such de- Data supporting such claims must be vices. described. (B) Precision (reproducibility): Preci- (F) Specimen type and matrix com- sion data must be generated using mul- parison data: Specimen type and ma- tiple instruments and multiple opera- trix comparison data must be gen- tors, on multiple non-consecutive days, erated if more than one specimen type and using multiple reagent lots. The or anticoagulant can be tested with the sample panel must include specimens device, including failure rates for the with claimed sample type (e.g. saliva different specimen types. samples) representing different (iii) If the device is offered over-the- genotypes (i.e., wild type, counter, including cases in which the heterozygous). Performance criteria test results are provided direct-to-con- must be predefined. A detailed study sumer, the manufacturer must conduct protocol must be created in advance of a study that assesses user comprehen- the study and then followed. The sion of the device’s labeling and test ‘‘failed quality control’’ rate must be process and provide a concise summary indicated. It must be clearly docu- of the results of the study. The fol- mented whether results were generated lowing items must be included in the from clinical specimens, contrived user study: samples, or cell lines. The study results (A) The test manufacturer must per- shall state, in a tabular format, the form pre- and post-test user com- variants tested in the study and the prehension studies to assess user abil- number of replicates for each variant, ity to understand the possible results and what testing conditions were stud- of a carrier test and their clinical ied (i.e., number of runs, days, instru- meaning. The comprehension test ques- ments, reagent lots, operators, speci- tions must directly evaluate the mate- mens/type, etc). The study must in- rial being presented to the user in the clude all nucleic acid extraction steps test reports. from the claimed specimen type or ma- (B) The test manufacturer must pro- trix, unless a separate extraction study vide a carrier testing education module for the claimed sample type is per- to potential and actual test report re- formed. If the device is to be used at cipients. The module must define more than one laboratory, different terms that are used in the test reports laboratories must be included in the and explain the significance of carrier precision study (and reproducibility status. must be evaluated). The percentage of (C) The user study must meet the fol- ‘‘no calls’’ or invalid calls, if any, in lowing criteria:

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(1) The study participants must be (1) Results regarding reports that are comprised of a statistically justified provided for each gene/variant/eth- and demographically diverse popu- nicity tested. lation (determined using methods such (2) Statistical methods used to ana- as quota-based sampling) that is rep- lyze all data sets. resentative of the intended user popu- (3) Completion rate, non-responder lation. Furthermore, the users must be rate, and reasons for non-response/data comprised of a diverse range of age and exclusion, as well as a summary table educational levels that have no prior of comprehension rates regarding com- experience with the test or its manu- prehension concepts (purpose of test, facturer. These factors shall be well-de- test results, test limitations, ethnicity fined in the inclusion and exclusion relevance for the test results, etc.) for criteria. each study report. (2) All sources of bias (e.g., non-re- (4) Your 21 CFR 809.10 compliant la- sponders) must be predefined and ac- beling and any test report generated counted for in the study results with must include the following warning regard to both responders and non-re- and limitation statements, as applica- sponders. ble: (3) The testing must follow a format (i) A warning that reads ‘‘The test is where users have limited time to com- intended only for autosomal recessive plete the studies (such as an onsite sur- carrier screening in adults of reproduc- vey format and a one-time visit with a tive age.’’ cap on the maximum amount of time (ii) A statement accurately dis- that a participant has to complete the closing the genetic coverage of the test tests). in lay terms, including, as applicable, (4) Users must be randomly assigned information on variants not queried by to study arms. Test reports given to the test, and the proportion of incident users must: Define the condition being disease that is not related to the tested and related symptoms; explain gene(s) tested. For example, where ap- the intended use and limitations of the plicable, the statement would have to test; explain the relevant ethnicities include a warning that the test does regarding the variant tested; explain not or may not detect all genetic carrier status and relevance to the variants related to the genetic disease, user’s ethnicity; and provide links to and that the absence of a variant test- additional information pertaining to ed does not rule out the presence of situations where the user is concerned other genetic variants that may be dis- about their test results or would like ease-related. Or, where applicable, the followup information as indicated in statement would have to include a test labeling. The study shall assess warning that the basis for the disease participants’ ability to understand the for which the genetic carrier status is following comprehension concepts: The being tested is unknown or believed to test’s limitations, purpose, and results. be non-heritable in a substantial num- (5) Study participants must be un- ber of people who have the disease, and trained, naive to the test subject of the that a negative test result cannot rule study, and be provided only the mate- out the possibility that any offspring rials that will be available to them may be affected with the disease. The when the test is marketed. statement would have to include any (6) The user comprehension study other warnings needed to accurately must meet the predefined primary end- convey to consumers the degree to point criteria, including a minimum of which the test is informative for car- a 90 percent or greater overall com- rier status. prehension rate (i.e. selection of the (iii) For prescription use tests, the correct answer) for each comprehen- following warnings that read: sion concept to demonstrate that the (A) ‘‘The results of this test are in- education module and test reports are tended to be interpreted by a board- adequate for over-the-counter use. certified clinical molecular geneticist (D) A summary of the user com- or equivalent and should be used in prehension study must be provided and conjunction with other available lab- include the following: oratory and clinical information.’’

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(B) ‘‘This device is not intended for both PPA and NPA. Variants that have disease diagnosis, prenatal testing of a point estimate for PPA or NPA of fetuses, risk assessment, prognosis or less than 99 percent (incorrect test re- pre-symptomatic testing, suscepti- sults as compared to bidirectional se- bility testing, or newborn screening.’’ quencing or other methods identified (iv) For over-the-counter tests, a as appropriate by FDA) must not be in- statement that reads ‘‘This test is not corporated into test claims and re- intended to diagnose a disease, or tell ports. you anything about your risk for devel- (ii) Precision (reproducibility) per- oping a disease in the future. On its formance must meet or exceed 99 per- own, this test is also not intended to cent for both positive and negative re- tell you anything about the health of sults. your fetus, or your newborn child’s risk of developing a particular disease (iii) The user comprehension study later on in life.’’ must obtain values of 90 percent or (v) For over-the-counter tests, the greater user comprehension for each following warnings that read: comprehension concept. (A) ‘‘This test is not a substitute for (6) The distribution of this device, ex- visits to a healthcare provider. It is cluding the collection device described recommended that you consult with a in paragraph (b)(2) of this section, shall healthcare provider if you have any be limited to the manufacturer, the questions or concerns about your remanufacturer’s subsidiaries, and lab- sults.’’ oratories regulated under the Clinical (B) ‘‘The test does not diagnose any Laboratory Improvement Amend- health conditions. Results should be ments. used along with other clinical information for any medical purposes.’’ [80 FR 65630, Oct. 27, 2015] (C) ‘‘The laboratory may not be able to process your sample. The prob- Subpart G—Tumor Associated ability that the laboratory cannot Antigen immunological Test process your saliva sample can be up to Systems [actual probability percentage].’’ (D) ‘‘Your ethnicity may affect how § 866.6010 Tumor-associated antigen your genetic health results are inter- immunological test system. preted.’’ (a) Identification. A tumor-associated (vi) For a positive result in an over- the-counter test when the positive pre- antigen immunological test system is a dictive value for a specific population device that consists of reagents used to is less than 50 percent and more than 5 qualitatively or quantitatively meas- percent, a warning that reads ‘‘The ure, by immunochemical techniques, positive result you obtained may false- tumor-associated antigens in serum, ly identify you as a carrier. Consider plasma, urine, or other body fluids. genetic counseling and followup test- This device is intended as an aid in ing.’’ monitoring patients for disease (vii) For a positive result in an over- progress or response to therapy or for the-counter test when the positive pre- the detection of recurrent or residual dictive value for a specific population disease. is less than 5 percent, a warning that (b) Classification. Class II (special reads ‘‘The positive result you obtained controls). Tumor markers must comply is very likely to be incorrect due to the with the following special controls: (1) rarity of this variant. Consider genetic A guidance document entitled ‘‘Guid- counseling and followup testing.’’ ance Document for the Submission of (5) The testing done to comply with Tumor Associated Antigen Premarket paragraph (b)(3) of this section must Notifications (510(k)s) to FDA,’’ and (2) show the device meets or exceeds each voluntary assay performance standards of the following performance specifica- issued by the National Committee on tions: Clinical Laboratory Standards. (i) The accuracy must be shown to be equal to or greater than 99 percent for [62 FR 66005, Dec. 17, 1997]

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§ 866.6020 Immunomagnetic circu- § 866.6040 Gene expression profiling lating cancer cell selection and enu- test system for breast cancer prog- meration system. nosis. (a) Identification. An (a) Identification. A gene expression immunomagnetic circulating cancer profiling test system for breast cancer cell selection and enumeration system prognosis is a device that measures the is a device that consists of biological ribonucleic acid (RNA) expression level probes, fluorochromes, and other re- of multiple genes and combines this in- agents; preservation and preparation formation to yield a signature (pattern devices; and a semiautomated analyt- or classifier or index) to aid in prognosis of previously diagnosed breast ical instrument to select and count cir- cancer. culating cancer cells in a prepared (b) Classification. Class II (special sample of whole blood. This device is controls). The special control is FDA’s intended for adjunctive use in moni- guidance document entitled ‘‘Class II toring or predicting cancer disease pro- Special Controls Guidance Document: gression, response to therapy, and for Gene Expression Profiling Test System the detection of recurrent disease. for Breast Cancer Prognosis.’’ See (b) Classification. Class II (special § 866.1(e) for the availability of this controls). The special control for this guidance document. device is FDA’s guidance document en- [72 FR 26291, May 9, 2007] titled ‘‘Class II Special Controls Guid- ance Document: Immunomagnetic Cir- § 866.6050 Ovarian adnexal mass as- culating Cancer Cell Selection and sessment score test system. Enumeration System.’’ See § 866.1(e) for (a) Identification. An ovarian/adnexal availability of this guidance document. mass assessment test system is a de- [69 FR 26038, May 11, 2004] vice that measures one or more proteins in serum or plasma. It yields a § 866.6030 AFP-L3% immunological test single result for the likelihood that an system. adnexal pelvic mass in a woman, for whom surgery is planned, is malignant. (a) Identification. An AFP-L3% The test is for adjunctive use, in the immunological test system is an in context of a negative primary clinical vitro device that consists of reagents and radiological evaluation, to aug- and an automated instrument used to ment the identification of patients quantitatively measure, by whose gynecologic surgery requires on- immunochemical techniques, AFP and cology expertise and resources. AFP-L3 subfraction in human serum. (b) Classification. Class II (special The device is intended for in vitro diag- controls). The special control for this nostic use as an aid in the risk assess- device is FDA’s guidance document en- ment of patients with chronic liver dis- titled ‘‘Class II Special Controls Guid- ease for development of hepatocellular ance Document: Ovarian Adnexal Mass carcinoma, in conjunction with other Assessment Score Test System.’’ For laboratory findings, imaging studies, the availability of this guidance docu- and clinical assessment. ment, see § 866.1(e). (b) Classification. Class II (special (c) Black box warning. Under section controls). The special control is FDA’s 520(e) of the Federal Food, Drug, and guidance document entitled ‘‘Class II Cosmetic Act these devices are subject Special Controls Guidance Document: to the following restriction: A warning AFP-L3% Immunological Test Sys- statement must be placed in a black tems.’’ See § 866.1(e) for the availability box and must appear in all advertising, of this guidance document. labeling, and promotional material for these devices. That warning statement [70 FR 57749, Oct. 4, 2005] must read:

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[76 FR 16294, Mar. 23, 2011, as amended at 76 868.1890 Predictive pulmonary-function FR 82131, Dec. 30, 2011] value calculator. 868.1900 Diagnostic pulmonary-function interpretation calculator. PART 868—ANESTHESIOLOGY 868.1910 Esophageal stethoscope. DEVICES 868.1920 Esophageal stethoscope with electrical conductors. Subpart A—General Provisions 868.1930 Stethoscope head. 868.1965 Switching valve (ploss). Sec. 868.1975 Water vapor analyzer. 868.1 Scope. 868.3 Effective dates of requirement for pre- Subpart C—Monitoring Devices market approval. 868.9 Limitations of exemptions from sec- 868.2025 Ultrasonic air embolism monitor. tion 510(k) of the Federal Food, Drug, 868.2300 Bourdon gauge flowmeter. and Cosmetic Act (the act). 868.2320 Uncompensated thorpe tube flowmeter. Subpart B—Diagnostic Devices 868.2340 Compensated thorpe tube flowmeter. 868.1030 Manual algesimeter. 868.2350 Gas calibration flowmeter. 868.1040 Powered algesimeter. 868.2375 Breathing frequency monitor. 868.1075 Argon gas analyzer. 868.2377 Apnea monitor. 868.1100 Arterial blood sampling kit. 868.2380 Nitric oxide analyzer. 868.1120 Indwelling blood oxyhemoglobin 868.2385 Nitrogen dioxide analyzer. concentration analyzer. 868.2450 Lung water monitor. 868.1150 Indwelling blood carbon dioxide 868.2480 Cutaneous carbon dioxide (PcCO2) partial pressure (PCO2) analyzer. monitor. 868.1170 Indwelling blood hydrogen ion con- 868.2500 Cutaneous oxygen (PcO2) monitor. centration (pH) analyzer. 868.2550 Pneumotachometer. 868.1200 Indwelling blood oxygen partial 868.2600 Airway pressure monitor. pressure (PO2) analyzer. 868.2610 Gas pressure gauge. 868.1400 Carbon dioxide gas analyzer. 868.2620 Gas pressure calibrator. 868.1430 Carbon monoxide gas analyzer. 868.2700 Pressure regulator. 868.1500 Enflurane gas analyzer. 868.2775 Electrical peripheral nerve stimu- 868.1575 Gas collection vessel. lator. 868.1620 Halothane gas analyzer. 868.2875 Differential pressure transducer. 868.1640 Helium gas analyzer. 868.2885 Gas flow transducer. 868.1670 Neon gas analyzer. 868.2900 Gas pressure transducer. 868.1690 Nitrogen gas analyzer. 868.1700 Nitrous oxide gas analyzer. Subparts D–E [Reserved] 868.1720 Oxygen gas analyzer. 868.1730 Oxygen uptake computer. Subpart F—Therapeutic Devices 868.1750 Pressure plethysmograph. 868.1760 Volume plethysmograph. 868.5090 Emergency airway needle. 868.1780 Inspiratory airway pressure meter. 868.5100 Nasopharyngeal airway. 868.1800 Rhinoanemometer. 868.5110 Oropharyngeal airway. 868.1840 Diagnostic spirometer. 868.5115 Device to relieve acute upper air- 868.1850 Monitoring spirometer. way obstruction. 868.1860 Peak-flow meter for spirometry. 868.5120 Anesthesia conduction catheter. 868.1870 Gas volume calibrator. 868.5130 Anesthesia conduction filter. 868.1880 Pulmonary-function data calcu- 868.5140 Anesthesia conduction kit. lator. 868.5150 Anesthesia conduction needle.

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868.5160 Gas machine for anesthesia or anal- 868.5895 Continuous ventilator. gesia. 868.5905 Noncontinuous ventilator (IPPB). 868.5165 Nitric oxide administration appa- 868.5915 Manual emergency ventilator. ratus. 868.5925 Powered emergency ventilator. 868.5170 Laryngotracheal topical anesthesia 868.5935 External negative pressure venti- applicator. lator. 868.5180 Rocking bed. 868.5955 Intermittent mandatory ventila- 868.5220 Blow bottle. tion attachment. 868.5240 Anesthesia breathing circuit. 868.5965 Positive end expiratory pressure 868.5250 Breathing circuit circulator. breathing attachment. 868.5260 Breathing circuit bacterial filter. 868.5975 Ventilator tubing. 868.5270 Breathing system heater. 868.5995 Tee drain (water trap). 868.5280 Breathing tube support. 868.5300 Carbon dioxide absorbent. Subpart G—Miscellaneous 868.5310 Carbon dioxide absorber. 868.5320 Reservoir bag. 868.6100 Anesthetic cabinet, table, or tray. 868.5330 Breathing gas mixer. 868.6175 Cardiopulmonary emergency cart. 868.5340 Nasal oxygen cannula. 868.6225 Nose clip. 868.5350 Nasal oxygen catheter. 868.6250 Portable air compressor. 868.5365 Posture chair for cardiac or pul- 868.6400 Calibration gas. monary treatment. 868.6700 Anesthesia stool. 868.5375 Heat and moisture condenser (arti- 868.6810 Tracheobronchial suction catheter. ficial nose). 868.5400 Electroanesthesia apparatus. 868.6820 Patient position support. 868.5420 Ether hook. 868.6885 Medical gas yoke assembly. 868.5430 Gas-scavenging apparatus. AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 868.5440 Portable oxygen generator. 360j, 371. 868.5450 Respiratory gas humidifier. 868.5460 Therapeutic humidifier for home SOURCE: 47 FR 31142, July 16, 1982, unless use. otherwise noted. 868.5470 Hyperbaric chamber. EDITORIAL NOTE: Nomenclature changes to 868.5530 Flexible laryngoscope. part 868 appear at 73 FR 35341, June 23, 2008. 868.5540 Rigid laryngoscope. 868.5550 Anesthetic gas mask. 868.5560 Gas mask head strap. Subpart A—General Provisions 868.5570 Nonrebreathing mask. 868.5580 Oxygen mask. § 868.1 Scope. 868.5590 Scavenging mask. 868.5600 Venturi mask. (a) This part sets forth the classifica- 868.5620 Breathing mouthpiece. tion of anesthesiology devices intended 868.5630 Nebulizer. for human use that are in commercial 868.5640 Medicinal nonventilatory nebulizer distribution. (atomizer). (b) The identification of a device in a 868.5650 Esophageal obturator. regulation in this part is not a precise 868.5655 Portable liquid oxygen unit. description of every device that is, or 868.5665 Powered percussor. 868.5675 Rebreathing device. will be, subject to the regulation. A 868.5690 Incentive spirometer. manufacturer who submits a pre- 868.5700 Nonpowered oxygen tent. market notification submission for a 868.5710 Electrically powered oxygen tent. device under part 807 may not show 868.5720 Bronchial tube. merely that the device is accurately 868.5730 Tracheal tube. described by the section title and iden- 868.5740 Tracheal/bronchial differential ven- tification provisions of a regulation in tilation tube. this part, but shall state why the de- 868.5750 Inflatable tracheal tube cuff. 868.5760 Cuff spreader. vice is substantially equivalent to 868.5770 Tracheal tube fixation device. other devices, as required by § 807.87. 868.5780 Tube introduction forceps. (c) To avoid duplicative listings, an 868.5790 Tracheal tube stylet. anesthesiology device that has two or 868.5795 Tracheal tube cleaning brush. more types of uses (e.g., used both as a 868.5800 Tracheostomy tube and tube cuff. diagnostic device and as a therapeutic 868.5810 Airway connector. device) is listed only in one subpart. 868.5820 Dental protector. 868.5830 Autotransfusion apparatus. (d) References in this part to regu- 868.5860 Pressure tubing and accessories. latory sections of the Code of Federal 868.5870 Nonrebreathing valve. Regulations are to chapter I of title 21, 868.5880 Anesthetic vaporizer. unless otherwise noted.

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(e) Guidance documents referenced in cial distribution on or after May 28, this part are available on the Internet 1976, including a device formerly mar- at http://www.fda.gov/MedicalDevices/ keted that has been substantially al- DeviceRegulationandGuidance/ tered, is classified by statute (section GuidanceDocuments/default.htm. 513(f) of the act) into class III without [52 FR 17734, May 11, 1987, as amended at 67 any grace period and FDA must have FR 76681, Dec. 13, 2002; 78 FR 18233, Mar. 26, issued an order approving a PMA or de- 2013] claring completed a PDP for the device before the device is commercially dis- § 868.3 Effective dates of requirement tributed unless it is reclassified. If for premarket approval. FDA knows that a device being com- A device included in this part that is mercially distributed may be a ‘‘new’’ classified into class III (premarket ap- device as defined in this section be- proval) shall not be commercially dis- cause of any new intended use or other tributed after the date shown in the reasons, FDA may codify the statutory regulation classifying the device unless classification of the device into class the manufacturer has an approval III for such new use. Accordingly, the under section 515 of the act (unless an regulation for such a class III device exemption has been granted under sec- states that as of the enactment date of tion 520(g)(2) of the act). An approval the amendments, May 28, 1976, the de- under section 515 of the act consists of vice must have an approval under sec- FDA’s issuance of an order approving tion 515 of the act before commercial an application for premarket approval distribution. (PMA) for the device or declaring completed a product development protocol [52 FR 17734, May 11, 1987] (PDP) for the device. (a) Before FDA requires that a device § 868.9 Limitations of exemptions from commercially distributed before the section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). enactment date of the amendments, or a device that has been found substan- The exemption from the requirement tially equivalent to such a device, has of premarket notification (section an approval under section 515 of the act 510(k) of the act) for a generic type of FDA must promulgate a regulation class I or II device is only to the extent under section 515(b) of the act requir- that the device has existing or reason- ing such approval, except as provided ably foreseeable characteristics of in paragraph (b) of this section. Such a commercially distributed devices with- regulation under section 515(b) of the in that generic type or, in the case of act shall not be effective during the in vitro diagnostic devices, only to the grace period ending on the 90th day extent that misdiagnosis as a result of after its promulgation or on the last using the device would not be associ- day of the 30th full calendar month ated with high morbidity or mortality. after the regulation that classifies the Accordingly, manufacturers of any device into class III is effective, which- commercially distributed class I or II ever is later. See section 501(f)(2)(B) of device for which FDA has granted an the act. Accordingly, unless an effec- exemption from the requirement of tive date of the requirement for pre- premarket notification must still sub- market approval is shown in the regu- mit a premarket notification to FDA lation for a device classified into class before introducing or delivering for in- III in this part, the device may be com- troduction into interstate commerce mercially distributed without FDA’s for commercial distribution the device issuance of an order approving a PMA when: or declaring completed a PDP for the (a) The device is intended for a use device. If FDA promulgates a regula- different from the intended use of a le- tion under section 515(b) of the act re- gally marketed device in that generic quiring premarket approval for a de- type of device; e.g., the device is in- vice, section 501(f)(1)(A) of the act ap- tended for a different medical purpose, plies to the device. or the device is intended for lay use (b) Any new, not substantially equiv- where the former intended use was by alent, device introduced into commer- health care professionals only;

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(b) The modified device operates (b) Classification. Class I (general con- using a different fundamental sci- trols). The device is exempt from the entific technology than a legally mar- premarket notification procedures in keted device in that generic type of de- subpart E of part 807 of this chapter vice; e.g., a surgical instrument cuts subject to the limitations in § 868.9. The tissue with a laser beam rather than device is also exempt from the current with a sharpened metal blade, or an in good manufacturing practice require- vitro diagnostic device detects or iden- ments of the quality system regulation tifies infectious agents by using in part 820 of this chapter, with the ex- deoxyribonucleic acid (DNA) probe or ception of § 820.180, with respect to gen- nucleic acid hybridization technology eral requirements concerning records, rather than culture or immunoassay and § 820.198, with respect to complaint technology; or files. (c) The device is an in vitro device that is intended: [54 FR 25048, June 12, 1989, as amended at 66 (1) For use in the diagnosis, moni- FR 38793, July 25, 2001] toring, or screening of neoplastic diseases with the exception of § 868.1040 Powered algesimeter. immunohistochemical devices; (a) Identification. A powered algesim- (2) For use in screening or diagnosis eter is a device using electrical stimu- of familial or acquired genetic dis- lation intended to determine a pa- orders, including inborn errors of me- tient’s sensitivity to pain after admin- tabolism; istration of an anesthetic agent. (3) For measuring an analyte that (b) Classification. Class II (perform- serves as a surrogate marker for ance standards). screening, diagnosis, or monitoring life-threatening diseases such as ac- § 868.1075 Argon gas analyzer. quired immune deficiency syndrome (a) Identification. An argon gas ana- (AIDS), chronic or active hepatitis, tu- lyzer is a device intended to measure berculosis, or myocardial infarction or the concentration of argon in a gas to monitor therapy; (4) For assessing the risk of cardio- mixture to aid in determining the pa- vascular diseases; tient’s ventilatory status. The device (5) For use in diabetes management; may use techniques such as mass spec- (6) For identifying or inferring the trometry or thermal conductivity. identity of a microorganism directly (b) Classification. Class II (perform- from clinical material; ance standards). (7) For detection of antibodies to microorganisms other than § 868.1100 Arterial blood sampling kit. immunoglobulin G (IgG) or IgG assays (a) Identification. An arterial blood when the results are not qualitative, or sampling kit is a device, in kit form, are used to determine immunity, or the used to obtain arterial blood samples assay is intended for use in matrices from a patient for blood gas determina- other than serum or plasma; tions. The kit may include a syringe, (8) For noninvasive testing as defined needle, cork, and heparin. in § 812.3(k) of this chapter; and (b) Classification. Class I (general con- (9) For near patient testing (point of trols). The device is exempt from the care). premarket notification procedures in [65 FR 2313, Jan. 14, 2000] subpart E of part 807 of this chapter subject to the limitations in § 868.9. Subpart B—Diagnostic Devices [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, § 868.1030 Manual algesimeter. 2001] (a) Identification. A manual algesimeter is a mechanical device intended to § 868.1120 Indwelling blood determine a patient’s sensitivity to oxyhemoglobin concentration ana- pain after administration of an anes- lyzer. thetic agent, e.g., by pricking with a (a) Identification. An indwelling blood sharp point. oxyhemoglobin concentration analyzer

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is a photoelectric device used to meas- to measure, in vivo, the hydrogen ion ure, in vivo, the oxygen-carrying ca- concentration (pH) in blood to aid in pacity of hemoglobin in blood to aid in determining the patient’s acid-base determining the patient’s physiological balance. status. (b) Classification. Class II (special (b) Classification. Class III (premarket controls). The special control for this approval). device is FDA’s ‘‘Class II Special Con- (c) Date PMA or notice of completion trols Guidance Document: Indwelling of PDP is required. A PMA or notice of Blood Gas Analyzers; Final Guidance completion of a PDP is required to be for Industry and FDA.’’ filed with the Food and Drug Adminis- tration on or before September 21, 2004, [47 FR 31142, July 16, 1982, as amended at 52 for any indwelling blood FR 17735, May 11, 1987; 66 FR 57368, Nov. 15, 2001] oxyhemoglobin concentration analyzer that was in commercial distribution § 868.1200 Indwelling blood oxygen before May 28, 1976, or that has, on or partial pressure (PO2) analyzer. before September 21, 2004, been found to be substantially equivalent to an in- (a) Identification. An indwelling blood dwelling blood oxyhemoglobin con- oxygen partial pressure (PO2) analyzer centration analyzer that was in com- is a device that consists of a catheter- mercial distribution before May 28, tip PO2 transducer (e.g., PO2 electrode) 1976. Any other indwelling blood and that is used to measure, in vivo, oxyhemoglobin concentration analyzer the partial pressure of oxygen in blood shall have an approved PMA or de- to aid in determining the patient’s cir- clared completed PDP in effect before culatory, ventilatory, and metabolic being placed in commercial distribu- status. tion. (b) Classification. Class II (special controls). The special control for this [47 FR 31142, July 16, 1982, as amended at 52 device is FDA’s ‘‘Class II Special Con- FR 17735, May 11, 1987; 52 FR 22577, June 12, trols Guidance Document: Indwelling 1987; 69 FR 34920, June 23, 2004] Blood Gas Analyzers; Final Guidance § 868.1150 Indwelling blood carbon di- for Industry and FDA.’’ oxide partial pressure (PCO2) ana- [47 FR 31142, July 16, 1982; 47 FR 40410, Sept. lyzer. 14, 1982, as amended at 52 FR 17735, May 11, (a) Identification. An indwelling blood 1987; 66 FR 57368, Nov. 15, 2001] carbon dioxide partial pressure PCO2 analyzer is a device that consists of a § 868.1400 Carbon dioxide gas analyzer. catheter-tip PCO2 transducer (e.g., PCO2 electrode) and that is used to measure, (a) Identification. A carbon dioxide in vivo, the partial pressure of carbon gas analyzer is a device intended to dioxide in blood to aid in determining measure the concentration of carbon the patient’s circulatory, ventilatory, dioxide in a gas mixture to aid in de- and metabolic status. termining the patient’s ventilatory, (b) Classification. Class II (special circulatory, and metabolic status. The controls). The special control for this device may use techniques such as device is FDA’s ‘‘Class II Special Con- chemical titration, absorption of infra- trols Guidance Document: Indwelling red radiation, gas chromatography, or Blood Gas Analyzers; Final Guidance mass spectrometry. for Industry and FDA.’’ (b) Classification. Class II (perform- [47 FR 31142, July 16, 1982; 47 FR 40410, Sept. ance standards). 14, 1982, as amended at 52 FR 17735, May 11, 1987; 66 FR 57368, Nov. 15, 2001] § 868.1430 Carbon monoxide gas analyzer. § 868.1170 Indwelling blood hydrogen (a) Identification. A carbon monoxide ion concentration (pH) analyzer. gas analyzer is a device intended to (a) Identification. An indwelling blood measure the concentration of carbon hydrogen ion concentration (pH) ana- monoxide in a gas mixture to aid in de- lyzer is a device that consists of a cath- termining the patient’s ventilatory eter-tip pH electrode and that is used status. The device may use techniques

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such as infrared absorption or gas chro- § 868.1690 Nitrogen gas analyzer. matography. (b) Classification. Class II (perform- (a) Identification. A nitrogen gas ana- ance standards). lyzer is a device intended to measure the concentration of nitrogen in res- § 868.1500 Enflurane gas analyzer. piratory gases to aid in determining a (a) Identification. An enflurane gas patient’s ventilatory status. The device analyzer is a device intended to meas- may use techniques such as gas chro- ure the concentration of enflurane an- matography or mass spectrometry. esthetic in a gas mixture. (b) Classification. Class II (perform- (b) Classification. Class II (performance standards). ance standards). § 868.1700 Nitrous oxide gas analyzer. § 868.1575 Gas collection vessel. (a) Identification. A nitrous oxide gas (a) Identification. A gas collection analyzer is a device intended to meas- vessel is a container-like device in- ure the concentration of nitrous oxide tended to collect a patient’s exhaled anesthetic in a gas mixture. The device gases for subsequent analysis. It does may use techniques such as infrared not include a sampling pump. absorption or mass spectrometry. (b) Classification. Class I (general con- (b) Classification. Class II (perform- trols). The device is exempt from the ance standards). premarket notification procedures in subpart E of part 807 of this chapter § 868.1720 Oxygen gas analyzer. subject to the limitations in § 868.9. (a) Identification. An oxygen gas ana- [47 FR 31142, July 16, 1982, as amended at 61 lyzer is a device intended to measure FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, the concentration of oxygen in res- 2001] piratory gases by techniques such as § 868.1620 Halothane gas analyzer. mass spectrometry, polarography, thermal conductivity, or gas chroma- (a) Identification. A halothane gas an- tography. This generic type of device alyzer is a device intended to measure the concentration of halothane anes- also includes paramagnetic analyzers. thetic in a gas mixture. The device (b) Classification. Class II (perform- may use techniques such as mass spec- ance standards). trometry or absorption of infrared or ultraviolet radiation. § 868.1730 Oxygen uptake computer. (b) Classification. Class II (perform- (a) Identification. An oxygen uptake ance standards). computer is a device intended to compute the amount of oxygen consumed § 868.1640 Helium gas analyzer. by a patient and may include compo- (a) Identification. A helium gas ana- nents for determining expired gas vol- lyzer is a device intended to measure ume and composition. the concentration of helium in a gas (b) Classification. Class II (perform- mixture during pulmonary function ance standards). testing. The device may use techniques such as thermal conductivity, gas chro- § 868.1750 Pressure plethysmograph. matography, or mass spectrometry. (a) Identification. A pressure (b) Classification. Class II (perform- plethysmograph is a device used to de- ance standards). termine a patient’s airway resistance § 868.1670 Neon gas analyzer. and lung volumes by measuring pressure changes while the patient is in an (a) Identification. A neon gas analyzer airtight box. is a device intended to measure the concentration of neon in a gas mixture (b) Classification. Class II (perform- exhaled by a patient. The device may ance standards). use techniques such as mass spectrometry or thermal conductivity. § 868.1760 Volume plethysmograph. (b) Classification. Class II (perform- (a) Identification. A volume ance standards). plethysmograph is an airtight box, in

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which a patient sits, that is used to de- medical purposes and that is used to termine the patient’s lung volume calibrate the output of gas volume changes. measurement instruments by deliv- (b) Classification. Class II (perform- ering a known gas volume. ance standards). (b) Classification. Class I (general controls). The device is exempt from the § 868.1780 Inspiratory airway pressure premarket notification procedures in meter. subpart E of part 807 of this chapter (a) Identification. An inspiratory air- subject to the limitations in § 868.9. way pressure meter is a device used to measure the amount of pressure pro- [47 FR 31142, July 16, 1982, as amended at 61 duced in a patient’s airway during FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, 2001] maximal inspiration. (b) Classification. Class II (perform- § 868.1880 Pulmonary-function data ance standards). calculator. § 868.1800 Rhinoanemometer. (a) Identification. A pulmonary-func- (a) Identification. A rhinoanemometer tion data calculator is a device used to is a device used to quantify the amount calculate pulmonary-function values of nasal congestion by measuring the based on actual physical data obtained airflow through, and differential pres- during pulmonary-function testing. sure across, a patient’s nasal passages. (b) Classification. Class II (perform- (b) Classification. Class II (performance standards). ance standards). § 868.1890 Predictive pulmonary-func- § 868.1840 Diagnostic spirometer. tion value calculator. (a) Identification. A diagnostic spi- (a) Identification. A predictive pul- rometer is a device used in pulmonary monary-function value calculator is a function testing to measure the volume device used to calculate normal pul- of gas moving in or out of a patient’s monary-function values based on em- lungs. pirical equations. (b) Classification. Class II (perform- (b) Classification. Class II (performance standards). ance standards).

§ 868.1850 Monitoring spirometer. § 868.1900 Diagnostic pulmonary-func- (a) Identification. A monitoring spi- tion interpretation calculator. rometer is a device used to measure (a) Identification. A diagnostic pul- continuously a patient’s tidal volume monary-function interpretation calcu- (volume of gas inhaled by the patient lator is a device that interprets pul- during each respiration cycle) or monary study data to determine clin- minute volume (the tidal volume mul- ical significance of pulmonary-function tiplied by the rate of respiration for 1 values. minute) for the evaluation of the pa- (b) Classification. Class II (perform- tient’s ventilatory status. ance standards). (b) Classification. Class II (performance standards). § 868.1910 Esophageal stethoscope. § 868.1860 Peak-flow meter for (a) Identification. An esophageal spirometry. stethoscope is a nonpowered device that is inserted into a patient’s esoph- (a) Identification. A peak-flow meter agus to enable the user to listen to for spirometry is a device used to heart and breath sounds. measure a patient’s maximum ventilatory flow rate. (b) Classification. Class I (general con- (b) Classification. Class II (perform- trols). The device is exempt from the ance standards). premarket notification procedures in subpart E of part 807 of this chapter § 868.1870 Gas volume calibrator. subject to § 868.9. (a) Identification. A gas volume cali- [47 FR 31142, July 16, 1982, as amended at 65 brator is a device that is intended for FR 2313, Jan. 14, 2000]

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§ 868.1920 Esophageal stethoscope the concentration of water vapor in a with electrical conductors. patient’s expired gases by using tech- (a) Identification. An esophageal niques such as mass spectrometry. stethoscope with electrical conductors (b) Classification. Class I (general con- is a device that is inserted into the trols). The device is exempt from the esophagus to listen to a patient’s heart premarket notification procedures in and breath sounds and to monitor subpart E of part 807 of this chapter electrophysiological signals. The de- subject to the limitations in § 868.9. vice may also incorporate a thermistor for temperature measurement. [47 FR 31142, July 16, 1982, as amended at 61 FR 1119, Jan. 16, 1996; 66 FR 38793, July 25, (b) Classification. Class II (perform- 2001] ance standards).

§ 868.1930 Stethoscope head. Subpart C—Monitoring Devices (a) Identification. A stethoscope head is a weighted chest piece used during § 868.2025 Ultrasonic air embolism monitor. anesthesia to listen to a patient’s heart, breath, and other physiological (a) Identification. An ultrasonic air sounds. embolism monitor is a device used to (b) Classification. Class I (general con- detect air bubbles in a patient’s blood trols). The device is exempt from the stream. It may use Doppler or other ul- premarket notification procedures in trasonic principles. subpart E of part 807 of this chapter (b) Classification. Class II (perform- subject to the limitations in § 868.9. ance standards). [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38793, July 25, § 868.2300 Bourdon gauge flowmeter. 2001] (a) Identification. A bourdon gauge flowmeter is a device intended for med- § 868.1965 Switching valve (ploss). ical purposes that is used in conjunc- (a) Identification. A switching valve tion with respiratory equipment to (ploss) is a three-way valve located be- sense gas pressure. The device is cali- tween a stethoscope placed over the brated to indicate gas flow rate when heart, a blood pressure cuff, and an ear- the outflow is open to the atmosphere. piece. The valve allows the user to (b) Class I (general con- eliminate one sound channel and listen Classification. only to a patient’s heart or korotkoff trols). The device is exempt from the (blood pressure) sounds through the premarket notification procedures in other channel. subpart E of part 807 of this chapter (b) Classification. Class I (general con- subject to the limitations in § 868.9. trols). The device is exempt from the [47 FR 31142, July 16, 1982, as amended at 61 premarket notification procedures in FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, subpart E of part 807 of this chapter 2001] subject to the limitations in § 868.9. The device is also exempt from the current § 868.2320 Uncompensated thorpe tube good manufacturing practice require- flowmeter. ments of the quality system regulation (a) Identification. An uncompensated in part 820 of this chapter, with the ex- thorpe tube flowmeter is a device in- ception of § 820.180, with respect to gen- tended for medical purposes that is eral requirements concerning records, used to indicate and control gas flow and § 820.198, with respect to complaint rate accurately. The device includes a files. vertically mounted tube and is cali- [47 FR 31142, July 16, 1982, as amended at 54 brated when the outlet of the flow- FR 25048, June 12, 1989; 66 FR 38793, July 25, meter is open to the atmosphere. 2001] (b) Classification. Class I (general con- § 868.1975 Water vapor analyzer. trols). The device is exempt from the premarket notification procedures in (a) Identification. A water vapor analyzer is a device intended to measure

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subpart E of part 807 of this chapter § 868.2377 Apnea monitor. subject to the limitations in § 868.9. (a) Identification. An apnea monitor is [47 FR 31142, July 16, 1982, as amended at 61 a complete system intended to alarm FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, primarily upon the cessation of breath- 2001] ing timed from the last detected breath. The apnea monitor also in- § 868.2340 Compensated thorpe tube cludes indirect methods of apnea detec- flowmeter. tion such as monitoring of heart rate (a) Identification. A compensated and other physiological parameters thorpe tube flowmeter is a device in- linked to the presence or absence of tended for medical purposes that is adequate respiration. used to control and measure gas flow (b) Classification. Class II (special rate accurately. The device includes a controls). The special control for this vertically mounted tube, with the out- device is the FDA guidance document let of the flowmeter calibrated to a ref- entitled ‘‘Class II Special Controls erence pressure. Guidance Document: Apnea Monitors; (b) Classification. Class I (general con- Guidance for Industry and FDA.’’ trols). The device is exempt from the [67 FR 46852, July 17, 2002] premarket notification procedures in subpart E of part 807 of this chapter § 868.2380 Nitric oxide analyzer. subject to the limitations in § 868.9. (a) Identification. The nitric oxide an- [47 FR 31142, July 16, 1982, as amended at 61 alyzer is a device intended to measure FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, the concentration of nitric oxide in res- 2001] piratory gas mixtures during administration of nitric oxide. § 868.2350 Gas calibration flowmeter. (b) Classification. Class II. The special (a) Identification. A gas calibration control for this device is FDA’s ‘‘Guid- flowmeter is a device intended for med- ance Document for Premarket Notifi- ical purposes that is used to calibrate cation Submissions for Nitric Oxide flowmeters and accurately measure gas Administration Apparatus, Nitric flow. Oxide Analyzer, and Nitrogen Dioxide (b) Classification. Class I (general con- Analyzer.’’ trols). The device is exempt from the [65 FR 14465, Mar. 3, 2000] premarket notification procedures in subpart E of part 807 of this chapter § 868.2385 Nitrogen dioxide analyzer. subject to the limitations in § 868.9. (a) Identification. The nitrogen diox- [47 FR 31142, July 16, 1982, as amended at 61 ide analyzer is a device intended to FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, measure the concentration of nitrogen 2001] dioxide in respiratory gas mixtures during administration of nitric oxide. § 868.2375 Breathing frequency mon- (b) Classification. Class II. The special itor. control for this device is FDA’s ‘‘Guid- (a) Identification. A breathing (venti- ance Document for Premarket Notifi- latory) frequency monitor is a device cation Submissions for Nitric Oxide intended to measure or monitor a pa- Administration Apparatus, Nitric tient’s respiratory rate. The device Oxide Analyzer, and Nitrogen Dioxide may provide an audible or visible Analyzer.’’ alarm when the respiratory rate, aver- [65 FR 11465, Mar. 3, 2000] aged over time, is outside operator settable alarm limits. This device does § 868.2450 Lung water monitor. not include the apnea monitor classi- (a) Identification. A lung water mon- fied in § 868.2377. itor is a device used to monitor the (b) Class II (perform- Classification. trend of fluid volume changes in a pa- ance standards). tient’s lung by measuring changes in [47 FR 31142, July 16, 1982, as amended at 67 thoracic electrical impedance (resist- FR 46852, July 17, 2002] ance to alternating current) by means

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of electrodes placed on the patient’s trols Guidance Document: Cutaneous chest. Carbon Dioxide (PcCO2) and Oxygen (b) Classification. Class III (premarket (PcO2) Monitors; Guidance for Industry approval). and FDA.’’ See § 868.1(e) for the avail- (c) Date PMA or notice of completion of ability of this guidance document. a PDP is required. A PMA or a notice of [67 FR 76681, Dec. 13, 2002] completion of a PDP for a device is required to be filed with the Food and § 868.2550 Pneumotachometer. Drug Administration on or before July 12, 2000, for any lung water monitor (a) Identification. A that was in commercial distribution pneumotachometer is a device intended before May 28, 1976, or that has, on or for medical purposes that is used to de- before July 12, 2000, been found to be termine gas flow by measuring the substantially equivalent to a lung pressure differential across a known re- water monitor that was in commercial sistance. The device may use a set of distribution before May 28, 1976. Any capillaries or a metal screen for the re- other lung water monitor device shall sistive element. have an approved PMA or declared (b) Classification. Class II (perform- completed PDP in effect before being ance standards). placed in commercial distribution. § 868.2600 Airway pressure monitor. [47 FR 31142, July 16, 1982, as amended at 52 (a) Identification. An airway pressure FR 17735, May 11, 1987; 65 FR 19834, Apr. 13, monitor is a device used to measure 2000] the pressure in a patient’s upper air- § 868.2480 Cutaneous carbon dioxide way. The device may include a pressure (PcCO2) monitor. gauge and an alarm. (a) Identification. A cutaneous carbon (b) Classification. Class II (perform- dioxide (PcCO2) monitor is a ance standards). noninvasive heated sensor and a pH- § 868.2610 Gas pressure gauge. sensitive glass electrode placed on a patient’s skin, which is intended to (a) Identification. A gas pressure monitor relative changes in a gauge (e.g., bourdon tube pressure hemodynamically stable patient’s cu- gauge) is a device intended for medical taneous carbon dioxide tension as an purposes that is used to measure gas adjunct to arterial carbon dioxide ten- pressure in a medical gas delivery sys- sion measurement. tem. (b) Classification. Class II (special (b) Classification. Class I (general con- controls). The special control for this trols). The device is exempt from the device is FDA’s ‘‘Class II Special Con- premarket notification procedures in trols Guidance Document: Cutaneous subpart E of part 807 of this chapter Carbon Dioxide (PcCO2) and Oxygen subject to the limitations in § 868.9. (PcO2) Monitors; Guidance for Industry [47 FR 31142, July 16, 1982, as amended at 61 and FDA.’’ See § 868.1(e) for the avail- FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, ability of this guidance document. 2001]

[54 FR 27160, June 28, 1989, as amended at 67 § 868.2620 Gas pressure calibrator. FR 76681, Dec. 13, 2002] (a) Identification. A gas pressure cali- § 868.2500 Cutaneous oxygen (PcO2) brator is a device intended for medical monitor. purposes that is used to calibrate pres- (a) Identification. A cutaneous oxygen sure-measuring instruments by gener- (PcO2) monitor is a noninvasive, heat- ating a known gas pressure. ed sensor (e.g., a Clark-type (b) Classification. Class I (general con- polargraphic electrode) placed on the trols). The device is exempt from the patient’s skin that is intended to mon- premarket notification procedures in itor relative changes in the cutaneous subpart E of part 807 of this chapter oxygen tension. subject to the limitations in § 868.9. (b) Classification. Class II (special [47 FR 31142, July 16, 1982, as amended at 61 controls). The special control for this FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, device is FDA’s ‘‘Class II Special Con- 2001]

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§ 868.2700 Pressure regulator. (b) Classification. Class I (general controls). The device is exempt from the (a) Identification. A pressure regu- premarket notification procedures in lator is a device, often called a pres- subpart E of part 807 of this chapter sure-reducing valve, that is intended subject to the limitations in § 868.9. for medical purposes and that is used to convert a medical gas pressure from [47 FR 31142, July 16, 1982, as amended at 61 a high variable pressure to a lower, FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, more constant working pressure. This 2001] device includes mechanical oxygen reg- § 868.2900 Gas pressure transducer. ulators. (b) Classification. Class I (general con- (a) Identification. A gas pressure trols). The device is exempt from the transducer is a device intended for medical purposes that is used to con- premarket notification procedures in vert gas pressure into an electrical sig- subpart E of part 807 of this chapter nal for subsequent display or proc- subject to the limitations in § 868.9. essing. [47 FR 31142, July 16, 1982, as amended at 61 (b) Classification. Class I. The device FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, is exempt from the premarket notifica- 2001] tion procedures in subpart E of part 807 of this chapter. § 868.2775 Electrical peripheral nerve stimulator. [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996] (a) Identification. An electrical peripheral nerve stimulator (neuro- Subparts D–E Reserved muscular blockade monitor) is a device [ ] used to apply an electrical current to a patient to test the level of pharma- Subpart F—Therapeutic Devices cological effect of anesthetic drugs and § 868.5090 Emergency airway needle. gases. (b) Classification. Class II (perform- (a) Identification. An emergency air- ance standards). way needle is a device intended to puncture a patient’s cricothyroid mem- § 868.2875 Differential pressure trans- brane to provide an emergency airway ducer. during upper airway obstruction. (b) Classification. Class II (perform- (a) Identification. A differential pres- ance standards). sure transducer is a two-chambered device intended for medical purposes that § 868.5100 Nasopharyngeal airway. is often used during pulmonary func- (a) Identification. A nasopharyngeal tion testing. It generates an electrical airway is a device used to aid breathing signal for subsequent display or proc- by means of a tube inserted into a pa- essing that is proportional to the dif- tient’s pharynx through the nose to ference in gas pressures in the two provide a patent airway. chambers. (b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to the limitations in § 868.9. subject to the limitations in § 868.9. [47 FR 31142, July 16, 1982, as amended at 61 [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, FR 1119, Jan. 16, 1996; 66 FR 38794, July 25, 2001] 2001] § 868.5110 Oropharyngeal airway. § 868.2885 Gas flow transducer. (a) Identification. An oropharyngeal (a) Identification. A gas flow trans- airway is a device inserted into a pa- ducer is a device intended for medical tient’s pharynx through the mouth to purposes that is used to convert gas provide a patent airway. flow rate into an electrical signal for (b) Classification. Class I (general con- subsequent display or processing. trols). The device is exempt from the

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premarket notification procedures in § 868.5150 Anesthesia conduction nee- subpart E of part 807 of this chapter dle. subject to the limitations in § 868.9. (a) Identification. An anesthesia con- [47 FR 31142, July 16, 1982, as amended at 61 duction needle is a device used to in- FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, ject local anesthetics into a patient to 2001] provide regional anesthesia. (b) Classification. Class II (perform- § 868.5115 Device to relieve acute ance standards). upper airway obstruction. (a) Identification. The device is a § 868.5160 Gas machine for anesthesia or analgesia. raised, rounded pad that, in the event of choking on a foreign body, can be (a) Gas machine for anesthesia—(1) applied to the abdomen and pushed up- Identification. A gas machine for anes- ward to generate expulsion pressure to thesia is a device used to administer to remove the obstruction to relieve acute a patient, continuously or intermit- upper airway obstruction. tently, a general inhalation anesthetic and to maintain a patient’s ventila- (b) Classification. Class II (special tion. The device may include a gas controls) (‘‘Class II Special Control flowmeter, vaporizer, ventilator, Guidance Document for Acute Upper breathing circuit with bag, and emer- Airway Obstruction Devices’’). The de- gency air supply. vice is exempt from the premarket no- (2) Classification. Class II (perform- tification procedures in subpart E of ance standards). part 807 of this chapter, subject to (b) Gas machine for analgesia—(1) § 868.9. Identification. A gas machine for anal- [65 FR 39099, June 23, 2000; 65 FR 47669, Aug. gesia is a device used to administer to 3, 2000] a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (max- § 868.5120 Anesthesia conduction cath- imum concentration of 70 percent ni- eter. trous oxide). (a) Identification. An anesthesia con- (2) Classification. Class II (perform- duction catheter is a flexible tubular ance standards). device used to inject local anesthetics § 868.5165 Nitric oxide administration into a patient and to provide contin- apparatus. uous regional anesthesia. (a) Identification. The nitric oxide ad- (b) Classification. Class II (perform- ministration apparatus is a device used ance standards). to add nitric oxide to gases that are to be breathed by a patient. The nitric § 868.5130 Anesthesia conduction filter. oxide administration apparatus is to be used in conjunction with a ventilator (a) Identification. An anesthesia con- or other breathing gas administration duction filter is a microporous filter system. used while administering to a patient (b) Classification. Class II. The special injections of local anesthetics to mini- control for this device is FDA’s ‘‘Guid- mize particulate (foreign material) ance Document for Premarket Notifi- contamination of the injected fluid. cation Submissions for Nitric Oxide (b) Classification. Class II (perform- Administration Apparatus, Nitric ance standards). Oxide Analyzer, and Nitrogen Dioxide Analyzer.’’ § 868.5140 Anesthesia conduction kit. [65 FR 11465, Mar. 3, 2000] (a) Identification. An anesthesia conduction kit is a device used to admin- § 868.5170 Laryngotracheal topical an- ister to a patient conduction, regional, esthesia applicator. or local anesthesia. The device may (a) Identification. A laryngotracheal contain syringes, needles, and drugs. topical anesthesia applicator is a de- (b) Classification. Class II (perform- vice used to apply topical anesthetics ance standards). to a patient’s laryngotracheal area.

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(b) Classification. Class II (perform- § 868.5250 Breathing circuit circulator. ance standards). (a) Identification. A breathing circuit § 868.5180 Rocking bed. circulator is a turbine device that is attached to a closed breathing circuit (a) Identification. A rocking bed is a and that is intended to circulate anes- device intended for temporary use to thetic gases continuously by maintain- help patient ventilation (breathing) by ing the unidirectional valves in an repeatedly tilting the patient, thereby open position and reducing mechanical using the weight of the abdominal con- dead space and resistance in the tents to move the diaphragm. breathing circuit. (b) Classification. Class II (perform- (b) Classification. Class II (performance standards). ance standards).

§ 868.5220 Blow bottle. § 868.5260 Breathing circuit bacterial (a) Identification. A blow bottle is a filter. device that is intended for medical pur- (a) Identification. A breathing circuit poses to induce a forced expiration bacterial filter is a device that is in- from a patient. The patient blows into tended to remove microbiological and the device to move a column of water particulate matter from the gases in from one bottle to another. the breathing circuit. (b) Classification. Class I (general con- (b) Classification. Class II (perform- trols). The device is exempt from the ance standards). premarket notification procedures in subpart E of part 807 of this chapter § 868.5270 Breathing system heater. subject to the limitations in § 868.9. If (a) Identification. A breathing system the device is not labeled or otherwise heater is a device that is intended to represented as sterile, it is exempt warm breathing gases before they enter from the current good manufacturing a patient’s airway. The device may in- practice requirements of the quality clude a temperature controller. system regulation in part 820 of this (b) Classification. Class II (perform- chapter, with the exception of § 820.180, ance standards). with respect to general requirements concerning records, and § 820.198, with § 868.5280 Breathing tube support. respect to complaint files. (a) Identification. A breathing tube [47 FR 31142, July 16, 1982, as amended at 54 support is a device that is intended to FR 25048, June 12, 1989; 66 FR 38794, July 25, support and anchor a patient’s breath- 2001] ing tube(s). (b) Classification. Class I (general con- § 868.5240 Anesthesia breathing cir- trols). The device is exempt from the cuit. premarket notification procedures in (a) Identification. An anesthesia subpart E of part 807 of this chapter breathing circuit is a device that is in- subject to the limitations in § 868.9. tended to administer medical gases to [47 FR 31142, July 16, 1982, as amended at 54 a patient during anesthesia. It provides FR 25048, June 12, 1989; 66 FR 38794, July 25, both an inhalation and exhalation 2001] route and may include a connector, adaptor, and Y-piece. § 868.5300 Carbon dioxide absorbent. (b) Classification. Class I (general con- (a) Identification. A carbon dioxide ab- trols). The device is exempt from the sorbent is a device intended for med- premarket notification procedures in ical purposes that consists of an ab- subpart E of part 807 of this chapter sorbent material (e.g., soda lime) that subject to the limitations in § 868.9. is intended to remove carbon dioxide from the gases in the breathing circuit. [47 FR 31142, July 16, 1982, as amended at 61 (b) Classification. Class I (general con- FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, trols). The device is exempt from the 2001] premarket notification procedures in

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subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to the limitations in § 868.9. subject to the limitations in § 868.9. [47 FR 31142, July 16, 1982, as amended at 61 [47 FR 31142, July 16, 1982, as amended at 59 FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, FR 63007, Dec. 7, 1994; 66 FR 38794, July 25, 2001] 2001]

§ 868.5310 Carbon dioxide absorber. § 868.5350 Nasal oxygen catheter. (a) Identification. A carbon dioxide ab- (a) Identification. A nasal oxygen sorber is a device that is intended for catheter is a device intended to be in- medical purposes and that is used in a serted through a patient’s nostril to breathing circuit as a container for administer oxygen. carbon dioxide absorbent. It may in- (b) Classification. Class I (general conclude a canister and water drain. trols). The device is exempt from the (b) Classification. Class I (general con- premarket notification procedures in trols). The device is exempt from the subpart E of part 807 of this chapter premarket notification procedures in subject to the limitations in § 868.9. subpart E of part 807 of this chapter subject to the limitations in § 868.9. [47 FR 31142, July 16, 1982, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38794, July 25, [47 FR 31142, July 16, 1982, as amended at 61 2001] FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001] § 868.5365 Posture chair for cardiac or pulmonary treatment. § 868.5320 Reservoir bag. (a) Identification. A posture chair for (a) Identification. A reservoir bag is a cardiac or pulmonary treatment is a device, usually made of conductive rub- device intended to assist in the reha- ber, intended for use in a breathing cir- bilitation and mobilization of patients cuit as a reservoir for breathing gas with chronic heart or lung disease. and to assist, control, or monitor a pa- (b) Classification. Class I (general con- tient’s ventilation. trols). The device is exempt from the (b) Classification. Class I (general con- premarket notification procedures in trols). The device is exempt from the subpart E of part 807 of this chapter premarket notification procedures in subject to the limitations in § 868.9. subpart E of part 807 of this chapter subject to the limitations in § 868.9. [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38794, July 25, [47 FR 31142, July 16, 1982, as amended at 61 2001] FR 1120, Jan. 16, 1996; 66 FR 38794, July 25, 2001] § 868.5375 Heat and moisture condenser (artificial nose). § 868.5330 Breathing gas mixer. (a) Identification. A heat and moisture (a) Identification. A breathing gas condenser (artificial nose) is a device mixer is a device intended for use in intended to be positioned over a tra- conjunction with a respiratory support cheotomy (a surgically created opening apparatus to control the mixing of in the throat) or tracheal tube (a tube gases that are to be breathed by a patient. inserted into the trachea) to warm and humidify gases breathed in by a pa- (b) Classification. Class II (performance standards). tient. (b) Classification. Class I (general con- § 868.5340 Nasal oxygen cannula. trols). The device is exempt from the premarket notification procedures in (a) Identification. A nasal oxygen subpart E of part 807 of this chapter cannula is a two-pronged device used to subject to the limitations in § 868.9. administer oxygen to a patient through both nostrils. [47 FR 31142, July 16, 1982, as amended at 61 (b) Classification. Class I (general con- FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, trols). The device is exempt from the 2001] premarket notification procedures in

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§ 868.5400 Electroanesthesia appa- § 868.5430 Gas-scavenging apparatus. ratus. (a) Identification. A gas-scavenging (a) Identification. An apparatus is a device intended to col- electroanesthesia apparatus is a device lect excess anesthetic, analgesic, or used for the induction and mainte- trace gases or vapors from a patient’s nance of anesthesia during surgical breathing system, ventilator, or procedures by means of an alternating extracorporeal pump-oxygenator, and or pulsed electric current that is to conduct these gases out of the area passed through electrodes fixed to a pa- by means of an exhaust system. tient’s head. (b) Classification. Class II (perform- (b) Classification. Class III (premarket ance standards). approval). (c) Date PMA or notice of completion of § 868.5440 Portable oxygen generator. a PDP is required. A PMA or notice of (a) Identification. A portable oxygen completion of a PDP is required to be generator is a device that is intended filed with the Food and Drug Adminis- to release oxygen for respiratory ther- tration on or before December 26, 1996 apy by means of either a chemical re- for any electroanesthesia apparatus action or physical means (e.g., a molec- that was in commercial distribution ular sieve). before May 28, 1976, or that has, on or (b) Classification. Class II (perform- before December 26, 1996 been found to ance standards). be substantially equivalent to an electroanesthesia apparatus that was § 868.5450 Respiratory gas humidifier. in commercial distribution before May (a) Identification. A respiratory gas 28, 1976. Any other electroanesthesia humidifier is a device that is intended apparatus shall have an approved PMA to add moisture to, and sometimes to or a declared completed PDP in effect warm, the breathing gases for adminis- before being placed in commercial dis- tration to a patient. Cascade, gas, tribution. heated, and prefilled humidifiers are [47 FR 31142, July 16, 1982, as amended at 52 included in this generic type of device. FR 17735, May 11, 1987; 61 FR 50706, Sept. 27, (b) Classification. Class II (perform- 1996] ance standards).

§ 868.5420 Ether hook. § 868.5460 Therapeutic humidifier for (a) Identification. An ether hook is a home use. device that fits inside a patient’s (a) Identification. A therapeutic hu- mouth and that is intended to deliver midifier for home use is a device that vaporized ether. adds water vapor to breathing gases (b) Classification. Class I (general con- and that is intended for respiratory trols). The device is exempt from the therapy or other medical purposes. The premarket notification procedures in vapor produced by the device pervades subpart E of part 807 of this chapter the area surrounding the patient, who subject to the limitations in § 868.9. If breathes the vapor during normal res- the device is not labeled or otherwise piration. represented as sterile, it is exempt (b) Classification. Class I (general con- from the current good manufacturing trols). The device is exempt from the practice requirements of the quality premarket notification procedures in system regulation in part 820 of this subpart E of part 807 of this chapter chapter, with the exception of § 820.180, subject to the limitations in § 868.9. with respect to general requirements concerning records, and § 820.198, with [47 FR 31142, July 16, 1982; 47 FR 40410, Sept. 14, 1982, as amended at 61 FR 1120, Jan. 16, respect to complaint files. 1996; 66 FR 38795, July 25, 2001] [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38795, July 25, 2001]

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§ 868.5470 Hyperbaric chamber. § 868.5560 Gas mask head strap. (a) Identification. A hyperbaric cham- (a) Identification. A gas mask head ber is a device that is intended to in- strap is a device used to hold an anes- crease the environmental oxygen pres- thetic gas mask in position on a pa- sure to promote the movement of oxy- tient’s face. gen from the environment to a pa- (b) Classification. Class I (general con- tient’s tissue by means of pressuriza- trols). The device is exempt from the tion that is greater than atmospheric premarket notification procedures in pressure. This device does not include subpart E of part 807 of this chapter topical oxygen chambers for extrem- subject to the limitations in § 868.9. ities (§ 878.5650). (b) Classification. Class II (perform- [47 FR 41107, Sept. 17, 1982, as amended at 54 ance standards). FR 25048, June 12, 1989; 66 FR 38795, July 25, 2001] § 868.5530 Flexible laryngoscope. § 868.5570 Nonrebreathing mask. (a) Identification. A flexible laryngoscope is a fiberoptic device used to (a) Identification. A nonrebreathing examine and visualize a patient’s upper mask is a device fitting over a pa- airway and aid placement of a tracheal tient’s face to administer oxygen. It tube. utilizes one-way valves to prevent the (b) Classification. Class I (general con- patient from rebreathing previously ex- trols). The device is exempt from the haled gases. premarket notification procedures in (b) Classification. Class I (general con- subpart E of part 807 of this chapter trols). The device is exempt from the subject to the limitations in § 868.9. premarket notification procedures in [47 FR 41107, Sept. 17, 1982, as amended at 61 subpart E of part 807 of this chapter FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, subject to the limitations in § 868.9. 2001] [47 FR 31142, July 16, 1982, as amended at 61 § 868.5540 Rigid laryngoscope. FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] (a) Identification. A rigid laryngoscope is a device used to examine § 868.5580 Oxygen mask. and visualize a patient’s upper airway and aid placement of a tracheal tube. (a) Identification. An oxygen mask is (b) Classification. Class I (general con- a device placed over a patient’s nose, trols). The device is exempt from the mouth, or tracheostomy to administer premarket notification procedures in oxygen or aerosols. subpart E of part 807 of this chapter (b) Classification. Class I (general con- subject to the limitations in § 868.9 trols). The device is exempt from the premarket notification procedures in [47 FR 41107, Sept. 17, 1982, as amended at 61 subpart E of part 807 of this chapter FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] subject to the limitations in § 868.9. [47 FR 31142, July 16, 1982, as amended at 61 § 868.5550 Anesthetic gas mask. FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, (a) Identification. An anesthetic gas 2001] mask is a device, usually made of conductive rubber, that is positioned over § 868.5590 Scavenging mask. a patient’s nose or mouth to direct an- (a) Identification. A scavenging mask esthetic gases to the upper airway. is a device positioned over a patient’s (b) Classification. Class I (general con- nose to deliver anesthetic or analgesic trols). The device is exempt from the gases to the upper airway and to re- premarket notification procedures in move excess and exhaled gas. It is usu- subpart E of part 807 of this chapter ally used during dentistry. subject to the limitations in § 868.9. (b) Classification. Class I (general con- [47 FR 41107, Sept. 17, 1982, as amended at 61 trols). The device is exempt from the FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, premarket notification procedures in 2001]

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subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to the limitations in § 868.9. subject to § 868.9. [47 FR 31142, July 16, 1982, as amended at 61 [47 FR 31142, July 16, 1982, as amended at 65 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, FR 2313, Jan. 14, 2000] 2001] § 868.5650 Esophageal obturator. § 868.5600 Venturi mask. (a) Identification. An esophageal obtu- (a) Identification. A venturi mask is a rator is a device inserted through a pa- device containing an air-oxygen mixing tient’s mouth to aid ventilation of the mechanism that dilutes 100 percent ox- patient during emergency resuscitation ygen to a predetermined concentration by occluding (blocking) the esophagus, and delivers the mixed gases to a pa- thereby permitting positive pressure tient. ventilation through the trachea. The (b) Classification. Class I (general con- device consists of a closed-end trols). The device is exempt from the semirigid esophageal tube that is at- premarket notification procedures in tached to a face mask. subpart E of part 807 of this chapter (b) Classification. Class II (perform- subject to the limitations in § 868.9. ance standards). [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, § 868.5655 Portable liquid oxygen unit. 2001] (a) Identification. A portable liquid oxygen unit is a portable, thermally in- § 868.5620 Breathing mouthpiece. sulated container of liquid oxygen that (a) Identification. A breathing mouth- is intended to supplement gases to be piece is a rigid device that is inserted inhaled by a patient, is sometimes ac- into a patient’s mouth and that con- companied by tubing and an oxygen nects with diagnostic or therapeutic mask. An empty portable liquid oxygen respiratory devices. unit is a device, while the oxygen con- (b) Classification. Class I (general contained therein is a drug. trols). The device is exempt from the (b) Classification. Class II (perform- premarket notification procedures in ance standards). subpart E of part 807 of this chapter subject to § 868.9. § 868.5665 Powered percussor. [47 FR 31142, July 16, 1982, as amended at 65 (a) Identification. A powered percussor FR 2313, Jan. 14, 2000] is a device that is intended to transmit vibration through a patient’s chest § 868.5630 Nebulizer. wall to aid in freeing mucus deposits in the lung in order to improve bronchial (a) Identification. A nebulizer is a de- drainage and that may be powered by vice intended to spray liquids in aer- electricity or compressed gas. osol form into gases that are delivered directly to the patient for breathing. (b) Classification. Class II (perform- Heated, ultrasonic, gas, venturi, and ance standards). refillable nebulizers are included in § 868.5675 Rebreathing device. this generic type of device. (b) Classification. Class II (perform- (a) Identification. A rebreathing de- ance standards). vice is a device that enables a patient to rebreathe exhaled gases. It may be § 868.5640 Medicinal nonventilatory used in conjunction with pulmonary nebulizer (atomizer). function testing or for increasing (a) Identification. A medicinal non- minute ventilation. ventilatory nebulizer (atomizer) is a (b) Classification. Class I (general con- device that is intended to spray liquid trols). The device is exempt from the medication in aerosol form into the air premarket notification procedures in that a patient will breathe. subpart E of part 807 of this chapter (b) Classification. Class I (general con- subject to § 868.9. trols). The device is exempt from the [47 FR 31142, July 16, 1982, as amended at 65 premarket notification procedures in FR 2313, Jan. 14, 2000]

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§ 868.5690 Incentive spirometer. § 868.5740 Tracheal/bronchial differential ventilation tube. (a) Identification. An incentive spirometer is a device that indicates a pa- (a) Identification. A tracheal/bron- tient’s breathing volume or flow and chial differential ventilation tube is a that provides an incentive to the pa- device used to isolate the left or the tient to improve his or her ventilation. right lung of a patient for anesthesia (b) Classification. Class II (perform- or pulmonary function testing. ance standards). (b) Classification. Class II (performance standards). § 868.5700 Nonpowered oxygen tent. § 868.5750 Inflatable tracheal tube (a) Identification. A nonpowered oxy- cuff. gen tent is a device that encloses a patient’s head and upper body to contain (a) Identification. An inflatable tra- oxygen delivered to the patient for cheal tube cuff is a device used to pro- breathing. This generic type of device vide an airtight seal between a tra- includes infant oxygen hoods. cheal tube and a patient’s trachea. (b) Classification. Class I (general con- (b) Classification. Class II (perform- trols). The device is exempt from the ance standards). premarket notification procedures in § 868.5760 Cuff spreader. subpart E of part 807 of this chapter subject to § 868.9. (a) Identification. A cuff spreader is a device used to install tracheal tube [47 FR 31142, July 16, 1982, as amended at 65 cuffs on tracheal or tracheostomy FR 2313, Jan. 14, 2000] tubes. (b) Classification. Class I (general con- § 868.5710 Electrically powered oxygen tent. trols). The device is exempt from the premarket notification procedures in (a) Identification. An electrically pow- subpart E of part 807 of this chapter ered oxygen tent is a device that en- subject to the limitations in § 868.9. If closes a patient’s head and, by means the device is not labeled or otherwise of an electrically powered unit, admin- represented as sterile, it is exempt isters breathing oxygen and controls from the current good manufacturing the temperature and humidity of the practice requirements of the quality breathing gases. This generic type de- system regulation in part 820 of this vice includes the pediatric aerosol chapter, with the exception of § 820.180, tent. with respect to general requirements (b) Classification. Class II (perform- concerning records, and § 820.198, with ance standards). respect to complaint files.

§ 868.5720 Bronchial tube. [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38795, July 25, (a) Identification. A bronchial tube is 2001] a device used to differentially intubate a patient’s bronchus (one of the two § 868.5770 Tracheal tube fixation de- main branches of the trachea leading vice. directly to the lung) in order to isolate (a) Identification. A tracheal tube fix- a portion of lung distal to the tube. ation device is a device used to hold a (b) Classification. Class II (perform- tracheal tube in place, usually by ance standards). means of straps or pinch rings. (b) Classification. Class I (general con- § 868.5730 Tracheal tube. trols). The device is exempt from the (a) Identification. A tracheal tube is a premarket notification procedures in device inserted into a patient’s trachea subpart E of part 807 of this chapter via the nose or mouth and used to subject to the limitations in § 868.9. maintain an open airway. [47 FR 31142, July 16, 1982, as amended at 61 (b) Classification. Class II (perform- FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, ance standards). 2001]

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§ 868.5780 Tube introduction forceps. the trachea to facilitate ventilation to (a) Identification. Tube introduction the lungs. The cuff may be a separate forceps (e.g., Magill forceps) are a or integral part of the tracheostomy right-angled device used to grasp a tra- tube and is, when inflated, intended to cheal tube and place it in a patient’s establish a seal between the tracheal trachea. wall and the tracheostomy tube. The (b) Classification. Class I (general con- cuff is used to prevent the patient’s as- trols). The device is exempt from the piration of substances, such as blood or premarket notification procedures in vomit, or to provide a means for posi- subpart E of part 807 of this chapter tive-pressure ventilation of the pa- subject to the limitations in § 868.9. tient. This device is made of either stainless steel or plastic. [47 FR 31142, July 16, 1982, as amended at 61 (b) Classification. Class II. FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] [51 FR 40389, Nov. 6, 1986]

§ 868.5790 Tracheal tube stylet. § 868.5810 Airway connector. (a) Identification. A tracheal tube sty- (a) Identification. An airway con- let is a device used temporarily to nector is a device intended to connect make rigid a flexible tracheal tube to a breathing gas source to a tracheal aid its insertion into a patient. tube, tracheostomy tube, or mask. (b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to the limitations in § 868.9. subject to the limitations in § 868.9. [47 FR 31142, July 16, 1982, as amended at 61 [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, 2001] 2001]

§ 868.5795 Tracheal tube cleaning § 868.5820 Dental protector. brush. (a) Identification. A tracheal tube (a) Identification. A dental protector cleaning brush is a device consisting of is a device intended to protect a pa- a brush with plastic bristles intended tient’s teeth during manipulative pro- to clean tracheal cannula devices after cedures within a patient’s oral cavity. their removal from patients. (b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to the limitations in § 868.9. subject to the limitations in § 868.9. If [47 FR 31142, July 16, 1982, as amended at 61 the device is not labeled or otherwise FR 1120, Jan. 16, 1996; 66 FR 38795, July 25, represented as sterile, it is exempt 2001] from the current good manufacturing practice requirements of the quality § 868.5830 Autotransfusion apparatus. system regulation in part 820 of this (a) Identification. An autotransfusion chapter, with the exception of § 820.180, apparatus is a device used to collect with respect to general requirements and reinfuse the blood lost by a patient concerning records, and § 820.198, with due to surgery or trauma. respect to complaint files. (b) Classification. Class II (perform- [51 FR 40388, Nov. 6, 1986, as amended at 66 ance standards). FR 38795, July 25, 2001] § 868.5860 Pressure tubing and acces- § 868.5800 Tracheostomy tube and tube sories. cuff. (a) Identification. Pressure tubing and (a) Identification. A tracheostomy accessories are flexible or rigid devices tube and tube cuff is a device intended intended to deliver pressurized medical to be placed into a surgical opening of gases.

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(b) Classification. Class I (general con- § 868.5925 Powered emergency venti- trols). The device is exempt from the lator. premarket notification procedures in (a) Identification. A powered emer- subpart E of part 807 of this chapter gency ventilator is a demand valve or subject to the limitations in § 868.9. inhalator intended to provide emer- [47 FR 31142, July 16, 1982, as amended at 61 gency respiratory support by means of FR 1120, Jan. 16, 1996; 66 FR 38796, July 25, a face mask or a tube inserted into a 2001] patient’s airway. § 868.5870 Nonrebreathing valve. (b) Classification. Class II (perform- (a) Identification. A nonrebreathing ance standards). valve is a one-way valve that directs breathing gas flow to the patient and § 868.5935 External negative pressure ventilator. vents exhaled gases into the atmosphere. (a) Identification. An external nega- (b) Classification. Class II (perform- tive pressure ventilator (e.g., iron lung, ance standards). cuirass) is a device chamber that is intended to support a patient’s ventila- § 868.5880 Anesthetic vaporizer. tion by alternately applying and re- (a) Identification. An anesthetic va- leasing external negative pressure over porizer is a device used to vaporize liq- the diaphragm and upper trunk of the uid anesthetic and deliver a controlled patient. amount of the vapor to the patient. (b) Classification. Class II (perform- (b) Classification. Class II (performance standards). ance standards). § 868.5955 Intermittent mandatory § 868.5895 Continuous ventilator. ventilation attachment. (a) Identification. A continuous venti- (a) Identification. An intermittent lator (respirator) is a device intended mandatory ventilation (IMV) attach- to mechanically control or assist pa- ment is a device attached to a mechan- tient breathing by delivering a pre- ical ventilator that allows spontaneous determined percentage of oxygen in the breathing gas. Adult, pediatric, and breathing by a patient while providing neonatal ventilators are included in mechanical ventilation at a preset this generic type of device. rate. (b) Classification. Class II (perform- (b) Classification. Class II (performance standards). ance standards).

§ 868.5905 Noncontinuous ventilator § 868.5965 Positive end expiratory (IPPB). pressure breathing attachment. (a) Identification. A noncontinuous (a) Identification. A positive end ex- ventilator (intermittent positive pres- piratory pressure (PEEP) breathing at- sure breathing-IPPB) is a device in- tachment is a device attached to a ven- tended to deliver intermittently an tilator that is used to elevate pressure aerosol to a patient’s lungs or to assist in a patient’s lungs above atmospheric a patient’s breathing. pressure at the end of exhalation. (b) Classification. Class II (perform- (b) Classification. Class II (performance standards). ance standards). § 868.5915 Manual emergency ventilator. § 868.5975 Ventilator tubing. (a) Identification. A manual emer- (a) Identification. Ventilator tubing is gency ventilator is a device, usually in- a device intended for use as a conduit corporating a bag and valve, intended for gases between a ventilator and a to provide emergency respiratory sup- patient during ventilation of the pa- port by means of a face mask or a tube tient. inserted into a patient’s airway. (b) Classification. Class I (general con- (b) Classification. Class II (perform- trols). The device is exempt from the ance standards). premarket notification procedures in

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subpart E of part 807 of this chapter ception of § 820.180, with respect to gen- subject to the limitations in § 868.9. eral requirements concerning records, and § 820.198, with respect to complaint [47 FR 31142, July 16, 1982, as amended at 61 FR 1120, Jan. 16, 1996; 66 FR 38796, July 25, files. 2001] [47 FR 31142, July 16, 1982, as amended at 54 FR 25048, June 12, 1989; 66 FR 38796, July 25, § 868.5995 Tee drain (water trap). 2001] (a) Identification. A tee drain (water trap) is a device intended to trap and § 868.6225 Nose clip. drain water that collects in ventilator (a) Identification. A nose clip is a de- tubing during respiratory therapy, vice intended to close a patient’s exter- thereby preventing an increase in nal nares (nostrils) during diagnostic breathing resistance. or therapeutic procedures. (b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter subject to the limitations in § 868.9. subject to the limitations in § 868.9. The [47 FR 31142, July 16, 1982, as amended at 61 device is also exempt from the current FR 1120, Jan. 16, 1996; 66 FR 38796, July 25, good manufacturing practice require- 2001] ments of the quality system regulation in part 820 of this chapter, with the ex- Subpart G—Miscellaneous ception of § 820.180, with respect to general requirements concerning records, § 868.6100 Anesthetic cabinet, table, or and § 820.198, with respect to complaint tray. files. (a) Identification. An anesthetic cabi- [47 FR 31142, July 16, 1982, as amended at 54 net, table, or tray is a device intended FR 25048, June 12, 1989; 66 FR 38796, July 25, to store anesthetic equipment and 2001] drugs. The device is usually constructed to eliminate build-up of static § 868.6250 Portable air compressor. electrical charges. (a) Identification. A portable air com- (b) Classification. Class I (general con- pressor is a device intended to provide trols). The device is exempt from the compressed air for medical purposes, premarket notification procedures in e.g., to drive ventilators and other res- subpart E of part 807 of this chapter piratory devices. subject to the limitations in § 868.9. (b) Classification. Class II (perform- [47 FR 31142, July 16, 1982, as amended at 54 ance standards). FR 25048, June 12, 1989; 66 FR 38796, July 25, 2001] § 868.6400 Calibration gas. § 868.6175 Cardiopulmonary emer- (a) Identification. A calibration gas is gency cart. a device consisting of a container of gas of known concentration intended (a) A cardiopulmonary Identification. to calibrate medical gas concentration emergency cart is a device intended to measurement devices. store and transport resuscitation sup- (b) Classification. Class I (general con- plies for emergency treatment. The de- trols). The device is exempt from the vice does not include any equipment premarket notification procedures in used in cardiopulmonary resuscitation. subpart E of part 807 of this chapter (b) Classification. Class I (general con- subject to the limitations in § 868.9. trols). The device is exempt from the premarket notification procedures in [47 FR 31142, July 16, 1982, as amended at 61 subpart E of part 807 of this chapter FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, subject to the limitations in § 868.9. The 2001] device is also exempt from the current good manufacturing practice require- § 868.6700 Anesthesia stool. ments of the quality system regulation (a) Identification. An anesthesia stool in part 820 of this chapter, with the ex- is a device intended for use as a stool

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for the anesthesiologist in the oper- PART 870—CARDIOVASCULAR ating room. DEVICES (b) Classification. Class I (general controls). The device is exempt from the Subpart A—General Provisions premarket notification procedures in subpart E of part 807 of this chapter Sec. 870.1 Scope. subject to the limitations in § 868.9. 870.3 Effective dates of requirement for pre- [47 FR 31142, July 16, 1982, as amended at 54 market approval. 870.9 Limitations of exemptions from sec- FR 25049, June 12, 1989; 66 FR 38796, July 25, tion 510(k) of the Federal Food, Drug, 2001] and Cosmetic Act (the act).

§ 868.6810 Tracheobronchial suction Subpart B—Cardiovascular Diagnostic catheter. Devices (a) Identification. A tracheobronchial 870.1025 Arrhythmia detector and alarm (in- suction catheter is a device used to as- cluding ST-segment measurement and pirate liquids or semisolids from a pa- alarm). tient’s upper airway. 870.1100 Blood pressure alarm. (b) Classification. Class 1 (general con- 870.1110 Blood pressure computer. trols). The device is exempt from the 870.1120 Blood pressure cuff. 870.1130 Noninvasive blood pressure meas- premarket notification procedures in urement system. subpart E of part 807 of this chapter 870.1140 Venous blood pressure manometer. subject to § 868.9. 870.1200 Diagnostic intravascular catheter. 870.1210 Continuous flush catheter. [47 FR 31142, July 16, 1982, as amended at 65 870.1220 Electrode recording catheter or FR 2314, Jan. 14, 2000] electrode recording probe. 870.1230 Fiberoptic oximeter catheter. § 868.6820 Patient position support. 870.1240 Flow-directed catheter. 870.1250 Percutaneous catheter. (a) Identification. A patient position 870.1270 Intracavitary phonocatheter sys- support is a device intended to main- tem. tain the position of an anesthetized pa- 870.1280 Steerable catheter. tient during surgery. 870.1290 Steerable catheter control system. 870.1300 Catheter cannula. (b) Classification. Class I (general con- 870.1310 Vessel dilator for percutaneous trols). The device is exempt from the catheterization. premarket notification procedures in 870.1330 Catheter guide wire. subpart E of part 807 of this chapter 870.1340 Catheter introducer. subject to the limitations in § 868.9. 870.1350 Catheter balloon repair kit. 870.1360 Trace microsphere. [47 FR 31142, July 16, 1982, as amended at 61 870.1370 Catheter tip occluder. FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 870.1380 Catheter stylet. 2001] 870.1390 Trocar. 870.1415 Coronary vascular physiologic sim- § 868.6885 Medical gas yoke assembly. ulation software device. 870.1425 Programmable diagnostic com- (a) Identification. A medical gas yoke puter. assembly is a device intended to con- 870.1435 Single-function, preprogrammed di- nect medical gas cylinders to regu- agnostic computer. 870.1450 Densitometer. lators or needle valves to supply gases 870.1650 Angiographic injector and syringe. for anesthesia or respiratory therapy. 870.1660 Indicator injector. The device may include a particulate 870.1670 Syringe actuator for an injector. filter. 870.1750 External programmable pacemaker (b) Classification. Class I (general con- pulse generator. 870.1800 Withdrawal-infusion pump. trols). The device is exempt from the 870.1875 Stethoscope. premarket notification procedures in 870.1915 Thermodilution probe. subpart E of part 807 of this chapter subject to the limitations in § 868.9. Subpart C—Cardiovascular Monitoring Devices [47 FR 31142, July 16, 1982, as amended at 61 FR 1121, Jan. 16, 1996; 66 FR 38796, July 25, 870.2050 Biopotential amplifier and signal 2001] conditioner.

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870.2060 Transducer signal amplifier and sig- 870.3610 Implantable pacemaker pulse gen- nal conditioner. erator. 870.2100 Cardiovascular blood flowmeter. 870.3620 Pacemaker lead adaptor. 870.2120 Extravascular blood flow probe. 870.3630 Pacemaker generator function ana- 870.2300 Cardiac monitor (including lyzer. cardiotachometer and rate alarm). 870.3640 Indirect pacemaker generator func- 870.2310 Apex cardiograph tion analyzer. (vibrocardiograph). 870.3650 Pacemaker polymeric mesh bag. 870.2320 Ballistocardiograph. 870.3670 Pacemaker charger. 870.2330 Echocardiograph. 870.3680 Cardiovascular permanent or tem- 870.2340 Electrocardiograph. porary pacemaker electrode. 870.2350 Electrocardiograph lead switching 870.3690 Pacemaker test magnet. adaptor. 870.3700 Pacemaker programmers. 870.2360 Electrocardiograph electrode. 870.3710 Pacemaker repair or replacement 870.2370 Electrocardiograph surface elec- material. trode tester. 870.3720 Pacemaker electrode function test- 870.2390 Phonocardiograph. er. 870.2400 Vectorcardiograph. 870.3730 Pacemaker service tools. 870.2450 Medical cathode-ray tube display. 870.3800 Annuloplasty ring. 870.2600 Signal isolation system. 870.3850 Carotid sinus nerve stimulator. 870.2620 Line isolation monitor. 870.3925 Replacement heart valve. 870.2640 Portable leakage current alarm. 870.3935 Prosthetic heart valve holder. 870.2675 Oscillometer. 870.3945 Prosthetic heart valve sizer. 870.2700 Oximeter. 870.2710 Ear oximeter. Subpart E—Cardiovascular Surgical 870.2750 Impedance phlebograph. Devices 870.2770 Impedance plethysmograph. 870.2780 Hydraulic, pneumatic, or photo- 870.4075 Endomyocardial biopsy device. electric plethysmographs. 870.4100 Extracorporeal circuit and acces- 870.2800 Medical magnetic tape recorder. sories for long-term respiratory/ 870.2810 Paper chart recorder. cardiopulmonary failure. 870.2840 Apex cardiographic transducer. 870.4200 Cardiopulmonary bypass accessory 870.2850 Extravascular blood pressure trans- equipment. ducer. 870.4205 Cardiopulmonary bypass bubble de- 870.2855 Implantable Intra-aneurysm Pres- tector. sure Measurement System. 870.4210 Cardiopulmonary bypass vascular 870.2860 Heart sound transducer. catheter, cannula, or tubing. 870.2870 Catheter tip pressure transducer. 870.4220 Cardiopulmonary bypass heart-lung 870.2880 Ultrasonic transducer. machine console. 870.2890 Vessel occlusion transducer. 870.4230 Cardiopulmonary bypass defoamer. 870.2900 Patient transducer and electrode 870.4240 Cardiopulmonary bypass heat ex- cable (including connector). changer. 870.2910 Radiofrequency physiological sig- 870.4250 Cardiopulmonary bypass tempera- nal transmitter and receiver. ture controller. 870.2920 Telephone electrocardiograph 870.4260 Cardiopulmonary bypass arterial transmitter and receiver. line blood filter. 870.4270 Cardiopulmonary bypass cardi- Subpart D—Cardiovascular Prosthetic otomy suction line blood filter. Devices 870.4280 Cardiopulmonary prebypass filter. 870.4290 Cardiopulmonary bypass adaptor, 870.3250 Vascular clip. stopcock, manifold, or fitting. 870.3260 Vena cava clip. 870.4300 Cardiopulmonary bypass gas con- 870.3300 Vascular embolization device. trol unit. 870.3375 Cardiovascular intravascular filter. 870.4310 Cardiopulmonary bypass coronary 870.3450 Vascular graft prosthesis. pressure gauge. 870.3460 Endovascular suturing system. 870.4320 Cardiopulmonary bypass pulsatile 870.3470 Intracardiac patch or pledget made flow generator. of polypropylene, polyethylene 870.4330 Cardiopulmonary bypass on-line terephthalate, or polytetrafluoro- blood gas monitor. ethylene. 870.4340 Cardiopulmonary bypass level sens- 870.3535 Intra-aortic balloon and control ing monitor and/or control. system. 870.4350 Cardiopulmonary bypass 870.3545 Ventricular bypass (assist) device. oxygenator. 870.3600 External pacemaker pulse gener- 870.4360 Nonroller-type blood pump. ator. 870.4370 Roller-type cardiopulmonary by- 870.3605 Pacing system analyzer. pass blood pump.

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870.4380 Cardiopulmonary bypass pump market notification submission for a speed control. device under part 807 may not show 870.4390 Cardiopulmonary bypass pump tub- merely that the device is accurately ing. described by the section title and iden- 870.4400 Cardiopulmonary bypass blood reservoir. tification provisions of a regulation in 870.4410 Cardiopulmonary bypass in-line this part, but shall state why the de- blood gas sensor. vice is substantially equivalent to 870.4420 Cardiopulmonary bypass cardi- other devices, as required by § 807.87. otomy return sucker. (c) To avoid duplicative listings, a 870.4430 Cardiopulmonary bypass cardiovascular device that has two or intracardiac suction control. more types of uses (e.g., used both as a 870.4450 Vascular clamp. 870.4475 Surgical vessel dilator. diagnostic device and as a therapeutic 870.4500 Cardiovascular surgical instru- device) is listed only in one subpart. ments. (d) References in this part to regu- 870.4510 Apical closure device. latory sections of the Code of Federal 870.4875 Intraluminal artery stripper. Regulations are to chapter I of title 21, 870.4885 External vein stripper. unless otherwise noted. (e) Guidance documents referenced in Subpart F—Cardiovascular Therapeutic this part are available on the Internet Devices at http://www.fda.gov/MedicalDevices/ 870.5050 Patient care suction apparatus. DeviceRegulationandGuidance/ 870.5100 Percutaneous Transluminal Coro- GuidanceDocuments/default.htm.. nary Angioplasty (PTCA) Catheter. 870.5150 Embolectomy catheter. [52 FR 17735, May 11, 1987, as amended at 68 870.5175 Septostomy catheter. FR 61344, Oct. 28, 2003; 78 FR 18233, Mar. 26, 870.5200 External cardiac compressor. 2013] 870.5210 Cardiopulmonary resuscitation (CPR) aid. § 870.3 Effective dates of requirement 870.5225 External counter-pulsating device. for premarket approval. 870.5300 DC-defibrillator (including paddles). A device included in this part that is 870.5310 Automated external defibrillator system. classified into class III (premarket ap- 870.5325 Defibrillator tester. proval) shall not be commercially dis- 870.5550 External transcutaneous cardiac tributed after the date shown in the pacemaker (noninvasive). regulation classifying the device unless 870.5700 Steerable cardiac ablation catheter the manufacturer has an approval remote control system. under section 515 of the act (unless an 870.5800 Compressible limb sleeve. exemption has been granted under sec- 870.5900 Thermal regulating system. 870.5910 Esophageal thermal regulation de- tion 520(g)(2) of the act). An approval vice. under section 515 of the act consists of 870.5925 Automatic rotating tourniquet. FDA’s issuance of an order approving an application for premarket approval AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. (PMA) for the device or declaring completed a product development protocol SOURCE: 45 FR 7907, Feb. 5, 1980, unless oth- (PDP) for the device. erwise noted. (a) Before FDA requires that a device EDITORIAL NOTE: Nomenclature changes to commercially distributed before the part 870 appear at 73 FR 35341, June 23, 2008. enactment date of the amendments, or a device that has been found substan- Subpart A—General Provisions tially equivalent to such a device, has an approval under section 515 of the act § 870.1 Scope. FDA must promulgate a regulation (a) This part sets forth the classifica- under section 515(b) of the act requir- tion of cardiovascular devices intended ing such approval, except as provided for human use that are in commercial in paragraph (b) of this section. Such a distribution. regulation under section 515(b) of the (b) The identification of a device in a act shall not be effective during the regulation in this part is not a precise grace period ending on the 90th day description of every device that is, or after its promulgation or on the last will be, subject to the regulation. A day of the 30th full calendar month manufacturer who submits a pre- after the regulation that classifies the

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device into class III is effective, which- device for which FDA has granted an ever is later. See section 501(f)(2)(B) of exemption from the requirement of the act. Accordingly, unless an effec- premarket notification must still sub- tive date of the requirement for pre- mit a premarket notification to FDA market approval is shown in the regu- before introducing or delivering for in- lation for a device classified into class troduction into interstate commerce III in this part, the device may be com- for commercial distribution the device mercially distributed without FDA’s when: issuance of an order approving a PMA (a) The device is intended for a use or declaring completed a PDP for the different from the intended use of a le- device. If FDA promulgates a regula- gally marketed device in that generic tion under section 515(b) of the act re- type of device; e.g., the device is in- quiring premarket approval for a de- tended for a different medical purpose, vice, section 501(f)(1)(A) of the act ap- or the device is intended for lay use plies to the device. where the former intended use was by (b) Any new, not substantially equiv- health care professionals only; alent, device introduced into commer- (b) The modified device operates cial distribution on or after May 28, using a different fundamental sci- 1976, including a device formerly mar- entific technology than a legally marketed that has been substantially al- keted device in that generic type of de- tered, is classified by statute (section vice; e.g., a surgical instrument cuts 513(f) of the act) into class III without tissue with a laser beam rather than any grace period and FDA must have with a sharpened metal blade, or an in issued an order approving a PMA or de- vitro diagnostic device detects or iden- claring completed a PDP for the device tifies infectious agents by using before the device is commercially dis- deoxyribonucleic acid (DNA) probe or tributed unless it is reclassified. If nucleic acid hybridization technology FDA knows that a device being com- rather than culture or immunoassay mercially distributed may be a ‘‘new’’ technology; or device as defined in this section because of any new intended use or other (c) The device is an in vitro device reasons, FDA may codify the statutory that is intended: classification of the device into class (1) For use in the diagnosis, moni- III for such new use. Accordingly, the toring, or screening of neoplastic dis- regulation for such a class III device eases with the exception of states that as of the enactment date of immunohistochemical devices; the amendments, May 28, 1976, the de- (2) For use in screening or diagnosis vice must have an approval under sec- of familial or acquired genetic dis- tion 515 of the act before commercial orders, including inborn errors of me- distribution. tabolism; (3) For measuring an analyte that [52 FR 17735, May 11, 1987] serves as a surrogate marker for § 870.9 Limitations of exemptions from screening, diagnosis, or monitoring section 510(k) of the Federal Food, life-threatening diseases such as ac- Drug, and Cosmetic Act (the act). quired immune deficiency syndrome The exemption from the requirement (AIDS), chronic or active hepatitis, tu- of premarket notification (section berculosis, or myocardial infarction or 510(k) of the act) for a generic type of to monitor therapy; class I or II device is only to the extent (4) For assessing the risk of cardio- that the device has existing or reason- vascular diseases; ably foreseeable characteristics of (5) For use in diabetes management; commercially distributed devices with- (6) For identifying or inferring the in that generic type or, in the case of identity of a microorganism directly in vitro diagnostic devices, only to the from clinical material; extent that misdiagnosis as a result of (7) For detection of antibodies to using the device would not be associ- microorganisms other than ated with high morbidity or mortality. immunoglobulin G (IgG) or IgG assays Accordingly, manufacturers of any when the results are not qualitative, or commercially distributed class I or II are used to determine immunity, or the

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assay is intended for use in matrices conjunction with another device to de- other than serum or plasma; termine a subject’s blood pressure. (8) For noninvasive testing as defined (b) Classification. Class II (perform- in § 812.3(k) of this chapter; and ance standards). (9) For near patient testing (point of care). § 870.1130 Noninvasive blood pressure measurement system. [65 FR 2314, Jan. 14, 2000] (a) Identification. A noninvasive blood pressure measurement system is a de- Subpart B—Cardiovascular vice that provides a signal from which Diagnostic Devices systolic, diastolic, mean, or any combination of the three pressures can be § 870.1025 Arrhythmia detector and derived through the use of tranducers alarm (including ST-segment meas- placed on the surface of the body. urement and alarm). (b) Classification. Class II (perform- (a) Identification. The arrhythmia de- ance standards). tector and alarm device monitors an electrocardiogram and is designed to § 870.1140 Venous blood pressure ma- produce a visible or audible signal or nometer. alarm when atrial or ventricular ar- (a) Identification. A venous blood rhythmia, such as premature contrac- pressure manometer is a device at- tion or ventricular fibrillation, occurs. tached to a venous catheter to indicate (b) Classification. Class II (special manometrically the central or periph- controls). The guidance document enti- eral venous pressure. tled ‘‘Class II Special Controls Guid- (b) Classification. Class II (performance Document: Arrhythmia Detector ance standards). and Alarm’’ will serve as the special control. See § 870.1 for the availability § 870.1200 Diagnostic intravascular of this guidance document. catheter. (a) Identification. An intravascular di- [68 FR 61344, Oct. 28, 2003] agnostic catheter is a device used to § 870.1100 Blood pressure alarm. record intracardiac pressures, to sample blood, and to introduce substances (a) Identification. A blood pressure into the heart and vessels. Included in alarm is a device that accepts the sig- this generic device are right-heart nal from a blood pressure transducer catheters, left-heart catheters, and amplifier, processes the signal, and angiographic catheters, among others. emits an alarm when the blood pres- (b) Classification. Class II (perform- sure falls outside a pre-set upper or ance standards). lower limit. (b) Classification. Class II (perform- § 870.1210 Continuous flush catheter. ance standards). (a) Identification. A continuous flush catheter is an attachment to a cath- § 870.1110 Blood pressure computer. eter-transducer system that permits (a) Identification. A blood pressure continuous intravascular flushing at a computer is a device that accepts the slow infusion rate for the purpose of electrical signal from a blood pressure eliminating clotting, back-leakage, transducer amplifier and indicates the and waveform damping. systolic, diastolic, or mean pressure (b) Classification. Class II (perform- based on the input signal. ance standards). (b) Classification. Class II (performance standards). § 870.1220 Electrode recording catheter or electrode recording probe. § 870.1120 Blood pressure cuff. (a) Identification. An electrode record- (a) Identification. A blood pressure ing catheter or an electrode recording cuff is a device that has an inflatable probe is a device used to detect an bladder in an inelastic sleeve (cuff) intracardiac electrocardiogram, or to with a mechanism for inflating and de- detect cardiac output or left-to-right flating the bladder. The cuff is used in heart shunts. The device may be

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unipolar or multipolar for electro- (b) Classification. Class II (perform- cardiogram detection, or may be a ance standards). platinum-tipped catheter which senses the presence of a special indicator for § 870.1290 Steerable catheter control cardiac output or left-to-right heart system. shunt determinations. (a) Identification. A steerable catheter (b) Classification. Class II (perform- control system is a device that is con- ance standards). nected to the proximal end of a steerable guide wire that controls the mo- § 870.1230 Fiberoptic oximeter cath- tion of the steerable catheter. eter. (b) Classification. Class II (perform- (a) Identification. A fiberoptic oxim- ance standards). eter catheter is a device used to estimate the oxygen saturation of the § 870.1300 Catheter cannula. blood. It consists of two fiberoptic bun- (a) Identification. A catheter cannula dles that conduct light at a desired is a hollow tube which is inserted into wavelength through blood and detect a vessel or cavity; this device provides the reflected and scattered light at the a rigid or semirigid structure which distal end of the catheter. can be connected to a tube or con- (b) Classification. Class II (perform- nector. ance standards). (b) Classification. Class II (performance standards). § 870.1240 Flow-directed catheter. (a) Identification. A flow-directed § 870.1310 Vessel dilator for catheter is a device that incorporates a percutaneous catheterization. gas-filled balloon to help direct the (a) Identification. A vessel dilator for catheter to the desired position. percutaneous catheterization is a de- (b) Classification. Class II (perform- vice which is placed over the guide wire ance standards). to enlarge the opening in the vessel, and which is then removed before slid- § 870.1250 Percutaneous catheter. ing the catheter over the guide wire. (a) Identification. A percutaneous (b) Classification. Class II (perform- catheter is a device that is introduced ance standards). into a vein or artery through the skin using a dilator and a sheath (intro- § 870.1330 Catheter guide wire. ducer) or guide wire. (a) Identification. A catheter guide (b) Classification. Class II (perform- wire is a coiled wire that is designed to ance standards). fit inside a percutaneous catheter for the purpose of directing the catheter § 870.1270 Intracavitary phonocatheter through a blood vessel. system. (b) Classification. Class II (perform- (a) Identification. An intracavitary ance standards). phonocatheter system is a system that includes a catheter with an acoustic § 870.1340 Catheter introducer. transducer and the associated device (a) Identification. A catheter intro- that processes the signal from the ducer is a sheath used to facilitate transducer; this device records bio- placing a catheter through the skin acoustic phenomena from a transducer into a vein or artery. placed within the heart, blood vessels, (b) Classification. Class II (perform- or body cavities. ance standards). (b) Classification. Class II (performance standards). § 870.1350 Catheter balloon repair kit. (a) Identification. A catheter balloon § 870.1280 Steerable catheter. repair kit is a device used to repair or (a) Identification. A steerable catheter replace the balloon of a balloon cath- is a catheter used for diagnostic and eter. The kit contains the materials, monitoring purposes whose movements such as glue and balloons, necessary to are directed by a steering control unit. effect the repair or replacement.

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(b) Classification. Class III (premarket § 870.1380 Catheter stylet. approval). (a) Identification. A catheter stylet is (c) Date PMA or notice of completion of a wire that is run through a catheter or a PDP is required. A PMA or notice of cannula to render it stiff. completion of a PDP is required to be filed with the Food and Drug Adminis- (b) Classification. Class II (perform- tration on or before December 26, 1996 ance standards). for any catheter balloon repair kit that § 870.1390 Trocar. was in commercial distribution before May 28, 1976, or that has, on or before (a) Identification. A trocar is a sharp- December 26, 1996 been found to be sub- pointed instrument used with a stantially equivalent to a catheter bal- cannula for piercing a vessel or cham- loon repair kit that was in commercial ber to facilitate insertion of the distribution before May 28, 1976. Any cannula. other catheter balloon repair kit shall (b) Classification. Class II (perform- have an approved PMA or a declared ance standards). completed PDP in effect before being placed in commercial distribution. § 870.1415 Coronary vascular physiologic simulation software device. [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 61 FR 50706, Sept. 27, 1996] (a) Identification. A coronary vascular physiologic simulation software device § 870.1360 Trace microsphere. is a prescription device that provides (a) Identification. A trace microsphere simulated functional assessment of is a radioactively tagged nonbiodegrad- blood flow in the coronary vascular able particle that is intended to be in- system using data extracted from med- jected into an artery or vein and ical device imaging to solve algorithms trapped in the capillary bed for the and yield simulated metrics of physio- purpose of studying blood flow within logic information (e.g., blood flow, cor- or to an organ. onary flow reserve, fractional flow re- (b) Classification. Class III (premarket serve, myocardial perfusion). A coro- approval). nary vascular physiologic simulation (c) Date PMA or notice of completion of software device is intended to generate a PDP is required. A PMA or notice of results for use and review by a quali- completion of a PDP is required to be fied clinician. filed with the Food and Drug Adminis- (b) Classification. Class II (special tration on or before December 26, 1996 controls). The special controls for this for any trace microsphere that was in device are: commercial distribution before May 28, (1) Adequate software verification 1976, or that has, on or before Decem- and validation based on comprehensive ber 26, 1996 been found to be substan- hazard analysis, with identification of tially equivalent to a trace micro- appropriate mitigations, must be per- sphere that was in commercial dis- formed, including: tribution before May 28, 1976. Any (i) Full characterization of the tech- other trace microsphere shall have an approved PMA or a declared completed nical parameters of the software, in- PDP in effect before being placed in cluding: commercial distribution. (A) Any proprietary algorithm(s) used to model the vascular anatomy; [45 FR 7907, Feb. 5, 1980, as amended at 52 FR and 17736, May 11, 1987; 61 FR 50706, Sept. 27, 1996] (B) Adequate description of the ex- § 870.1370 Catheter tip occluder. pected impact of all applicable image acquisition hardware features and (a) Identification. A catheter tip characteristics on performance and any occluder is a device that is inserted associated minimum specifications; into certain catheters to prevent flow (ii) Adequate consideration of pri- through one or more orifices. vacy and security issues in the system (b) Classification. Class II (perform- design; and ance standards).

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(iii) Adequate mitigation of the im- across the range of intended image ac- pact of failure of any subsystem com- quisition hardware; and ponents (e.g., signal detection and anal- (ix) If the device uses a cutoff thresh- ysis, data storage, system communica- old or operates across a spectrum of tions and cybersecurity) with respect disease, it must be established prior to to incorrect patient reports and oper- validation, and it must be justified as ator failures. to how it was determined and clinically (2) Adequate non-clinical perform- validated; ance testing must be provided to dem- (4) Adequate validation must be per- onstrate the validity of computational formed and controls implemented to modeling methods for flow measure- characterize and ensure consistency ment; and (i.e., repeatability and reproducibility) (3) Clinical data supporting the proof measurement outputs: posed intended use must be provided, (i) Acceptable incoming image qual- including the following: ity control measures and the resulting (i) Output measure(s) must be com- image rejection rate for the clinical pared to a clinically acceptable method data must be specified, and and must adequately represent the (ii) Data must be provided within the simulated measure(s) the device pro- clinical validation study or using vides in an accurate and reproducible equivalent datasets demonstrating the manner; consistency (i.e., repeatability and re- (ii) Clinical utility of the device producibility) of the output that is rep- measurement accuracy must be dem- resentative of the range of data quality onstrated by comparison to that of likely to be encountered in the in- other available diagnostic tests (e.g., tended use population and relevant use from literature analysis); conditions in the intended use environ- (iii) Statistical performance of the ment; device within clinical risk strata (e.g., (A) Testing must be performed using age, relevant comorbidities, disease multiple operators meeting planned stability) must be reported; qualification criteria and using the (iv) The dataset must be adequately procedure that will be implemented in representative of the intended use pop- the production use of the device, and ulation for the device (e.g., patients, (B) The factors (e.g., medical imaging range of vessel sizes, imaging device dataset, operator) must be identified models). Any selection criteria or limi- regarding which were held constant tations of the samples must be fully de- and which were varied during the eval- scribed and justified; uation, and a description must be pro- (v) Statistical methods must consider vided for the computations and statis- the predefined endpoints: tical analyses used to evaluate the (A) Estimates of probabilities of in- data; correct results must be provided for (5) Human factors evaluation and val- each endpoint, idation must be provided to dem- (B) Where multiple samples from the onstrate adequate performance of the same patient are used, statistical anal- user interface to allow for users to ac- ysis must not assume statistical inde- curately measure intended parameters, pendence without adequate justifica- particularly where parameter settings tion, and that have impact on measurements re- (C) The report must provide appro- quire significant user intervention; and priate confidence intervals for each (6) Device labeling must be provided performance metric; that adequately describes the fol- (vi) Sensitivity and specificity must lowing: be characterized across the range of (i) The device’s intended use, includ- available measurements; ing the type of imaging data used, (vii) Agreement of the simulated what the device measures and outputs measure(s) with clinically acceptable to the user, whether the measure is measure(s) must be assessed across the qualitative or quantitative, the clin- full range of measurements; ical indications for which it is to be (viii) Comparison of the measure- used, and the specific population for ment performance must be provided which the device use is intended;

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(ii) Appropriate warnings specifying parameter based on information ob- the intended patient population, iden- tained from one or more electrodes, tifying anatomy and image acquisition transducers, or measuring devices. factors that may impact measurement (b) Classification. Class II (perform- results, and providing cautionary guidance standards). ance for interpretation of the provided measurements; § 870.1450 Densitometer. (iii) Key assumptions made in the (a) Identification. A densitometer is a calculation and determination of simu- device used to measure the translated measurements; mission of light through an indicator (iv) The measurement performance of in a sample of blood. the device for all presented param- (b) Classification. Class II (perform- eters, with appropriate confidence in- ance standards). tervals, and the supporting evidence for this performance. Per-vessel clin- § 870.1650 Angiographic injector and ical performance, including where ap- syringe. plicable localized performance accord- (a) Identification. An angiographic ining to vessel and segment, must be injector and syringe is a device that concluded as well as a characterization of sists of a syringe and a high-pressure the measurement error across the ex- injector which are used to inject con- pected range of measurement for key trast material into the heart, great parameters based on the clinical data; vessels, and coronary arteries to study (v) A detailed description of the pa- the heart and vessels by x-ray photog- tients studied in the clinical validation raphy. (e.g., age, gender, race or ethnicity, (b) Classification. Class II (perform- clinical stability, current treatment ance standards). regimen) as well as procedural details of the clinical study (e.g., scanner rep- § 870.1660 Indicator injector. resentation, calcium scores, use of (a) Identification. An indicator injec- beta-blockers or nitrates); and tor is an electrically or gas-powered (vi) Where significant human inter- device designed to inject accurately an face is necessary for accurate analysis, indicator solution into the blood adequately detailed description of the stream. This device may be used in analysis procedure using the device and conjuction with a densitometer or any data features that could affect ac- thermodilution device to determine curacy of results. cardiac output. [80 FR 63673, Oct. 21, 2015] (b) Classification. Class II (performance standards). § 870.1425 Programmable diagnostic computer. § 870.1670 Syringe actuator for an in- (a) Identification. A programmable di- jector. agnostic computer is a device that can (a) Identification. A syringe actuator be programmed to compute various for an injector is an electrical device physiologic or blood flow parameters that controls the timing of an injection based on the output from one or more by an angiographic or indicator injec- electrodes, transducers, or measuring tor and synchronizes the injection with devices; this device includes any asso- the electrocardiograph signal. ciated commercially supplied pro- (b) Classification. Class II (perform- grams. ance standards). (b) Classification. Class II (performance standards). § 870.1750 External programmable pacemaker pulse generator. § 870.1435 Single-function, (a) Identification. An external pro- preprogrammed diagnostic com- grammable pacemaker pulse genera- puter. tors is a device that can be pro- (a) Identification. A single-function, grammed to produce one or more preprogrammed diagnostic computer is pulses at preselected intervals; this de- a hard-wired computer that calculates vice is used in electrophysiological a specific physiological or blood-flow studies.

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(b) Classification. Class II (perform- § 870.2060 Transducer signal amplifier ance standards). and conditioner. (a) Identification. A transducer signal § 870.1800 Withdrawal-infusion pump. amplifier and conditioner is a device (a) Identification. A withdrawal-infu- used to provide the excitation energy sion pump is a device designed to inject for the transducer and to amplify or accurately drugs into the bloodstream condition the signal emitted by the and to withdraw blood samples for use transducer. in determining cardiac output. (b) Classification. Class II (perform- (b) Classification. Class II (performance standards). ance standards). § 870.2100 Cardiovascular blood flow- § 870.1875 Stethoscope. meter. (a) Manual stethoscope—(1) Identifica- (a) Identification. A cardiovascular tion. A manual stethoscope is a me- blood flowmeter is a device that is con- chanical device used to project the nected to a flow transducer that ener- sounds associated with the heart, arte- gizes the transducer and processes and ries, and veins and other internal or- displays the blood flow signal. gans. (b) Classification. Class II (perform- (2) Classification. Class I (general con- ance standards). trols). The device is exempt from the § 870.2120 Extravascular blood flow premarket notification procedures in probe. subpart E of part 807 of this chapter subject to the limitations in § 870.9. (a) Identification. An extravascular blood flow probe is an extravascular ul- (b) Electronic stethoscope—(1) Identi- trasonic or electromagnetic probe used fication. An electronic stethoscope is an in conjunction with a blood flowmeter electrically amplified device used to to measure blood flow in a chamber or project the sounds associated with the vessel. heart, arteries, and veins and other in- (b) Classification. Class II (perform- ternal organs. ance standards). (2) Classification. Class II (performance standards). § 870.2300 Cardiac monitor (including cardiotachometer and rate alarm). [45 FR 7907, Feb. 5, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38796, July 25, 2001] (a) Identification. A cardiac monitor (including cardiotachometer and rate § 870.1915 Thermodilution probe. alarm) is a device used to measure the (a) Identification. A thermodilution heart rate from an analog signal pro- probe is a device that monitors cardiac duced by an electrocardiograph, output by use of thermodilution tech- vectorcardiograph, or blood pressure niques; this device is commonly at- monitor. This device may sound an tached to a catheter that may have one alarm when the heart rate falls outside or more probes. preset upper and lower limits. (b) Classification. Class II (perform- (b) Classification. Class II (performance standards). ance standards). § 870.2310 Apex cardiograph Subpart C—Cardiovascular (vibrocardiograph). Monitoring Devices (a) Identification. An apex cardiograph (vibrocardiograph) is a device § 870.2050 Biopotential amplifier and used to amplify or condition the signal signal conditioner. from an apex cardiographic transducer (a) Identification. A biopotential am- and to produce a visual display of the plifier and signal conditioner is a de- motion of the heart; this device also vice used to amplify or condition an provides any excitation energy re- electrical signal of biologic origin. quired by the transducer. (b) Classification. Class II (perform- (b) Classification. Class II (performance standards). ance standards).

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§ 870.2320 Ballistocardiograph. special control for this device is the (a) Identification. A FDA guidance document entitled ballistocardiograph is a device, includ- ‘‘Class II Special Controls Guidance ing a supporting structure on which Document: Electrocardiograph Elec- the patient is placed, that moves in re- trodes.’’ See § 870.1(e) for availability sponse to blood ejection from the information of guidance documents. heart. The device often provides a vis- [45 FR 7907, Feb. 5, 1980, as amended at 76 FR ual display. 43585, July 21, 2011] (b) Classification. Class II (performance standards). § 870.2370 Electrocardiograph surface electrode tester. § 870.2330 Echocardiograph. (a) Identification. An electrocardio- (a) Identification. An echocardiograph graph surface electrode tester is a de- is a device that uses ultrasonic energy vice used to test the function and ap- to create images of cardiovascular plication of electrocardiograph elec- structures. It includes phased arrays trodes. and two-dimensional scanners. (b) Classification. Class II (perform- (b) Classification. Class II (performance standards). ance standards).

§ 870.2340 Electrocardiograph. § 870.2390 Phonocardiograph. (a) Identification. An electrocardio- (a) Identification. A phonocardiograph graph is a device used to process the is a device used to amplify or condition electrical signal transmitted through the signal from a heart sound trans- two or more electrocardiograph elec- ducer. This device furnishes the exci- trodes and to produce a visual display tation energy for the transducer and of the electrical signal produced by the provides a visual or audible display of heart. the heart sounds. (b) Classification. Class II (perform- (b) Classification. Class I (general con- ance standards). trols). The device is exempt from the premarket notification procedures in § 870.2350 Electrocardiograph lead switching adaptor. subpart E of part 807 of this chapter subject to the limitations in § 870.9. (a) Identification. An electrocardiograph lead switching adaptor is a pas- [45 FR 7907, Feb. 5, 1980, as amended at 61 FR sive switching device to which electro- 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] cardiograph limb and chest leads may be attached. This device is used to con- § 870.2400 Vectorcardiograph. nect various combinations of limb and (a) Identification. A vectorcardiograph chest leads to the output terminals in is a device used to process the elec- order to create standard lead combina- trical signal transmitted through elec- tions such as leads I, II, and III. trocardiograph electrodes and to (b) Classification. Class II (perform- produce a visual display of the mag- ance standards). nitude and direction of the electrical § 870.2360 Electrocardiograph elec- signal produced by the heart. trode. (b) Classification. Class II (performance standards). (a) Identification. An electrocardiograph electrode is the electrical con- § 870.2450 Medical cathode-ray tube ductor which is applied to the surface display. of the body to transmit the electrical signal at the body surface to a proc- (a) Identification. A medical cathode- essor that produces an electrocardio- ray tube display is a device designed gram or vectorcardiogram. primarily to display selected biological (b) Classification. Class II (special signals. This device often incorporates controls). The device is exempt from special display features unique to a the premarket notification procedures specific biological signal. in subpart E of part 807 of this chapter (b) Classification. Class II (perform- subject to the limitations in § 870.9. The ance standards).

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§ 870.2600 Signal isolation system. § 870.2700 Oximeter. (a) Identification. A signal isolation (a) Identification. An oximeter is a de- system is a device that electrically iso- vice used to transmit radiation at a lates the patient from equipment con- known wavelength(s) through blood nected to the commercial power supply and to measure the blood oxygen satu- received from a utility company. This ration based on the amount of reflected isolation may be accomplished, for ex- or scattered radiation. It may be used ample, by transformer coupling, acous- alone or in conjunction with a tic coupling, or optical coupling. fiberoptic oximeter catheter. (b) Classification. Class I (general con- (b) Classification. Class II (perform- trols). The device is exempt from the ance standards). premarket notification procedures in § 870.2710 Ear oximeter. subpart E of part 807 of this chapter subject to the limitations in § 870.9. (a) Identification. An ear oximeter is an extravascular device used to trans- [45 FR 7907, Feb. 5, 1980, as amended at 61 FR mit light at a known wavelength(s) 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] through blood in the ear. The amount of reflected or scattered light as indi- § 870.2620 Line isolation monitor. cated by this device is used to measure (a) Identification. A line isolation the blood oxygen saturation. monitor is a device used to monitor the (b) Classification. Class II (perform- electrical leakage current from a ance standards). power supply electrically isolated from the commercial power supply received § 870.2750 Impedance phlebograph. from a utility company. (a) Identification. An impedance (b) Classification. Class I (general con- phlebograph is a device used to provide trols). The device is exempt from the a visual display of the venous pulse or premarket notification procedures in drainage by measuring electrical im- subpart E of part 807 of this chapter pedance changes in a region of the subject to the limitations in § 870.9. body. (b) Classification. Class II (perform- [45 FR 7907, Feb. 5, 1980, as amended at 61 FR ance standards). 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] § 870.2770 Impedance plethysmograph. § 870.2640 Portable leakage current (a) Identification. An impedance alarm. plethysmograph is a device used to es- (a) Identification. A portable leakage timate peripheral blood flow by meas- current alarm is a device used to measuring electrical impedance changes in ure the electrical leakage current be- a region of the body such as the arms tween any two points of an electrical and legs. system and to sound an alarm if the (b) Classification. Class II (perform- current exceeds a certain threshold. ance standards). (b) Classification. Class I (general controls). The device is exempt from the § 870.2780 Hydraulic, pneumatic, or premarket notification procedures in photoelectric plethysmographs. subpart E of part 807 of this chapter (a) Identification. A hydraulic, pneu- subject to the limitations in § 870.9. matic, or photoelectric plethysmograph is a device used to es- [45 FR 7907, Feb. 5, 1980, as amended at 61 FR timate blood flow in a region of the 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] body using hydraulic, pneumatic, or photoelectric measurement techniques. § 870.2675 Oscillometer. (b) Classification. Class II (perform- (a) Identification. An oscillometer is a ance standards). device used to measure physiological oscillations of any kind, e.g., changes § 870.2800 Medical magnetic tape rein the volume of arteries. corder. (b) Classification. Class II (perform- (a) Identification. A medical magnetic ance standards). tape recorder is a device used to record

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and play back signals from, for exam- guidance document entitled ‘‘Class II ple, physiological amplifiers, signal Special Controls Guidance Document: conditioners, or computers. Implantable Intra-Aneurysm Pressure (b) Classification. Class II (perform- Measurement System.’’ See § 870.1 (e) ance standards). for the availability of this guidance document. § 870.2810 Paper chart recorder. (a) Identification. A paper chart re- [71 FR 7871, Feb. 15, 2006] corder is a device used to print on paper, and create a permanent record § 870.2860 Heart sound transducer. of the signal from, for example, a phys- (a) Identification. A heart sound iological amplifier, signal conditioner, transducer is an external transducer or computer. that exhibits a change in mechanical (b) Classification. Class I (general con- or electrical properties in relation to trols). The device is exempt from the sounds produced by the heart. This de- premarket notification procedures in vice may be used in conjunction with a subpart E of part 807 of this chapter phonocardiograph to record heart subject to the limitations in § 870.9. sounds. [45 FR 7907, Feb. 5, 1980, as amended at 61 FR (b) Classification. Class II (perform- 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] ance standards).

§ 870.2840 Apex cardiographic trans- § 870.2870 Catheter tip pressure transducer. ducer. (a) Identification. An apex cardiographic transducer is a device used to (a) Identification. A catheter tip pres- detect motion of the heart (accelera- sure transducer is a device incor- tion, velocity, or displacement) by porated into the distal end of a cath- changes in the mechanical or electrical eter. When placed in the bloodstream, properties of the device. its mechanical or electrical properties (b) Classification. Class II (perform- change in relation to changes in blood ance standards). pressure. These changes are transmitted to accessory equipment for § 870.2850 Extravascular blood pres- processing. sure transducer. (b) Classification. Class II (perform- (a) Identification. An extravascular ance standards). blood pressure transducer is a device used to measure blood pressure by § 870.2880 Ultrasonic transducer. changes in the mechanical or electrical (a) Identification. An ultrasonic trans- properties of the device. The proximal ducer is a device applied to the skin to end of the transducer is connected to a transmit and receive ultrasonic energy pressure monitor that produces an ana- that is used in conjunction with an log or digital electrical signal related to the electrical or mechanical changes echocardiograph to provide imaging of produced in the transducer. cardiovascular structures. This device (b) Classification. Class II (perform- includes phased arrays and two-dimen- ance standards). sional scanning transducers. (b) Classification. Class II (perform- § 870.2855 Implantable Intra-aneurysm ance standards). Pressure Measurement System. (a) Identification. Implantable intra- § 870.2890 Vessel occlusion transducer. aneurysm pressure measurement sys- (a) Identification. A vessel occlusion tem is a device used to measure the transducer is a device used to provide intra-sac pressure in a vascular aneu- an electrical signal corresponding to rysm. The device consists of a pressure sounds produced in a partially occluded transducer that is implanted into the vessel. This device includes motion, aneurysm and a monitor that reads the sound, and ultrasonic transducers. pressure from the transducer. (b) Classification. Class II (perform- (b) Classification. Class II (special controls). The special control is FDA’s ance standards).

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§ 870.2900 Patient transducer and elec- signed to occlude partially the vena trode cable (including connector). cava for the purpose of inhibiting the (a) Identification. A patient trans- flow of thromboemboli through that ducer and electrode cable (including vessel. connector) is an electrical conductor (b) Classification. Class II (perform- used to transmit signals from, or power ance standards). or excitation signals to, patient-con- § 870.3300 Vascular embolization de- nected electrodes or transducers. vice. (b) Classification. Class II (performance standards). (a) Identification. A vascular embolization device is an intravascular § 870.2910 Radiofrequency physio- implant intended to control hem- logical signal transmitter and re- orrhaging due to aneurysms, certain ceiver. types of tumors (e.g., nephroma, (a) Identification. A radiofrequency hepatoma, uterine fibroids), and physiological signal transmitter and arteriovenous malformations. This receiver is a device used to condition a does not include cyanoacrylates and physiological signal so that it can be other embolic agents, which act by po- transmitted via radiofrequency from lymerization or precipitation. one location to another, e.g., a central Embolization devices used in neuro- monitoring station. The received signal vascular applications are also not in- is reconditioned by the device into its cluded in this classification, see original format so that it can be dis- § 882.5950 of this chapter. played. (b) Classification. Class II (special (b) Classification. Class II (perform- controls.) The special control for this ance standards). device is the FDA guidance document entitled ‘‘Class II Special Controls § 870.2920 Telephone electrocardio- Guidance Document: Vascular and graph transmitter and receiver. Neurovascular Embolization Devices.’’ (a) Identification. A telephone electro- For availability of this guidance docu- cardiograph transmitter and receiver is ment, see § 870.1(e). a device used to condition an electro- [69 FR 77899, Dec. 29, 2004] cardiograph signal so that it can be transmitted via a telephone line to an- § 870.3375 Cardiovascular other location. This device also in- intravascular filter. cludes a receiver that reconditions the (a) Identification. A cardiovascular received signal into its original format intravascular filter is an implant that so that it can be displayed. The device is placed in the inferior vena cava for includes devices used to transmit and the purpose of preventing pulmonary receive pacemaker signals. thromboemboli (blood clots generated (b) Classification. Class II (perform- in the lower limbs and broken loose ance standards). into the blood stream) from flowing into the right side of the heart and the Subpart D—Cardiovascular pulmonary circulation. Prosthetic Devices (b) Classification. Class II. The special controls for this device are: § 870.3250 Vascular clip. (1) ‘‘Use of International Standards (a) Identification. A vascular clip is an Organization’s ISO 10993 ‘Biological implanted extravascular device de- Evaluation of Medical Devices Part I: signed to occlude, by compression, Evaluation and Testing,’ ’’ and blood flow in small blood vessels other (2) FDA’s: than intracranial vessels. (i) ‘‘510(k) Sterility Review Guidance (b) Classification. Class II (perform- and Revision of 2/12/90 (K90–1)’’ and ance standards). (ii) ‘‘Guidance for Cardiovascular Intravascular Filter 510(k) Submis- § 870.3260 Vena cava clip. sions.’’ (a) Identification. A vena cava clip is [45 FR 7907, Feb. 5, 1980, as amended at 52 FR an implanted extravascular device de- 17736, May 11, 1987; 65 FR 17144, Mar. 31, 2000]

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§ 870.3450 Vascular graft prosthesis. (6) The sale, distribution, and use of the device are restricted to prescrip- (a) Identification. A vascular graft tion use in accordance with 21 CFR prosthesis is an implanted device in- 801.109 of this chapter; and tended to repair, replace, or bypass sec- (7) Labeling must bear all informa- tions of native or artificial vessels, ex- tion required for the safe and effective cluding coronary or cerebral use of the device as outlined in vasculature, and to provide vascular § 801.109(c) of this chapter, including a access. It is commonly constructed of detailed summary of the non-clinical materials such as polyethylene and clinical evaluations pertinent to terephthalate and polytetrafluoro- use of the device. ethylene, and it may be coated with a biological coating, such as albumin or [77 FR 8119, Feb. 14, 2012] collagen, or a synthetic coating, such as silicone. The graft structure itself is § 870.3470 Intracardiac patch or pledg- not made of materials of animal origin, et made of polypropylene, poly- including human umbilical cords. ethylene terephthalate, or polytetrafluoroethylene. (b) Classification. Class II (special controls). The special control for this (a) Identification. An intracardiac device is the FDA guidance document patch or pledget made of poly- entitled ‘‘Guidance Document for Vas- propylene, polyethylene terephthalate, cular Prostheses 510(k) Submissions.’’ or polytetrafluoroethylene is a fabric device placed in the heart that is used [66 FR 18542, Apr. 10, 2001] to repair septal defects, for patch grafting, to repair tissue, and to buttress su- § 870.3460 Endovascular Suturing Sys- tures. tem. (b) Classification. Class II (perform- (a) Identification. An endovascular su- ance standards). turing system is a medical device intended to provide fixation and sealing § 870.3535 Intra-aortic balloon and between an endovascular graft and the control system. native artery. The system is comprised (a) Identification. An intra-aortic bal- of the implant device and an loon and control system is a prescrip- endovascular delivery device used to tion device that consists of an inflat- implant the endovascular suture. able balloon, which is placed in the (b) Classification. Class II (special aorta to improve cardiovascular func- controls). The special controls for this tioning during certain life-threatening device are: emergencies, and a control system for (1) The device should be dem- regulating the inflation and deflation onstrated to be biocompatible; of the balloon. The control system, (2) Sterility and shelf life testing which monitors and is synchronized should demonstrate the sterility of pa- with the electrocardiogram, provides a tient-contacting components and the means for setting the inflation and de- shelf-life of these components; flation of the balloon with the cardiac (3) Non-clinical and clinical perform- cycle. ance testing should demonstrate sub- (b) Classification. (1) Class II (special stantial equivalence in safety and ef- controls) when the device is indicated fectiveness, including durability, com- for acute coronary syndrome, cardiac patibility, migration resistance, corro- and non-cardiac surgery, or complica- sion resistance, and delivery and de- tions of heart failure. The special con- ployment; trols for this device are: (4) Non-clinical testing should evalu- (i) Appropriate analysis and non-clin- ate the compatibility of the device in ical testing must be conducted to vali- an magnetic resonance (MR) environ- date electromagnetic compatibility ment; and electrical safety of the device; (5) Appropriate analysis and non-clin- (ii) Software verification, validation, ical testing should validate electro- and hazard analysis must be performed; magnetic compatibility (EMC) and (iii) The device must be dem- electrical safety; onstrated to be biocompatible;

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(iv) Sterility and shelf-life testing or before November 21, 2011, been found must demonstrate the sterility of pa- to be substantially equivalent to any tient-contacting components and the ventricular bypass (assist) device that shelf life of these components; was in commercial distribution before (v) Non-clinical performance evalua- May 28, 1976. Any other ventricular by- tion of the device must demonstrate pass (assist) device shall have an ap- mechanical integrity, durability, and proved PMA or declared completed reliability to support its intended pur- PDP in effect before being placed in pose; and commercial distribution. (vi) Labeling must include a detailed summary of the device- and procedure- [45 FR 7907, Feb. 5, 1980, as amended at 52 FR related complications pertinent to use 17736, May 11, 1987; 76 FR 50666, Aug. 16, 2011] of the device. (2) Class III (premarket approval) § 870.3600 External pacemaker pulse when the device is indicated for septic generator. shock and pulsatile flow generation. (a) Identification. An external pace- (c) Date premarket approval application maker pulse generator (EPPG) is a pre- (PMA) or notice of completion of product scription device that has a power sup- development protocol (PDP) is required. A ply and electronic circuits that PMA or notice of completion of a PDP produce a periodic electrical pulse to is required to be filed with the Food stimulate the heart. This device, which and Drug Administration on or before is used outside the body, is used as a March 31, 2014, for any intra-aortic bal- temporary substitute for the heart’s loon and control system indicated for intrinsic pacing system until a perma- septic shock or pulsatile flow genera- nent pacemaker can be implanted, or tion that was in commercial distribu- to control irregular heartbeats in pa- tion before May 28, 1976, or that has, on tients following cardiac surgery or a or before March 31, 2014, been found to myocardial infarction. The device may be substantially equivalent to any have adjustments for impulse strength, intra-aortic balloon and control system duration, R-wave sensitivity, and other indicated for septic shock or pulsatile pacing variables. flow generation that was in commercial distribution before May 28, 1976. (b) Classification. Class II (special Any other intra-aortic balloon and con- controls). The special controls for this trol system indicated for septic shock device are: or pulsatile flow generation shall have (1) Appropriate analysis/testing must an approved PMA or declared com- validate electromagnetic compatibility pleted PDP in effect before being (EMC) within a hospital environment. placed in commercial distribution. (2) Electrical bench testing must demonstrate device safety during in- [78 FR 79303, Dec. 31, 2013] tended use. This must include testing § 870.3545 Ventricular bypass (assist) with the specific power source (i.e., bat- device. tery power, AC mains connections, or both). (a) Identification. A ventricular bypass (assist) device is a device that as- (3) Non-clinical performance testing sists the left or right ventricle in main- data must demonstrate the perform- taining circulatory blood flow. The de- ance characteristics of the device. vice is either totally or partially im- Testing must include the following: planted in the body. (i) Testing must demonstrate the ac- (b) Classification. Class III (premarket curacy of monitoring functions, approval). alarms, measurement features, thera- (c) Date PMA or notice of completion of peutic features, and all adjustable or PDP is required. A PMA or notice of programmable parameters as identified completion of a PDP is required to be in labeling; filed with the Food and Drug Adminis- (ii) Mechanical bench testing of ma- tration on or before November 21, 2011, terial strength must demonstrate that for any ventricular bypass (assist) de- the device and connection cables will vice that was in commercial distribu- withstand forces or conditions encoun- tion before May 28, 1976, or that has, on tered during use;

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(iii) Simulated use analysis/testing (b) Classification. Class II (special must demonstrate adequate user inter- controls). The special controls for this face for adjustable parameters, per- device are: formance of alarms, display screens, (1) Appropriate analysis/testing must interface with external devices (e.g. validate electromagnetic compatibility data storage, printing), and indi- (EMC) within a hospital environment. cator(s) functionality under intended (2) Electrical bench testing must use conditions; and demonstrate device safety during in- (iv) Methods and instructions for tended use. This must include testing cleaning the pulse generator and con- with the specific power source (i.e., bat- nection cables must be validated. tery power, AC mains connections, or (4) Appropriate software verification, both). validation, and hazard analysis must (3) Non-clinical performance testing be performed. data must demonstrate the perform- (5) Labeling must include the fol- ance characteristics of the device. lowing: Testing must include the following: (i) The labeling must clearly state (i) Testing must demonstrate the ac- that these devices are intended for use curacy of monitoring functions, in a hospital environment and under alarms, measurement features, thera- the supervision of a clinician trained in peutic features, and all adjustable or their use; programmable parameters as identified (ii) Connector terminals should be in labeling; clearly, unambiguously marked on the (ii) Mechanical bench testing of ma- outside of the EPPG device. The mark- terial strength must demonstrate that ings should identify positive (+) and the device and connection cables will negative (¥) polarities. Dual chamber withstand forces or conditions encoun- devices should clearly identify atrial tered during use; and ventricular terminals; (iii) Simulated use analysis/testing (iii) The labeling must list all pacing must demonstrate adequate user inter- modes available in the device; face for adjustable parameters, per- (iv) Labeling must include a detailed formance of alarms, display screens, description of any special capabilities interface with external devices (e.g. (e.g., overdrive pacing or automatic data storage, printing), and indi- mode switching); and cator(s) functionality under intended use conditions; and (v) Appropriate electromagnetic compatibility information must be in- (iv) Methods and instructions for cluded. cleaning the pulse generator and connection cables must be validated. [81 FR 22529, Apr. 18, 2016] (4) Appropriate software verification, validation, and hazard analysis must § 870.3605 Pacing system analyzer. be performed. (a) Identification. A pacing system an- (5) Labeling must include the fol- alyzer (PSA) is a prescription device lowing: that combines the functionality of a (i) The labeling must clearly state pacemaker electrode function tester that these devices are intended for use (§ 870.3720) and an external pacemaker in a hospital environment and under pulse generator (EPPG) (§ 870.3600). It is the supervision of a clinician trained in connected to a pacemaker lead and their use; uses a power supply and electronic cir- (ii) Connector terminals should be cuits to supply an accurately cali- clearly, unambiguously marked on the brated, variable pacing pulse for meas- outside of the PSA. The markings uring the patient’s pacing threshold should identify positive (+) and nega- and intracardiac R-wave potential. A tive (¥) polarities. Dual chamber de- PSA may be a single, dual, or triple vices should clearly identify atrial and chamber system and can simulta- ventricular terminals. Triple chamber neously deliver pacing therapy while devices should clearly identify atrial, testing one or more implanted pacing right ventricular, and left ventricular leads. terminals;

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(iii) The labeling must list all pacing (b) Classification. Class II (special modes available in the device; controls). The special control for this (iv) Labeling must include a detailed device is the FDA guidance document description of any special capabilities entitled ‘‘Guidance for the Submission (e.g., overdrive pacing or automatic of Research and Marketing Applica- mode switching); tions for Permanent Pacemaker Leads (v) Labeling must limit the use of ex- and for Pacemaker Lead Adaptor 510(k) ternal pacing to the implant procedure; Submissions.’’ and [45 FR 7907, Feb. 5, 1980, as amended at 52 FR (vi) Appropriate electromagnetic 17736, May 11, 1987; 66 FR 18542, Apr. 10, 2001] compatibility information must be included. § 870.3630 Pacemaker generator function analyzer. [81 FR 22350, Apr. 18, 2016] (a) Identification. A pacemaker gener- § 870.3610 Implantable pacemaker ator function analyzer is a device that pulse generator. is connected to a pacemaker pulse generator to test any or all of the genera- (a) Identification. An implantable tor’s parameters, including pulse dura- pacemaker pulse generator is a device tion, pulse amplitude, pulse rate, and that has a power supply and electronic sensing threshold. circuits that produce a periodic elec- (b) Classification. Class II (perform- trical pulse to stimulate the heart. ance standards). This device is used as a substitute for the heart’s intrinsic pacing system to § 870.3640 Indirect pacemaker gener- correct both intermittent and contin- ator function analyzer. uous cardiac rhythm disorders. This (a) Identification. An indirect pace- device may include triggered, inhib- maker generator function analyzer is ited, and asynchronous modes and is an electrically powered device that is implanted in the human body. used to determine pacemaker function (b) Classification. Class III (premarket or pacemaker battery function by peri- approval). odically monitoring an implanted pace- (c) Date PMA or notice of completion of maker’s pulse rate and pulse width. PDP is required. A PMA or notice of The device is noninvasive, and it de- completion of a PDP is required to be tects pacemaker pulse rate and width filed with the Food and Drug Adminis- via external electrodes in contact with tration on or before September 20, 2012, the patient’s skin. for any implantable pacemaker pulse (b) Classification. Class II (perform- generator device that was in commer- ance standards). cial distribution before May 28, 1976, or that has, on or before September 20, § 870.3650 Pacemaker polymeric mesh 2012, been found to be substantially bag. equivalent to any implantable pace- (a) Identification. A pacemaker poly- maker pulse generator device that was meric mesh bag is an implanted device in commercial distribution before May used to hold a pacemaker pulse gener- 28, 1976. Any other implantable pace- ator. The bag is designed to create a maker pulse generator device shall stable implant environment for the have an approved PMA or declared pulse generator. completed PDP in effect before being (b) Classification. Class I (general con- placed in commercial distribution. trols). The device is exempt from the [45 FR 7907, Feb. 5, 1980, as amended at 52 FR premarket notification procedures in 17736, May 11, 1987; 77 FR 37576, June 22, 2012] subpart E of part 807 of this chapter subject to the limitations in § 870.9. § 870.3620 Pacemaker lead adaptor. [45 FR 7907, Feb. 5, 1980, as amended at 61 FR (a) Identification. A pacemaker lead 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] adaptor is a device used to adapt a pacemaker lead so that it can be con- § 870.3670 Pacemaker charger. nected to a pacemaker pulse generator (a) Identification. A pacemaker charg- produced by a different manufacturer. er is a device used transcutaneously to

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recharge the batteries of a recharge- fect before being placed in commercial able pacemaker. distribution. (b) Classification. Class I (general con- [45 FR 7907, Feb. 5, 1980, as amended at 52 FR trols). The device is exempt from the 17736, May 11, 1987; 77 FR 39927, July 6, 2012] premarket notification procedures in subpart E of part 807 of this chapter § 870.3690 Pacemaker test magnet. subject to the limitations in § 870.9. (a) Identification. A pacemaker test [45 FR 7907, Feb. 5, 1980, as amended at 61 FR magnet is a device used to test an in- 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] hibited or triggered type of pacemaker pulse generator and cause an inhibited § 870.3680 Cardiovascular permanent or triggered generator to revert to or temporary pacemaker electrode. asynchronous operation. (a) Temporary pacemaker electrode—(1) (b) Classification. Class I (general con- Identification. A temporary pacemaker trols). The device is exempt from the electrode is a device consisting of flexi- premarket notification procedures in ble insulated electrical conductors subpart E of part 807 of this chapter subject to the limitations in § 870.9. with one end connected to an external pacemaker pulse generator and the [45 FR 7907, Feb. 5, 1980, as amended at 61 FR other end applied to the heart. The de- 1121, Jan. 16, 1996; 66 FR 38796, July 25, 2001] vice is used to transmit a pacing electrical stimulus from the pulse gener- § 870.3700 Pacemaker programmers. ator to the heart and/or to transmit (a) Identification. A pacemaker pro- the electrical signal of the heart to the grammer is a device used to pulse generator. noninvasively change one or more of (2) Classification. Class II (perform- the electrical operating characteristics ance standards). of a pacemaker. (b) Permanent pacemaker electrode—(1) (b) Classification. Class III (premarket Identification. A permanent pacemaker approval). electrode is a device consisting of flexi- (c) Date PMA or notice of completion of ble insulated electrical conductors PDP is required. A PMA or notice of with one end connected to an completion of a PDP is required to be implantable pacemaker pulse gener- filed with the Food and Drug Adminis- tration on or before September 20, 2012, ator and the other end applied to the for any pacemaker programmer that heart. The device is used to transmit a was in commercial distribution before pacing electrical stimulus from the May 28, 1976, or that has, on or before pulse generator to the heart and/or to September 20, 2012, been found to be transmit the electrical signal of the substantially equivalent to any pace- heart to the pulse generator. maker programmer that was in com- (2) Classification. Class III (premarket mercial distribution before May 28, approval). 1976. Any other pacemaker programmer (c) Date PMA or notice of completion of shall have an approved PMA or de- PDP is required. A PMA or notice of clared completed PDP in effect before completion of a PDP is required to be being placed in commercial distribu- filed with the Food and Drug Adminis- tion. tration on or before October 4, 2012, for [45 FR 7907, Feb. 5, 1980, as amended at 52 FR any permanent pacemaker electrode 17736, May 11, 1987; 77 FR 37573, June 22, 2012] device that was in commercial distribution before May 28, 1976, or that § 870.3710 Pacemaker repair or re- has, on or before October 4, 2012, been placement material. found to be substantially equivalent to (a) Identification. A pacemaker repair any permanent pacemaker electrode or replacement material is an adhesive, device that was in commercial dis- a sealant, a screw, a crimp, or any tribution before May 28, 1976. Any other material used to repair a pace- other pacemaker repair or replacement maker lead or to reconnect a pace- material device shall have an approved maker lead to a pacemaker pulse gen- PMA or declared completed PDP in ef- erator.

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(b) Classification. Class III (premarket device is the FDA guidance document approval). entitled ‘‘Guidance for Annuloplasty (c) Date PMA or notice of completion of Rings 510(k) Submissions.’’ PDP is required. A PMA or notice of completion of a PDP is required to be [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 66 FR 18542, Apr. 10, 2001] filed with the Food and Drug Adminis- tration on or before November 21, 2011, § 870.3850 Carotid sinus nerve stimu- for any pacemaker repair or replace- lator. ment material device that was in commercial distribution before May 28, (a) Identification. A carotid sinus 1976, or that has, on or before Novem- nerve stimulator is an implantable de- ber 21, 2011, been found to be substan- vice used to decrease arterial pressure tially equivalent to any pacemaker re- by stimulating Hering’s nerve at the pair or replacement material device carotid sinus. that was in commercial distribution (b) Classification. Class III (premarket before May 28, 1976. Any other pace- approval). maker repair or replacement material (c) Date PMA or notice of completion of device shall have an approved PMA or a PDP is required. A PMA or a notice of declared completed PDP in effect be- completion of a PDP is required to be fore being placed in commercial dis- filed with the Food and Drug Adminis- tribution. tration on or before December 26, 1996 [45 FR 7907, Feb. 5, 1980, as amended at 52 FR for any carotid sinus nerve stimulator 17736, May 11, 1987; 76 FR 50666, Aug. 16, 2011] that was in commercial distribution before May 28, 1976, or that has, on or § 870.3720 Pacemaker electrode func- before December 26, 1996 been found to tion tester. be substantially equivalent to a carotid (a) Identification. A pacemaker elec- sinus nerve stimulator that was in trode function tester is a device which commercial distribution before May 28, is connected to an implanted pace- 1976. Any other carotid sinus nerve maker lead that supplies an accurately stimulator shall have an approved calibrated, variable pacing pulse for PMA or a declared completed PDP in measuring the patient’s pacing thresh- effect before being placed in commer- old and intracardiac R-wave potential. cial distribution. (b) Classification. Class II (performance standards). [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 17736, May 11, 1987; 61 FR 50706, Sept. 27, 1996] § 870.3730 Pacemaker service tools. § 870.3925 Replacement heart valve. (a) Identification. Pacemaker service tools are devices such as screwdrivers (a) Identification. A replacement and Allen wrenches, used to repair a heart valve is a device intended to per- pacemaker lead or to reconnect a pace- form the function of any of the heart’s maker lead to a pacemaker generator. natural valves. This device includes (b) Classification. Class I (general con- valves constructed of prosthetic mate- trols). The device is exempt from the rials, biologic valves (e.g., porcine premarket notification procedures in valves), or valves constructed of a com- subpart E of part 807 of this chapter bination of prosthetic and biologic ma- subject to the limitations in § 870.9. terials. [45 FR 7907, Feb. 5, 1980, as amended at 54 FR (b) Classification. Class III (premarket 25049, June 12, 1989; 66 FR 38797, July 25, 2001] approval). (c) Date premarket approval application § 870.3800 Annuloplasty ring. (PMA) or notice of completion of a prod- (a) Identification. An annuloplasty uct development protocol (PDP) is re- ring is a rigid or flexible ring im- quired. A PMA or a notice of comple- planted around the mitral or tricuspid tion of a PDP is required to be filed heart valve for reconstructive treat- with the Food and Drug Administra- ment of valvular insufficiency. tion on or before December 9, 1987 for (b) Classification. Class II (special any replacement heart valve that was controls). The special control for this in commercial distribution before May

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28, 1976, or that has on or before De- (>6 hours) is a system of devices and cember 9, 1987 been found to be sub- accessories that provides assisted stantially equivalent to a replacement extracorporeal circulation and physio- heart valve that was in commercial logic gas exchange of the patient’s distribution before May 28, 1976. Any blood in patients with acute res- other replacement heart valve shall piratory failure or acute have an approved PMA or a declared cardiopulmonary failure, where other completed PDP in effect before being available treatment options have placed in commercial distribution. failed, and continued clinical deterioration is expected or the risk of death [45 FR 7907, Feb. 5, 1980, as amended at 52 FR 18163, May 13, 1987; 52 FR 23137, June 17, 1987] is imminent. The main devices and accessories of the system include, but are § 870.3935 Prosthetic heart valve hold- not limited to, the console (hardware), er. software, and disposables, including, (a) Identification. A prosthetic heart but not limited to, an oxygenator, valve holder is a device used to hold a blood pump, heat exchanger, cannulae, replacement heart valve while it is tubing, filters, and other accessories being sutured into place. (e.g., monitors, detectors, sensors, con- (b) Classification. Class I. The device nectors). is exempt from the premarket notifica- (b) Classification—Class II (special tion procedures in subpart E of part 807 controls). The special controls for this of this chapter. device are: (1) The technological characteristics [45 FR 7907, Feb. 5, 1980, as amended at 61 FR of the device must ensure that the ge- 1121, Jan. 16, 1996] ometry and design parameters are con- § 870.3945 Prosthetic heart valve sizer. sistent with the intended use, and that the devices and accessories in the cir- (a) Identification. A prosthetic heart cuit are compatible; valve sizer is a device used to measure (2) The devices and accessories in the the size of the natural valve opening to circuit must be demonstrated to be bio- determine the size of the appropriate compatible; replacement heart valve. (3) Sterility and shelf-life testing (b) Classification. Class I (general con- must demonstrate the sterility of any trols). The device is exempt from the patient-contacting devices and acces- premarket notification procedures in sories in the circuit and the shelf life of subpart E of part 807 of this chapter these devices and accessories; subject to the limitations in § 870.9. (4) Non-clinical performance evalua- [45 FR 7907, Feb. 5, 1980, as amended at 61 FR tion of the devices and accessories in 1121, Jan. 16, 1996; 66 FR 38797, July 25, 2001] the circuit must demonstrate substantial equivalence of the performance Subpart E—Cardiovascular characteristics on the bench, mechan- Surgical Devices ical integrity, electromagnetic compatibility (where applicable), software, § 870.4075 Endomyocardial biopsy de- durability, and reliability; vice. (5) In vivo evaluation of the devices (a) Identification. An endomyocardial and accessories in the circuit must biopsy device is a device used in a cath- demonstrate their performance over eterization procedure to remove sam- the intended duration of use, including ples of tissue from the inner wall of the a detailed summary of the clinical heart. evaluation pertinent to the use of the (b) Classification. Class II (perform- devices and accessories to demonstrate ance standards). their effectiveness if a specific indication (patient population and/or condi- § 870.4100 Extracorporeal circuit and tion) is identified; and accessories for long-term res- (6) Labeling must include a detailed piratory/cardiopulmonary failure. summary of the non-clinical and in (a) Identification. An extracorporeal vivo evaluations pertinent to use of the circuit and accessories for long-term devices and accessories in the circuit respiratory/cardiopulmonary support and adequate instructions with respect

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to anticoagulation, circuit setup, per- the vessels, perfuse the coronary arte- formance characteristics with respect ries, and to interconnect the catheters to compatibility among different de- and cannulas with an oxygenator. The vices and accessories in the circuit, and device includes accessory bypass equip- maintenance during a procedure. ment. (b) Classification. Class II (perform- [81 FR 7451, Feb. 12, 2016] ance standards). § 870.4200 Cardiopulmonary bypass accessory equipment. § 870.4220 Cardiopulmonary bypass heart-lung machine console. (a) Identification. Cardiopulmonary bypass accessory equipment is a device (a) Identification. A cardiopulmonary that has no contact with blood and bypass heart-lung machine console is a that is used in the cardiopulmonary device that consists of a control panel bypass circuit to support, adjoin, or and the electrical power and control connect components, or to aid in the circuitry for a heart-lung machine. The setup of the extracorporeal line, e.g., console is designed to interface with an oxygenator mounting bracket or the basic units used in a gas exchange system-priming equipment. system, including the pumps, (b) Classification. (1) Class I. The de- oxygenator, and heat exchanger. vice is classified as class I if it does not (b) Classification. Class II (perform- involve an electrical connection to the ance standards). patient. The device is exempt from the premarket notification procedures in § 870.4230 Cardiopulmonary bypass defoamer. subpart E of part 807 of this chapter subject to § 870.9. (a) Identification. A cardiopulmonary (2) Class II (special controls). The de- bypass defoamer is a device used in vice is classified as class II if it in- conjunction with an oxygenator during volves an electrical connection to the cardiopulmonary bypass surgery to re- patient. The special controls are as fol- move gas bubbles from the blood. lows: (b) Classification. Class II (special (i) The performance standard under controls). The special control for this part 898 of this chapter, and device is the FDA guidance document (ii) The guidance document entitled entitled ‘‘Guidance for Extracorporeal ‘‘Guidance on the Performance Stand- Blood Circuit Defoamer 510(k) Submis- ard for Electrode Lead Wires and Pa- sions.’’ tient Cables.’’ The device is exempt [45 FR 7907, Feb. 5, 1980, as amended at 52 FR from the premarket notification proce- 17737, May 11, 1987; 66 FR 18542, Apr. 10, 2001] dures in subpart E of part 807 of this chapter subject to § 870.9. § 870.4240 Cardiopulmonary bypass heat exchanger. [65 FR 19319, Apr. 11, 2000] (a) Identification. A cardiopulmonary § 870.4205 Cardiopulmonary bypass bypass heat exchanger is a device, con- bubble detector. sisting of a heat exchange system used (a) Identification. A cardiopulmonary in extracorporeal circulation to warm bypass bubble detector is a device used or cool the blood or perfusion fluid to detect bubbles in the arterial return flowing through the device. line of the cardiopulmonary bypass cir- (b) Classification. Class II (perform- cuit. ance standards). (b) Classification. Class II (performance standards). § 870.4250 Cardiopulmonary bypass temperature controller. § 870.4210 Cardiopulmonary bypass (a) Identification. A cardiopulmonary vascular catheter, cannula, or tub- bypass temperature controller is a de- ing. vice used to control the temperature of (a) Identification. A cardiopulmonary the fluid entering and leaving a heat bypass vascular catheter, cannula, or exchanger. tubing is a device used in (b) Classification. Class II (perform- cardiopulmonary surgery to cannulate ance standards).

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§ 870.4260 Cardiopulmonary bypass ar- (b) Classification. Class II (perform- terial line blood filter. ance standards). (a) Identification. A cardiopulmonary bypass arterial line blood filter is a de- § 870.4300 Cardiopulmonary bypass vice used as part of a gas exchange gas control unit. (oxygenator) system to filter nonbio- (a) Identification. A cardiopulmonary logic particles and emboli (blood clots bypass gas control unit is a device used or pieces of foreign material flowing in to control and measure the flow of gas the bloodstream which will obstruct into the oxygenator. The device is cali- circulation by blocking a vessel) out of brated for a specific gas. the blood. It is used in the arterial re- (b) Classification. Class II (perform- turn line. ance standards). (b) Classification. Class II (special controls). The special control for this § 870.4310 Cardiopulmonary bypass device is the FDA guidance document coronary pressure gauge. entitled ‘‘Guidance for Cardiopulmonary Bypass Arterial Line (a) Identification. A cardiopulmonary Blood Filter 510(k) Submissions.’’ bypass coronary pressure gauge is a device used in cardiopulmonary bypass [45 FR 7907, Feb. 5, 1980, as amended at 52 FR surgery to measure the pressure of the 17737, May 11, 1987; 66 FR 18542, Apr. 10, 2001] blood perfusing the coronary arteries. § 870.4270 Cardiopulmonary bypass (b) Classification. Class II (perform- cardiotomy suction line blood filter. ance standards). (a) Identification. A cardiopulmonary bypass cardiotomy suction line blood § 870.4320 Cardiopulmonary bypass filter is a device used as part of a gas pulsatile flow generator. exchange (oxygenator) system to filter (a) Identification. A cardiopulmonary nonbiologic particles and emboli (a bypass pulsatile flow generator is an blood clot or a piece of foreign mate- electrically and pneumatically oper- rial flowing in the bloodstream which ated device used to create pulsatile will obstruct circulation by blocking a blood flow. The device is placed in a vessel) out of the blood. This device is cardiopulmonary bypass circuit down- intended for use in the cardiotomy suc- stream from the oxygenator. tion line. (b) Classification. Class III (premarket (b) Classification. Class II (perform- approval). ance standards). (c) Date PMA or notice of completion § 870.4280 Cardiopulmonary prebypass of PDP is required. A PMA or notice of filter. completion of a PDP is required to be (a) Identification. A cardiopulmonary filed with the Food and Drug Adminis- prebypass filter is a device used during tration on or before September 21, 2004, priming of the oxygenator circuit to for any cardiopulmonary bypass remove particulates or other debris pulsatile flow generator that was in from the circuit prior to initiating by- commercial distribution before May 28, pass. The device is not used to filter 1976, or that has, on or before Sep- blood. tember 21, 2004, been found to be sub- (b) Classification. Class II (perform- stantially equivalent to any ance standards). cardiopulmonary bypass pulsatile flow generator that was in commercial dis- § 870.4290 Cardiopulmonary bypass tribution before May 28, 1976. Any adaptor, stopcock, manifold, or fitting. other cardiopulmonary bypass pulsatile flow generator shall have an (a) Identification. A cardiopulmonary approved PMA or declared completed bypass adaptor, stopcock, manifold, or fitting is a device used in cardio- PDP in effect before being placed in vascular diagnostic, surgical, and commercial distribution. therapeutic applications to inter- [45 FR 7907, Feb. 5, 1980, as amended at 52 FR connect tubing, catheters, or other de- 17737, May 11, 1987; 69 FR 34920, June 23, 2004] vices.

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§ 870.4330 Cardiopulmonary bypass necessary for open surgical procedures on-line blood gas monitor. on the aorta or vena cava. (a) Identification. A cardiopulmonary (2) Classification—Class II (special bypass on-line blood gas monitor is a controls). The special controls for this device used in conjunction with a blood device are: gas sensor to measure the level of gases (i) Non-clinical performance testing in the blood. must perform as intended over the in- (b) Classification. Class II (perform- tended duration of use and dem- ance standards). onstrate the following: Operating parameters, dynamic blood damage, heat § 870.4340 Cardiopulmonary bypass generation, air entrapment, mechan- level sensing monitor and/or control. ical integrity, and durability/reliability; (a) Identification. A cardiopulmonary bypass level sensing monitor and/or (ii) The patient-contacting compo- control is a device used to monitor and/ nents of the device must be dem- or control the level of blood in the onstrated to be biocompatible; blood reservoir and to sound an alarm (iii) Sterility and shelf life testing when the level falls below a predeter- must demonstrate the sterility of pa- mined value. tient-contacting components and the (b) Classification. Class II (perform- shelf life of these components; and ance standards). (iv) Labeling must include information regarding the duration of use, and § 870.4350 Cardiopulmonary bypass a detailed summary of the device- and oxygenator. procedure-related complications perti- (a) Identification. A cardiopulmonary nent to use of the device. bypass oxygenator is a device used to (b) Nonroller-type temporary ventric- exchange gases between blood and a ular support blood pump—(1) Identifica- gaseous environment to satisfy the gas tion. A nonroller-type temporary ven- exchange needs of a patient during tricular support blood pump is a pre- open-heart surgery. scription device that uses any method (b) Classification. Class II (special resulting in blood propulsion to provide controls). The special control for this the temporary ventricular assistance device is the FDA guidance document required for support of the systemic entitled ‘‘Guidance for Cardiopulmonary Bypass Oxygenators and/or pulmonary circulations during 510(k) Submissions.’’ periods when there is ongoing or anticipated hemodynamic instability due [45 FR 7907, Feb. 5, 1980, as amended at 52 FR to immediately reversible alterations 17737, May 11, 1987; 66 FR 18542, Apr. 10, 2001] in ventricular myocardial function re- § 870.4360 Nonroller-type blood pump. sulting from mechanical or physiologic causes. Duration of use would be less (a) Nonroller-type cardiopulmonary and than 6 hours. circulatory bypass blood pump—(1) Iden- (2) Classification. Class III (premarket tification. A nonroller-type approval). cardiopulmonary and circulatory bypass blood pump is a prescription de- (c) Date premarket approval application vice that uses a method other than re- (PMA) or notice of completion of product volving rollers to pump the blood development protocol (PDP) is required. A through an extracorporeal circuit for PMA or notice of completion of a PDP periods lasting less than 6 hours for the is required to be filed with FDA on or purpose of providing either: before September 8, 2015, for any non- (i) Full or partial cardiopulmonary roller-type temporary ventricular sup- bypass (i.e., circuit includes an port blood pump that was in commer- oxygenator) during open surgical pro- cial distribution before May 28, 1976, or cedures on the heart or great vessels; that has, on or before September 8, or 2015, been found to be substantially (ii) Temporary circulatory bypass for equivalent to any nonroller-type tem- diversion of flow around a planned dis- porary ventricular support blood pump ruption of the circulatory pathway that was in commercial distribution

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before May 28, 1976. Any other non- § 870.4410 Cardiopulmonary bypass in- roller-type temporary ventricular sup- line blood gas sensor. port blood pump shall have an ap- (a) Identification. A cardiopulmonary proved PMA or declared completed bypass in-line blood gas sensor is a PDP in effect before being placed in transducer that measures the level of commercial distribution. gases in the blood. [80 FR 32311, June 8, 2015] (b) Classification. Class II (performance standards). § 870.4370 Roller-type cardiopulmonary bypass blood § 870.4420 Cardiopulmonary bypass pump. cardiotomy return sucker. (a) Identification. A roller-type (a) Identification. A cardiopulmonary cardiopulmonary bypass blood pump is bypass cardiotomy return sucker is a a device that uses a revolving roller device that consists of tubing, a con- mechanism to pump the blood through nector, and a probe or tip that is used the cardiopulmonary bypass circuit to remove blood from the chest or during bypass surgery. heart during cardiopulmonary bypass (b) Classification. Class II (perform- surgery. ance standards). (b) Classification. Class II (performance standards). § 870.4380 Cardiopulmonary bypass pump speed control. § 870.4430 Cardiopulmonary bypass (a) Identification. A cardiopulmonary intracardiac suction control. bypass pump speed control is a device (a) Identification. A cardiopulmonary used that incorporates an electrical bypass intracardiac suction control is a system or a mechanical system, or device which provides the vacuum and both, and is used to control the speed of blood pumps used in control for a cardiotomy return sucker. cardiopulmonary bypass surgery. (b) Classification. Class II (perform- (b) Classification. Class II (performance standards). ance standards). § 870.4450 Vascular clamp. § 870.4390 Cardiopulmonary bypass (a) Identification. A vascular clamp is pump tubing. a surgical instrument used to occlude a (a) Identification. A cardiopulmonary blood vessel temporarily. bypass pump tubing is polymeric tub- (b) Classification. Class II (performing which is used in the blood pump ance standards). head and which is cyclically compressed by the pump to cause the blood § 870.4475 Surgical vessel dilator. to flow through the cardiopulmonary (a) Identification. A surgical vessel di- bypass circuit. lator is a device used to enlarge or cali- (b) Classification. Class II (perform- brate a vessel. ance standards). (b) Classification. Class II (performance standards). § 870.4400 Cardiopulmonary bypass blood reservoir. § 870.4500 Cardiovascular surgical in- (a) Identification. A cardiopulmonary struments. bypass blood reservoir is a device used (a) Identification. Cardiovascular sur- in conjunction with short-term gical instruments are surgical instru- extracorporeal circulation devices to ments that have special features for hold a reserve supply of blood in the use in cardiovascular surgery. These bypass circulation. devices include, e.g., forceps, retrac- (b) Classification. Class II (perform- tors, and scissors. ance standards), except that a reservoir (b) Classification. Class I (general con- that contains a defoamer or filter is trols). The device is exempt from the classified into the same class as the premarket notification procedures in defoamer or filter.

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subpart E of part 807 of this chapter form an endarterectomy (removal of subject to the limitations in § 870.9. plaque deposits from arterisclerotic arteries.) [45 FR 7907, Feb. 5, 1980, as amended at 54 FR 25049, June 12, 1989; 66 FR 38797, July 25, 2001] (b) Classification. Class II (performance standards). § 870.4510 Apical closure device. § 870.4885 External vein stripper. (a) Identification. An apical closure device is a prescription device con- (a) Identification. An external vein sisting of a delivery system and im- stripper is an extravascular device used plant component that is used for soft to remove a section of a vein. tissue approximation of cardiac apical (b) Classification. Class II (perform- tissue during transcatheter valve re- ance standards). placement procedures. (b) Classification. Class II (special Subpart F—Cardiovascular controls). The special controls for this Therapeutic Devices device are: (1) The patient contacting materials § 870.5050 Patient care suction appa- must be evaluated to be biocompatible. ratus. (2) Performance data must validate (a) Identification. A patient care suc- the sterility of the patient-contacting tion apparatus is a device used with an components of the device. intrathoracic catheter to withdraw (3) Performance data must support fluid from the chest during the recov- the shelf life of the device by dem- ery period following surgery. onstrating continued sterility, package (b) Classification. Class II (perform- integrity, and device functionality ance standards). over the labeled shelf life. (4) Non-clinical performance testing § 870.5100 Percutaneous Transluminal data must demonstrate that the device Coronary Angioplasty (PTCA) Cath- performs as intended under anticipated eter. conditions of use. The following per- (a) Standard PTCA Catheter—(1) Iden- formance characteristics must be test- tification. A PTCA catheter is a device ed: that operates on the principle of hy- (i) Consistent and reliable implant draulic pressurization applied through deployment; an inflatable balloon attached to the (ii) Assessment of implant pull-out distal end. A PTCA balloon catheter force; and has a single or double lumen shaft. The (iii) Sheath size compatibility with catheter features a balloon of appro- implant. priate compliance for the clinical ap- (5) In vivo evaluation of the device plication, constructed from a polymer. must demonstrate device performance, The balloon is designed to uniformly including device operation resulting in expand to a specified diameter and closure of the myocardial wound. length at a specific pressure as labeled, (6) Labeling must include the fol- with well characterized rates of infla- lowing: tion and deflation and a defined burst (i) Detailed information explaining pressure. The device generally features how the device operates; a type of radiographic marker to facili- (ii) Sheath size that device can ac- tate fluoroscopic visualization of the commodate; balloon during use. A PTCA catheter is (iii) Identification of the minimum intended for balloon dilatation of a myocardial wall thickness to ensure hemodynamically significant coronary optimal device function; and artery or bypass graft stenosis in pa- (iv) A shelf life. tients evidencing coronary ischemia [81 FR 71371, Oct. 17, 2016] for the purpose of improving myocardial perfusion. A PTCA catheter may § 870.4875 Intraluminal artery strip- also be intended for the treatment of per. acute myocardial infarction; treatment (a) Identification. An intraluminal ar- of in-stent restenosis (ISR) and/or post- tery stripper is a device used to per- deployment stent expansion.

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(2) Classification. Class II (special con- rest. External cardiac compressor de- trols). The special control for this devices are used as an adjunct to manual vice is ‘‘Class II Special Controls Guid- cardiopulmonary resuscitation (CPR) ance Document for Certain when effective manual CPR is not pos- Percutaneous Transluminal Coronary sible (e.g., during patient transport or Angioplasty (PTCA) Catheters.’’ See extended CPR when fatigue may pro- § 870.1(e) for the availability of this hibit the delivery of effective/con- guidance document. sistent compressions to the victim, or (b) Cutting/scoring PTCA Catheter—(1) when insufficient EMS personnel are Identification. A cutting/scoring PTCA available to provide effective CPR). catheter is a balloon-tipped catheter (b) Classification. Class II (special with cutting/scoring elements at- controls). The special controls for this tached, which is used in those cir- device are: cumstances where a high pressure bal- (1) Nonclinical performance testing loon resistant lesion is encountered. A under simulated physiological condi- cutting/scoring PTCA catheter is in- tions must demonstrate the reliability tended for the treatment of of the delivery of specific compression hemodynamically significant coronary depth and rate over the intended dura- artery stenosis for the purpose of im- tion of use. proving myocardial perfusion. A cut- (2) Labeling must include the fol- ting/scoring PTCA catheter may also lowing: be indicated for use in complex type C (i) The clinical training necessary for lesions or for the treatment of in-stent the safe use of this device; restenosis. (ii) Adjunctive use only indication (2) Classification. Class III (premarket prominently displayed on labels phys- approval). As of May 28, 1976, an ap- ically placed on the device and in any proval under section 515 of the act is device manuals or other labeling; required before this device may be (iii) Information on the patient popu- commercially distributed. See § 870.3. lation for which the device has been [75 FR 54496, Sept. 8, 2010] demonstrated to be effective (including patient size and/or age limitations, e.g., § 870.5150 Embolectomy catheter. adult, pediatric and/or infant); and (iv) Information on the time nec- (a) Identification. An embolectomy catheter is a balloon-tipped catheter essary to deploy the device as dem- that is used to remove thromboemboli, onstrated in the performance testing. i.e., blood clots which have migrated in (3) For devices that incorporate elec- blood vessels from one site in the vas- trical components, appropriate anal- cular tree to another. ysis and testing must demonstrate that (b) Classification. Class II (perform- the device is electrically safe and elec- ance standards). tromagnetically compatible in its intended use environment. § 870.5175 Septostomy catheter. (4) Human factors testing and analysis must validate that the device de- (a) Identification. A septostomy cath- sign and labeling are sufficient for ef- eter is a special balloon catheter that fective use by the intended user, in- is used to create or enlarge the atrial septal defect found in the heart of cer- cluding an evaluation for the time nec- tain infants. essary to deploy the device. (b) Classification. Class II (perform- (5) For devices containing software, ance standards). software verification, validation, and hazard analysis must be performed. § 870.5200 External cardiac com- (6) Components of the device that pressor. come into human contact must be dem- (a) Identification. An external cardiac onstrated to be biocompatible. compressor is an externally applied [81 FR 33133, May 25, 2016] prescription device that is electrically, pneumatically, or manually powered § 870.5210 Cardiopulmonary resuscita- and is used to compress the chest peri- tion (CPR) aid. odically in the region of the heart to (a) CPR aid without feedback—(1) Iden- provide blood flow during cardiac ar- tification. A CPR aid without feedback

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is a device that performs a simple func- electromagnetically compatible in its tion such as proper hand placement intended use environment. and/or simple prompting for rate and/or (iv) For devices containing software, timing of compressions/breathing for software verification, validation, and the professionally trained rescuer, but hazard analysis must be performed. offers no feedback related to the qual- (v) Components of the device that ity of the CPR being provided. These come into human contact must be dem- devices are intended for use by persons onstrated to be biocompatible. professionally trained in CPR to assure (vi) Human factors testing and anal- proper use and the delivery of optimal ysis must validate that the device de- CPR to the victim. sign and labeling are sufficient for ef- (2) Classification. Class I (general con- fective use by the intended user. trols). The device is exempt from the (3) Premarket notification. The CPR premarket notification procedures in Aid with feedback device is exempt subpart E of part 807 of this chapter from the premarket notification proce- subject to the limitations in § 870.9. dures in subpart E of part 807 of this (b) CPR aid with feedback—(1) Identi- chapter if it does not contain software fication. A CPR Aid device with feed- (e.g., is mechanical or electro-mechan- back is a device that provides real-time ical) and is in compliance with the spe- feedback to the rescuer regarding the cial controls under paragraph (b)(2) of quality of CPR being delivered to the this section, subject to the limitations victim, and provides either audio and/ of exemptions in § 870.9. or visual information to encourage the rescuer to continue the consistent ap- [81 FR 33134, May 25, 2016] plication of effective manual CPR in accordance with current accepted CPR § 870.5225 External counter-pulsating device. guidelines (to include, but not be limited to, parameters such as compres- (a) Identification. An external sion rate, compression depth, ventila- counter-pulsating device is a tion, recoil, instruction for one or mul- noninvasive, prescription device used tiple rescuers, etc.). These devices may to assist the heart by applying positive also perform a coaching function to aid or negative pressure to one or more of rescuers in the sequence of steps nec- the body’s limbs in synchrony with the essary to perform effective CPR on a heart cycle. victim. (b) Classification. (1) Class II (special (2) Classification. Class II (special con- controls) when the device is intended trols). The special controls for this de- for the treatment of chronic stable an- vice are: gina that is refractory to optimal anti- (i) Nonclinical performance testing anginal medical therapy and without under simulated physiological or use options for revascularization. The spe- conditions must demonstrate the accu- cial controls for this device are: racy and reliability of the feedback to (i) Nonclinical performance evalua- the user on specific compression rate, tion of the device must demonstrate a depth and/or respiration over the in- reasonable assurance of safety and ef- tended duration, and environment of fectiveness for applied pressure, syn- use. chronization of therapy with the appro- (ii) Labeling must include the clin- priate phase of the cardiac cycle, and ical training, if needed, for the safe use functionality of alarms during a device of this device and information on the malfunction or an abnormal patient patient population for which the device condition; has been demonstrated to be effective (ii) Reliabilities of the mechanical (including patient size and/or age limi- and electrical systems must be estab- tations, e.g., adult, pediatric and/or in- lished through bench testing under fant). simulated use conditions and matched (iii) For devices that incorporate by appropriate maintenance schedules; electrical components, appropriate (iii) Software design and verification analysis and testing must demonstrate and validation must be appropriately that the device is electrically safe and documented;

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(iv) The skin-contacting components tion shall have an approved PMA or de- of the device must be demonstrated to clared completed PDP in effect before be biocompatible; being placed in commercial distribu- (v) Appropriate analysis and testing tion. must be conducted to verify electrical safety and electromagnetic compat- [78 FR 79307, Dec. 30, 2013] ibility of the device; and § 870.5300 DC-defibrillator (including (vi) Labeling must include a detailed paddles). summary of the device-related and procedure-related complications pertinent (a) Low-energy DC-defibrillator—(1) to use of the device. Identification. A low-energy DC- (2) Class III (premarket approval) for defibrillator is a device that delivers the following intended uses: Unstable into a 50 ohm test load an electrical angina pectoris; acute myocardial in- shock of a maximum of 360 joules of en- farction; cardiogenic shock; congestive ergy used for defibrillating (restoring heart failure; postoperative treatment normal heart rhythm) the atria or ven- of patients who have undergone coro- tricles of the heart or to terminate nary artery bypass surgery; peripheral other cardiac arrhythmias. This ge- arterial disease associated with neric type of device includes low en- ischemic ulcers rest pain or ergy defibrillators with a maximum claudication, threatened gangrene, in- electrical output of less than 360 joules sufficient blood supply at an amputa- of energy that are used in pediatric tion site, persisting ischemia after defibrillation or in cardiac surgery. embolectomy or bypass surgery, and/or The device may either synchronize the pre- and post-arterial reconstruction to shock with the proper phase of the improve runoff; diabetes complicated electrocardiogram or may operate by peripheral arterial disease or other asynchronously. The device delivers conditions possibly related to arterial the electrical shock through paddles insufficiency including nocturnal leg placed either directly across the heart cramps and/or necrobiosis or on the surface of the body. diabeticorum; venous diseases, includ- (2) Classification. Class II (performing prophylaxis of deep vein ance standards). thrombophlebitis, edema (e.g., chronic (b) High-energy DC-defibrillator—(1) lymphedema) and/or induration (e.g., Identification. A high-energy DC- stasis dermatitis) associated with defibrillator is a device that delivers chronic venous stasis, venous stasis ul- into a 50 ohm test load an electrical cers, and/or thrombophlebitis; athletic shock of greater than 360 joules of en- injuries, including Charley horses, ergy used for defibrillating the atria or pulled muscles and/or edematous mus- ventricles of the heart or to terminate cles; necrotizing cellulitis. other cardiac arrhythmias. The device (c) Date premarket approval application may either synchronize the shock with (PMA) or notice of completion of product the proper phase of the electrocardio- development protocol (PDP) is required. A gram or may operate asynchronously. PMA or notice of completion of a PDP The device delivers the electrical shock is required to be filed with FDA on or through paddles placed either directly before March 31, 2014, for any external across the heart or on the surface of counter-pulsating device, with an in- the body. tended use described in paragraph (b)(2) (2) Classification. Class III (premarket of this section, that was in commercial approval). distribution before May 28, 1976, or that (c) Date PMA or notice of completion of has, on or before March 31, 2014, been a PDP is required. A PMA or a notice of found to be substantially equivalent to completion of a PDP is required to be any external counter-pulsating device, filed with the Food and Drug Adminis- with an intended use described in para- tration on or before December 26, 1996 graph (b)(2) of this section, that was in for any DC-defibrillator (including pad- commercial distribution before May 28, dles) described in paragraph (b)(1) of 1976. Any other external counter-pul- this section that was in commercial sating device with an intended use de- distribution before May 28, 1976, or that scribed in paragraph (b)(2) of this sec- has, on or before December 26, 1996

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been found to be substantially equiva- being placed in commercial distribu- lent to a DC-defibrillator (including tion. paddles) described in paragraph (b)(1) [68 FR 61344, Oct. 28, 2003; 69 FR 10615, Mar. of this section that was in commercial 8, 2004, as amended at 80 FR 5682, Feb. 3, 2015] distribution before May 28, 1976. Any other DC-defibrillator (including pad- § 870.5325 Defibrillator tester. dles) described in paragraph (b)(1) of (a) Identification. A defibrillator test- this section shall have an approved er is a device that is connected to the PMA or declared completed PDP in ef- output of a defibrillator and is used to fect before being placed in commercial measure the energy delivered by the distribution. defibrillator into a standard resistive [45 FR 7907, Feb. 5, 1980, as amended at 52 FR load. Some testers also provide wave- 17737, May 11, 1987; 61 FR 50706, Sept. 27, 1996] form information. (b) Classification. Class II (perform- § 870.5310 Automated external ance standards). defibrillator system. (a) Identification. An automated ex- § 870.5550 External transcutaneous ternal defibrillator (AED) system con- cardiac pacemaker (noninvasive). sists of an AED and those accessories (a) Identification. An external trans- necessary for the AED to detect and in- cutaneous cardiac pacemaker terpret an electrocardiogram and de- (noninvasive) is a device used to supply liver an electrical shock (e.g., battery, a periodic electrical pulse intended to pad electrode, adapter, and hardware pace the heart. The pulse from the de- key for pediatric use). An AED system vice is usually applied to the surface of analyzes the patient’s electrocardio- the chest through electrodes such as gram, interprets the cardiac rhythm, defibrillator paddles. and automatically delivers an elec- (b) Classification. Class II. The special trical shock (fully automated AED), or controls for this device are: advises the user to deliver the shock (1) ‘‘American National Standards In- (semi-automated or shock advisory stitute/American Association for Med- AED) to treat ventricular fibrillation ical Instrumentation’s DF–21 ‘Cardiac or pulseless ventricular tachycardia. Defibrillator Devices’ ’’ 2d ed., 1996, and (b) Classification. Class III (premarket (2) ‘‘The maximum pulse amplitude approval) should not exceed 200 milliamperes. (c) Date PMA or notice of completion of The maximum pulse duration should PDP is required. A PMA will be required not exceed 50 milliseconds.’’ to be submitted to the Food and Drug Administration by April 29, 2015, for [45 FR 7907, Feb. 5, 1980, as amended at 52 FR any AED that was in commercial dis- 17737, May 11, 1987; 65 FR 17144, Mar. 31, 2000] tribution before May 28, 1976, or that has, by April 29, 2015, been found to be § 870.5700 Steerable cardiac ablation substantially equivalent to any AED catheter remote control system. that was in commercial distribution (a) Identification. A steerable cardiac before May 28, 1976. A PMA will be re- ablation catheter remote control sys- quired to be submitted to the Food and tem is a prescription device that is ex- Drug Administration by April 29, 2015, ternal to the body and interacts with for any AED accessory described in the manual handle of a steerable car- paragraph (a) that was in commercial diac ablation catheter to remotely con- distribution before May 28, 1976, or that trol the advancement, retraction, rota- has, by April 29, 2015, been found to be tion, and deflection of a compatible, substantially equivalent to any AED steerable ablation catheter used for the accessory described in paragraph (a) treatment of cardiac arrhythmias in that was in commercial distribution the right side of the heart. The device before May 28, 1976. Any other AED and allows reversion to manual control of AED accessory described in paragraph the steerable cardiac ablation catheter (a), shall have an approved PMA or de- without withdrawal of the catheter and clared completed PDP in effect before interruption of the procedure.

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(b) Classification. Class II (special under anticipated conditions of use, in- controls). The special controls for this cluding an assessment of the system device are: impact on the functionality and per- (1) Non-clinical mechanical perform- formance of compatible catheters, and ance testing must demonstrate that documentation of the adverse event the device performs as intended under profile associated with clinical use. anticipated conditions of use. The fol- Evidence must be submitted to address lowing performance testing must be the following: performed: (i) Manipulation and Positioning: (i) Mechanical performance of the Ability to manipulate compatible cath- system (without catheter connected); eters to pre-specified cardiac locations (ii) Mechanical performance of the and confirm proper anatomic place- system with compatible catheters con- ment and tissue contact, in accordance nected to verify that the system does with the system indications for use and not impact catheter function or per- the compatible catheter indications for formance. Assessments must include use; the following: (ii) Safety: Assess device-related (A) Side-by-side remote control and complication rate and major proce- manual comparisons of catheter ma- dural complication rate (regardless of nipulation (including all ranges of mo- device relatedness) in comparison to tion of catheter deflection and tip curl) literature and/or a manual comparison for all compatible catheters; must in- group for compatible ablation cath- clude testing for worst-case conditions, eters to support the indications for use; and (iii) Efficacy: Assess ablation success (B) Evaluation of the accuracy and in comparison to literature and/or a function of all device control safety manual comparison group for compat- features; and ible ablation catheters to support the (iii) Simulated-use testing in a bench indications for use; and anatomic model or animal model. (iv) User assessment of device remote (2) Non-clinical electrical testing controls and safety features. must include validation of electro- (4) Post-market surveillance (PMS) magnetic compatibility (EMC), elec- must be conducted and completed in trical safety, thermal safety, and elec- accordance with FDA agreed upon PMS trical system performance. The fol- protocol. lowing performance testing must be (5) A training program must be in- performed: cluded with sufficient educational ele- (i) Electrical performance of the sys- ments that, upon completion of the tem with compatible catheters con- training program, the clinician and nected to verify that the system does supporting staff can: not impact catheter function or per- (i) Identify the safe environments for formance. Assessments must include device use, the following: (ii) Use all safety features of device, (A) Side-by-side remote control and and manual comparisons of catheter ma- (iii) Operate the device in simulated nipulation (including all ranges of mo- or actual use environments representation of catheter deflection and tip curl) tive of indicated environments and use for all compatible catheters; must infor the indication of compatible cath- clude testing for worst-case conditions, eters. and (6) Performance data must dem- (B) Evaluation of the accuracy and onstrate the sterility of the sterile dis- function of all device control safety posable components of the system. features; and (7) Performance data must support (ii) Electrical safety between the de- shelf life by demonstrating continued vice and ablation catheter system and sterility of the device (of the sterile with other electrical equipment ex- disposable components), package integ- pected in the catheter lab or operating rity, and device functionality over the room. requested shelf life. (3) In vivo testing must demonstrate (8) Labeling must include the fol- that the device performs as intended lowing:

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(i) Appropriate instructions, warn- (C) An expiration date/shelf life and ings, cautions, limitations, and infor- storage conditions for the sterile acces- mation related to the intended patient sories; and population, compatible ablation cath- (vi) When available, and according to eters, and the device safeguards for the the timeframe included in the PMS safe use of the device; protocol agreed upon with FDA, pro- (ii) Specific instructions and the clin- vide a detailed summary of the PMS ical training needed for the safe use of data including: the device, which includes: (A) Updates to the labeling to accu- (A) Instructions on assembling the rately reflect outcomes or necessary device in all available configurations, modifications based upon data col- including installation and removal of lected during the PMS experience, and compatible catheters; (B) Inclusion of results and adverse (B) Instructions and explanation of events associated with utilization of all controls, inputs, and outputs; the device during the PMS. (C) Instructions on all available [80 FR 58606, Sept. 30, 2015] modes or states of the device; (D) Instructions on all safety fea- § 870.5800 Compressible limb sleeve. tures of the device; and (a) Identification. A compressible limb (E) Validated methods and instruc- sleeve is a device that is used to pre- tions for reprocessing/disinfecting any vent pooling of blood in a limb by in- reusable components; flating periodically a sleeve around the (iii) A detailed summary of the me- limb. chanical compatibility testing includ- (b) Classification. Class II (performing: ance standards). (A) A table with a complete list of compatible catheters tested (manufac- § 870.5900 Thermal regulating system. turer trade name and model number), (a) Identification. A thermal regu- and lating system is an external system (B) A table with detailed test results, consisting of a device that is placed in including type of test, acceptance cri- contact with the patient and a tem- teria, and test results (i.e., pass for perature controller for the device. The meeting acceptance criteria); system is used to regulate patient tem- (iv) A detailed summary of the in perature. vivo testing including: (b) Classification. Class II (perform- (A) A table with a complete list of ance standards). compatible catheters used during testing (manufacturer trade name and § 870.5910 Esophageal thermal regula- model number); tion device. (B) Adverse events encountered perti- (a) Identification. An esophageal ther- nent to use of the device under use con- mal regulation device is a prescription ditions; device used to apply a specified tem- (C) A detailed summary of the perature to the endoluminal surface of device- and procedure-related com- the esophagus via an external con- plications; and troller. This device may incorporate a (D) A summary of study outcomes mechanism for gastric decompression and endpoints. Information pertinent and suctioning. The device is used to to the fluoroscopy times/exposure for regulate patient temperature. the procedure, patient, and operator (b) Classification. Class II (special fluoroscopic exposure; controls). The special controls for this (v) Other labeling items: device are: (A) A detailed summary of pertinent (1) The patient contacting materials non-clinical testing information: EMC, must be demonstrated to be biocompat- mechanical, electrical, and steriliza- ible. tion of device and components; (2) Non-clinical performance evalua- (B) A detailed summary of the device tion must demonstrate that the device technical parameters; and performs as intended under anticipated

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conditions of use. The following per- 872.1745 Laser fluorescence caries detection formance characteristics must be test- device. ed: 872.1800 Extraoral source x-ray system. 872.1810 Intraoral source x-ray system. (i) Mechanical integrity testing. 872.1820 Dental x-ray exposure alignment (ii) Testing to determine tempera- device. ture change rate(s). 872.1830 Cephalometer. (iii) Testing to demonstrate compat- 872.1840 Dental x-ray position indicating de- ibility with the indicated external con- vice. troller. 872.1850 Lead-lined position indicator. (iv) Shelf life testing. 872.1870 Sulfide detection device. 872.1905 Dental x-ray film holder. (3) Animal testing must demonstrate 872.2050 Dental sonography device. that the device does not cause esopha- 872.2060 Jaw tracking device. geal injury and that body temperature remains within appropriate boundaries Subpart C [Reserved] under anticipated conditions of use. (4) Labeling must include the fol- Subpart D—Prosthetic Devices lowing: 872.3060 Noble metal alloy. (i) Detailed insertion instructions. 872.3070 Dental amalgam, mercury, and (ii) Warning against attaching the amalgam alloy. device to unintended connections, such 872.3080 Mercury and alloy dispenser. as external controllers for which the 872.3100 Dental amalgamator. device is not indicated, or pressurized 872.3110 Dental amalgam capsule. 872.3130 Preformed anchor. air outlets instead of vacuum outlets 872.3140 Resin applicator. for those devices, including gastric suc- 872.3150 Articulator. tion. 872.3165 Precision attachment. (iii) The operating parameters, name, 872.3200 Resin tooth bonding agent. and model number of the indicated ex- 872.3220 Facebow. ternal controller. 872.3240 Dental bur. (iv) The intended duration of use. 872.3250 Calcium hydroxide cavity liner. 872.3260 Cavity varnish. [80 FR 49896, Aug. 18, 2015] 872.3275 Dental cement. 872.3285 Preformed clasp. § 870.5925 Automatic rotating tour- 872.3300 Hydrophilic resin coating for den- niquet. tures. 872.3310 Coating material for resin fillings. (a) Identification. An automatic rotat- 872.3330 Preformed crown. ing tourniquet is a device that prevents 872.3350 Gold or stainless steel cusp. blood flow in one limb at a time, which 872.3360 Preformed cusp. temporarily reduces the total blood 872.3400 Karaya and sodium borate with or volume, thereby reducing the normal without acacia denture adhesive. workload of the heart. 872.3410 Ethylene oxide homopolymer and/or (b) Classification. Class II (perform- carboxymethylcellulose sodium denture adhesive. ance standards). 872.3420 Carboxymethylcellulose sodium and cationic polyacrylamide polymer PART 872—DENTAL DEVICES denture adhesive. 872.3450 Ethylene oxide homopolymer and/or Subpart A—General Provisions karaya denture adhesive. 872.3480 Polyacrylamide polymer (modified Sec. cationic) denture adhesive. 872.1 Scope. 872.3490 Carboxymethylcellulose sodium 872.3 Effective dates of requirement for pre- and/or polyvinylmethylether maleic acid market approval. calcium-sodium double salt denture ad- 872.9 Limitations of exemptions from sec- hesive. tion 510(k) of the Federal Food, Drug, 872.3500 Polyvinylmethylether maleic anhy- and Cosmetic Act (the act). dride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium Subpart B—Diagnostic Devices (NACMC) denture adhesive. 872.3520 OTC denture cleanser. 872.1500 Gingival fluid measurer. 872.3530 Mechanical denture cleaner. 872.1720 Pulp tester. 872.3540 OTC denture cushion or pad. 872.1730 Electrode gel for pulp testers. 872.3560 OTC denture reliner. 872.1740 Caries detection device. 872.3570 OTC denture repair kit.

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872.3580 Preformed gold denture tooth. Subpart F—Therapeutic Devices 872.3590 Preformed plastic denture tooth. 872.3600 Partially fabricated denture kit. 872.5410 Orthodontic appliance and acces- 872.3630 Endosseous dental implant abut- sories. ment. 872.5470 Orthodontic plastic bracket. 872.3640 Endosseous dental implant. 872.5500 Extraoral orthodontic headgear. 872.3645 Subperiosteal implant material. 872.5525 Preformed tooth positioner. 872.3660 Impression material. 872.5550 Teething ring. 872.3661 Optical Impression Systems for 872.5560 Electrical salivary stimulatory sys- CAD/CAM. tem. 872.3670 Resin impression tray material. 872.5570 Intraoral devices for snoring and 872.3680 Polytetrafluoroethylene (PTFE) intraoral devices for snoring and obstruc- vitreous carbon materials. tive sleep apnea. 872.3690 Tooth shade resin material. 872.5580 Oral rinse to reduce the adhesion of 872.3710 Base metal alloy. dental plaque. 872.3730 Pantograph. 872.3740 Retentive and splinting pin. Subpart G—Miscellaneous Devices 872.3750 Bracket adhesive resin and tooth conditioner. 872.6010 Abrasive device and accessories. 872.3760 Denture relining, repairing, or re- 872.6030 Oral cavity abrasive polishing basing resin. agent. 872.3765 Pit and fissure sealant and condi- 872.6050 Saliva absorber. tioner. 872.6070 Ultraviolet activator for polym- 872.3770 Temporary crown and bridge resin. erization. 872.3810 Root canal post. 872.6080 Airbrush. 872.3820 Root canal filling resin. 872.6100 Anesthetic warmer. 872.3830 Endodontic paper point. 872.6140 Articulation paper. 872.3840 Endodontic silver point. 872.6200 Base plate shellac. 872.3850 Gutta percha. 872.6250 Dental chair and accessories. 872.3890 Endodontic stabilizing splint. 872.6290 Prophylaxis cup. 872.3900 Posterior artificial tooth with a 872.6300 Rubber dam and accessories. metal insert. 872.6350 Ultraviolet detector. 872.3910 Backing and facing for an artificial 872.6390 Dental floss. tooth. 872.6475 Heat source for bleaching teeth. 872.3920 Porcelain tooth. 872.6510 Oral irrigation unit. 872.3930 Bone grafting material. 872.6570 Impression tube. 872.3940 Total temporomandibular joint 872.6640 Dental operative unit and acces- prosthesis. sories. 872.3950 Glenoid fossa prosthesis. 872.6650 Massaging pick or tip for oral hy- 872.3960 Mandibular condyle prosthesis. giene. 872.3970 Interarticular disc prosthesis 872.6660 Porcelain powder for clinical use. (interpositional implant). 872.6670 Silicate protector. 872.3980 Endosseous dental implant acces- 872.6710 Boiling water sterilizer. sories. 872.6730 Endodontic dry heat sterilizer. 872.6770 Cartridge syringe. Subpart E—Surgical Devices 872.6855 Manual toothbrush. 872.6865 Powered toothbrush. 872.4120 Bone cutting instrument and acces- 872.6870 Disposable fluoride tray. sories. 872.6880 Preformed impression tray. 872.4130 Intraoral dental drill. 872.6890 Intraoral dental wax. 872.4200 Dental handpiece and accessories. 872.4465 Gas-powered jet injector. AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 872.4475 Spring-powered jet injector. 360j, 371. 872.4535 Dental diamond instrument. SOURCE: 52 FR 30097, Aug. 12, 1987, unless 872.4565 Dental hand instrument. otherwise noted. 872.4600 Intraoral ligature and wire lock. 872.4620 Fiber optic dental light. EDITORIAL NOTE: Nomenclature changes to 872.4630 Dental operating light. part 872 appear at 73 FR 35341, June 23, 2008. 872.4730 Dental injecting needle. 872.4760 Bone plate. Subpart A—General Provisions 872.4770 Temporary mandibular condyle reconstruction plate. § 872.1 Scope. 872.4840 Rotary scaler. 872.4850 Ultrasonic scaler. (a) This part sets forth the classifica- 872.4880 Intraosseous fixation screw or wire. tion of dental devices intended for 872.4920 Dental electrosurgical unit and ac- human use that are in commercial dis- cessories. tribution.

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(b) The identification of a device in a tion 515(b) of the act shall not be effec- regulation in this part is not a precise tive during the grace period ending on description of every device that is, or the 90th day after its promulgation or will be, subject to the regulation. A on the last day of the 30th full calendar manufacturer who submits a pre- month after the regulation that classi- market notification submission for a fies the device into class III is effec- device under part 807 cannot show tive, whichever is later. See section merely that the device is accurately 501(f)(2)(B) of the act. Accordingly, un- described by the section title and iden- less an effective date of the require- tification provisions of a regulation in ment for premarket approval is shown this part, but shall state why the de- in the regulation for a device classified vice is substantially equivalent to into class III in this part, the device other devices, as required by § 807.87. may be commercially distributed with- (c) To avoid duplicative listings, a out FDA’s issuance of an order approv- dental device that has two or more ing a PMA or declaring completed a types of uses (e.g., used both as a diag- PDP for the device. If FDA promul- nostic device and as a therapeutic de- gates a regulation under section 515(b) vice) is listed in one subpart only. of the act requiring premarket ap- (d) References in this part to regu- proval for a device, section 501(f)(1)(A) latory sections of the Code of Federal of the act applies to the device. Regulations are to chapter I of title 21 (b) Any new, not substantially equiv- unless otherwise noted. alent, device introduced into commer- (e) Guidance documents referenced in cial distribution on or after May 28, this part are available on the Internet 1976, including a device formerly mar- at http://www.fda.gov/MedicalDevices/ keted that has been substantially al- DeviceRegulationandGuidance/ tered, is classified by statute (section GuidanceDocuments/default.htm. 513(f) of the act) into class III without [52 FR 30097, Aug. 12, 1987, as amended at 68 any grace period and FDA must have FR 19737, Apr. 22, 2003; 79 FR 50552, Aug. 25, issued an order approving a PMA or de- 2014] claring completed a PDP for the device before the device is commercially dis- § 872.3 Effective dates of requirement tributed unless it is reclassified. If for premarket approval. FDA knows that a device being com- A device included in this part that is mercially distributed may be a ‘‘new’’ classified into class III (premarket ap- device as defined in this section be- proval) shall not be commercially dis- cause of any new intended use or other tributed after the date shown in the reasons, FDA may codify the statutory regulation classifying the device unless classification of the device into class the manufacturer has an approval III for such new use. Accordingly, the under section 515 of the act (unless an regulation for such a class III device exemption has been granted under sec- states that as of the enactment date of tion 520(g)(2) of the act). An approval the amendments, May 28, 1976, the de- under section 515 of the act consists of vice must have an approval under sec- FDA’s issuance of an order approving tion 515 of the act before commercial an application for premarket approval distribution. (PMA) for the device or declaring com- (c) A device identified in a regulation pleted a product development protocol in this part that is classified into class (PDP) for the device. III and that is subject to the transi- (a) Before FDA requires that a device tional provisions of section 520(1) of the commercially distributed before the act is automatically classified by stat- enactment date of the amendments, or ute into class III and must have an ap- a device that has been found substan- proval under section 515 of the act be- tially equivalent to such a device, has fore being commercially distributed. an approval under section 515 of the Accordingly, the regulation for such a act, FDA must promulgate a regula- class III transitional device states that tion under section 515(b) of the act re- as of the enactment date of the amend- quiring such approval, except as pro- ments, May 28, 1976, the device must vided in paragraphs (b) and (c) of this have an approval under section 515 of section. Such a regulation under sec- the act before commercial distribution.

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§ 872.9 Limitations of exemptions from life-threatening diseases such as ac- section 510(k) of the Federal Food, quired immune deficiency syndrome Drug, and Cosmetic Act (the act). (AIDS), chronic or active hepatitis, tu- The exemption from the requirement berculosis, or myocardial infarction or of premarket notification (section to monitor therapy; 510(k) of the act) for a generic type of (4) For assessing the risk of cardio- class I or II device is only to the extent vascular diseases; that the device has existing or reason- (5) For use in diabetes management; ably foreseeable characteristics of (6) For identifying or inferring the commercially distributed devices with- identity of a microorganism directly in that generic type or, in the case of from clinical material; in vitro diagnostic devices, only to the (7) For detection of antibodies to extent that misdiagnosis as a result of microorganisms other than using the device would not be associ- immunoglobulin G (IgG) or IgG assays ated with high morbidity or mortality. when the results are not qualitative, or Accordingly, manufacturers of any are used to determine immunity, or the commercially distributed class I or II assay is intended for use in matrices device for which FDA has granted an other than serum or plasma; exemption from the requirement of (8) For noninvasive testing as defined premarket notification must still sub- in § 812.3(k) of this chapter; and mit a premarket notification to FDA (9) For near patient testing (point of before introducing or delivering for in- care). troduction into interstate commerce [65 FR 2314, Jan. 14, 2000] for commercial distribution the device when: Subpart B—Diagnostic Devices (a) The device is intended for a use different from the intended use of a le- § 872.1500 Gingival fluid measurer. gally marketed device in that generic type of device; e.g., the device is in- (a) Identification. A gingival fluid tended for a different medical purpose, measurer is a gauge device intended to or the device is intended for lay use measure the amount of fluid in the gin- where the former intended use was by gival sulcus (depression between the health care professionals only; tooth and gums) to determine if there (b) The modified device operates is a gingivitis condition. using a different fundamental sci- (b) Classification. Class I (general con- entific technology than a legally mar- trols). The device is exempt from the keted device in that generic type of de- premarket notification procedures in vice; e.g., a surgical instrument cuts subpart E of part 807 of this chapter tissue with a laser beam rather than subject to the limitations in § 872.9. with a sharpened metal blade, or an in [52 FR 30097, Aug. 12, 1987, as amended at 59 vitro diagnostic device detects or iden- FR 63007, Dec. 7, 1994; 66 FR 38797, July 25, tifies infectious agents by using 2001] deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology § 872.1720 Pulp tester. rather than culture or immunoassay (a) Identification. A pulp tester is an technology; or AC or battery powered device intended (c) The device is an in vitro device to evaluate the pulpal vitality of teeth that is intended: by employing high frequency current (1) For use in the diagnosis, moni- transmitted by an electrode to stimu- toring, or screening of neoplastic dis- late the nerve tissue in the dental pulp. eases with the exception of (b) Classification. Class II. immunohistochemical devices; (2) For use in screening or diagnosis § 872.1730 Electrode gel for pulp test- of familial or acquired genetic dis- ers. orders, including inborn errors of me- (a) Identification. An electrode gel for tabolism; pulp testers is a device intended to be (3) For measuring an analyte that applied to the surface of a tooth before serves as a surrogate marker for use of a pulp tester to aid conduction screening, diagnosis, or monitoring of electrical current.

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(b) Classification. Class I (general con- for dental radiographic examination trols). The device is exempt from the and diagnosis of diseases of the teeth, premarket notification procedures in jaw, and oral structures. The x-ray subpart E of part 807 of this chapter source (a tube) is located outside the subject to the limitations in § 872.9. mouth. This generic type of device may [52 FR 30097, Aug. 12, 1987, as amended at 54 include patient and equipment sup- FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, ports and component parts. 2001] (b) Classification. Class II.

§ 872.1740 Caries detection device. § 872.1810 Intraoral source x-ray sys- (a) Identification. The caries detection tem. device is a device intended to show the (a) Identification. An intraoral source existence of decay in a patient’s tooth x-ray system is an electrically powered by use of electrical current. device that produces x-rays and is in- (b) Classification. Class II. tended for dental radiographic examination and diagnosis of diseases of the § 872.1745 Laser fluorescence caries teeth, jaw, and oral structures. The x- detection device. ray source (a tube) is located inside the (a) Identification. A laser fluorescence mouth. This generic type of device may caries detection device is a laser, a flu- include patient and equipment sup- orescence detector housed in a dental ports and component parts. handpiece, and a control console that (b) Classification. Class II. performs device calibration, as well as variable tone emitting and fluores- § 872.1820 Dental x-ray exposure align- cence measurement functions. The in- ment device. tended use of the device is to aid in the (a) Identification. A dental x-ray expo- detection of tooth decay by measuring sure alignment device is a device in- increased laser induced fluorescence. tended to position x-ray film and to (b) Classification. Class II, subject to align the examination site with the x- the following special controls: ray beam. (1) Sale, distribution, and use of this (b) Classification. Class I (general con- device are restricted to prescription trols). The device is exempt from the use in accordance with § 801.109 of this premarket notification procedures in chapter; subpart E of part 807 of this chapter (2) Premarket notifications must in- subject to the limitations in § 872.9. clude clinical studies, or other relevant information, that demonstrates that [52 FR 30097, Aug. 12, 1987, as amended at 59 the device aids in the detection of FR 63008, Dec. 7, 1994; 66 FR 38797, July 25, tooth decay by measuring increased 2001] laser induced fluorescence; and (3) The labeling must include de- § 872.1830 Cephalometer. tailed use instructions with pre- (a) Identification. A cephalometer is a cautions that urge users to: device used in dentistry during x-ray (i) Read and understand all directions procedures. The device is intended to before using the device, place and to hold a patient’s head in a (ii) Store probe tips under proper standard position during dental x-rays. conditions, (b) Classification. Class II. (iii) Properly sterilize the emitter-detector handpick before each use, and § 872.1840 Dental x-ray position indi- (iv) Properly maintain and handle cating device. the instrument in the specified manner (a) Identification. A dental x-ray posi- and condition. tion indicating device is a device, such [65 FR 18235, Apr. 7, 2000] as a collimator, cone, or aperture, that is used in dental radiographic examina- § 872.1800 Extraoral source x-ray sys- tion. The device is intended to align tem. the examination site with the x-ray (a) Identification. An extraoral source beam and to restrict the dimensions of x-ray system is an AC-powered device the dental x-ray field by limiting the that produces x-rays and is intended size of the primary x-ray beam.

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(b) Classification. Class I (general con- subpart E of part 807 of this chapter trols). The device is exempt from the subject to the limitations in § 872.9. If premarket notification procedures in the device is not labeled or otherwise subpart E of part 807 of this chapter represented as sterile, it is also exempt subject to the limitations in § 872.9. from the current good manufacturing [52 FR 30097, Aug. 12, 1987, as amended at 61 practice requirements of the quality FR 1121, Jan. 16, 1996; 66 FR 38797, July 25, system regulation in part 820 of this 2001] chapter, with the exceptions of § 820.180, with respect to general re- § 872.1850 Lead-lined position indi- quirements concerning records, and cator. § 820.198, with respect to complaint (a) Identification. A lead-lined posi- files. tion indicator is a cone-shaped device lined with lead that is attached to a [52 FR 30097, Aug. 12, 1987, as amended at 54 dental x-ray tube and intended to aid FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, in positioning the tube, to prevent the 2001] misfocusing of the x-rays by absorbing § 872.2050 Dental sonography device. divergent radiation, and to prevent leakage of radiation. (a) Dental sonography device for moni- (b) Classification. Class I (general con- toring—(1) Identification. A dental trols). The device is exempt from the sonography device for monitoring is an premarket notification procedures in electrically powered device, intended subpart E of part 807 of this chapter to be used to monitor subject to the limitations in § 872.9. temporomandibular joint sounds. The [52 FR 30097, Aug. 12, 1987, as amended at 61 device detects and records sounds made FR 1121, Jan. 16, 1996; 66 FR 38797, July 25, by the temporomandibular joint. 2001] (2) Classification. Class I. The device is exempt from the premarket notifica- § 872.1870 Sulfide detection device. tion provisions of subpart E of part 807 (a) Identification. A sulfide detection of this chapter subject to § 872.9. device is a device consisting of an AC- (b) Dental sonography device for inter- powered control unit, probe handle, pretation and diagnosis—(1) Identifica- probe tips, cables, and accessories. This tion. A dental sonography device for in- device is intended to be used in vivo, to terpretation and diagnosis is an elec- manually measure periodontal pocket trically powered device, intended to in- probing depths, detect the presence or terpret temporomandibular joint absence of bleeding on probing, and de- sounds for the diagnosis of tect the presence of sulfides in peri- temporomandibular joint disorders and odontal pockets, as an adjunct in the associated orofacial pain. The device diagnosis of periodontal diseases in detects, records, displays, and stores adult patients. sounds made by the (b) Classification. Class II (special temporomandibular joint during jaw controls) prescription use in accord- movement. The device interprets these ance with § 801.109 of this chapter; con- sounds to generate meaningful output, formance with recognized standards of biocompatibility, electrical safety, and either directly or by connection to a sterility; clinical and analytical per- personal computer. The device may be formance testing, and proper labeling. part of a system of devices, contrib- uting joint sound information to be [63 FR 59717, Nov. 5, 1998] considered with data from other diagnostic components. § 872.1905 Dental x-ray film holder. (2) Classification. Class II (special con- (a) Identification. A dental x-ray film trols). The special control for this de- holder is a device intended to position vice is FDA’s guidance document enti- and to hold x-ray film inside the tled ‘‘Class II Special Controls Guid- mouth. ance Document: Dental Sonography (b) Classification. Class I (general con- and Jaw Tracking Devices.’’ trols). The device is exempt from the premarket notification procedures in [68 FR 67367, Dec. 2, 2003]

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§ 872.2060 Jaw tracking device. Subpart D—Prosthetic Devices (a) Jaw tracking device for monitoring § 872.3060 Noble metal alloy. mandibular jaw positions relative to the maxilla—(1) Identification. A jaw track- (a) Identification. A noble metal alloy ing device for monitoring mandibular is a device composed primarily of noble jaw positions relative to the maxilla is metals, such as gold, palladium, platinum, or silver, that is intended for use a nonpowered or electrically powered in the fabrication of cast or porcelain- device that measures and records ana- fused-to-metal crown and bridge res- tomical distances and angles in three torations. dimensional space, to determine the (b) Classification. Class II (special relative position of the mandible with controls). The special control for these respect to the location and position of devices is FDA’s ‘‘Class II Special Con- the maxilla, while at rest and during trols Guidance Document: Dental jaw movement. Noble Metal Alloys.’’ The devices are (2) Classification. Class I (general con- exempt from the premarket notifica- trols). The device is exempt from the tion procedures in subpart E of part 807 premarket notification provisions of of this chapter subject to the limita- subpart E of part 807 of this chapter tions in § 872.9. See § 872.1(e) for avail- subject to § 872.9. ability of guidance information. (b) Jaw tracking device for interpreta- [69 FR 51766, Aug. 23, 2004] tion of mandibular jaw positions for the diagnosis—(1) Identification. A jaw § 872.3070 Dental amalgam, mercury, tracking device for interpretation of and amalgam alloy. mandibular jaw positions relative to (a) Identification. Dental amalgam is the maxilla for the diagnosis of a device that consists of a combination temporomandibular joint disorders and of elemental mercury, supplied as a liq- associated orofacial pain is a nonpow- uid in bulk, sachet, or predosed capsule ered or electrically powered device form, and amalgam alloy composed pri- that measures and records anatomical marily of silver, tin, and copper, sup- distances and angles to determine the plied as a powder in bulk, tablet, or relative position of the mandible in predosed capsule form, for the direct three dimensional space, with respect filling of carious lesions or structural to the location and position of the defects in teeth. This device also in- maxilla, while at rest and during jaw cludes the individual component de- movement. The device records, dis- vices, mercury and amalgam alloy, when intended to be combined with plays, and stores information about each other to form dental amalgam. jaw position. The device interprets jaw (b) Classification. Class II (special position to generate meaningful out- controls). The special control for this put, either directly or by connection to device is FDA’s ‘‘Class II Special Con- a personal computer. The device may trols Guidance Document: Dental be a part of a system of devices, con- Amalgam, Mercury, and Amalgam tributing jaw position information to Alloy.’’ See § 872.1(e) for the availability be considered with data from other di- of this guidance document. agnostic components. [74 FR 38714, Aug. 4, 2009] (2) Classification. Class II (special controls). The special control for this de- § 872.3080 Mercury and alloy dis- vice is FDA’s guidance document enti- penser. tled ‘‘Class II Special Controls Guid- (a) Identification. A mercury and ance Document: Dental Sonography alloy dispenser is a device with a and Jaw Tracking Devices.’’ spring-activated valve intended to [68 FR 67367, Dec. 2, 2003] measure and dispense into a mixing capsule a predetermined amount of dental mercury in droplet form and a Subpart C [Reserved] premeasured amount of alloy pellets. (b) Classification. Class I (general controls). The device is exempt from the

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premarket notification procedures in § 872.3140 Resin applicator. subpart E of part 807 of this chapter (a) Identification. A resin applicator is subject to the limitations in § 872.9. a brushlike device intended for use in [52 FR 30097, Aug. 12, 1987, as amended at 54 spreading dental resin on a tooth dur- FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, ing application of tooth shade mate- 2001] rial. (b) Classification. Class I (general con- § 872.3100 Dental amalgamator. trols). The device is exempt from the (a) Identification. A dental amalga- premarket notification procedures in mator is a device, usually AC-powered, subpart E of part 807 of this chapter intended to mix, by shaking, amalgam subject to the limitations in § 872.9. If capsules containing mercury and den- the device is not labeled or otherwise tal alloy particles, such as silver, tin, represented as sterile, the device is ex- zinc, and copper. The mixed dental empt from the current good manufac- amalgam material is intended for fill- turing practice requirements of the ing dental caries. quality system regulation in part 820 of this chapter, with the exceptions of (b) Classification. Class I (general con- § 820.180, with respect to general re- trols). The device is exempt from the quirements concerning records, and premarket notification procedures in § 820.198, with respect to complaint subpart E of part 807 of this chapter files. subject to the limitations in § 872.9. [52 FR 30097, Aug. 12, 1987, as amended at 54 [55 FR 48439, Nov. 20, 1990, as amended at 59 FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, FR 63008, Dec. 7, 1994; 66 FR 38797, July 25, 2001] 2001] § 872.3150 Articulator. § 872.3110 Dental amalgam capsule. (a) Identification. An articulator is a (a) Identification. A dental amalgam mechanical device intended to simu- capsule is a container device in which late movements of a patient’s upper silver alloy is intended to be mixed and lower jaws. Plaster casts of the pa- with mercury to form dental amalgam. tient’s teeth and gums are placed in (b) Classification. Class I (general con- the device to reproduce the occlusion trols). The device is exempt from the (bite) and articulation of the patient’s premarket notification procedures in jaws. An articulator is intended to fit subpart E of part 807 of this chapter dentures or provide orthodontic treat- subject to the limitations in § 872.9. ment. (b) Classification. Class I (general con- [52 FR 30097, Aug. 12, 1987, as amended at 54 trols). The device is exempt from the FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, premarket notification procedures in 2001] subpart E of part 807 of this chapter § 872.3130 Preformed anchor. subject to the limitations in § 872.9. If the device is not labeled or otherwise (a) Identification. A preformed anchor represented as sterile, the device is ex- is a device made of austenitic alloys or empt from the current good manufac- alloys containing 75 percent or greater turing practice requirements of the gold or metals of the platinum group quality system regulation in part 820 of intended to be incorporated into a den- this chapter, with the exceptions of tal appliance, such as a denture, to § 820.180, with respect to general re- help stabilize the appliance in the pa- quirements concerning records, and tient’s mouth. § 820.198, with respect to complaint (b) Classification. Class I (general con- files. trols). The device is exempt from the [52 FR 30097, Aug. 12, 1987, as amended at 54 premarket notification procedures in FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, subpart E of part 807 of this chapter 2001] subject to the limitations in § 872.9. § 872.3165 Precision attachment. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38797, July 25, (a) Identification. A precision attach- 2001] ment or preformed bar is a device made

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of austenitic alloys or alloys con- § 820.198, with respect to complaint taining 75 percent or greater gold and files. metals of the platinum group intended [52 FR 30097, Aug. 12, 1987, as amended at 54 for use in prosthetic dentistry in con- FR 13830, Apr. 5, 1989; 66 FR 38797, July 25, junction with removable partial den- 2001] tures. Various forms of the device are intended to connect a lower partial § 872.3240 Dental bur. denture with another lower partial (a) Identification. A dental bur is a ro- denture, to connect an upper partial tary cutting device made from carbon denture with another upper partial steel or tungsten carbide intended to denture, to connect either an upper or cut hard structures in the mouth, such lower partial denture to a tooth or a as teeth or bone. It is also intended to crown, or to connect a fixed bridge to a cut hard metals, plastics, porcelains, partial denture. and similar materials intended for use (b) Classification. Class I (general con- in the fabrication of dental devices. trols). The device is exempt from the (b) Classification. Class I (general con- premarket notification procedures in trols). The device is exempt from the subpart E of part 807 of this chapter premarket notification procedures in subject to the limitations in § 872.9. subpart E of part 807 of this chapter subject to the limitations in § 872.9. [52 FR 30097, Aug. 12, 1987, as amended at 59 [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38797, July 25, FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001] 2001]

§ 872.3200 Resin tooth bonding agent. § 872.3250 Calcium hydroxide cavity (a) Identification. A resin tooth bond- liner. ing agent is a device material, such as (a) Identification. A calcium hydrox- methylmethacrylate, intended to be ide cavity liner is a device material in- painted on the interior of a prepared tended to be applied to the interior of cavity of a tooth to improve retention a prepared cavity before insertion of of a restoration, such as a filling. restorative material, such as amalgam, (b) Classification. Class II. to protect the pulp of a tooth. (b) Classification. Class II. § 872.3220 Facebow. § 872.3260 Cavity varnish. (a) Identification. A facebow is a device intended for use in denture fab- (a) Identification. Cavity varnish is a rication to determine the spatial rela- device that consists of a compound in- tionship between the upper and lower tended to coat a prepared cavity of a tooth before insertion of restorative jaws. This determination is intended materials. The device is intended to for use in placing denture casts accu- prevent penetration of restorative ma- rately into an articulator (§ 872.3150) terials, such as amalgam, into the and thereby aiding correct placement dentinal tissue. of artificial teeth into a denture base. (b) Classification. Class II. (b) Classification. Class I (general controls). The device is exempt from the § 872.3275 Dental cement. premarket notification procedures in (a) Zinc oxide-eugenol—(1) Identifica- subpart E of part 807 of this chapter tion. Zinc oxide-eugenol is a device subject to the limitations in § 872.9. If composed of zinc oxide-eugenol in- the device is not labeled or otherwise tended to serve as a temporary tooth represented as sterile, the device is ex- filling or as a base cement to affix a empt from the current good manufac- temporary tooth filling, to affix dental turing practice requirements of the devices such as crowns or bridges, or to quality system regulation in part 820 of be applied to a tooth to protect the this chapter, with the exceptions of tooth pulp. § 820.180, with respect to general re- (2) Classification. Class I (general con- quirements concerning records, and trols). The device is exempt from the premarket notification procedures in

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subpart E of part 807 of this chapter § 872.3330 Preformed crown. subject to § 872.9. (b) Dental cement other than zinc (a) Identification. A preformed crown oxide-eugenol—(1) Identification. Dental is a prefabricated device made of plas- cement other than zinc oxide-eugenol tic or austenitic alloys or alloys con- is a device composed of various mate- taining 75 percent or greater gold and rials other than zinc oxide-eugenol in- metals of the platinum group intended tended to serve as a temporary tooth to be affixed temporarily to a tooth filling or as a base cement to affix a after removal of, or breakage of, the temporary tooth filling, to affix dental natural crown (that portion of the devices such as crowns or bridges, or to tooth that normally protrudes above be applied to a tooth to protect the the gums). It is intended for use as a tooth pulp. functional restoration until a perma- (2) Classification. Class II. nent crown is constructed. The device also may be intended for use as a func- [52 FR 30097, Aug. 12, 1987, as amended at 65 tional restoration for a badly decayed FR 2314, Jan. 14, 2000] deciduous (baby) tooth until the adult § 872.3285 Preformed clasp. tooth erupts. (b) Classification. Class I (general con- (a) Identification. A preformed clasp trols). The device is exempt from the or a preformed wire clasp is a prefab- premarket notification procedures in ricated device made of austenitic al- subpart E of part 807 of this chapter loys or alloys containing 75 percent or greater gold and metals of the plat- subject to the limitations in § 872.9. inum group intended to be incor- [52 FR 30097, Aug. 12, 1987, as amended at 59 porated into a dental appliance, such FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, as a partial denture, to help stabilize 2001] the appliance in the patient’s mouth by fastening the appliance to an adjacent § 872.3350 Gold or stainless steel cusp. tooth. (a) Identification. A gold or stainless (b) Classification. Class I (general con- steel cusp is a prefabricated device trols). The device is exempt from the made of austenitic alloys or alloys con- premarket notification procedures in taining 75 percent or greater gold and subpart E of part 807 of this chapter metals of the platinum group or stain- subject to the limitations in § 872.9. less steel intended to provide a perma- [52 FR 30097, Aug. 12, 1987, as amended at 59 nent cusp (a projection on the chewing FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, surface of a tooth) to achieve occlusal 2001] harmony (a proper bite) between the teeth and a removable denture. § 872.3300 Hydrophilic resin coating (b) Classification. Class I (general con- for dentures. trols). The device is exempt from the (a) Identification. A hydrophilic resin premarket notification procedures in coating for dentures is a device that subpart E of part 807 of this chapter consists of a water-retaining polymer subject to the limitations in § 872.9. that is intended to be applied to the base of a denture before the denture is [52 FR 30097, Aug. 12, 1987, as amended at 59 inserted into the patient’s mouth to FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, improve denture retention and com- 2001] fort. (b) Classification. Class II. § 872.3360 Preformed cusp. (a) Identification. A performed cusp is § 872.3310 Coating material for resin a prefabricated device made of plastic fillings. or austenitic alloys or alloys con- (a) Identification. A coating material taining 75 percent or greater gold and for resin fillings is a device intended to metals of the platinum group intended be applied to the surface of a restora- to be used as a temporary cusp (a pro- tive resin dental filling to attain a jection on the chewing surface of a smooth, glaze-like finish on the surface tooth) to achieve occlusal harmony (a of the filling. proper bite) before permanent restora- (b) Classification. Class II. tion of a tooth.

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(b) Classification. Class I (general con- § 872.3410 Ethylene oxide trols). The device is exempt from the homopolymer and/or premarket notification procedures in carboxymethylcellulose sodium subpart E of part 807 of this chapter denture adhesive. subject to the limitations in § 872.9. (a) Identification. An ethylene oxide [52 FR 30097, Aug. 12, 1987, as amended at 59 homopolymer and/or FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, carboxymethylcellulose sodium den- 2001] ture adhesive is a device containing ethylene oxide homopolymer and/or § 872.3400 Karaya and sodium borate carboxymethylcellulose sodium in- with or without acacia denture ad- tended to be applied to the base of a hesive. denture before the denture is inserted (a) Identification. A karaya and so- in a patient’s mouth to improve den- dium borate with or without acacia ture retention and comfort. denture adhesive is a device composed (b) Classification. Class I (general con- of karaya and sodium borate with or trols). The device is exempt from the without acacia intended to be applied premarket notification procedures in to the base of a denture before the den- subpart E of part 807 of this chapter ture is inserted into patient’s mouth to subject to the limitations in § 872.9. improve denture retention and com- [52 FR 30097, Aug. 12, 1987, as amended at 59 fort. FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, (b) Classification. (1) Class I (general 2001] controls) if the device contains less than 12 percent by weight of sodium § 872.3420 Carboxymethylcellulose so- borate. The class I device is exempt dium and cationic polyacrylamide from the premarket notification proce- polymer denture adhesive. dures in subpart E of part 807 of this (a) Identification. A chapter subject to § 872.9. carboxymethylcellulose sodium and (2) Class III if the device contains 12 cationic polyacrylamide polymer den- percent or more by weight of sodium ture adhesive is a device composed of borate. carboxymethylcellulose sodium and (c) Date PMA or notice of completion of cationic polyacrylamide polymer in- a PDP is required. A PMA or a notice of tended to be applied to the base of a completion of a PDP is required to be denture before the denture is inserted filed with the Food and Drug Adminis- in a patient’s mouth to improve den- tration on or before December 26, 1996 ture retention and comfort. for any karaya and sodium borate with (b) Classification. Class III. or without acacia denture adhesive (c) Date PMA or notice of completion of that was in commercial distribution a PDP is required. A PMA or a notice of before May 28, 1976, or that has, on or completion of a PDP is required to be before December 26, 1996 been found to filed with the Food and Drug Adminis- be substantially equivalent to a karaya tration on or before December 26, 1996 and sodium borate with or without aca- for any carboxymethylcellulose sodium cia denture adhesive that was in com- and cationic polyacrylamide polymer mercial distribution before May 28, denture adhesive that was in commer- 1976. Any other karaya and sodium bo- cial distribution before May 28, 1976, or rate with or without acacia denture ad- that has, on or before December 26, 1996 hesive shall have an approved PMA or been found to be substantially equiva- a declared completed PDP in effect be- lent to a carboxymethylcellulose so- fore being placed in commercial dis- dium and cationic polyacrylamide tribution. polymer denture adhesive that was in [52 FR 30097, Aug. 12, 1987, as amended at 61 commercial distribution before May 28, FR 50706, Sept. 27, 1996; 65 FR 2315, Jan. 14, 1976. Any other carboxymethylcellulose 2000] sodium and cationic polyacrylamide polymer denture adhesive shall have an approved PMA or a declared completed

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PDP in effect before being placed in sive shall have an approved PMA or a commercial distribution. declared completed PDP in effect before being place in commercial dis- [52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50707, Sept. 27, 1996] tribution. [52 FR 30097, Aug. 12, 1987, as amended at 61 § 872.3450 Ethylene oxide FR 50707, Sept. 27, 1996] homopolymer and/or karaya denture adhesive. § 872.3490 Carboxymethylcellulose so- (a) Identification. Ethylene oxide dium and/or polyvinylmethylether homopolymer and/or karaya denture maleic acid calcium-sodium double adhesive is a device composed of ethyl- salt denture adhesive. ene oxide homopolymer and/or karaya (a) Identification. A intended to be applied to the base of a carboxymethylcellulose sodium and/or denture before the denture is inserted polyvinylmethylether maleic acid cal- in a patient’s mouth to improve den- cium-sodium double salt denture adhe- ture retention and comfort. sive is a device composed of (b) Classification. (1) Class I if the de- carboxymethylcellulose sodium and/or vice is made of wax-impregnated cot- polyvinylmethylether maleic acid cal- ton cloth that the patient applies to cium-sodium double salt intended to be the base or inner surface of a denture applied to the base of a denture before before inserting the denture into the the denture is inserted in a patient’s mouth. The device is intended to be mouth to improve denture retention discarded following 1 day’s use. The and comfort. class I device is exempt from the pre- (b) Classification. Class I (general con- market notification procedures in sub- trols). The device is exempt from the part E of part 807 of this chapter sub- premarket notification procedures in ject to § 872.9. subpart E of part 807 of this chapter [52 FR 30097, Aug. 12, 1987, as amended at 59 subject to the limitations in § 872.9. FR 63008, Dec. 7, 1994; 65 FR 2315, Jan. 14, [52 FR 30097, Aug. 12, 1987, as amended at 59 2000] FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001] § 872.3480 Polyacrylamide polymer (modified cationic) denture adhe- § 872.3500 Polyvinylmethylether ma- sive. leic anhydride (PVM-MA), acid co- (a) Identification. A polyacrylamide polymer, and polymer (modified cationic) denture carboxymethylcellulose sodium adhesive is a device composed of (NACMC) denture adhesive. polyacrylamide polymer (modified cat- (a) Identification. ionic) intended to be applied to the Polyvinylmethylether maleic anhy- base of a denture before the denture is dride (PVM-MA), acid copolymer, and inserted in a patient’s mouth to im- carboxymethylcellulose sodium prove denture retention and comfort. (NACMC) denture adhesive is a device (b) Classification. Class III. composed of polyvinylmethylether ma- (c) Date PMA or notice of completion of leic anhydride, acid copolymer, and a PDP is required. A PMA or a notice of carboxymethylcellulose sodium in- completion of a PDP is required to be tended to be applied to the base of a filed with the Food and Drug Adminis- denture before the denture is inserted tration on or before December 26, 1996 in a patient’s mouth to improve den- for any polyacrylamide polymer (modi- ture retention and comfort. fied cationic) denture adhesive that (b) Classification. Class III. was in commercial distribution before (c) Date PMA or notice of completion of May 28, 1976, or that has, on or before a PDP is required. A PMA or a notice of December 26, 1996 been found to be sub- completion of a PDP is required to be stantially equivalent to a filed with the Food and Drug Adminis- polyacrylamide polymer (modified cat- tration on or before December 26, 1996 ionic) denture adhesive that was in for any polyvinylmethylether maleic commercial distribution before May 28, anhydride (PVM-MA), acid copolymer, 1976. Any other polyacrylamide poly- and carboxymethylcellulose sodium mer (modified cationic) denture adhe- (NACMC) denture adhesive that was in

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commercial distribution before May 28, § 872.3540 OTC denture cushion or 1976, or that has, on or before Decem- pad. ber 26, 1996 been found to be substan- (a) Identification. An OTC denture tially equivalent to a cushion or pad is a prefabricated or polyvinylmethylether maleic anhy- noncustom made disposable device that dride (PVM-MA), acid copolymer, and is intended to improve the fit of a loose carboxymethylcellulose sodium or uncomfortable denture, and may be (NACMC) denture adhesive that was in available for purchase over-the- commercial distribution before May 28, counter. 1976. Any other polyvinylmethylether (b) Classification. (1) Class I if the de- maleic anhydride (PVM-MA), acid co- vice is made of wax-impregnated cot- polymer, and carboxymethylcellulose ton cloth that the patient applies to sodium (NACMC) denture adhesive the base or inner surface of a denture shall have an approved PMA or a de- before inserting the denture into the clared completed PDP in effect before mouth. The device is intended to be being placed in commercial distribu- discarded following 1 day’s use. The tion. class I device is exempt from the pre- [52 FR 30097, Aug. 12, 1987, as amended at 61 market notification procedures in sub- FR 50707, Sept. 27, 1996] part E of part 807 of this chapter subject to § 872.9. § 872.3520 OTC denture cleanser. (2) Class II if the OTC denture cush- (a) Identification. An OTC denture ion or pad is made of a material other cleanser is a device that consists of than wax-impregnated cotton cloth or material in the form of a powder, tab- if the intended use of the device differs let, or paste that is intended to remove from that described in paragraph (b)(1) debris from removable prosthetic den- of this section. The special controls for tal appliances, such as bridges or den- this device are FDA’s: tures. The dental appliance is removed (i) ‘‘Use of International Standard from the patient’s mouth when the ap- ISO 10993 ‘Biological Evaluation of pliance is cleaned. Medical—Devices Part I: Evaluation (b) Classification. Class I (general con- and Testing,’ ’’ and trols). The device is exempt from the (ii) ‘‘OTC Denture Reliners, Repair premarket notification procedures in Kits, and Partially Fabricated Denture subpart E of part 807 of this chapter Kits.’’ subject to the limitations in § 872.9. [52 FR 30097, Aug. 12, 1987, as amended at 65 [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 2315, 2000; 65 FR 17144, Mar. 31, 2000] FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001] § 872.3560 OTC denture reliner. § 872.3530 Mechanical denture cleaner. (a) Identification. An OTC denture reliner is a device consisting of a mate- (a) Identification. A mechanical den- rial such as plastic resin that is in- ture cleaner is a device, usually AC- tended to be applied as a permanent powered, that consists of a container for mechanically agitating a denture coating or lining on the base or tissue- cleansing solution. The device is in- contacting surface of a denture. The tended to clean a denture by submer- device is intended to replace a worn sion in the agitating cleansing solution denture lining and may be available for in the container. purchase over the counter. (b) Classification. Class I (general con- (b) Classification. Class II. The special trols). The device is exempt from the controls for this device are FDA’s: premarket notification procedures in (1) ‘‘Use of International Standard subpart E of part 807 of this chapter ISO 10993 ‘Biological Evaluation of subject to the limitations in § 872.9. Medical Devices—Part I: Evaluation and Testing,’ ’’ and [55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001]

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(2) ‘‘OTC Denture Reliners, Repair § 872.3600 Partially fabricated denture Kits, and Partially Fabricated Denture kit. Kits.’’ (a) Identification. A partially fab- [52 FR 30097, Aug. 12, 1987, as amended at 61 ricated denture kit is a device com- FR 50707, Sept. 27, 1996; 65 FR 17144, Mar. 31, posed of connected preformed teeth 2000] that is intended for use in construction of a denture. A denture base is con- § 872.3570 OTC denture repair kit. structed using the patient’s mouth as a mold, by partially polymerizing the (a) Identification. An OTC denture re- resin denture base materials while the pair kit is a device consisting of a ma- materials are in contact with the oral terial, such as a resin monomer system tissues. After the denture base is con- of powder and liquid glues, that is instructed, the connected preformed tended to be applied permanently to a teeth are chemically bonded to the denture to mend cracks or breaks. The base. device may be available for purchase (b) Classification. Class II. The special over-the counter. controls for this device are FDA’s: (b) Classification. Class II. The special (1) ‘‘Use of International Standard controls for this device are FDA’s: ISO 10993 ‘Biological Evaluation of (1) ‘‘Use of International Standard Medical Devices—Part I: Evaluation ISO 10993 ‘Biological Evaluation of and Testing,’ ’’ and Medical Devices—Part I: Evaluation (2) ‘‘OTC Denture Reliners, Repair and Testing,’ ’’ and Kits, and Partially Fabricated Denture (2) ‘‘OTC Denture Reliners, Repair Kits.’’ Kits, and Partially Fabricated Denture [52 FR 30097, Aug. 12, 1987, as amended at 65 Kits.’’ FR 17144, Mar. 31, 2000] [52 FR 30097, Aug. 12, 1987, as amended at 65 § 872.3630 Endosseous dental implant FR 17144, Mar. 31, 2000] abutment. (a) Identification. An endosseous den- § 872.3580 Preformed gold denture tooth. tal implant abutment is a premanufactured prosthetic component (a) Identification. A preformed gold directly connected to the endosseous denture tooth is a device composed of dental implant and is intended for use austenitic alloys or alloys containing as an aid in prosthetic rehabilitation. 75 percent or greater gold and metals of (b) Classification. Class II (special the platinum group intended for use as controls). The guidance document enti- a tooth or a portion of a tooth in a tled ‘‘Class II Special Controls Guid- fixed or removable partial denture. ance Document: Root-Form (b) Classification. Class I (general con- Endosseous Dental Implants and trols). The device is exempt from the Endosseous Dental Implant Abut- premarket notification procedures in ments’’ will serve as the special con- subpart E of part 807 of this chapter trol. (See § 872.1(e) for the availability subject to the limitations in § 872.9. of this guidance document.) [69 FR 26304, May 12, 2004] [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, § 872.3640 Endosseous dental implant. 2001] (a) Identification. An endosseous den- § 872.3590 Preformed plastic denture tal implant is a prescription device tooth. made of a material such as titanium or titanium alloy that is intended to be (a) Identification. A preformed plastic surgically placed in the bone of the denture tooth is a prefabricated device, upper or lower jaw arches to provide composed of materials such as methyl support for prosthetic devices, such as methacrylate, that is intended for use artificial teeth, in order to restore a as a tooth in a denture. patient’s chewing function. (b) Classification. Class II. (b) Classification. (1) Class II (special controls). The device is classified as

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class II if it is a root-form endosseous (ix) Documented clinical experience dental implant. The root-form must demonstrate safe and effective endosseous dental implant is charac- use and capture any adverse events ob- terized by four geometrically distinct served during clinical use. types: Basket, screw, solid cylinder, [69 FR 26304, May 12, 2004, as amended at 79 and hollow cylinder. The guidance doc- FR 34625, June 18, 2014] ument entitled ‘‘Class II Special Con- trols Guidance Document: Root-Form § 872.3645 Subperiosteal implant mate- Endosseous Dental Implants and rial. Endosseous Dental Implant Abut- (a) Identification. Subperiosteal im- ments’’ will serve as the special con- plant material is a device composed of trol. (See § 872.1(e) for the availability titanium or cobalt chrome molyb- of this guidance document.) denum intended to construct custom (2) Classification. Class II (special con- prosthetic devices which are surgically trols). The device is classified as class implanted into the lower or upper jaw II if it is a blade-form endosseous den- between the periosteum (connective tal implant. The special controls for tissue covering the bone) and sup- this device are: porting bony structures. The device is (i) The design characteristics of the intended to provide support for pros- device must ensure that the geometry theses, such as dentures. and material composition are con- (b) Classification. Class II. sistent with the intended use; (ii) Mechanical performance (fatigue) § 872.3660 Impression material. testing under simulated physiological conditions to demonstrate maximum (a) Identification. Impression material load (endurance limit) when the device is a device composed of materials such is subjected to compressive and shear as alginate or polysulfide intended to loads; be placed on a preformed impression (iii) Corrosion testing under simu- tray and used to reproduce the struc- lated physiological conditions to dem- ture of a patient’s teeth and gums. The onstrate corrosion potential of each device is intended to provide models metal or alloy, couple potential for an for study and for production of restora- assembled dissimilar metal implant tive prosthetic devices, such as gold in- system, and corrosion rate for an as- lays and dentures. sembled dissimilar metal implant sys- (b) Classification. Class II (Special tem; Controls). (iv) The device must be demonstrated [52 FR 30097, Aug. 12, 1987, as amended at 68 to be biocompatible; FR 19738, Apr. 22, 2003] (v) Sterility testing must demonstrate the sterility of the device; § 872.3661 Optical Impression Systems (vi) Performance testing to evaluate for CAD/CAM. the compatibility of the device in a (a) Identification. An optical impres- magnetic resonance (MR) environment; sion system for computer assisted de- (vii) Labeling must include a clear sign and manufacturing (CAD/CAM) is description of the technological fea- a device used to record the topo- tures, how the device should be used in graphical characteristics of teeth, den- patients, detailed surgical protocol and tal impressions, or stone models by restoration procedures, relevant pre- analog or digital methods for use in the cautions and warnings based on the computer-assisted design and manufac- clinical use of the device, and quali- turing of dental restorative prosthetic fications and training requirements for devices. Such systems may consist of a device users including technicians and camera, scanner, or equivalent type of clinicians; sensor and a computer with software. (viii) Patient labeling must contain a (b) Classification. Class II (Special description of how the device works, Controls). The device is exempt from how the device is placed, how the pa- the premarket notification procedures tient needs to care for the implant, in subpart E of part 807 of the chapter possible adverse events and how to re- subject to the limitations in § 872.9. The port any complications; and special control for these devices is the

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FDA guidance document entitled tains the sockets in which teeth are ‘‘Class II Special Controls Guidance rooted) or intended to coat metal sur- Document: Optical Impression Systems gical implants to be placed in the for Computer Assisted Design and Man- alveoli (sockets in which the teeth are ufacturing (CAD/CAM) of Dental Res- rooted) or the temporomandibular torations; Guidance for Industry and joints (the joint between the upper and FDA.’’ For the availability of this lower jaws). guidance document, see § 872.1(e). (b) Classification. Class II. [68 FR 19738, Apr. 22, 2003] [52 FR 30097, Aug. 12, 1987; 52 FR 34456, Sept. 11, 1987] § 872.3670 Resin impression tray material. § 872.3690 Tooth shade resin material. (a) Identification. Resin impression (a) Identification. Tooth shade resin tray material is a device intended for material is a device composed of mate- use in a two-step dental mold fabri- rials such as bisphenol-A glycidyl cating process. The device consists of a methacrylate (Bis-GMA) intended to resin material, such as methyl meth- restore carious lesions or structural de- acrylate, and is used to form a custom fects in teeth. impression tray for use in cases in (b) Classification. Class II. which a preformed impression tray is not suitable, such as the fabrication of § 872.3710 Base metal alloy. crowns, bridges, or full dentures. A pre- (a) Identification. A base metal alloy liminary plaster or stone model of the is a device composed primarily of base patient’s teeth and gums is made. The metals, such as nickel, chromium, or resin impression tray material is ap- cobalt, that is intended for use in fab- plied to this preliminary study model rication of cast or porcelain-fused-to- to form a custom tray. This tray is metal crown and bridge restorations. then filled with impression material (b) Classification. Class II (special and inserted into the patient’s mouth controls). The special control for this to make an impression, from which a device is FDA’s ‘‘Class II Special Con- final, more precise, model of the pa- trols Guidance Document: Dental Base tient’s mouth is cast. Metal Alloys.’’ The device is exempt (b) Classification. Class I (general con- from the premarket notification proce- trols). The device is exempt from the dures in subpart E of part 807 of this premarket notification procedures in chapter subject to the limitations in subpart E of part 807 of this chapter § 872.9. See § 872.1(e) for availability of subject to the limitations in § 872.9. If guidance information. the device is not labeled or otherwise represented as sterile, it is exempt [69 FR 51766, Aug. 23, 2004] from the current good manufacturing practice requirements of the quality § 872.3730 Pantograph. system regulation in part 820 of this (a) Identification. A pantograph is a chapter, with the exception of § 820.180, device intended to be attached to a pa- with respect to general requirements tient’s head to duplicate lower jaw concerning records, and § 820.198, with movements to aid in construction of respect to complaint files. restorative and prosthetic dental de- [52 FR 30097, Aug. 12, 1987, as amended at 59 vices. A marking pen is attached to the FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, lower jaw component of the device and, 2001] as the patient’s mouth opens, the pen records on graph paper the angle be- § 872.3680 Polytetrafluoroethylene tween the upper and the lower jaw. (PTFE) vitreous carbon materials. (b) Classification. Class I (general con- (a) Identification. Polytetrafluoro- trols). The device is exempt from the ethylene (PTFE) vitreous carbon mate- premarket notification procedures in rial is a device composed of polytetra- subpart E of part 807 of this chapter fluoroethylene (PTFE) vitreous carbon subject to the limitations in § 872.9. If intended for use in maxillofacial alve- the device is not labeled or otherwise olar ridge augmentation (building up represented as sterile, it is exempt the upper or lower jaw area that con- from the current good manufacturing

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practice requirements of the quality the enamel) in the biting surfaces of system regulation in part 820 of this teeth to prevent cavities. chapter, with the exception of § 820.180, (b) Classification. Class II. with respect to general requirements concerning records, and § 820.198, with § 872.3770 Temporary crown and respect to complaint files. bridge resin. [52 FR 30097, Aug. 12, 1987, as amended at 66 (a) Identification. A temporary crown FR 38798, July 25, 2001] and bridge resin is a device composed of a material, such as § 872.3740 Retentive and splinting pin. polymethylmethacrylate, intended to (a) Identification. A retentive and make a temporary prosthesis, such as a splinting pin is a device made of aus- crown or bridge, for use until a perma- tenitic alloys or alloys containing 75 nent restoration is fabricated. percent or greater gold and metals of (b) Classification. Class II. the platinum group intended to be placed permanently in a tooth to pro- § 872.3810 Root canal post. vide retention and stabilization for a (a) Identification. A root canal post is restoration, such as a crown, or to join a device made of austenitic alloys or two or more teeth together. alloys containing 75 percent or greater (b) Classification. Class I (general con- gold and metals of the platinum group trols). The device is exempt from the intended to be cemented into the root premarket notification procedures in canal of a tooth to stabilize and sup- subpart E of part 807 of this chapter port a restoration. subject to the limitations in § 872.9 (b) Classification. Class I (general con- [52 FR 30097, Aug. 12, 1987, as amended at 60 trols). The device is exempt from the FR 38900, July 28, 1995; 66 FR 38798, July 25, premarket notification procedures in 2001] subpart E of part 807 of this chapter subject to the limitations in § 872.9. § 872.3750 Bracket adhesive resin and tooth conditioner. [52 FR 30097, Aug. 12, 1987, as amended at 60 (a) Identification. A bracket adhesive FR 38900, July 28, 1995; 66 FR 38798, July 25, 2001] resin and tooth conditioner is a device composed of an adhesive compound, § 872.3820 Root canal filling resin. such as polymethylmethacrylate, intended to cement an orthodontic (a) Identification. A root canal filling bracket to a tooth surface. resin is a device composed of material, (b) Classification. Class II. such as methylmethacrylate, intended for use during endodontic therapy to § 872.3760 Denture relining, repairing, fill the root canal of a tooth. or rebasing resin. (b) Classification. (1) Class II if chloro- (a) Identification. A denture relining, form is not used as an ingredient in the repairing, or rebasing resin is a device device. composed of materials such as (2) Class III if chloroform is used as methylmethacrylate, intended to re- an ingredient in the device. line a denture surface that contacts (c) Date PMA or notice of completion of tissue, to repair a fractured denture, or a PDP is required. A PMA or a notice of to form a new denture base. This device completion of a PDP is required to be is not available for over-the-counter filed with the Food and Drug Adminis- (OTC) use. tration on or before December 26, 1996 (b) Classification. Class II. for any root canal filling resin described in paragraph (b)(2) of this sec- § 872.3765 Pit and fissure sealant and tion that was in commercial distribu- conditioner. tion before May 28, 1976, or that has, on (a) Identification. A pit and fissure or before December 26, 1996 been found sealant and conditioner is a device to be substantially equivalent to a root composed of resin, such as canal filling resin described in para- polymethylmethacrylate, intended for graph (b)(2) of this section that was in use primarily in young children to seal commercial distribution before May 28, pit and fissure depressions (faults in 1976. Any other root canal filling resin

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shall have an approved PMA or a de- terial, such as titanium, intended to be clared completed PDP in effect before inserted through the root canal into being placed in commercial distribu- the upper or lower jaw bone to stabilize tion. a tooth. [52 FR 30097, Aug. 12, 1987, as amended at 61 (b) Classification. Class II. FR 50707, Sept. 27, 1996] § 872.3900 Posterior artificial tooth § 872.3830 Endodontic paper point. with a metal insert. (a) Identification. An endodontic (a) Identification. A posterior artifi- paper point is a device made of paper cial tooth with a metal insert is a por- intended for use during endodontic celain device with an insert made of therapy to dry, or apply medication to, austenitic alloys or alloys containing the root canal of a tooth. 75 percent or greater gold and metals of (b) Classification. Class I (general con- the platinum group intended to replace trols). The device is exempt from the a natural tooth. The device is attached premarket notification procedures in to surrounding teeth by a bridge and is subpart E of part 807 of this chapter intended to provide both an improve- subject to the limitations in § 872.9. ment in appearance and functional oc- [52 FR 30097, Aug. 12, 1987, as amended at 54 clusion (bite). FR 13830, Apr. 5, 1989; 66 FR 38798, July 25, (b) Classification. Class I (general con- 2001] trols). The device is exempt from the § 872.3840 Endodontic silver point. premarket notification procedures in subpart E of part 807 of this chapter (a) Identification. An endodontic sil- subject to the limitations in § 872.9. ver point is a device made of silver intended for use during endodontic ther- [52 FR 30097, Aug. 12, 1987, as amended at 59 apy to fill permanently the root canal FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, of a tooth. 2001] (b) Classification. Class I (general controls). The device is exempt from the § 872.3910 Backing and facing for an premarket notification procedures in artificial tooth. subpart E of part 807 of this chapter (a) Identification. A backing and fac- subject to the limitations in § 872.9. ing for an artificial tooth is a device [52 FR 30097, Aug. 12, 1987, as amended at 54 intended for use in fabrication of a FR 13830, Apr. 5, 1989; 66 FR 38798, July 25, fixed or removable dental appliance, 2001] such as a crown or bridge. The backing, which is made of gold, is attached to § 872.3850 Gutta percha. the dental appliance and supports the (a) Identification. Gutta percha is a tooth-colored facing, which is made of device made from coagulated sap of porcelain or plastic. certain tropical trees intended to fill (b) Classification. Class I (general con- the root canal of a tooth. The gutta trols). The device is exempt from the percha is softened by heat and inserted premarket notification procedures in into the root canal, where it hardens as subpart E of part 807 of this chapter it cools. subject to the limitations in § 872.9. (b) Classification. Class I (general controls). The device is exempt from the [52 FR 30097, Aug. 12, 1987, as amended at 59 premarket notification procedures in FR 63008, Dec. 7, 1994; 66 FR 38799, July 25, subpart E of part 807 of this chapter 2001] subject to the limitations in § 872.9. § 872.3920 Porcelain tooth. [52 FR 30097, Aug. 12, 1987, as amended at 54 (a) Identification. A porcelain tooth is FR 13830, Apr. 5, 1989; 66 FR 38798, July 25, 2001] a prefabricated device made of porcelain powder for clinical use § 872.3890 Endodontic stabilizing (§ 872.6660) intended for use in construc- splint. tion of fixed or removable prostheses, (a) Identification. An endodontic sta- such as crowns and partial dentures. bilizing splint is a device made of a ma- (b) Classification. Class II.

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§ 872.3930 Bone grafting material. total temporomandibular joint prosthesis shall have an approved PMA or a (a) Identification. Bone grafting mate- declared completed PDP in effect be- rial is a material such as fore being placed in commercial dis- hydroxyapatite, tricalcium phosphate, tribution. polylactic and polyglycolic acids, or collagen, that is intended to fill, aug- [59 FR 65478, Dec. 20, 1994, as amended at 63 ment, or reconstruct periodontal or FR 71746, Dec. 30, 1998] bony defects of the oral and maxillofacial region. § 872.3950 Glenoid fossa prosthesis. (b) Classification. (1) Class II (special (a) Identification. A glenoid fossa controls) for bone grafting materials prosthesis is a device that is intended that do not contain a drug that is a to be implanted in the therapeutic biologic. The special con- temporomandibular joint to augment a trol is FDA’s ‘‘Class II Special Controls glenoid fossa or to provide an articula- Guidance Document: Dental Bone tion surface for the head of a man- Grafting Material Devices.’’ (See dibular condyle. § 872.1(e) for the availability of this (b) Classification. Class III. guidance document.) (c) Date PMA or notice of completion of (2) Class III (premarket approval) for a PDP is required. A PMA or a notice of bone grafting materials that contain a completion of a PDP is required to be drug that is a therapeutic biologic. filed with the Food and Drug Adminis- Bone grafting materials that contain a tration on or before March 30, 1999, for drug that is a therapeutic biologic, any glenoid fossa prosthesis that was such as biological response modifiers, in commercial distribution before May require premarket approval. 28, 1976, or that has on or before March (c) Date premarket approval application 30, 1999, been found to be substantially (PMA) or notice of product development equivalent to a glenoid fossa prosthesis protocol (PDP) is required. Devices de- that was in commercial distribution scribed in paragraph (b)(2) of this sec- before May 28, 1976. Any other glenoid tion shall have an approved PMA or a fossa prosthesis shall have an approved declared completed PDP in effect be- PMA or a declared completed PDP in fore being placed in commercial dis- effect before being placed in commer- tribution. cial distribution. [70 FR 21949, Apr. 28, 2005] [59 FR 65478, Dec. 20, 1994, as amended at 63 FR 71746, Dec. 30, 1998] § 872.3940 Total temporomandibular joint prosthesis. § 872.3960 Mandibular condyle pros- (a) Identification. A total thesis. temporomandibular joint prosthesis is (a) Identification. A mandibular a device that is intended to be im- condyle prosthesis is a device that is planted in the human jaw to replace intended to be implanted in the human the mandibular condyle and augment jaw to replace the mandibular condyle the glenoid fossa to functionally recon- and to articulate within a glenoid struct the temporomandibular joint. fossa. (b) Classification. Class III. (b) Classification. Class III. (c) Date PMA or notice of completion of (c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of a PDP is required. A PMA or a notice of completion of a PDP is required to be completion of a PDP is required to be filed with the Food and Drug Adminis- filed with the Food and Drug Adminis- tration on or before March 30, 1999, for tration on or before March 30, 1999, for any total temporomandibular joint any mandibular condyle prosthesis prosthesis that was in commercial dis- that was in commercial distribution tribution before May 28, 1976, or that before May 28, 1976, or that has, on or has, on or before March 30, 1999, been before March 30, 1999, been found to be found to be substantially equivalent to substantially equivalent to a man- a total temporomandibular joint pros- dibular condyle prosthesis that was in thesis that was in commercial distribu- commercial distribution before May 28, tion before May 28, 1976. Any other 1976. Any other mandibular condyle

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prosthesis shall have an approved PMA (b) Classification. Class I (general con- or a declared completed PDP in effect trols). The device is exempt from the before being placed in commercial dis- premarket notification procedures in tribution. subpart E of part 807 of this chapter [59 FR 65478, Dec. 20, 1994, as amended at 63 subject to the limitations in § 872.9. FR 71746, Dec. 30, 1998; 78 FR 79310, Dec. 30, [65 FR 60099, Oct. 10, 2000] 2013]

§ 872.3970 Interarticular disc pros- Subpart E—Surgical Devices thesis (interpositional implant). § 872.4120 Bone cutting instrument (a) Identification. An interarticular and accessories. disc prosthesis (interpositional implant) is a device that is intended to be (a) Identification. A bone cutting in- an interface between the natural ar- strument and accessories is a metal de- ticulating surface of the mandibular vice intended for use in reconstructive condyle and glenoid fossa. oral surgery to drill or cut into the (b) Classification. Class III. upper or lower jaw and may be used to (c) Date PMA or notice of completion of prepare bone to insert a wire, pin, or a PDP is required. A PMA or a notice of screw. The device includes the manual completion of a PDP is required to be bone drill and wire driver, powered filed with the Food and Drug Adminis- bone drill, rotary bone cutting hand- tration on or before March 30, 1999, for piece, and AC-powered bone saw. any interarticular disc prosthesis (b) Classification. Class II. (interpositional implant) that was in commercial distribution before May 28, § 872.4130 Intraoral dental drill. 1976, or that has on or before March 30, (a) Identification. An intraoral dental 1999, been found to be substantially drill is a rotary device intended to be equivalent to an interarticular disc attached to a dental handpiece to drill prosthesis (interpositional implant) holes in teeth to secure cast or that was in commercial distribution preformed pins to retain operative den- before May 28, 1976. Any other inter- tal appliances. articular disc prosthesis (interposi- (b) Classification. Class I (general con- tional implant) shall have an approved trols). The device is exempt from the PMA or a declared completed PDP in premarket notification procedures in effect before being placed in commer- subpart E of part 807 of this chapter cial distribution. subject to the limitations in § 872.9. [59 FR 65478, Dec. 20, 1994, as amended at 63 [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 71746, Dec. 30, 1998] FR 63008, Dec. 7, 1994; 66 FR 38799, July 25, 2001] § 872.3980 Endosseous dental implant accessories. § 872.4200 Dental handpiece and acces- (a) Identification. Endosseous dental sories. implant accessories are manually pow- (a) Identification. A dental handpiece ered devices intended to aid in the and accessories is an AC-powered, placement or removal of endosseous water-powered, air-powered, or belt- dental implants and abutments, pre- driven, hand-held device that may in- pare the site for placement of clude a foot controller for regulation of endosseous dental implants or abut- speed and direction of rotation or a ments, aid in the fitting of endosseous contra-angle attachment for difficult dental implants or abutments, aid in to reach areas intended to prepare den- the fabrication of dental prosthetics, tal cavities for restorations, such as and be used as an accessory with fillings, and for cleaning teeth. endosseous dental implants when tis- (b) Classification. Class I. sue contact will last less than 1 hour. These devices include drill bits, screw- [55 FR 48439, Nov. 20, 1990] drivers, countertorque devices, placement and removal tools, laboratory § 872.4465 Gas-powered jet injector. pieces used for fabrication of dental (a) Identification. A gas-powered jet prosthetics, and trial abutments. injector is a syringe device intended to

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administer a local anesthetic. The sy- endodontic pulp canal reamer, crown ringe is powered by a cartridge con- remover, periodontic scaler, collar and taining pressurized carbon dioxide crown scissors, endodontic pulp canal which provides the pressure to force filling material spreader, surgical the anesthetic out of the syringe. osteotome chisel, endodontic broach, (b) Classification. Class II. dental wax carver, endodontic pulp canal file, hand instrument for calculus § 872.4475 Spring-powered jet injector. removal, dental depth gauge instru- (a) Identification. A spring-powered ment, plastic dental filling instrument, jet injector is a syringe device intended dental instrument handle, surgical tis- to administer a local anesthetic. The sue scissors, mouth mirror, ortho- syringe is powered by a spring mecha- dontic band driver, orthodontic band nism which provides the pressure to pusher, orthodontic band setter, ortho- force the anesthetic out of the syringe. dontic bracket aligner, orthodontic (b) Classification. Class II. pliers, orthodontic ligature tucking in- § 872.4535 Dental diamond instrument. strument, forceps, for articulation paper, forceps for dental dressing, den- (a) Identification. A dental diamond tal matrix band, matrix retainer, den- instrument is an abrasive device in- tal retractor, dental retractor acces- tended to smooth tooth surfaces during sories, periodontic or endodontic irri- the fitting of crowns or bridges. The gating syringe, and restorative or im- device consists of a shaft which is in- pression material syringe. serted into a handpiece and a head which has diamond chips imbedded into (b) Classification. Class I (general con- it. Rotation of the diamond instrument trols). If the device is made of the same provides an abrasive action when it materials that were used in the device contacts a tooth. before May 28, 1976, it is exempt from (b) Classification. Class I. The device the premarket notification procedures is exempt from the premarket notifica- in subpart E of part 807 of this chapter tion procedures in subpart E of part 807 subject to the limitations in § 872.9. of this chapter. [52 FR 30097, Aug. 12, 1987, as amended at 54 [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 13830, Apr. 5, 1989; 66 FR 38799, July 25, FR 63008, Dec. 7, 1994] 2001]

§ 872.4565 Dental hand instrument. § 872.4600 Intraoral ligature and wire (a) Identification. A dental hand in- lock. strument is a hand-held device in- (a) Identification. An intraoral liga- tended to perform various tasks in gen- ture and wire lock is a metal device in- eral dentistry and oral surgery proce- tended to constrict fractured bone seg- dures. The device includes the opera- ments in the oral cavity. The bone seg- tive burnisher, operative amalgam car- ments are stabilized by wrapping the rier, operative dental amalgam carver, ligature (wire) around the fractured surgical bone chisel, operative amal- bone segments and locking the ends to- gam and foil condenser, endodontic cu- gether. rette, operative curette, periodontic (b) Classification. Class II. curette, surgical curette, dental surgical elevator, operative dental exca- § 872.4620 Fiber optic dental light. vator, operative explorer surgical bone file, operative margin finishing file, (a) Identification. A fiber optic dental periodontic file, periodontic probe, sur- light is a device that is a light, usually gical rongeur forceps, surgical tooth AC-powered, that consists of glass or extractor forceps, surgical hemostat, plastic fibers which have special opti- periodontic hoe, operative matrix cal properties. The device is usually at- contouring instrument, operative cut- tached to a dental handpiece and is in- ting instrument, operative margin fin- tended to illuminate a patient’s oral ishing periodontic knife, periodontic structures. marker, operative pliers, endodontic (b) Classification. Class I (general con- root canal plugger, endodontic root trols). The device is exempt from the canal preparer, surgical biopsy punch, premarket notification procedures in

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subpart E of part 807 of this chapter ment of temporomandibular joint dis- subject to the limitations in § 872.9. orders. [55 FR 48439, Nov. 20, 1990, as amended at 59 (b) Classification. Class II (special FR 63008, Dec. 7, 1994; 66 FR 38799, July 25, controls). The special controls for this 2001] device is FDA’s guideline entitled ‘‘Temporary Mandibular Condyle Re- § 872.4630 Dental operating light. construction Plate Class II Special (a) Identification. A dental operating Controls Guideline.’’ See § 872.1(e) for light, including the surgical headlight, the availability of this guidance docu- is an AC-powered device intended to il- ment. luminate oral structures and operating areas. [78 FR 79310, Dec. 30, 2013] (b) Classification. Class I (general controls). The device is exempt from the § 872.4840 Rotary scaler. premarket notification procedures in (a) Identification. A rotary scaler is subpart E of part 807 of this chapter an abrasive device intended to be at- subject to the limitations in § 872.9. tached to a powered handpiece to re- [52 FR 30097, Aug. 12, 1987, as amended at 61 move calculus deposits from teeth dur- FR 1121, Jan. 16, 1996; 66 FR 38799, July 25, ing dental cleaning and periodontal 2001] (gum) therapy. (b) Classification. Class II. § 872.4730 Dental injecting needle. (a) Identification. A dental injecting § 872.4850 Ultrasonic scaler. needle is a slender, hollow metal device (a) Identification. An ultrasonic scaler with a sharp point intended to be at- is a device intended for use during den- tached to a syringe to inject local anes- tal cleaning and periodontal (gum) thetics and other drugs. therapy to remove calculus deposits (b) Classification. Class I (general con- from teeth by application of an ultra- trols). The device is exempt from the sonic vibrating scaler tip to the teeth. premarket notification procedures in (b) Classification. Class II. subpart E of part 807 of this chapter subject to the limitations in § 872.9. § 872.4880 Intraosseous fixation screw [52 FR 30097, Aug. 12, 1987, as amended at 59 or wire. FR 63008, Dec. 7, 1994; 66 FR 38799, July 25, (a) Identification. An intraosseous fix- 2001] ation screw or wire is a metal device § 872.4760 Bone plate. intended to be inserted into fractured jaw bone segments to prevent their (a) Identification. A bone plate is a metal device intended to stabilize frac- movement. tured bone structures in the oral cav- (b) Classification. Class II. ity. The bone segments are attached to the plate with screws to prevent move- § 872.4920 Dental electrosurgical unit and accessories. ment of the segments. (b) Classification. Class II. (a) Identification. A dental electrosurgical unit and accessories is § 872.4770 Temporary mandibular an AC-powered device consisting of a condyle reconstruction plate. controlled power source and a set of (a) Identification. A temporary man- cutting and coagulating electrodes. dibular condyle reconstruction plate is This device is intended to cut or re- a device that is intended to stabilize move soft tissue or to control bleeding mandibular bone and provide for tem- during surgical procedures in the oral porary reconstruction of the man- cavity. An electrical current passes dibular condyle until permanent recon- through the tip of the electrode into struction is completed in patients who the tissue and, depending upon the op- have undergone resective surgical pro- erating mode selected, cuts through cedures requiring removal of the man- soft tissue or coagulates the tissue. dibular condyle and mandibular bone. (b) Classification. Class II. This device is not intended for treat-

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Subpart F—Therapeutic Devices a final position or to maintain the teeth in their corrected position. § 872.5410 Orthodontic appliance and (b) Classification. Class I (general con- accessories. trols). The device is exempt from the (a) Identification. An orthodontic ap- premarket notification procedures in pliance and accessories is a device in- subpart E of part 807 of this chapter tended for use in orthodontic treat- subject to the limitations in § 872.9. ment. The device is affixed to a tooth [52 FR 30097, Aug. 12, 1987, as amended at 59 so that pressure can be exerted on the FR 63009, Dec. 7, 1994; 66 FR 38799, July 25, teeth. This device includes the 2001] preformed orthodontic band, orthodontic band material, orthodontic elas- § 872.5550 Teething ring. tic band, orthodontic metal bracket, (a) Identification. A teething ring is a orthodontic wire clamp, preformed or- divice intended for use by infants for thodontic space maintainer, ortho- medical purposes to soothe gums dur- dontic expansion screw retainer, ortho- ing the teething process. dontic spring, orthodontic tube, and or- (b)(1) Classification. Class I if the thodontic wire. teething ring does not contain a fluid, (b) Class I (general con- Classification. such as water. The device is exempt trols). The device is exempt from the from the premarket notification proce- premarket notification procedures in dures in subpart E of part 807 of this subpart E of part 807 of this chapter chapter. subject to the limitations in § 872.9. (2) Class II if the teething ring con- [52 FR 30097, Aug. 12, 1987, as amended at 59 tains a fluid, such as water. FR 63009, Dec. 7, 1994; 66 FR 38799, July 25, 2001] [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994] § 872.5470 Orthodontic plastic bracket. § 872.5560 Electrical salivary stimu- (a) Identification. An orthodontic latory system. plastic bracket is a plastic device intended to be bonded to a tooth to apply (a) Identification. An electrical sali- pressure to a tooth from a flexible or- vary stimulatory system is a prescrip- thodontic wire to alter its position. tion intraoral device that is intended (b) Classification. Class II. to electrically stimulate a relative increase in saliva production. § 872.5500 Extraoral orthodontic head- (b) Classification—Class II (special gear. controls). The special controls for this (a) Identification. An extraoral ortho- device are: dontic headgear is a device intended (1) The design characteristics of the for use with an orthodontic appliance device must ensure that the device de- to exert pressure on the teeth from sign, material composition, and elec- outside the mouth. The headgear has a trical output characteristics are con- strap intended to wrap around the pa- sistent with the intended use; tient’s neck or head and an inner bow (2) Any element of the device that portion intended to be fastened to the contacts the patient must be dem- orthodontic appliance in the patient’s onstrated to be biocompatible; mouth. (3) Appropriate analysis and/or test- (b) Classification. Class II. ing must validate electromagnetic compatibility and electrical safety, in- § 872.5525 Preformed tooth positioner. cluding the safety of any battery used (a) Identification. A preformed tooth in the device; positioner is a plastic device that is an (4) Software validation, verification, impression of a perfected bite intended and hazard testing must be performed; to prevent a patient’s teeth from shift- and ing position or to move teeth to a final (5) Documented clinical experience position after orthodontic appliances must demonstrate safe and effective (braces) have been removed. The pa- use for stimulating saliva production tient bites down on the device for sev- by addressing the risks of damage to eral hours a day to force the teeth into intraoral tissue and of ineffective

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treatment and must capture any ad- of various abrasives, such as diamond verse events observed during clinical chips, that are glued to shellac-based use. paper. The device is intended to remove excessive restorative materials, [80 FR 72586, Nov. 22, 2015] such as gold, and to smooth rough sur- § 872.5570 Intraoral devices for snor- faces from oral restorations, such as ing and intraoral devices for snor- crowns. The device is attached to a ing and obstructive sleep apnea. shank that is held by a handpiece. The (a) Identification. Intraoral devices for device includes the abrasive disk, snoring and intraoral devices for snor- guard for an abrasive disk, abrasive ing and obstructive sleep apnea are de- point, polishing agent strip, and vices that are worn during sleep to re- polishing wheel. duce the incidence of snoring and to (b) Classification. Class I (general con- treat obstructive sleep apnea. The de- trols). The device is exempt from the vices are designed to increase the pa- premarket notification procedures in tency of the airway and to decrease air subpart E of part 807 of this chapter turbulence and airway obstruction. subject to the limitations in § 872.9. If The classification includes palatal lift- the device is not labeled or otherwise ing devices, tongue retaining devices, represented as sterile, it is exempt and mandibular repositioning devices. from the current good manufacturing (b) Classification. Class II (special practice requirements of the quality controls). The special control for these system regulation in part 820 of this devices is the FDA guidance document chapter, with the exception of § 820.180, entitled ‘‘Class II Special Controls with respect to general requirements Guidance Document: Intraoral Devices concerning records, and § 820.198, with for Snoring and/or Obstructive Sleep respect to complaint files. Apnea; Guidance for Industry and [52 FR 30097, Aug. 12, 1987, as amended at 54 FDA.’’ FR 13830, Apr. 5, 1989; 66 FR 38799, July 25, 2001] [67 FR 68512, Nov. 12, 2002] § 872.6030 Oral cavity abrasive § 872.5580 Oral rinse to reduce the ad- polishing agent. hesion of dental plaque. (a) Identification. An oral cavity abra- (a) Identification. The device is as- sive polishing agent is a device in paste signed the generic name oral rinse to or powder form that contains an abra- reduce the adhesion of dental plaque sive material, such as silica pumice, in- and is identified as a device intended to tended to remove debris from the reduce the presence of bacterial plaque teeth. The abrasive polish is applied to on teeth and oral mucosal surfaces by the teeth by a handpiece attachment physical means. The device type in- (prophylaxis cup). cludes those devices that act by reduc- (b) Classification. Class I (general con- ing the attachment and inhibiting the trols). The device is exempt from the growth of bacterial plaque. premarket notification procedures in (b) Classification. Class II (special subpart E of part 807 of this chapter controls). The special control is FDA’s subject to the limitations in § 872.9. guidance document entitled ‘‘Class II Special Controls Guidance Document: [52 FR 30097, Aug. 12, 1987, as amended at 59 Oral Rinse to Reduce the Adhesion of FR 63009, Dec. 7, 1994; 66 FR 38799, July 25, Dental Plaque.’’ See § 872.1(e) for the 2001] availability of this guidance document. § 872.6050 Saliva absorber. [70 FR 55028, Sept. 20, 2005] (a) Identification. A saliva absorber is a device made of paper or cotton in- Subpart G—Miscellaneous tended to absorb moisture from the Devices oral cavity during dental procedures. (b) Classification. Class I (general con- § 872.6010 Abrasive device and acces- trols). The device is exempt from the sories. premarket notification procedures in (a) Identification. An abrasive device subpart E of part 807 of this chapter and accessories is a device constructed subject to the limitations in § 872.9. If

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the device is not labeled or otherwise § 872.6140 Articulation paper. represented as sterile, it is exempt (a) Identification. Articulation paper from the current good manufacturing is a device composed of paper coated practice requirements of the quality system regulation in part 820 of this with an ink dye intended to be placed chapter, with the exception of § 820.180, between the patient’s upper and lower with respect to general requirements teeth when the teeth are in the bite po- concerning records, and § 820.198, with sition to locate uneven or high areas. respect to complaint files. (b) Classification. Class I (general controls). The device is exempt from the [52 FR 30097, Aug. 12, 1987, as amended at 54 premarket notification procedures in FR 13830, Apr. 5, 1989; 66 FR 38799, July 25, subpart E of part 807 of this chapter 2001] subject to the limitations in § 872.9. If § 872.6070 Ultraviolet activator for po- the device is not labeled or otherwise lymerization. represented as sterile, it is exempt from the current good manufacturing (a) Identification. An ultraviolet acti- practice requirements of the quality vator for polymerization is a device system regulation in part 820 of this that produces ultraviolet radiation in- chapter, with the exception of § 820.180, tended to polymerize (set) resinous with respect to general requirements dental pit and fissure sealants or restorative materials by transmission of concerning records, and § 820.198, with light through a rod. respect to complaint files. (b) Classification. Class II. [52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38799, July 25, § 872.6080 Airbrush. 2001] (a) Identification. An airbrush is an AC-powered device intended for use in § 872.6200 Base plate shellac. conjunction with articulation paper. (a) Identification. Base plant shellac is The device uses air-driven particles to a device composed of shellac intended roughen the surfaces of dental restora- to rebuild the occlusal rim of full or tions. Uneven areas of the restorations partial dentures. are then identified by use of articula- (b) Classification. Class I (general con- tion paper. trols). The device is exempt from the (b) Classification. Class II. The special premarket notification procedures in control for this device is International subpart E of part 807 of this chapter Electrotechnical Commission’s IEC subject to the limitations in § 872.9. If 60601–1–AM2 (1995–03), Amendment 2, the device is not labeled or otherwise ‘‘Medical Electrical Equipment—Part represented as sterile, it is exempt 1: General Requirements for Safety.’’ from the current good manufacturing [52 FR 30097, Aug. 12, 1987; 52 FR 49250, Dec. practice requirements of the quality 30, 1987, as amended at 71 FR 17144, Mar. 31, system regulation in part 820 of this 2006] chapter, with the exception of § 820.180, with respect to general requirements § 872.6100 Anesthetic warmer. concerning records, and § 820.198, with (a) Identification. An anesthetic respect to complaint files. warmer is an AC-powered device into [52 FR 30097, Aug. 12, 1987, as amended at 54 which tubes containing anesthetic so- FR 13830, Apr. 5, 1989; 66 FR 38799, July 25, lution are intended to be placed to 2001] warm them prior to administration of the anesthetic. § 872.6250 Dental chair and acces- (b) Classification. Class I (general con- sories. trols). The device is exempt from the (a) Identification. A dental chair and premarket notification procedures in accessories is a device, usually AC- subpart E of part 807 of this chapter powered, in which a patient sits. The subject to the limitations in § 872.9. device is intended to properly position [52 FR 30097, Aug. 12, 1987, as amended at 60 a patient to perform dental procedures. FR 38900, July 28, 1995; 66 FR 38799, July 25, A dental operative unit may be at- 2001] tached.

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(b) Classification. Class I. The dental beled or otherwise represented as ster- chair without the operative unit device ile, it is exempt from the current good is exempt from the premarket notifica- manufacturing practice requirements tion procedures in subpart E of part 807 of the quality system regulation in of this chapter. part 820 of this chapter, with the excep- [55 FR 48439, Nov. 20, 1990, as amended at 59 tion of § 820.180 of this chapter, with re- FR 63009, Dec. 7, 1994] spect to general requirements concerning records, and § 820.198 of this § 872.6290 Prophylaxis cup. chapter, with respect to complaint (a) Identification. A prophylaxis cup is files. a device made of rubber intended to be [65 FR 2315, Jan. 14, 2000] held by a dental handpiece and used to apply polishing agents during prophy- § 872.6350 Ultraviolet detector. laxis (cleaning). The dental handpiece (a) Identification. An ultraviolet de- spins the rubber cup holding the tector is a device intended to provide a polishing agent and the user applies it source of ultraviolet light which is to the teeth to remove debris. used to identify otherwise invisible (b) Classification. Class I (general con- material, such as dental plaque, trols). The device is exempt from the present in or on teeth. premarket notification procedures in (b) Classification. Class II. subpart E of part 807 of this chapter subject to the limitations in § 872.9. If § 872.6390 Dental floss. the device is not labeled or otherwise (a) Identification. Dental floss is a represented as sterile, it is exempt string-like device made of cotton or from the current good manufacturing other fibers intended to remove plaque practice requirements of the quality and food particles from between the system regulation in part 820 of this teeth to reduce tooth decay. The fibers chapter, with the exception of § 820.180, of the device may be coated with wax with respect to general requirements for easier use. concerning records, and § 820.198, with (b) Classification. Class I (general con- respect to complaint files. trols). The device is exempt from the [52 FR 30097, Aug. 12, 1987, as amended at 54 premarket notification procedures in FR 13831, Apr. 5, 1989; 66 FR 38799, July 25, subpart E of part 807 of this chapter 2001] subject to § 872.9. § 872.6300 Rubber dam and acces- [52 FR 30097, Aug. 12, 1987, as amended at 61 sories. FR 1121, Jan. 16, 1996; 65 FR 2315, Jan. 14, (a) Identification. A rubber dam and 2000] accessories is a device composed of a § 872.6475 Heat source for bleaching thin sheet of latex with a hole in the teeth. center intended to isolate a tooth from fluids in the mouth during dental pro- (a) Identification. A heat source for cedures, such as filling a cavity prepa- bleaching teeth is an AC-powered de- ration. The device is stretched around vice that consists of a light or an elec- a tooth by inserting a tooth through a tric heater intended to apply heat to a hole in the center. The device includes tooth after it is treated with a bleach- the rubber dam, rubber dam clamp, ing agent. rubber dam frame, and forceps for a (b) Classification. Class I (general con- rubber dam clamp. This classification trols). The device is exempt from the does not include devices intended for premarket notification procedures in use in preventing transmission of sexu- subpart E of part 807 of this chapter ally transmitted diseases through oral subject to the limitations in § 872.9. sex; those devices are classified as [55 FR 48439, Nov. 20, 1990, as amended at 59 condoms in § 884.5300 of this chapter. FR 63009, Dec. 7, 1994; 66 FR 38799, July 25, (b) Classification. Class I (general con- 2001] trols). The device is exempt from the premarket notification procedures in § 872.6510 Oral irrigation unit. subpart E of part 807 of this chapter (a) Identification. An oral irrigation subject to § 872.9. If the device is not la- unit is an AC-powered device intended

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to provide a pressurized stream of part 807 of this chapter subject to water to remove food particles from be- § 872.9. tween the teeth and promote good peri- [55 FR 48439, Nov. 20, 1990, as amended at 59 odontal (gum) condition. FR 63009, Dec. 7, 1994; 65 FR 2315, Jan. 14, (b) Classification. Class I (general con- 2000] trols). The device is exempt from the premarket notification procedures in § 872.6650 Massaging pick or tip for subpart E of part 807 of this chapter oral hygiene. subject to the limitations in § 872.9. (a) Identification. A massaging pick or tip for oral hygiene is a rigid, pointed [55 FR 48439, Nov. 20, 1990, as amended at 59 FR 63009, Dec. 7, 1994; 66 FR 38800, July 25, device intended to be used manually to 2001] stimulate and massage the gums to promote good periodontal (gum) condi- § 872.6570 Impression tube. tion. (b) Classification. Class I (general con- (a) Identification. An impression tube trols). The device is exempt from the is a device consisting of a hollow cop- premarket notification procedures in per tube intended to take an impres- subpart E of part 807 of this chapter sion of a single tooth. The hollow tube subject to the limitations in § 872.9. If is filled with impression material. One the device is not labeled or otherwise end of the tube is sealed with a soft- represented as sterile, it is exempt ened material, such as wax, the re- from the current good manufacturing maining end is slipped over the tooth practice requirements of the quality to make the impression. system regulation in part 820 of this (b) Classification. Class I (general con- chapter, with the exception of § 820.180, trols). The device is exempt from the with respect to general requirements premarket notification procedures in concerning records, and § 820.198, with subpart E of part 807 of this chapter respect to complaint files. subject to the limitations in § 872.9. If the device is not labeled or otherwise [52 FR 30097, Aug. 12, 1987, as amended at 54 represented as sterile, it is exempt FR 13831, Apr. 5, 1989; 66 FR 38800, July 25, 2001] from the current good manufacturing practice requirements of the quality § 872.6660 Porcelain powder for clin- system regulation in part 820 of this ical use. chapter, with the exception of § 820.180, (a) Identification. Porcelain powder with respect to general requirements for clinical use is a device consisting of concerning records, and § 820.198, with a mixture of kaolin, felspar, quartz, or respect to complaint files. other substances intended for use in [52 FR 30097, Aug. 12, 1987, as amended at 54 the production of artificial teeth in FR 13831, Apr. 5, 1989; 66 FR 38800, July 25, fixed or removable dentures, of jacket 2001] crowns, facings, and veneers. The device is used in prosthetic dentistry by § 872.6640 Dental operative unit and heating the powder mixture to a high accessories. temperature in an oven to produce a (a) Identification. A dental operative hard prosthesis with a glass-like finish. unit and accessories is an AC-powered (b) Classification. Class II. device that is intended to supply power to and serve as a base for other dental § 872.6670 Silicate protector. devices, such as a dental handpiece, a (a) Identification. A silicate protector dental operating light, an air or water is a device made of silicone intended to syringe unit, and oral cavity be applied with an absorbent tipped ap- evacuator, a suction operative unit, plicator to the surface of a new res- and other dental devices and acces- toration to exclude temporarily fluids sories. The device may be attached to a from its surface. dental chair. (b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the trols). Except for dental operative unit, premarket notification procedures in accessories are exempt from premarket subpart E of part 807 of this chapter notification procedures in subpart E of subject to the limitations in § 872.9. If

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the device is not labeled or otherwise § 872.6770 Cartridge syringe. represented as sterile, it is exempt (a) Identification. A cartridge syringe from the current good manufacturing is a device intended to inject anes- practice requirements of the quality system regulation in part 820 of this thetic agents subcutaneously or chapter, with the exception of § 820.180, intramuscularly. The device consists of with respect to general requirements a metal syringe body into which a dis- concerning records, and § 820.198, with posable, previously filled, glass carpule respect to complaint files. (a cylindrical cartridge) containing anesthetic is placed. After attaching a [52 FR 30097, Aug. 12, 1987, as amended at 54 needle to the syringe body and acti- FR 13831, Apr. 5, 1989; 66 FR 38800, July 25, vating the carpule by partially insert- 2001] ing the plunger on the syringe, the de- § 872.6710 Boiling water sterilizer. vice is used to administer an injection to the patient. (a) A boiling water Identification. (b) Classification. Class II. sterilizer is an AC-powered device that consists of a container for boiling § 872.6855 Manual toothbrush. water. The device is intended to sterilize dental and surgical instruments by (a) Identification. A manual tooth- submersion in the boiling water in the brush is a device composed of a shaft container. with either natural or synthetic bris- (b) Classification. Class I (general con- tles at one end intended to remove ad- trols). herent plaque and food debris from the teeth to reduce tooth decay. [55 FR 48439, Nov. 20, 1990, as amended at 66 (b) Classification. Class I (general con- FR 46952, Sept. 10, 2001] trols). The device is exempt from the § 872.6730 Endodontic dry heat steri- premarket notification procedures in lizer. subpart E of part 807 of this chapter subject to the limitations in § 872.9. If (a) Identification. An endodontic dry the device is not labeled or otherwise heat sterilizer is a device intended to represented as sterile, it is exempt sterilize endodontic and other dental instruments by the application of dry from the current good manufacturing heat. The heat is supplied through practice requirements of the quality glass beads which have been heated by system regulation in part 820 of this electricity. chapter, with the exception of § 820.180, (b) Classification. Class III. with respect to general requirements (c) Date premarket approval application concerning records, and § 820.198, with (PMA) or notice of completion of product respect to complaint files. development protocol (PDP) is required. A [52 FR 30097, Aug. 12, 1987, as amended at 54 PMA or notice of completion of a PDP FR 13831, Apr. 5, 1989; 66 FR 38800, July 25, is required to be filed with the Food 2001] and Drug Administration on or before April 21, 1997, for any endodontic dry § 872.6865 Powered toothbrush. heat sterilizer that was in commercial (a) Identification. A powered tooth- distribution before May 28, 1976, or that brush is an AC-powered or battery-pow- has on or before April 21, 1997, been ered device that consists of a handle found to be substantially equivalent to containing a motor that provides me- the endodontic dry heat sterilizer that chanical movement to a brush intended was in commercial distribution before to be applied to the teeth. The device is May 28, 1976. Any other endodontic dry heat sterilizer shall have an approved intended to remove adherent plaque PMA or declared completed PDP in ef- and food debris from the teeth to re- fect before being placed in commercial duce tooth decay. distribution. (b) Classification. Class I (general controls). The device is exempt from the [52 FR 30097, Aug. 12, 1987, as amended at 62 premarket notification procedures in FR 2902, Jan. 21, 1997; 62 FR 31512, June 10, 1997]

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subpart E of part 807 of this chapter § 872.6890 Intraoral dental wax. subject to the limitations in § 872.9. (a) Identification. Intraoral dental [55 FR 48440, Nov. 20, 1990, as amended at 59 wax is a device made of wax intended FR 63009, Dec. 7, 1994; 66 FR 38800, July 25, to construct patterns from which cus- 2001] tom made metal dental prostheses, such as crowns and bridges, are cast. In § 872.6870 Disposable fluoride tray. orthodontic dentistry, the device is in- (a) Identification. A disposable fluo- tended to make a pattern of a patient’s ride tray is a device made of styrofoam bite to make study models of the teeth. intended to apply fluoride topically to (b) Classification. Class I (general con- the teeth. To use the tray, the patient trols). The device is exempt from the bites down on the tray which has been premarket notification procedures in filled with a fluoride solution. subpart E of part 807 of this chapter (b) Classification. Class I (general con- subject to the limitations in § 872.9. If trols). The device is exempt from the the device is not labeled or otherwise premarket notification procedures in represented as sterile, it is exempt subpart E of part 807 of this chapter from the current good manufacturing subject to the limitations in § 872.9. If practice requirements of the quality the device is not labeled or otherwise system regulation in part 820 of this represented as sterile, it is exempt chapter, with the exception of § 820.180, from the current good manufacturing with respect to general requirements practice requirements of the quality concerning records, and § 820.198, with system regulation in part 820 of this respect to complaint files. chapter, with the exception of § 820.180, [52 FR 30097, Aug. 12, 1987, as amended at 59 with respect to general requirements FR 63009, Dec. 7, 1994; 66 FR 38800, July 25, concerning records, and § 820.198, with 2001] respect to complaint files. [52 FR 30097, Aug. 12, 1987, as amended at 54 PART 874—EAR, NOSE, AND FR 13831, Apr. 5, 1989; 66 FR 38800, July 25, THROAT DEVICES 2001] Subpart A—General Provisions § 872.6880 Preformed impression tray. Sec. (a) Identification. A preformed im- 874.1 Scope. pression tray is a metal or plastic de- 874.3 Effective dates of requirement for pre- vice intended to hold impression mate- market approval. rial, such as alginate, to make an im- 874.9 Limitations of exemptions from sec- pression of a patient’s teeth or alveolar tion 510(k) of the Federal Food, Drug, process (bony tooth sockets) to repro- and Cosmetic Act (the act). duce the structure of a patient’s teeth Subpart B—Diagnostic Devices and gums. (b) Classification. Class I (general con- 874.1050 Audiometer. trols). The device is exempt from the 874.1060 Acoustic chamber for audiometric premarket notification procedures in testing. subpart E of part 807 of this chapter 874.1070 Short increment sensitivity index subject to the limitations in § 872.9. If (SISI) adapter. 874.1080 Audiometer calibration set. the device is not labeled or otherwise 874.1090 Auditory impedance tester. represented as sterile, it is exempt 874.1100 Earphone cushion for audiometric from the current good manufacturing testing. practice requirements of the quality 874.1120 Electronic noise generator for system regulation in part 820 of this audiometric testing. chapter, with the exception of § 820.180, 874.1325 Electroglottograph. with respect to general requirements 874.1500 Gustometer. concerning records, and § 820.198, with 874.1600 Olfactory test device. respect to complaint files. 874.1800 Air or water caloric stimulator. 874.1820 Surgical nerve stimulator/locator. [52 FR 30097, Aug. 12, 1987, as amended at 54 874.1925 Toynbee diagnostic tube. FR 13832, Apr. 5, 1989; 66 FR 38800, July 25, 2001] Subpart C [Reserved] 408

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Subpart D—Prosthetic Devices Subpart F—Therapeutic Devices

874.3300 Hearing aid. 874.5220 Ear, nose, and throat drug adminis- 874.3305 Wireless air-conduction hearing aid. tration device. 874.3310 Hearing aid calibrator and analysis 874.5300 Ear, nose, and throat examination system. and treatment unit. 874.3315 Tympanic membrane contact hear- 874.5350 Suction antichoke device. ing aid. 874.5370 Tongs antichoke device. 874.3320 Group hearing aid or group audi- 874.5550 Powered nasal irrigator. tory trainer. 874.5800 External nasal splint. 874.3330 Master hearing aid. 874.5840 Antistammering device. 874.3375 Battery-powered artificial larynx. 874.5900 External upper esophageal sphinc- 874.3400 Tinnitus masker. ter compression device. 874.3430 Middle ear mold. AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 874.3450 Partial ossicular replacement pros- 360j, 371. thesis. 874.3495 Total ossicular replacement pros- SOURCE: 51 FR 40389, Nov. 6, 1986, unless thesis. otherwise noted. 874.3540 Prosthesis modification instrument EDITORIAL NOTE: Nomenclature changes to for ossicular replacement surgery. part 874 appear at 73 FR 35341, June 23, 2008. 874.3620 Ear, nose, and throat synthetic polymer material. 874.3695 Mandibular implant facial pros- Subpart A—General Provisions thesis. 874.3730 Laryngeal prosthesis (Taub design). § 874.1 Scope. 874.3760 Sacculotomy tack (Cody tack). (a) This part sets forth the classifica- 874.3820 Endolymphatic shunt. tion of ear, nose, and throat devices in- 874.3850 Endolymphatic shunt tube with tended for human use that are in com- valve. 874.3880 Tympanostomy tube. mercial distribution. 874.3900 Nasal dilator. (b) The identification of a device in a 874.3930 Tympanostomy tube with regulation in this part is not a precise semipermeable membrane. description of every device that is, or 874.3950 Transcutaneous air conduction will be, subject to the regulation. A hearing aid system. manufacturer who submits a premarket notification submission for a Subpart E—Surgical Devices device under part 807 cannot show 874.4100 Epistaxis balloon. merely that the device is accurately 874.4140 Ear, nose, and throat bur. described by the section title and iden- 874.4175 Nasopharyngeal catheter. tification provision of a regulation in 874.4180 Eustachian tube balloon dilation this part, but shall state why the de- system. vice is substantially equivalent to 874.4250 Ear, nose, and throat electric or other devices, as required by § 807.87. pneumatic surgical drill. (c) To avoid duplicative listings, an 874.4350 Ear, nose, and throat fiberoptic ear, nose, and throat device that has light source and carrier. two or more types of uses (e.g., used 874.4420 Ear, nose, and throat manual sur- both as a diagnostic device and as a gical instrument. therapeutic device) is listed in one sub- 874.4490 Argon laser for otology, rhinology, and laryngology. part only. 874.4500 Ear, nose, and throat microsurgical (d) References in this part to regu- carbon dioxide laser. latory sections of the Code of Federal 874.4680 Bronchoscope (flexible or rigid) and Regulations are to chapter I of title 21 accessories. unless otherwise noted. 874.4710 Esophagoscope (flexible or rigid) (e) Guidance documents referenced in and accessories. this part are available on the Internet 874.4720 Mediastinoscope and accessories. at http://www.fda.gov/MedicalDevices/ 874.4750 Laryngostroboscope. DeviceRegulationandGuidance/ 874.4760 Nasopharyngoscope (flexible or GuidanceDocuments/default.htm.. rigid) and accessories. 874.4770 Otoscope. [51 FR 40389, Nov. 6, 1986, as amended at 67 874.4780 Intranasal splint. FR 67790, Nov. 7, 2002; 78 FR 18233, Mar. 26, 874.4800 Bone particle collector. 2013]

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§ 874.3 Effective dates of requirement tributed unless it is reclassified. If for premarket approval. FDA knows that a device being com- A device included in this part that is mercially distributed may be a ‘‘new’’ classified into class III (premarket ap- device as defined in this section be- proval) shall not be commercially dis- cause of any new intended use or other tributed after the date shown in the reasons, FDA may codify the statutory regulation classifying the device unless classification of the device into class the manufacturer has an approval III for such new use. Accordingly, the under section 515 of the act (unless an regulation for such a class III device exemption has been granted under sec- states that as of the enactment date of tion 520(g)(2) of the act). An approval the amendments, May 28, 1976, the de- under section 515 of the act consists of vice must have an approval under sec- FDA’s issuance of an order approving tion 515 of the act before commercial an application for premarket approval distribution. (PMA) for the device or declaring completed a product development protocol § 874.9 Limitations of exemptions from (PDP) for the device. section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). (a) Before FDA requires that a device commercially distributed before the The exemption from the requirement enactment date of the amendments, or of premarket notification (section a device that has been found substan- 510(k) of the act) for a generic type of tially equivalent to such a device, has class I or II device is only to the extent an approval under section 515 of the act that the device has existing or reason- FDA must promulgate a regulation ably foreseeable characteristics of under section 515(b) of the act requir- commercially distributed devices with- ing such approval, except as provided in that generic type or, in the case of in paragraph (b) of this section. Such a in vitro diagnostic devices, only to the regulation under section 515(b) of the extent that misdiagnosis as a result of act shall not be effective during the using the device would not be associ- grace period ending on the 90th day ated with high morbidity or mortality. after its promulgation or on the last Accordingly, manufacturers of any day of the 30th full calendar month commercially distributed class I or II after the regulation that classifies the device for which FDA has granted an device into class III is effective, which- exemption from the requirement of ever is later. See section 501(f)(2)(B) of premarket notification must still sub- the act. Accordingly, unless an effec- mit a premarket notification to FDA tive date of the requirement for pre- before introducing or delivering for in- market approval is shown in the regu- troduction into interstate commerce lation for a device classified into class for commercial distribution the device III in this part, the device may be com- when: mercially distributed without FDA’s (a) The device is intended for a use issuance of an order approving a PMA different from the intended use of a le- declaring completed a PDP for the de- gally marketed device in that generic vice. If FDA promulgates a regulation type of device; e.g., the device is in- under section 515(b) of the act requir- tended for a different medical purpose, ing premarket approval for a device, or the device is intended for lay use section 501(f)(1)(A) of the act applies to where the former intended use was by the device. health care professionals only; (b) Any new, not substantially equiv- (b) The modified device operates alent, device introduced into commer- using a different fundamental sci- cial distribution on or after May 28, entific technology than a legally mar- 1976, including a device formerly marketed device in that generic type of de- keted that has been substantially al- vice; e.g., a surgical instrument cuts tered, is classified by statute (section tissue with a laser beam rather than 513(f) of the act) into class III without with a sharpened metal blade, or an in any grace period and FDA must have vitro diagnostic device detects or iden- issued an order approving a PMA or de- tifies infectious agents by using claring completed a PDP for the device deoxyribonucleic acid (DNA) probe or before the device is commercially dis- nucleic acid hybridization technology

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rather than culture or immunoassay for Audiometers,’’ and subject to the technology; or limitations in § 874.9. (c) The device is an in vitro device [51 FR 40389, Nov. 6, 1986, as amended at 64 that is intended: FR 14831, Mar. 29, 1999] (1) For use in the diagnosis, monitoring, or screening of neoplastic dis- § 874.1060 Acoustic chamber for eases with the exception of audiometric testing. immunohistochemical devices; (a) Identification. An acoustic cham- (2) For use in screening or diagnosis ber for audiometric testing is a room of familial or acquired genetic dis- that is intended for use in conducting orders, including inborn errors of me- diagnostic hearing evaluations and tabolism; that eliminates sound reflections and (3) For measuring an analyte that provides isolation from outside sounds. serves as a surrogate marker for (b) Classification. Class I (general con- screening, diagnosis, or monitoring trols). The device is exempt from the life-threatening diseases such as ac- premarket notification procedures in quired immune deficiency syndrome subpart E of part 807 of this chapter (AIDS), chronic or active hepatitis, tu- subject to the limitations in § 874.9. berculosis, or myocardial infarction or to monitor therapy; [51 FR 40389, Nov. 6, 1986, as amended at 61 (4) For assessing the risk of cardio- FR 1121, Jan. 16, 1996; 66 FR 38800, July 25, vascular diseases; 2001] (5) For use in diabetes management; § 874.1070 Short increment sensitivity (6) For identifying or inferring the index (SISI) adapter. identity of a microorganism directly from clinical material; (a) Identification. A short increment sensitivity index (SISI) adapter is a de- (7) For detection of antibodies to vice used with an audiometer in diag- microorganisms other than nostic hearing evaluations. A SISI immunoglobulin G (IgG) or IgG assays adapter provides short periodic sound when the results are not qualitative, or pulses in specific small decibel incre- are used to determine immunity, or the ments that are intended to be super- assay is intended for use in matrices imposed on the audiometer’s output other than serum or plasma; tone frequency. (8) For noninvasive testing as defined (b) Classification. Class I (general con- in § 812.3(k) of this chapter; and trols). The device is exempt from the (9) For near patient testing (point of premarket notification procedures in care). subpart E of part 807 of this chapter [65 FR 2315, Jan. 14, 2000] subject to § 874.9. [55 FR 48440, Nov. 20, 1990, as amended at 65 Subpart B—Diagnostic Devices FR 2315, Jan. 14, 2000]

§ 874.1050 Audiometer. § 874.1080 Audiometer calibration set. (a) Identification. An audiometer or (a) Identification. An audiometer cali- automated audiometer is an bration set is an electronic reference electroacoustic device that produces device that is intended to calibrate an controlled levels of test tones and sig- audiometer. It measures the sound fre- nals intended for use in conducting di- quency and intensity characteristics agnostic hearing evaluations and as- that emanate from an audiometer ear- sisting in the diagnosis of possible phone. The device consists of an acous- otologic disorders. tic cavity of known volume, a sound (b) Classification. Class II. Except for level meter, a microphone with calibra- the otoacoustic emission device, the tion traceable to the National Bureau device is exempt from the premarket of Standards, oscillators, frequency notification procedures in subpart E of counters, microphone amplifiers, and a part 807 of this chapter, if it is in com- recorder. The device can measure se- pliance with American National Stand- lected audiometer test frequencies at a ard Institute S3.6–1996, ‘‘Specification given intensity level, and selectable

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audiometer attenuation settings at a during an audiometric evaluation. The given test frequency. device minimizes the non-test ear’s (b) Classification. Class I (general con- sensing of test tones and signals being trols). The device is exempt from the generated for the ear being tested. premarket notification procedures in (b) Classification. Class II. subpart E of part 807 of this chapter subject to the limitations in § 874.9. § 874.1325 Electroglottograph. [51 FR 40389, Nov. 6, 1986, as amended at 61 (a) Identification. An FR 1121, Jan. 16, 1996; 66 FR 38800, July 25, electroglottograph is an AC-powered 2001] device that employs a pair of electrodes that are placed in contact with § 874.1090 Auditory impedance tester. the skin on both sides of the larynx (a) Identification. An auditory imped- and held in place by a collar. It is in- ance tester is a device that is intended tended to measure the electrical im- to change the air pressure in the exter- pedance of the larynx to aid in assess- nal auditory canal and measure and ing the degree of closure of the vocal graph the mobility characteristics of cords, confirm larygeal diagnosis, aid the tympanic membrane to evaluate behavioral treatment of voice dis- the functional condition of the middle orders, and aid research concerning the ear. The device is used to determine ab- laryngeal mechanism. normalities in the mobility of the tym- (b) Classification. Class II. panic membrane due to stiffness, flac- cidity, or the presence of fluid in the § 874.1500 Gustometer. middle ear cavity. The device is also (a) Identification. A gustometer is a used to measure the acoustic reflex battery-powered device that consists of threshold from contractions of the two electrodes that are intended to be stapedial muscle, to monitor healing of placed on both sides of the tongue at tympanic membrane grafts or different taste centers and that pro- stapedectomies, or to monitor followup vides a galvanic stimulus resulting in treatment for inflammation of the taste sensation. It is used for assessing middle ear. the sense of taste. (b) Classification. Class II. (b) Classification. Class I (general controls). The device is exempt from the § 874.1100 Earphone cushion for premarket notification procedures in audiometric testing. subpart E of part 807 of this chapter (a) Identification. An earphone cush- subject to § 874.9. If the device is not la- ion for audiometric testing is a device beled or otherwise represented as ster- that is used to cover an audiometer ile, it is exempt from the current good earphone during audiometric testing to manufacturing practice requirements provide an acoustic coupling (sound of the quality system regulation in connection path) between the audiom- part 820 of this chapter, with the excep- eter earphone and the patient’s ear. tion of § 820.180 of this chapter, with re- (b) Classification. Class I (general con- spect to general requirements controls). The device is exempt from the cerning records, and § 820.198 of this premarket notification procedures in chapter, with respect to complaint subpart E of part 807 of this chapter files. subject to § 874.9. [51 FR 40389, Nov. 6, 1986, as amended at 65 [51 FR 40389, Nov. 9, 1986; 52 FR 18495, May 15, FR 2316, Jan. 14, 2000] 1987, as amended at 52 FR 32111, Aug. 25, 1987; 65 FR 2315, Jan. 14, 2000] § 874.1600 Olfactory test device. (a) Identification. An olfactory test § 874.1120 Electronic noise generator device is used to determine whether an for audiometric testing. olfactory loss is present. The device in- (a) Identification. An electronic noise cludes one or more odorants that are generator for audiometric testing is a presented to the patient’s nose to sub- device that consists of a swept fre- jectively assess the patient’s ability to quency generator, an amplifier, and an perceive odors. earphone. It is intended to introduce a (b) Classification. Class II (special masking noise into the non-test ear controls). The special control for these

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devices is the FDA guidance document Subpart C [Reserved] entitled ‘‘Class II Special Controls Guidance Document: Olfactory Test Device.’’ For the availability of this Subpart D—Prosthetic Devices guidance document, see § 874.1(e). The § 874.3300 Hearing Aid. device is exempt from the premarket notification procedures in subpart E of (a) Identification. A hearing aid is part 807 of this chapter subject to the wearable sound-amplifying device that limitations in § 874.9. When indicated is intended to compensate for impaired for the screening or diagnosis of dis- hearing. This generic type of device in- eases or conditions other than the loss cludes the air-conduction hearing aid of olfactory function, the device is not and the bone-conduction hearing aid, exempt from premarket notification but excludes the group hearing aid or procedures. group auditory trainer (§ 874.3320), mas- [71 FR 32835, June 7, 2006] ter hearing aid (§ 874.3330), and tinnitus masker (§ 874.3400). § 874.1800 Air or water caloric stimu- (b) Classification. (1) Class I (general lator. controls) for the air-conduction hear- (a) Identification. An air or water ca- ing aid. The air-conduction hearing aid loric stimulator is a device that deliv- is exempt from the premarket notifica- ers a stream of air or water to the ear tion procedures in subpart E of part 807 canal at controlled rates of flow and of this chapter subject to § 874.9. temperature and that is intended for (2) Class II for the bone-conduction vestibular function testing of a pa- hearing aid. tient’s body balance system. The vestibular stimulation of the semicircular [51 FR 40389, Nov. 6, 1986, as amended at 65 canals produce involuntary eye move- FR 2316, Jan. 14, 2000] ments that are measured and recorded by a nystagmograph. § 874.3305 Wireless air-conduction (b) Classification. Class I (general con- hearing aid. trols). The device is exempt from the (a) Identification. A wireless air-con- premarket notification procedures in duction hearing aid is a wearable subpart E of part 807 of this chapter sound-amplifying device, intended to subject to § 874.9. compensate for impaired hearing that [55 FR 48440, Nov. 20, 1990, as amended at 65 incorporates wireless technology in its FR 2316, Jan. 14, 2000] programming or use. (b) Classification: Class II (special § 874.1820 Surgical nerve stimulator/lo- controls). The special controls for this cator. device are: (a) Identification. A surgical nerve (1) Appropriate analysis/testing stimulator/locator is a device that is should validate electro magnetic com- intended to provide electrical stimula- patibility (EMC) and safety of exposure tion to the body to locate and identify to non-ionizing radiation; nerves and to test their excitability. (2) Design, description, and perform- (b) Classification. Class II. ance data should validate wireless § 874.1925 Toynbee diagnostic tube. technology functions; and (3) Labeling should specify appro- (a) Identification. The toynbee diag- priate instructions, warnings, and in- nostic tube is a listening device information relating to EMC and wireless tended to determine the degree of technology and human exposure to openness of the eustachian tube. (b) Classification. Class I (general con- non-ionizing radiation. trols). The device is exempt from the (c) Premarket notification. The wire- premarket notification procedures in less air-conduction hearing aid is ex- subpart E of part 807 of this chapter empt from the premarket notification subject to § 874.9. procedures in subpart E of part 807 of this chapter subject to § 874.9. [51 FR 40389, Nov. 6, 1986, as amended at 65 FR 2316, Jan. 14, 2000] [76 FR 34846, June 15, 2011]

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§ 874.3310 Hearing aid calibrator and (4) Professional training must in- analysis system. clude the ear impression procedure, (a) Identification. A hearing aid cali- correct placement, fitting, monitoring, brator and analysis system is an elec- care, and maintenance of the device. tronic reference device intended to (5) Labeling must include the fol- calibrate and assess the lowing: electroacoustic frequency and sound (i) A detailed summary of the adverse intensity characteristics emanating events and effectiveness outcomes from from a hearing aid, master hearing aid, the clinical performance testing; group hearing aid or group auditory (ii) Detailed instructions on how to trainer. The device consists of an fit the device to the patient; acoustic complex of known cavity vol- (iii) Instructions for periodic clean- ume, a sound level meter, a micro- ing of any reusable components; phone, oscillators, frequency counters, (iv) Information related to electro- microphone amplifiers, a distoration magnetic compatibility; and analyzer, a chart recorder, and a hear- (v) Patient labeling that includes: ing aid test box. (A) A patient card that identifies if a (b) Classification. Class II. patient has been fitted with any nonself- removable components of the de- § 874.3315 Tympanic membrane con- vice and provides relevant information tact hearing aid. in cases of emergency; (a) Identification. A tympanic mem- (B) Information on how to correctly brane contact hearing aid is a prescrip- use and maintain the device; tion device that compensates for im- (C) The potential risks and benefits paired hearing. Amplified sound is associated with the use of the device; transmitted by vibrating the tympanic and membrane through a transducer that is (D) Alternative treatments. in direct contact with the tympanic membrane. [81 FR 3326, Jan. 21, 2015] (b) Classification. Class II (special controls). The special controls for this § 874.3320 Group hearing aid or group device are: auditory trainer. (1) The patient contacting compo- (a) Identification. A group hearing aid nents must be demonstrated to be bio- or group auditory trainer is a hearing compatible. aid that is intended for use in commu- (2) Non-clinical performance testing nicating simultaneously with one or must demonstrate that the device per- more listeners having hearing impair- forms as intended under anticipated ment. The device is used with an asso- conditions of use, and must include: ciated transmitter microphone. It may (i) Mechanical integrity testing; be either monaural or binaural, and it (ii) Electrical and thermal safety provides coupling to the ear through testing; either earphones or earmolds. The ge- (iii) Software verification, valida- neric type of device includes three tion, and hazard analysis; types of applications: hardwire sys- (iv) Reliability testing consistent tems, inductance loop systems, and with expected device life; wireless systems. (v) Electromagnetic compatibility (b) Classification. Class II. testing; and (vi) Validation testing of device out- § 874.3330 Master hearing aid. put and mechanical force applied to (a) Identification. A master hearing the tympanic membrane in a clinically aid is an electronic device intended to appropriate model. simulate a hearing aid during (3) Clinical performance testing must audiometric testing. It has adjustable characterize any adverse events ob- acoustic output levels, such as those served during clinical use, and dem- for gain, output, and frequency re- onstrate that the device performs as sponse. The device is used to select and intended under anticipated conditions adjust a person’s wearable hearing aid. of use. (b) Classification. Class II.

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§ 874.3375 Battery-powered artificial polyethylene, but does not contain po- larynx. rous polyethylene. (a) Identification. A battery-powered (b) Classification. Class II. artificial larynx is an externally ap- § 874.3450 Partial ossicular replace- plied device intended for use in the ab- ment prosthesis. sence of the larynx to produce sound. When held against the skin in the area (a) Identification. A partial ossicular of the voicebox, the device generates replacement prosthesis is a device in- mechanical vibrations which resonate tended to be implanted for the func- in the oral and nasal cavities and can tional reconstruction of segments of be modulated by the tongue and lips in the ossicular chain and facilitates the a normal manner, thereby allowing the conduction of sound wave from the production of speech. tympanic membrane to the inner ear. (b) Classification. Class I (general con- The device is made of materials such as trols). The device is exempt from the stainless steel, tantalum, polytetra- premarket notification procedures in fluoroethylene, polyethylene, poly- subpart E of part 807 of this chapter tetrafluoroethylene with carbon fibers subject to the limitations in § 874.9. composite, absorbable gelatin material, porous polyethylene, or from a [51 FR 40389, Nov. 6, 1986, as amended at 59 combination of these materials. FR 63009, Dec. 7, 1994; 66 FR 38800, July 25, (b) Classification. Class II. 2001] § 874.3495 Total ossicular replacement § 874.3400 Tinnitus masker. prosthesis. (a) Identification. A tinnitus masker (a) Identification. A total ossicular re- is an electronic device intended to gen- placement prosthesis is a device in- erate noise of sufficient intensity and tended to be implanted for the total bandwidth to mask ringing in the ears functional reconstruction of the ossic- or internal head noises. Because the de- ular chain and facilitates the conduc- vice is able to mask internal noises, it tion of sound waves from the tympanic is also used as an aid in hearing exter- membrance to the inner ear. The de- nal noises and speech. vice is made of materials such as poly- (b) Classification. Class II. The special tetrafluoroethylene, polytetrafluoro- control for this device is patient label- ethylene with vitreous carbon fibers ing regarding: composite, porous polyethylene, or (1) Hearing health care professional from a combination of these materials. diagnosis, fitting of the device, and fol- (b) Classification. Class II. lowup care, (2) Risks, § 874.3540 Prosthesis modification instrument for ossicular replacement (3) Benefits, surgery. (4) Warnings for safe use, and (5) Specifications. (a) Identification. A prosthesis modification instrument for ossicular re- [51 FR 40389, Nov. 6, 1986, as amended at 65 placement surgery is a device intended FR 17145, Mar. 31, 2000] for use by a surgeon to construct ossicular replacements. This generic type of § 874.3430 Middle ear mold. device includes the ear, nose, and (a) Identification. A middle ear mold throat cutting block; wire crimper, is a preformed device that is intended wire bending die; wire closure forceps; to be implanted to reconstruct the piston cutting jib; gelfoam TM punch; middle ear cavity during repair of the wire cutting scissors; and ossicular fin- tympanic membrane. The device per- ger vise. mits an ample air-filled cavity to be (b) Classification. Class I (general con- maintained in the middle ear and pro- trols). The device is exempt from the motes regeneration of the mucous premarket notification procedures in membrane lining of the middle ear cav- subpart E of part 807 of this chapter ity. A middle ear mold is made of ma- subject to § 874.9. If the device is not la- terials such as polyamide, polytetra- beled or otherwise represented as ster- fluoroethylene, silicone elastomer, or ile, it is exempt from the current good

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manufacturing practice requirements a sound source that is articulated as of the quality system regulation in speech. part 820 of this chapter, with the excep- (b) Classification. Class II. tion of § 820.180 of this chapter, with respect to general requirements con- § 874.3760 Sacculotomy tack (Cody cerning records, and § 820.198 of this tack) chapter, with respect to complaint (a) Identification. A sacculotomy tack files. (Cody tack) is a device that consists of a pointed stainless steel tack intended [51 FR 40389, Nov. 9, 1986, as amended at 52 to be implanted to relieve the symp- FR 32111, Aug. 25, 1987; 65 FR 2316, Jan. 14, 2000] toms of vertigo. The device repet- itively ruptures the utricular mem- § 874.3620 Ear, nose, and throat syn- brane as the membrane expands under thetic polymer material. increased endolymphatic pressure. (a) Identification. Ear, nose, and (b) Classification. Class II. throat synthetic polymer material is a § 874.3820 Endolymphatic shunt. device material that is intended to be implanted for use as a space-occupying (a) Identification. An endolymphatic substance in the reconstructive sur- shunt is a device that consists of a tube gery of the head and neck. The device or sheet intended to be implanted to is used, for example, in augmentation relieve the symptons of vertigo. The rhinoplasty and in tissue defect clo- device permits the unrestricted flow of sures in the esophagus. The device is excess endolymph from the distended shaped and formed by the suregon to end of the endolymphatic system into conform to the patient’s needs. This the mastoid cavity where resorption generic type of device is made of mate- occurs. This device is made of poly- rial such as polyamide mesh or foil and tetrafluoroethylene or silicone elas- porous polyethylene. tomer. (b) Classification. Class II. (b) Classification. Class II.

§ 874.3695 Mandibular implant facial § 874.3850 Endolymphatic shunt tube prosthesis. with valve. (a) Identification. A mandibular im- (a) Identification. An endolymphatic plant facial prosthesis is a device that shunt tube with valve is a device that is intended to be implanted for use in consists of a pressure-limiting valve the functional reconstruction of man- associated with a tube intended to be dibular deficits. The device is made of implanted in the inner ear to relieve materials such as stainless steel, tan- symptoms of vertigo and hearing loss due to endolymphatic hydrops (in- talum, titanium, cobalt-chromium crease in endolymphatic fluid) of based alloy, polytetrafluoroethylene, Meniere’s disease. silicone elastomer, polyethylene, poly- (b) Classification. Class II (special urethane, or polytetrafluoroethylene controls). The special control for this with carbon fibers composite. device is the FDA guidance document (b) Classification. Class II. ‘‘Class II Special Controls Guidance § 874.3730 Laryngeal prosthesis (Taub Document: Endolymphatic Shunt Tube design). With Valve; Guidance for Industry and FDA.’’ (a) Identification. A laryngeal prosthesis (Taub design) is a device in- [67 FR 20894, Apr. 29, 2002] tended to direct pulmonary air flow to the pharynx in the absence of the lar- § 874.3880 Tympanostomy tube. ynx, thereby permitting esophageal (a) Identification. A tympanostomy speech. The device is interposed be- tube is a device that is intended to be tween openings in the trachea and the implanted for ventilation or drainage esophagus and may be removed and re- of the middle ear. The device is in- placed each day by the patient. During serted through the tympanic mem- phonation, air from the lungs is di- brane to permit a free exchange of air rected to flow through the device and between the outer ear and middle ear. over the esophageal mucosa to provide A type of tympanostomy tube known

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as the malleous clip tube attaches to § 874.3950 Transcutaneous air conduc- the malleous to provide middle ear tion hearing aid system. ventilation. The device is made of ma- (a) Identification. A transcutaneous terials such as polytetrafluoro- air conduction hearing aid system is a ethylene, polyethylene, silicon elas- wearable sound-amplifying device in- tomer, or porous polyethylene. tended to compensate for impaired (b) Classification. Class II. hearing without occluding the ear canal. The device consists of an air § 874.3900 Nasal dilator. conduction hearing aid attached to a (a) Identification. A nasal dilator is a surgically fitted tube system, which is device intended to provide temporary placed through soft tissue between the relief from transient causes of breath- post auricular region and the outer ear ing difficulties resulting from struc- canal. tural abnormalities and/or transient (b) Classification. Class II (special causes of nasal congestion associated controls). The special control for this with reduced nasal airflow. The device device is FDA’s guidance document en- decreases airway resistance and in- titled ‘‘Class II Special Controls Guid- creases nasal airflow. The external ance Document: Transcutaneous Air nasal dilator is constructed from one Conduction Hearing Aid System or more layers of material upon which (TACHAS); Guidance for Industry and a spring material is attached, with a FDA.’’ See § 874.1 for the availability of skin adhesive applied to adhere to the this guidance document. skin of the nose; it acts with a pulling action to open the nares. The internal [67 FR 67790, Nov. 7, 2002] nasal dilator is constructed from metal or plastic and is placed inside the nos- Subpart E—Surgical Devices trils; it acts by pushing the nostrils open or by gently pressing on the § 874.4100 Epistaxis balloon. columella. (a) Identification. An epistaxis balloon (b) Classification. Class I (general con- is a device consisting of an inflatable trols). The device is exempt from the balloon intended to control internal premarket notification procedures in nasal bleeding by exerting pressure subpart E of part 807 of this chapter against the sphenopalatine artery. subject to the limitations in § 874.9. (b) Classification Class I (general con- [64 FR 10949, Mar. 8, 1999] trols). The device is exempt from the premarket notification procedures in § 874.3930 Tympanostomy tube with subpart E of part 807 of this chapter semipermeable membrane. subject to § 874.9. (a) Identification. A tympanostomy [51 FR 40389, Nov. 6, 1986, as amended at 65 tube with a semipermeable membrane FR 2316, Jan. 14, 2000] is a device intended to be implanted for ventilation or drainage of the middle § 874.4140 Ear, nose, and throat bur. ear and for preventing fluids from en- (a) Identification. An ear, nose, and tering the middle ear cavity. The de- throat bur is a device consisting of an vice is inserted through the tympanic interchangeable drill bit that is in- membrane to permit a free exchange of tended for use in an ear, nose, and air between the outer ear and middle throat electric or pneumatic surgical ear. The tube portion of the device is drill (§ 874.4250) for incising or removing made of silicone elastomer or porous bone in the ear, nose, or throat area. polyethylene, and the membrane por- The bur consists of a carbide cutting tion is made of polytetrafluoro- tip on a metal shank or a coating of di- ethylene. amond on a metal shank. The device is (b) Classification. Class II. The special used in mastoid surgery, frontal sinus control for this device is FDA’s surgery, and surgery of the facial ‘‘Tympanostomy Tubes, Submission nerves. Guidance for a 510(k).’’ (b) Classification. Class I (general con- [51 FR 40389, Nov. 6, 1986, as amended at 65 trols). The device is exempt from the FR 17145, Mar. 31, 2000] premarket notification procedures in

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subpart E of part 807 of this chapter the reliability of the device to remain subject to the limitations in § 874.9. mechanically functional throughout the anticipated conditions of use, and [51 FR 40389, Nov. 6, 1986, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38800, July 25, validate that the design features limit 2001] access to only the cartilaginous portion of the Eustachian tube. § 874.4175 Nasopharyngeal catheter. (3) The patient-contacting compo- (a) Identification. A nasopharyngeal nents of the device must be dem- catheter is a device consisting of a bou- onstrated to be biocompatible. gie or filiform catheter that is in- (4) Performance data must dem- tended for use in probing or dilating onstrate the sterility of the device. the eustachian tube. This generic type (5) Performance data must support of device includes eustachian cath- shelf life by demonstrating continued eters. sterility of the device, package integ- (b) Classification. Class I (general con- rity, and device functionality over the trols). The device is exempt from the identified shelf life. premarket notification procedures in (6) Training must include simulated subpart E of part 807 of this chapter use on cadavers to ensure users can fol- subject to the limitations in § 874.9. low the instructions for use to allow safe use of the device. [51 FR 40389, Nov. 6, 1986, as amended at 61 (7) Labeling must include: FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, (i) Detailed instructions for use. 2001] (ii) A detailed summary of the device § 874.4180 Eustachian tube balloon di- technical parameters, including max- lation system. imum allowed inflation pressure, allowable catheter geometries, and avail- (a) Identification. A Eustachian tube able balloon sizes. balloon dilation system is a prescrip- (iii) A shelf life. tion device that includes a flexible catheter attached to an inflatable bal- [81 FR 73041, Oct. 24, 2016] loon. The system is intended for use in dilating the cartilaginous portion of § 874.4250 Ear, nose, and throat elec- the Eustachian tube for treating per- tric or pneumatic surgical drill. sistent Eustachian tube dysfunction. (a) Identification. An ear, nose, and (b) Classification. Class II (special throat electric or pneumatic surgical controls). The special controls for this drill is a rotating drilling device, in- device are: cluding the handpiece, that is intended (1) Non-clinical performance testing to drive various accessories, such as an must demonstrate that the device per- ear, nose, and throat bur (§ 874.4140), for forms as intended under anticipated the controlled incision or removal of conditions of use. The following per- bone in the ear, nose, and throat area. formance characteristics must be eval- (b) Classification. Class II. uated: (i) Mechanical testing, including ten- § 874.4350 Ear, nose, and throat sile and flexural testing of catheter fiberoptic light source and carrier. joints and materials. (a) Identification. An ear, nose, and (ii) Durability testing, including fa- throat fiberoptic light source and car- tigue and burst pressure testing of the rier is an AC-powered device that gen- balloon materials and components. erates and transmits light through (iii) Inflation and deflation charac- glass of plastic fibers and that is in- terization testing, including time and tended to provide illumination at the pressure measurements, and leak test- tip of an ear, nose, or throat endoscope. ing of the balloon. Endoscopic devices which utilize (iv) Verification testing of safety fea- fiberoptic light sources and carriers in- tures built into the device must be per- clude the bronchoscope, esophagoscope, formed, including the characterization laryngoscope, mediastinoscope, laryn- of catheter geometries and distal tip geal-bronchial telescope, and insertion limitation mechanisms. nasopharyngoscope. (2) Simulated use testing in a clini- (b) Classification. Class I (general con- cally relevant model must demonstrate trols). The device is exempt from the

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premarket notification procedures in for the purpose of coagulating and va- subpart E of part 807 of this chapter porizing soft and fibrous tissues, in- subject to the limitations in § 874.9. cluding osseous tissue. In rhinology [51 FR 40389, Nov. 6, 1986, as amended at 61 and laryngology, the device is used to FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, coagulate and vaporize soft and fibrous 2001] tissues, but not including osseous tissues. § 874.4420 Ear, nose, and throat man- (b) Classification. Class II. ual surgical instrument. [58 FR 29534, May 21, 1993] (a) Identification. An ear, nose, and throat manual surgical instrument is § 874.4500 Ear, nose, and throat micro- one of a variety of devices intended for surgical carbon dioxide laser. use in surgical procedures to examine or treat the bronchus, esophagus, tra- (a) Identification. An ear, nose, and chea, larynx, pharynx, nasal and para- throat microsurgical carbon dioxide nasal sinus, or ear. This generic type of laser is a device intended for the sur- device includes the esophageal dilator; gical excision of tissue from the ear, tracheal bistour (a long, narrow sur- nose, and throat area. The device is gical knife); tracheal dilator; tracheal used, for example, in microsurgical hook; laryngeal injection set; laryngeal procedures to excise lesions and tumors knife; laryngeal saw; laryngeal trocar; of the vocal cords and adjacent areas. laryngectomy tube; adenoid curette; (b) Classification. Class II. adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal cu- § 874.4680 Bronchoscope (flexible or rette; tonsillectome; tonsil guillotine; rigid) and accessories. tonsil screw; tonsil snare; tonsil suc- (a) Identification. A bronchoscope tion tube; tonsil suturing hook; antom (flexible or rigid) and accessories is a reforator; ethmoid curette; frontal tubular endoscopic device with any of a sinus-rasp; nasal curette; nasal rasp; group of accessory devices which at- nasal rongeur; nasal saw; nasal scis- tach to the bronchoscope and is in- sors; nasal snare; sinus irrigator; sinus tended to examine or treat the larynx trephine; ear curette; ear excavator; and tracheobronchial tree. It is typi- ear rasp; ear scissor, ear snare; ear cally used with a fiberoptic light spoon; ear suction tube; malleous rip- source and carrier to provide illumina- per; mastoid gauge; microsurgical ear tion. The device is made of materials chisel; myringotomy tube inserter; such as stainless steel or flexible plas- ossici holding clamp; sacculotomy tack tic. This generic type of device in- inserter; vein press; wire ear loop; cludes the rigid ventilating broncho- microrule; mirror; mobilizer; ear, nose, scope, rigid nonventilating broncho- and throat punch; ear, nose and throat scope, nonrigid bronchoscope, laryn- knife; and ear, nose, and throat trocar. geal-bronchial telescope, flexible for- (b) Classification Class I (general con- eign body claw, bronchoscope tubing, trols). The device is exempt from the flexible biopsy forceps, rigid biopsy cu- premarket notification procedures in rette, flexible biopsy brush, rigid bi- subpart E of part 807 of this chapter opsy forceps, flexible biopsy curette, subject to § 874.9. and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source [51 FR 40389, Nov. 9, 1986, as amended at 52 FR 32111, Aug. 25, 1987; 65 FR 2316, Jan. 14, and carrier. 2000; 72 FR 17400, Apr. 9, 2007] (b) Classification. Class II.

§ 874.4490 Argon laser for otology, rhi- § 874.4710 Esophagoscope (flexible or nology, and laryngology. rigid) and accessories. (a) Identification. The argon laser de- (a) Identification. An esophagoscope vice for use in otology, rhinology, and (flexible or rigid) and accessories is a laryngology is an electro-optical device tubular endoscopic device with any of a which produces coherent, electro- group of accessory devices which at- magnetic radiation with principal tach to the esophagoscope and is in- wavelength peaks of 488 and 514 nano- tended to examine or treat esophageal meters. In otology, the device is used malfunction symptoms, esophageal or

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mediastinal disease, or to remove for- subpart E of part 807 of this chapter eign bodies from the esophagus. When subject to the limitations in § 874.9. inserted, the device extends from the [55 FR 48440, Nov. 20, 1990, as amended at 59 area of the hypopharynx to the stom- FR 63009, Dec. 7, 1994; 66 FR 38801, July 25, ach. It is typically used with a 2001] fiberoptic light source and carrier to provide illumination. The device is § 874.4760 Nasopharyngoscope (flexi- made of materials such as stainless ble or rigid) and accessories. steel or flexible plastic. This generic (a) Identification. A type of device includes the flexible for- nasopharyngoscope (flexible or rigid) eign body claw, flexible biopsy forceps, and accessories is a tubular endoscopic rigid biopsy curette, flexible biopsy device with any of a group of accessory brush, rigid biopsy forceps and flexible devices which attach to the biopsy curette, but excludes the nasopharyngoscope and is intended to fiberoptic light source and carrier. examine or treat the nasal cavity and (b) Classification. Class II. nasal pharynx. It is typically used with a fiberoptic light source and carrier to § 874.4720 Mediastinoscope and acces- provide illumination. The device is sories. made of materials such as stainless steel and flexible plastic. This generic (a) Identification. A mediastinoscope type of device includes the antroscope, and accessories is a tubular tapered nasopharyngolaryngoscope, electrical endoscopic device with any nasosinuscope, nasoscope, of a group of accessory devices which postrhinoscope, rhinoscope, attach to the mediastinoscope and is salpingoscope, flexible foreign body intended to examine or treat tissue in claw, flexible biopsy forceps, rigid bi- the area separating the lungs. The de- opsy curette, flexible biospy brush, vice is inserted transthoracicly and is rigid biopsy forceps and flexible biopsy used in diagnosis of tumors and lesions curette, but excludes the fiberoptic and to determine whether excision of light source and carrier. certain organs or tissues is indicated. (b) Classification. Class II. It is typically used with a fiberoptic light source and carrier to provide illu- § 874.4770 Otoscope. mination. The device is made of mate- (a) Identification. An otoscope is a de- rials such as stainless steel. This ge- vice intended to allow inspection of the neric type of device includes the flexi- external ear canal and tympanic mem- ble foreign body claw, flexible biopsy brane under magnification. The device forceps, rigid biopsy curette, flexible provides illumination of the ear canal biopsy brush, rigid biopsy forceps, and for observation by using an AC- or bat- flexible biopsy curette, but excludes tery-powered light source and an opti- the fiberoptic light source and carrier. cal magnifying system. (b) Classification. Class II. (b) Classification. Class I (general controls). The device is exempt from the § 874.4750 Laryngostroboscope. premarket notification procedures in (a) Identification. A subpart E of part 807 of this chapter laryngostroboscope is a device that is subject to the limitations in § 874.9 only intended to allow observation of glottic when used in the external ear canal. action during phonation. The device [55 FR 48440, Nov. 20, 1990, as amended at 61 operates by focusing a stroboscopic FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, light through a lens for direct or mir- 2001] ror reflected viewing of glottic action. The light and microphone that ampli- § 874.4780 Intranasal splint. fies acoustic signals from the glottic (a) Identification. An intranasal splint area may or may not contact the pa- is intended to minimize bleeding and tient. edema and to prevent adhesions be- (b) Classification. Class I (general con- tween the septum and the nasal cavity. trols). The device is exempt from the It is placed in the nasal cavity after premarket notification procedures in surgery or trauma. The intranasal

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splint is constructed from plastic, sili- support a patient during an otologic cone, or absorbent material. examination while providing special- (b) Classification. Class I (general con- ized features for examination and trols). The device is exempt from the treatment. The unit consists of a pa- premarket notification procedures in tient chair and table, drawers for subpart E of part 807 of this chapter equipment, suction and blowing appa- subject to the limitations in § 874.9. ratus, and receptacles for connection of [64 FR 10949, Mar. 8, 1999] specialized lights and examining instruments. § 874.4800 Bone particle collector. (b) Classification. Class I (general con- (a) Identification. A bone particle col- trols). The device is exempt from the lector is a filtering device intended to premarket notification procedures in be inserted into a suction tube during subpart E of part 807 of this chapter the early stages of otologic surgery to subject to § 874.9. collect bone particles for future use. [55 FR 48440, Nov. 20, 1990, as amended at 65 (b) Classification. Class I (general con- FR 2316, Jan. 14, 2000] trols). The device is exempt from premarket notification procedures in sub- § 874.5350 Suction antichoke device. part E of part 807 of this chapter sub- (a) Identification. A suction antichoke ject to the limitations in § 874.9. device is a device intended to be used [64 FR 10949, Mar. 8, 1999] in an emergency situation to remove, by the application of suction, foreign Subpart F—Therapeutic Devices objects that obstruct a patient’s airway to prevent asphyxiation to the pa- § 874.5220 Ear, nose, and throat drug tient. administration device. (b) Classification. Class III. (a) Identification. An ear, nose, and (c) Date PMA or notice of completion of throat drug administration device is PDP is required. A PMA or a notice of one of a group of ear, nose, and throat completion of a PDP for a device is re- devices intended specifically to admin- quired to be filed with the Food and ister medicinal substances to treat ear, Drug Administration on or before July nose, and throat disorders. These in- 13, 1999 for any suction antichoke de- struments include the powder blower, vice that was in commercial distribu- dropper, ear wick, manual nebulizer tion before May 28, 1976, or that has, on pump, and nasal inhaler. or before July 13, 1999, been found to be (b) Classification. Class I (general con- substantially equivalent to a suction trols). The device is exempt from the antichoke device that was in commer- premarket notification procedures in cial distribution before May 28, 1976. subpart E of part 807 of this chapter Any other suction antichoke device subject to the limitations in § 874.9. If shall have an approved PMA or de- the device is not labeled or otherwise clared completed PDP in effect before represented as sterile, it is exempt being placed in commercial distribu- from the current good manufacturing tion. practice requirements of the quality [51 FR 40389, Nov. 6, 1986, as amended at 64 system regulation in part 820 of this FR 18329, Apr. 14, 1999; 65 FR 2316, Jan. 14, chapter, with the exception of § 820.180, 2000] with respect to general requirements concerning records, and § 820.198, with § 874.5370 Tongs antichoke device. respect to complaint files. (a) Identification. A tongs antichoke [51 FR 40389, Nov. 6, 1986, as amended at 59 device is a device that is intended to be FR 63009, Dec. 7, 1994; 66 FR 38801, July 25, used in an emergency situation to 2001] grasp and remove foreign objects that obstruct a patient’s airway to prevent § 874.5300 Ear, nose, and throat exam- asphyxiation of the patient. This ge- ination and treatment unit. neric type of device includes a plastic (a) Identification. An ear, nose, and instrument with serrated ends that is throat examination and treatment unit inserted into the airway in a blind is an AC-powered device intended to manner to grasp and extract foreign

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objects, and a stainless steel forceps when it senses the user’s speech and with spoon ends that is inserted under that is intended to prevent the user tactile guidance to grasp and extract from hearing the sounds of his or her foreign objects from the airway. own voice. The device is used to mini- (b) Classification. Class III. mize a user’s involuntary hesitative or (c) Date PMA or notice of completion of repetitive speech. PDP is required. A PMA or a notice of (b) Classification. Class I (general con- completion of a PDP for a device is re- trols). The device is exempt from the quired to be filed with the Food and premarket notification procedures in Drug Administration on or before July subpart E of part 807 of this chapter 13, 1999 for any tongs antichoke device subject to § 874.9. that was in commercial distribution [51 FR 40389, Nov. 6, 1986, as amended at 65 before May 28, 1976, or that has, on or FR 2316, Jan. 14, 2000] before July 13, 1999, been found to be substantially equivalent to a tongs § 874.5900 External upper esophageal antichoke device that was in commer- sphincter compression device. cial distribution before May 28, 1976. (a) Identification. An external upper Any other tongs antichoke device shall esophageal sphincter compression de- have an approved PMA or declared vice is a prescription device used to completed PDP in effect before being apply external pressure on the cricoid placed in commercial distribution. cartilage for the purpose of reducing [51 FR 40389, Nov. 6, 1986, as amended at 64 the symptoms of laryngopharyngeal FR 18329, Apr. 14, 1999] reflux disease. (b) Classification. Class II (special § 874.5550 Powered nasal irrigator. controls). The special controls for this (a) Identification. A powered nasal device are: irrigator is an AC-powered device in- (1) The patient contacting compo- tended to wash the nasal cavity by nents must be demonstrated to be bio- means of a pressure-controlled pul- compatible. sating stream of water. The device con- (2) Non-clinical performance testing sists of a control unit and pump con- must demonstrate that the device per- nected to a spray tube and nozzle. forms as intended under anticipated (b) Classification. Class I (general con- conditions of use. The following per- trols). The device is exempt from the formance characteristics must be dem- premarket notification procedures in onstrated: subpart E of part 807 of this chapter (i) Mechanical integrity testing (e.g., subject to § 874.9. tensile strength testing, fatigue testing) and [55 FR 48440, Nov. 20, 1990, as amended at 65 (ii) Shelf life testing. FR 2316, Jan. 14, 2000] (3) The technical specifications must § 874.5800 External nasal splint. include pressure measurement accuracy to characterize device perform- (a) Identification. An external nasal ance. splint is a rigid or partially rigid de- (4) Clinical performance testing must vice intended for use externally for im- document any adverse events observed mobilization of parts of the nose. during clinical use, and demonstrate (b) Classification. Class I (general con- that the device performs as intended trols). The device is exempt from the under anticipated conditions of use. premarket notification procedures in (5) Labeling must include the fol- subpart E of part 807 of this chapter lowing: subject to the limitations in § 874.9. (i) Appropriate warnings and pre- [51 FR 40389, Nov. 9, 1986, as amended at 52 cautions, FR 32111, Aug. 25, 1987; 59 FR 63009, Dec. 7, (ii) A detailed summary of the clin- 1994; 66 FR 38801, July 25, 2001] ical testing pertinent to use of the device including a detailed summary of § 874.5840 Antistammering device. the device-related complications or ad- (a) Identification. An antistammering verse events, device is a device that electronically (iii) Detailed instructions on how to generates a noise when activated or fit the device to the patient, and

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(iv) Instructions for reprocessing of 876.4500 Mechanical lithotriptor. any reusable components. 876.4530 Gastroenterology-urology (6) Patient labeling must be provided fiberoptic retractor. and must include: 876.4560 Ribdam. 876.4590 Interlocking urethral sound. (i) Relevant warnings, precautions, 876.4620 Ureteral stent. and adverse effects/complications, 876.4650 Water jet renal stone dislodger sys- (ii) Information on how to correctly tem. wear the device, 876.4680 Ureteral stone dislodger. (iii) The potential risks and benefits 876.4730 Manual gastroenterology-urology associated with the use of the device, surgical instrument and accessories. (iv) Alternative treatments, and 876.4770 Urethrotome. (v) Reprocessing instructions. 876.4890 Urological table and accessories. [80 FR 46194, Aug. 4, 2015] Subpart F—Therapeutic Devices 876.5010 Biliary catheter and accessories. PART 876—GASTROENTEROLOGY- 876.5011 Metallic biliary stent system for UROLOGY DEVICES benign strictures. 876.5015 Pancreatic drainage stent and de- Subpart A—General Provisions livery system. 876.5020 External penile rigidity devices. Sec. 876.5025 Vibrator for climax control of pre- 876.1 Scope. mature ejaculation. 876.3 Effective dates of requirement for pre- 876.5030 Continent ileostomy catheter. market approval. 876.5090 Suprapubic urological catheter and 876.9 Limitations of exemptions from sec- accessories. tion 510(k) of the Federal Food, Drug, 876.5130 Urological catheter and accessories. and Cosmetic Act (the act). 876.5140 Urethral insert with pump for bladder drainage. Subpart B—Diagnostic Devices 876.5160 Urological clamp for males. 876.5210 Enema kit. 876.1075 Gastroenterology-urology biopsy 876.5220 Colonic irrigation system. instrument. 876.5250 Urine collector and accessories. 876.1300 Ingestible telemetric gastro- 876.5270 Implanted electrical urinary con- intestinal capsule imaging system. tinence device. 876.1330 Colon capsule endoscopy system. 876.5280 Implanted mechanical/hydraulic 876.1400 Stomach pH electrode. urinary continence device. 876.1500 Endoscope and accessories. 876.5310 Nonimplanted, peripheral electrical 876.1620 Urodynamics measurement system. continence device. 876.1725 Gastrointestinal motility moni- 876.5320 Nonimplanted electrical continence toring system. device. 876.1735 Electrogastrography system. 876.5365 Esophageal dilator. 876.1800 Urine flow or volume measuring 876.5450 Rectal dilator. system. 876.5470 Ureteral dilator. 876.5520 Urethral dilator. Subpart C—Monitoring Devices 876.5530 Implantable transprostatic tissue retractor system. 876.2040 Enuresis alarm. 876.5540 Blood access device and accessories. 876.2050 Prostate lesion documentation sys- 876.5600 Sorbent regenerated dialysate de- tem. livery system for hemodialysis. 876.5630 Peritoneal dialysis system and ac- Subpart D—Prosthetic Devices cessories. 876.3350 Penile inflatable implant. 876.5665 Water purification system for 876.3630 Penile rigidity implant. hemodialysis. 876.3750 Testicular prosthesis. 876.5820 Hemodialysis system and accessories. Subpart E—Surgical Devices 876.5830 Hemodialyzer with disposable insert (Kiil type). 876.4020 Fiberoptic light ureteral catheter. 876.5860 High permeability hemodialysis 876.4270 Colostomy rod. system. 876.4300 Endoscopic electrosurgical unit and 876.5870 Sorbent hemoperfusion system. accessories. 876.5880 Isolated kidney perfusion and 876.4370 Gastroenterology-urology transport system and accessories. evacuator. 876.5885 Tissue culture media for human ex 876.4400 Hemorrhoidal ligator. vivo tissue and cell culture processing 876.4480 Electrohydraulic lithotriptor. applications.

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876.5895 Ostomy irrigator. § 876.3 Effective dates of requirement 876.5900 Ostomy pouch and accessories. for premarket approval. 876.5920 Protective garment for incontinence. A device included in this part that is 876.5930 Rectal control system. classified into class III (premarket ap- 876.5955 Peritoneo-venous shunt. proval) shall not be commercially dis- 876.5970 Hernia support. tributed after the date shown in the 876.5980 Gastrointestinal tube and acces- regulation classifying the device unless sories. the manufacturer has an approval 876.5990 Extracorporeal shock wave under section 515 of the act (unless an lithotripter. exemption has been granted under section 520(g)(2) of the act). An approval AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. under section 515 of the act consists of FDA’s issuance of an order approving SOURCE: 48 FR 53023, Nov. 23, 1983, unless an application for premarket approval otherwise noted. (PMA) for the device or declaring completed a product development protocol Subpart A—General Provisions (PDP) for the device. (a) Before FDA requires that a device EDITORIAL NOTE: Nomenclature changes to commercially distributed before the part 876 appear at 73 FR 35341, June 23, 2008. enactment date of the amendments, or a device that has been found substan- § 876.1 Scope. tially equivalent to such a device, has (a) This part sets forth the classifica- an approval under section 515 of the act tion of gastroenterology-urology de- FDA must promulgate a regulation vices intended for human use that are under section 515(b) of the act requir- in commercial distribution. ing such approval, except as provided (b) The identification of a device in a in paragraph (b) of this section. Such a regulation in this part is not a precise regulation under section 515(b) of the description of every device that is, or act shall not be effective during the will be, subject to the regulation. A grace period ending on the 90th day manufacturer who submits a pre- after its promulgation or on the last market notification submission for a day of the 30th full calendar month device under part 807 may not show after the regulation that classifies the merely that the device is accurately device into class III is effective, which- described by the section title and iden- ever is later. See section 501(f)2)(B) of tification provisions of a regulation in the act. Accordingly, unless an effec- this part, but shall state why the de- tive date of the requirement for pre- vice is substantially equivalent to market approval is shown in the regu- other devices, as required by § 807.87. lation for a device classified into class (c) To avoid duplicative listings, a III in this part, the device may be commerically distributed without gastroenterology-urology device that FDA’s issuance of an order approving a has two or more types of uses (e.g., PMA or declaring completed a PDP for used both as a diagnostic device and as the device. If FDA promulgates a regu- a therapeutic device) is listed only in lation under section 515(b) of the act one subpart. requiring premarket approval for a de- (d) References in this part to regu- vice, section 501(f)(1)(A) of the act ap- latory sections of the Code of Federal plies to the device. Regulations are to chapter I of title 21, (b) Any new, not substantially equiv- unless otherwise noted. alent, device introduced into commer- (e) Guidance documents referenced in cial distribution on or after May 28, this part are available on the Internet 1976, including a device formerly mar- at http://www.fda.gov/MedicalDevices/ keted that has been substantially al- DeviceRegulationandGuidance/ tered, is classified by statute (section GuidanceDocuments/default.htm.. 513(f) of the act) into class III without [52 FR 17737, May 11, 1987; 52 FR 22577, June any grace period and FDA must have 12, 1987, as amended at 69 FR 77623, Dec. 28, issued an order approving a PMA or de- 2004; 78 FR 18233, Mar. 26, 2013] claring completed a PDP for the device

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before the device is commercially dis- deoxyribonucleic acid (DNA) probe or tributed unless it is reclassified. If nucleic acid hybridization technology FDA knows that a device being com- rather than culture or immunoassay mercially distributed may be a ‘‘new’’ technology; or device as defined in this section be- (c) The device is an in vitro device cause of any new intended use or other that is intended: reasons, FDA may codify the statutory (1) For use in the diagnosis, moni- classification of the device into class toring, or screening of neoplastic dis- III for such new use. Accordingly, the eases with the exception of regulation for such a class III device immunohistochemical devices; states that as of the enactment date of (2) For use in screening or diagnosis the amendments, May 28, 1976, the de- of familial or acquired genetic dis- vice must have an approval under sec- orders, including inborn errors of me- tion 515 of the act before commercial tabolism; distribution. (3) For measuring an analyte that [52 FR 17737, May 11, 1987] serves as a surrogate marker for screening, diagnosis, or monitoring § 876.9 Limitations of exemptions from life-threatening diseases such as ac- section 510(k) of the Federal Food, quired immune deficiency syndrome Drug, and Cosmetic Act (the act). (AIDS), chronic or active hepatitis, tu- The exemption from the requirement berculosis, or myocardial infarction or of premarket notification (section to monitor therapy; 510(k) of the act) for a generic type of (4) For assessing the risk of cardio- class I or II device is only to the extent vascular diseases; that the device has existing or reason- (5) For use in diabetes management; ably foreseeable characteristics of (6) For identifying or inferring the commercially distributed devices with- identity of a microorganism directly in that generic type or, in the case of from clinical material; in vitro diagnostic devices, only to the (7) For detection of antibodies to extent that misdiagnosis as a result of microorganisms other than using the device would not be associ- immunoglobulin G (IgG) or IgG assays ated with high morbidity or mortality. when the results are not qualitative, or Accordingly, manufacturers of any are used to determine immunity, or the commercially distributed class I or II assay is intended for use in matrices device for which FDA has granted an other than serum or plasma; exemption from the requirement of (8) For noninvasive testing as defined premarket notification must still sub- in § 812.3(k) of this chapter; and mit a premarket notification to FDA (9) For near patient testing (point of before introducing or delivering for in- care). troduction into interstate commerce for commercial distribution the device [65 FR 2316, Jan. 14, 2000] when: (a) The device is intended for a use Subpart B—Diagnostic Devices different from the intended use of a legally marketed device in that generic § 876.1075 Gastroenterology-urology type of device; e.g., the device is in- biopsy instrument. tended for a different medical purpose, (a) Identification. A gastroenterology- or the device is intended for lay use urology biopsy instrument is a device where the former intended use was by used to remove, by cutting or aspira- health care professionals only; tion, a specimen of tissue for micro- (b) The modified device operates scopic examination. This generic type using a different fundamental sci- of device includes the biopsy punch, entific technology than a legally mar- gastrointestinal mechanical biopsy in- keted device in that generic type of de- strument, suction biopsy instrument, vice; e.g., a surgical instrument cuts gastro-urology biopsy needle and nee- tissue with a laser beam rather than dle set, and nonelectric biopsy forceps. with a sharpened metal blade, or an in This section does not apply to biopsy vitro diagnostic device detects or iden- instruments that have specialized uses tifies infectious agents by using in other medical specialty areas and

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that are covered by classification regu- (2) Non-clinical testing data must lations in other parts of the device demonstrate the mechanical and func- classification regulations. tional integrity of the device under (b) Classification. (1) Class II (per- physically stressed conditions. The fol- formance standards). lowing performance characteristics (2) Class I for the biopsy forceps must be tested and detailed protocols cover and the non-electric biopsy for- must be provided for each test: ceps. The devices subject to this para- (i) Bite test to ensure that the cap- graph (b)(2) are exempt from the pre- sule can withstand extreme cases of market notification procedures in sub- biting. part E of part 807 of this chapter sub- (ii) pH resistance test to evaluate inject to the limitations in § 876.9. tegrity of the capsule when exposed to [48 FR 53023, Nov. 23, 1983, as amended at 61 a range of pH values. FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, (iii) Battery life test to demonstrate 2001] that the capsule’s operating time is not constrained by the battery capacity. § 876.1300 Ingestible telemetric gastro- (iv) Shelf-life testing to demonstrate intestinal capsule imaging system. that the device performs as intended at (a) Identification. An ingestible tele- the proposed shelf-life date. metric gastrointestinal capsule imag- (v) Optical testing to evaluate funda- ing system is used for visualization of mental image quality characteristics the small bowel mucosa as an adjunc- such as resolution, field of view, depth tive tool in the detection of abnormali- of field, distortion, signal-to-noise ties of the small bowel. The device cap- ratio, uniformity, and image artifacts. tures images of the small bowel with a A test must be performed to evaluate wireless camera contained in a capsule. the potential of scratches, caused by This device includes an ingestible cap- travelling through the gastrointestinal sule (containing a light source, camera, tract, on the transparent window of the transmitter, and battery), an antenna capsule and their impact on the optical array, a receiving/recording unit, a and color performance. data storage device, computer software (vi) An optical safety analysis must to process the images, and accessories. be performed based on maximum (b) Classification. Class II (special (worst-case) light exposure to internal controls). The special control is FDA’s gastrointestinal mucosa, and covering guidance, ‘‘Class II Special Controls ultraviolet, visible, and near-infrared Guidance Document: Ingestible Tele- ranges, as appropriate. A mitigation metric Gastrointestinal Capsule Imag- analysis must be provided. ing Systems; Final Guidance for Indus- (vii) A color performance test must try and FDA.’’ be provided to compare the color dif- [67 FR 3433, Jan. 24, 2002] ferences between the input scene and output image. § 876.1330 Colon capsule endoscopy (viii) The video viewer must clearly system. present the temporal or spatial rela- (a) Identification. A prescription, sin- tionship between any two frames as a gle-use ingestible capsule designed to real-time lapse or a travel distance. acquire video images during natural The video viewer must alert the user propulsion through the digestive sys- when the specific video interval is cap- tem. It is specifically designed to vis- tured at a frame rate lower than the ualize the colon for the detection of nominal one due to communication er- polyps. It is intended for use only in rors. patients who had an incomplete optical (ix) A performance test evaluating colonoscopy with adequate prepara- the latency caused by any adaptive al- tion, and a complete evaluation of the gorithm such as adjustable frame rate colon was not technically possible. must be provided. (b) Classification. Class II (special (x) If the capsule includes a localiza- controls). The special controls for this tion module, a localization perform- device are: ance test must be performed to verify (1) The capsule must be demonstrated the accuracy and precision of locating to be biocompatible. the capsule position within the colon.

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(xi) A data transmission test must be cent of patients in which the capsule performed to verify the robustness of either missed or falsely identified a the data transmission between the cap- polyp with respect to the clinically ac- sule and the recorder. Controlled signal ceptable alternative structural imag- attenuation should be included for sim- ing method. ulating a non-ideal environment. (iv) A summary of the device- and (xii) Software validation, procedure-related complications perti- verification, and hazards analysis must nent to use of the device. be provided. [79 FR 28403, May 16, 2014] (xiii) Electrical equipment safety, including thermal and mechanical safety § 876.1400 Stomach pH electrode. and electromagnetic compatibility (EMC) testing must be performed. If (a) Identification. A stomach pH elec- the environments of intended use in- trode is a device used to measure clude locations outside of hospitals and intragastric and intraesophageal pH clinics, appropriate higher immunity (hydrogen ion concentration). The pH test levels must be used. Labeling must electrode is at the end of a flexible lead include appropriate EMC information. which may be inserted into the esoph- (xiv) Information demonstrating im- agus or stomach through the patient’s munity from wireless hazards. mouth. The device may include an in- (3) The clinical performance charac- tegral gastrointestinal tube. teristics of the device for the detection (b) Classification. Class I. The device of colon polyps must be established. is exempt from the premarket notifica- Demonstration of the performance tion procedures in subpart E of part 807 characteristics must include assess- of this chapter. ment of positive percent agreement [48 FR 53023, Nov. 23, 1983, as amended at 61 and negative percent agreement com- FR 1122, Jan. 16, 1996] pared to a clinically acceptable alternative structural imaging method. § 876.1500 Endoscope and accessories. (4) Clinician labeling must include: (a) Identification. An endoscope and (i) Specific instructions and the clin- accessories is a device used to provide ical and technical expertise needed for access, illumination, and allow obser- the safe use of the device. vation or manipulation of body cav- (ii) A detailed summary of the clin- ities, hollow organs, and canals. The ical testing pertinent to use of the de- device consists of various rigid or flexi- vice, including the percentage of pable instruments that are inserted into tients in which a polyp was correctly body spaces and may include an optical identified by capsule endoscopy, but system for conveying an image to the also the percent of patients in which user’s eye and their accessories may the capsule either missed or falsely assist in gaining access or increase the identified a polyp with respect to the versatility and augment the capabili- clinically acceptable alternative struc- ties of the devices. Examples of devices tural imaging method. that are within this generic type of de- (iii) The colon cleansing procedure. vice include cleaning accessories for (iv) A detailed summary of the device endoscopes, photographic accessories technical parameters. for endoscopes, nonpowered anoscopes, (v) A detailed summary of the device- binolcular attachments for endoscopes, and procedure-related complications pocket battery boxes, flexible or rigid pertinent to use of the device. choledochoscopes, colonoscopes, diag- (vi) An expiration date/shelf life. nostic cystoscopes, cystourethroscopes, (5) Patient labeling must include: enteroscopes, (i) An explanation of the device and esophagogastroduodenoscopes, rigid the mechanism of operation. esophagoscopes, fiberoptic illuminators (ii) Patient preparation procedure. for endoscopes, incandescent endoscope (iii) A brief summary of the clinical lamps, biliary pancreatoscopes, study. The summary should not only proctoscopes, resectoscopes, include the percentage of patients in nephroscopes, sigmoidoscopes, which a polyp was correctly identified ureteroscopes, urethroscopes, by capsule endoscopy, but also the per- endomagnetic retrievers, cytology

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brushes for endoscopes, and lubricating the premarket notification procedures jelly for transurethral surgical instru- in subpart E of part 807 of this chapter ments. This section does not apply to subject to § 876.9. endoscopes that have specialized uses [48 FR 53023, Nov. 23, 1983, as amended at 63 in other medical specialty areas and FR 59228, Nov. 3, 1998] that are covered by classification regulations in other parts of the device § 876.1725 Gastrointestinal motility classification regulations. monitoring system. (b) Classification. (1) Class II (per- (a) Identification. A gastrointestinal formance standards). motility monitoring system is a device (2) Class I for the photographic acces- used to measure peristalic activity or sories for endoscope, miscellaneous pressure in the stomach or esophagus bulb adapter for endoscope, binocular by means of a probe with transducers attachment for endoscope, eyepiece at- that is introduced through the mouth tachment for prescription lens, teach- into the gastrointestinal tract. The de- ing attachment, inflation bulb, meas- vice may include signal conditioning, uring device for panendoscope, photo- amplifying, and recording equipment. graphic equipment for physiologic This generic type of device includes the function monitor, special lens instru- esophageal motility monitor and tube, ment for endoscope, smoke removal the gastrointestinal motility (elec- tube, rechargeable battery box, pocket trical) system, and certain accessories, battery box, bite block for endoscope, such as a pressure transducer, ampli- and cleaning brush for endoscope. The fier, and external recorder. devices subject to this paragraph (b)(2) (b) Classification. Class II (perform- are exempt from the premarket notifi- ance standards). cation procedures in subpart E of part 807of this chapter, subject to the limi- § 876.1735 Electrogastrography system. tations in § 876.9. (a) Identification. An [48 FR 53023, Nov. 23, 1983, as amended at 61 electrogastrography system (EGG) is a FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, device used to measure gastric 2001] myoelectrical activity as an aid in the diagnosis of gastric motility disorders. § 876.1620 Urodynamics measurement The device system includes the exter- system. nal recorder, amplifier, skin electrodes, (a) Identification. A urodynamics strip chart, cables, analytical software, measurement system is a device used and other accessories. to measure volume and pressure in the (b) Classification. Class II (Special urinary bladder when it is filled Controls). The special controls are as through a catheter with carbon dioxide follows: or water. The device controls the sup- (1) The sale, distribution and use of ply of carbon dioxide or water and may this device are restricted to prescrip- also record the electrical activity of tion use in accordance with § 801.109 of the muscles associated with urination. this chapter. The device system may include trans- (2) The labeling must include specific ducers, electronic signal conditioning instructions: and display equipment, a catheter (i) To describe proper patient set-up withdrawal device to enable a urethral prior to the start of the test, including pressure profile to be obtained, and the proper placement of electrodes; special catheters for urethral (ii) To describe how background data profilometry and electrodes for should be gathered and used to elimi- electromyography. This generic type of nate artifact in the data signal; device includes the cystometric gas (iii) To describe the test protocol (in- (carbon dioxide) device, the cluding the measurement of baseline cystometric hydrualic device, and the data) that may be followed to obtain electrical recording cystometer, but the EGG signal; and excludes any device that uses air to fill (iv) To explain how data results may the bladder. be interpreted. (b) Classification. Class II (special (3) The device design should ensure controls). The device is exempt from that the EGG signal is distinguishable

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from background noise that may inter- § 876.2050 Prostate lesion documenta- fere with the true gastric myoelectric tion system. signal. (a) Identification. A prostate lesion (4) Data should be collected to dem- documentation system is a prescription onstrate that the device has adequate device intended for use in producing an precision and the EGG signal is repro- image of the prostate as an aid in docu- ducible and is interpretable. menting prostate abnormalities previously identified during a digital rec- [64 FR 51444, Sept. 23, 1999] tal examination. The device uses pres- § 876.1800 Urine flow or volume meas- sure sensors and image reconstruction uring system. software to produce a prostate image that highlights regional differences in (a) Identification. A urine flow or vol- intraprostatic tissue elasticity or stiff- ume measuring system is a device that ness. The device is limited to use as a measures directly or indirectly the vol- documentation tool and is not intended ume or flow of urine from a patient, ei- for diagnostic purposes or for influ- ther during the course of normal urina- encing any clinical decisions. tion or while the patient is catheter- (b) Classification. Class II (special ized. The device may include a drip controls). The special controls for this chamber to reduce the risk of retro- device are: grade bacterial contamination of the (1) Non-clinical and clinical perform- bladder and a transducer and electrical ance testing must demonstrate the ac- signal conditioning and display equip- curacy and reproducibility of the con- ment. This generic type of device instructed image. cludes the electrical urinometer, me- (2) Appropriate analysis/testing must chanical urinometer, nonelectric uri- validate electromagnetic compat- nometer, disposable nonelectric urine ibility, electrical safety, thermal safe- flow rate measuring device, and ty, and mechanical safety. (3) Appropriate software verification, uroflowmeter. validation, and hazard analysis must (b) Classification. (1) Class II (special be performed. controls). The device is exempt from (4) All elements of the device that the premarket notification procedures may contact the patient must be dem- in subpart E of part 807 of this chapter onstrated to be biocompatible. subject to § 876.9. (5) Methods and instructions for re- [48 FR 53023, Nov. 23, 1983, as amended at 61 processing of any reusable components FR 1122, Jan. 16, 1996; 63 FR 59228, Nov. 3, must be properly validated. 1998] (6) The labeling must include specific information needed to ensure proper Subpart C—Monitoring Devices use of the device. [80 FR 72900, Nov. 23, 2015] § 876.2040 Enuresis alarm. (a) Identification. An enuresis alarm Subpart D—Prosthetic Devices is a device intended for use in treatment of bedwetting. Through an elec- § 876.3350 Penile inflatable implant. trical trigger mechanism, the device (a) Identification. A penile inflatable sounds an alarm when a small quantity implant is a device that consists of two of urine is detected on a sensing pad. inflatable cylinders implanted in the This generic type of device includes penis, connected to a reservoir filled conditioned response enuresis alarms. with radiopaque fluid implanted in the (b) Classification. Class II (special abdomen, and a subcutaneous manual controls). The device is exempt from pump implanted in the scrotum. When the cylinders are inflated, they provide the premarket notification procedures rigidity to the penis. This device is in subpart E of part 807 of this chapter used in the treatment of erectile impo- subject to § 876.9. tence. [48 FR 53023, Nov. 23, 1983, as amended at 63 (b) Classification. Class III (premarket FR 59228, Nov. 3, 1998] approval).

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(c) Date premarket approval application ular prosthesis shall have an approved (PMA) or notice of completion of a prod- PMA or a declared completed PDP in uct development protocol (PDP) is re- effect before being placed in commer- quired. A PMA or a notice of comple- cial distribution. tion of a PDP is required to be filed with the Food and Drug Administra- [48 FR 53023, Nov. 23, 1983, as amended at 52 tion on or before July 11, 2000, for any FR 17738, May 11, 1987; 60 FR 17216, Apr. 5, penile inflatable implant that was in 1995] commercial distribution before May 28, 1976, or that has, on or before July 11, Subpart E—Surgical Devices 2000, been found to be substantially equivalent to a penile inflatable im- § 876.4020 Fiberoptic light ureteral plant that was in commercial distribu- catheter. tion before May 28, 1976. Any other (a) Identification. A fiberoptic light penile inflatable implant shall have an ureteral catheter is a device that con- approved PMA or a declared completed sists of a fiberoptic bundle that emits PDP in effect before being placed in light throughout its length and is commercial distribution. shaped so that it can be inserted into [48 FR 53023, Nov. 23, 1983, as amended at 52 the ureter to enable the path of the FR 17738, May 11, 1987; 65 FR 19658, Apr. 12, ureter to be seen during lower abdom- 2000] inal or pelvic surgery. (b) Classification. Class II (perform- § 876.3630 Penile rigidity implant. ance standards). (a) Identification. A penile rigidity implant is a device that consists of a § 876.4270 Colostomy rod. pair of semi-rigid rods implanted in the (a) Identification. A colostomy rod is corpora cavernosa of the penis to pro- a device used during the loop colos- vide rigidity. It is intended to be used tomy procedure. A loop of colon is sur- in men diagnosed as having erectile gically brought out through the ab- dysfunction. dominal wall and the stiff colostomy (b) Classification. Class II. The special rod is placed through the loop tempo- control for this device is the FDA guidance entitled ‘‘Guidance for the Con- rarily to keep the colon from slipping tent of Premarket Notifications for back through the surgical opening. Penile Rigidity Implants.’’ (b) Classification. Class II (performance standards). [65 FR 4882, Feb. 2, 2000] § 876.4300 Endoscopic electrosurgical § 876.3750 Testicular prosthesis. unit and accessories. (a) Identification. A testicular pros- (a) Identification. An endoscopic thesis is an implanted device that con- electrosurgical unit and accessories is sists of a solid or gel-filled silicone rub- a device used to perform ber prosthesis that is implanted sur- electrosurgical procedures through an gically to resemble a testicle. endoscope. This generic type of device (b) Classification. Class III (premarket includes the electrosurgical generator, approval). patient plate, electric biopsy forceps, (c) Date premarket approval application (PMA) or notice of product development electrode, flexible snare, protocol (PDP) is required. A PMA or no- electrosurgical alarm system, tice of completion of a PDP is required electrosurgical power supply unit, elec- to be filed with the Food and Drug Ad- trical clamp, self-opening rigid snare, ministration on or before July 5, 1995, flexible suction coagulator electrode, for any testicular prosthesis that was patient return wristlet, contact jelly, in commercial distribution before May adaptor to the cord for transurethral 28, 1976, or that has on or before July 5, surgical instruments, the electric cord 1995, been found to be substantially for transurethral surgical instruments, equivalent to a testicular prosthesis and the transurethral desiccator. that was in commercial distribution (b) Classification. Class II (perform- before May 28, 1976. Any other testic- ance standards).

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§ 876.4370 Gastroenterology-urology tifications for Intracorporeal evacuator. Lithotripters.’’ (a) Identification. A gastroenterology- [48 FR 53023, Nov. 23, 1983, as amended at 52 urology evacuator is a device used to FR 17738, May 11, 1987; 65 FR 17145, Mar. 31, remove debris and fluids during gastro- 2000] enterological and urological procedures by drainage, aspiration, or irrigation. § 876.4500 Mechanical lithotriptor. This generic type of device includes the (a) Identification. A mechanical fluid evacuator system, manually pow- lithotriptor is a device with steel jaws ered bladder evacuator, and the AC- that is inserted into the urinary blad- powered vacuum pump. der through the urethra to grasp and (b) Classification. (1) Class II (special crush bladder stones. controls) for the gastroenterology-urol- (b) Classification. Class II (perform- ogy evacuator when other than manu- ance standards). ally powered. The device is exempt § 876.4530 Gastroenterology-urology from the premarket notification proce- fiberoptic retractor. dures in subpart E of part 807 of this chapter subject to § 876.9. (a) Identification. A gastroenterology- urology fiberoptic retractor is a device (2) Class I for the gastroenterology- that consists of a mechanical retractor urology evacuator when manually pow- with a fiberoptic light system that is ered. The device subject to this para- used to illuminate deep surgical sites. graph (b)(2) is exempt from the pre- (b) Classification. Class I (general con- market notification procedures in sub- trols). The device is exempt from the part E of part 807 of this chapter. premarket notification procedures in [48 FR 53023, Nov. 23, 1983, as amended at 54 subpart E of part 807 of this chapter FR 25049, June 12, 1989; 63 FR 59228, Nov. 3, subject to the limitations in § 876.9. 1998] [48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25049, June 12, 1989; 66 FR 38801, July 25, § 876.4400 Hemorrhoidal ligator. 2001] (a) Identification. A hemorrhoidal ligator is a device used to cut off the § 876.4560 Ribdam. blood flow to hemorrhoidal tissue by (a) Identification. A ribdam is a device means of a ligature or band placed that consists of a broad strip of latex around the hemorrhoid. with supporting ribs used to drain sur- (b) Classification. Class II (perform- gical wounds where copious urine ance standards). drainage is expected. (b) Classification. Class I (general con- § 876.4480 Electrohydraulic trols). The device is exempt from the lithotriptor. premarket notification procedures in (a) Identification. An electrohydraulic subpart E of part 807 of this chapter lithotriptor is an AC-powered device subject to the limitations in § 876.9. used to fragment urinary bladder [48 FR 53023, Nov. 23, 1983, as amended at 54 stones. It consists of a high voltage FR 25049, June 12, 1989; 66 FR 38801, July 25, source connected by a cable to a bipo- 2001] lar electrode that is introduced into the urinary bladder through a cysto- § 876.4590 Interlocking urethral sound. scope. The electrode is held against the (a) Identification. An interlocking stone in a water-filled bladder and re- urethral sound is a device that consists peated electrical discharges between of two metal sounds (elongated instru- the two poles of the electrode cause ments for exploring or sounding body electrohydraulic shock waves which cavities) with interlocking ends, such disintegrate the stone. as with male and female threads or a (b) Classification. Class II. The special rounded point and mating socket, used control for this device is FDA’s ‘‘Guid- in the repair of a ruptured urethra. The ance for the Content of Premarket No- device may include a protective cap to fit over the metal threads.

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(b) Classification. Class I (general con- in subpart E of part 807 of this chapter trols). The device is exempt from the subject to § 876.9. premarket notification procedures in [48 FR 53023, Nov. 23, 1983, as amended at 63 subpart E of part 807 of this chapter FR 59228, Nov. 3, 1998] subject to the limitations in § 876.9. [48 FR 53023, Nov. 23, 1983, as amended at 61 § 876.4730 Manual gastroenterology- FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, urology surgical instrument and ac- 2001] cessories. (a) Identification. A manual gastro- § 876.4620 Ureteral stent. enterology-urology surgical instru- (a) Identification. A ureteral stent is a ment and accessories is a device de- tube-like implanted device that is in- signed to be used for gastro- serted into the ureter to provide enterological and urological surgical ureteral rigidity and allow the passage procedures. The device may be nonpow- of urine. The device may have finger- ered, hand-held, or hand-manipulated. like protrusions or hooked ends to keep Manual gastroenterology-urology sur- the tube in place. It is used in the gical instruments include the biopsy treatment of ureteral injuries and forceps cover, biopsy tray without bi- ureteral obstruction. opsy instruments, line clamp, nonpow- (b) Classification. Class II (perform- ered rectal probe, nonelectrical clamp, ance standards). colostomy spur-crushers, locking device for intestinal clamp, needle hold- § 876.4650 Water jet renal stone er, gastro-urology hook, gastro-urology dislodger system. probe and director, nonself-retaining (a) Identification. A water jet renal retractor, laparotomy rings, nonelec- stone dislodger system is a device used trical snare, rectal specula, bladder to dislodge stones from renal calyces neck spreader, self-retaining retractor, (recesses of the pelvis of the kidney) by and scoop. A manual surgical instru- means of a pressurized stream of water ment that is intended specifically for through a conduit. The device is used use as an aid in the insertion, place- in the surgical removal of kidney ment, fixation, or anchoring of surgical stones. mesh during urogynecologic procedures (b) Classification. Class II (special are classified under § 884.4910 of this controls). The device is exempt from chapter. the premarket notification procedures (b) Classification. Class I (general con- in subpart E of part 807 of this chapter trols). The device is exempt from the subject to § 876.9. premarket notification procedures in subpart E of part 807 of this chapter [48 FR 53023, Nov. 23, 1983, as amended at 63 subject to the limitations in § 876.9. FR 59228, Nov. 3, 1998] [48 FR 53023, Nov. 23, 1983, as amended at 54 § 876.4680 Ureteral stone dislodger. FR 25049, June 12, 1989; 66 FR 38801, July 25, (a) Identification. A ureteral stone 2001; 82 FR 12171, Mar. 1, 2017] dislodger is a device that consists of a § 876.4770 Urethrotome. bougie or a catheter with an expandable wire basket near the tip, a special (a) Identification. A urethrotome is a flexible tip, or other special construc- device that is inserted into the urethra tion. It is inserted through a cysto- and used to cut urethral strictures and scope and used to entrap and remove enlarge the urethra. It is a metal in- stones from the ureter. This generic strument equipped with a dorsal-fin type of device includes the metal bas- cutting blade which can be elevated ket and the flexible ureteral stone from its sheath. Some urethrotomes in- dislodger. corporate an optical channel for visual (b) Classification. Class II (special control. controls). The device is exempt from (b) Classification. Class II (perform- the premarket notification procedures ance standards).

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§ 876.4890 Urological table and acces- biliary stent in the bile duct. This de- sories. vice type is not intended for use in the (a) Identification. A urological table vasculature. and accessories is a device that con- (b) Classification. Class II (special sists of a table, stirrups, and belts used controls). The special controls for this to support a patient in a suitable posi- device are: tion for endoscopic procedures of the (1) Clinical performance testing must lower urinary tract. The table can be demonstrate or provide the following: adjusted into position manually or (i) The ability to safely place and electrically. subsequently remove the stent after (b) Classification. (1) Class II (special the maximum labeled indwell period. controls) for the electrically powered (ii) All adverse event data including urological table and accessories. The bile duct obstruction and trauma to device is exempt from the premarket the bile duct. notification procedures in subpart E of (iii) The stent resolves strictures dur- part 807 of this chapter subject to ing the maximum labeled indwell pe- § 876.9. riod. (2) Class I for the manually powered (iv) Stricture resolution is main- table and accessories, and for stirrups tained post-stent removal. for electrically powered table. The de- (2) Non-clinical performance testing vice subject to this paragraph (b)(2) is must demonstrate that the device per- exempt from the premarket notifica- forms as intended under anticipated tion procedures in subpart E of part 807 conditions of use. The following per- of this chapter subject to the limita- formance characteristics must be dem- tions in § 876.9. onstrated: (i) Corrosion testing to demonstrate [48 FR 53023, Nov. 23, 1983, as amended at 61 that the stent maintains its integrity FR 1122, Jan. 16, 1996; 63 FR 59228, Nov. 3, during indwell and does not release po- 1998; 66 FR 38801, July 25, 2001] tentially toxic levels of leachables. (ii) Stent dimensional testing sup- Subpart F—Therapeutic Devices ports the intended use. (iii) Compression and expansion § 876.5010 Biliary catheter and acces- forces must be characterized. sories. (iv) The delivery catheter must de- (a) Identification. A biliary catheter liver the stent to the intended location and accessories is a tubular flexible de- and the stent must not be adversely vice used for temporary or prolonged impacted by the delivery catheter dur- drainage of the biliary tract, for ing deployment and catheter with- splinting of the bile duct during heal- drawal. ing, or for preventing stricture of the (v) The delivery system must with- bile duct. This generic type of device stand clinically anticipated forces. may include a bile collecting bag that (vi) Compatibility in a magnetic res- is attached to the biliary catheter by a onance environment. connector and fastened to the patient (3) All patient contacting compo- with a strap. nents of the device must be dem- (b) Classification. Class II (perform- onstrated to be biocompatible. ance standards). (4) Performance data must demonstrate the sterility of the device § 876.5011 Metallic biliary stent system components intended to be provided for benign strictures. sterile. (a) Identification. A metallic biliary (5) Shelf life testing must dem- stent system for benign strictures is a onstrate that the device maintains its prescription device intended for the performance characteristics and that treatment of benign biliary strictures. packaging maintains sterility for the The biliary stents are intended to be duration of the labeled shelf life. left indwelling for a limited amount of (6) Labeling for the device must in- time and subsequently removed. The clude: device consists of a metallic stent and (i) A detailed summary of the clinical a delivery system intended to place the testing including device effectiveness,

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and device- and procedure-related ad- the stent will not damage the tissue verse events. surrounding the stent. (ii) Appropriate warning(s) to accu- (iv) Compression force testing must rately ensure usage of the device for be conducted. The compression force the intended patient population. must demonstrate that the stent will (iii) Shelf life. withstand the forces encountered dur- (iv) Compatibility information for ing use. use in the magnetic resonance environ- (v) Dimensional verification testing ment. must be conducted. (v) Stent foreshortening information (vi) Tensile testing of joints and ma- supported by dimensional testing. terials must be conducted. The minimum acceptance criteria must be ade- [81 FR 45231, July 13, 2016] quate for its intended use. § 876.5015 Pancreatic drainage stent (vii) Fatigue testing must be con- and delivery system. ducted. Material strength must demonstrate that the stent will withstand (a) Identification. A pancreatic drain- forces encountered during use. age stent is a prescription device that consists of a self-expanding, covered, (viii) Corrosion testing must be con- metallic stent, intended for placement ducted. Corrosion resistance must dem- to facilitate transmural endoscopic onstrate that the stent will withstand drainage of pancreatic pseudocysts. conditions encountered during use. This stent is intended to be removed (5) Non-clinical testing must evalu- upon confirmation of pseudocyst reso- ate the compatibility of the stent in a lution. This device may also include a magnetic resonance (MR) environment. delivery system. (6) Well-documented clinical experi- (b) Classification. Class II (special ence must demonstrate safe and effec- controls). The special controls for this tive use, and capture any adverse device are: events observed during clinical use. (1) The device and elements of the de- (7) Labeling must include the fol- livery device that may contact the pa- lowing: tient must be demonstrated to be bio- (i) Appropriate instructions, warn- compatible. ings, cautions, limitations, and infor- (2) Performance data must dem- mation related to the safe use of the onstrate the sterility of patient-con- device, including deployment of the de- tacting components of the device. vice, maintenance of the drainage (3) Performance data must support lumen, and removal of the device. the shelf life of the device by dem- (ii) A warning that the safety and pa- onstrating continued sterility, package tency of the stent has not been estab- integrity, and device functionality lished beyond the duration of the docu- over the requested shelf life. mented clinical experience. (4) Non-clinical testing data must (iii) Specific instructions and the demonstrate that the stent and deliv- qualifications and clinical training ery system perform as intended under needed for the safe use of the device, anticipated conditions of use. The fol- including deployment of the device, lowing performance characteristics maintenance of the drainage lumen, must be tested: and removal of the device. (i) Deployment testing of the stent (iv) Information on the patient popu- and delivery system must be conducted lation for which the device has been under simulated use conditions. demonstrated to be effective. (ii) Removal force testing must be (v) A detailed summary of the clin- conducted. The removal force testing ical experience pertinent to use of the must demonstrate that the stent can device. be safely removed, and that the stent (vi) A detailed summary of the device will remain in place when subjected to technical parameters. forces encountered during use. (vii) A detailed summary of the (iii) Expansion force testing must be device- and procedure-related com- conducted. The expansion force must plications pertinent to use of the de- demonstrate that the forces exerted by vice.

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(viii) An expiration date/shelf life. vice used as a form during surgery for continent ileostomy and it provides [79 FR 30724, May 29, 2014] drainage after surgery. Additionally, § 876.5020 External penile rigidity de- the device may be inserted periodically vices. by the patient for routine care to (a) Identification. External penile ri- empty the ileal pouch. This generic gidity devices are devices intended to type of device includes the rectal catheter for continent ileostomy. create or maintain sufficient penile ri- (b) Classification. Class I (general con- gidity for sexual intercourse. External trols). The device is exempt from the penile rigidity devices include vacuum premarket notification procedures in pumps, constriction rings, and penile subpart E of part 807 of this chapter splints which are mechanical, powered, subject to the limitations in § 876.9. or pneumatic devices. (b) Classification. Class II (special [48 FR 53023, Nov. 23, 1983, as amended at 54 controls). The devices are exempt from FR 25050, June 12, 1989; 66 FR 38801, July 25, the premarket notification procedures 2001] in subpart E of part 807 of this chapter § 876.5090 Suprapubic urological cath- subject to the limitations in § 876.9. The eter and accessories. special control for these devices is the FDA guidance document entitled (a) Identification. A suprapubic ‘‘Class II Special Controls Guidance urological catheter and accessories is a Document: External Penile Rigidity flexible tubular device that is inserted Devices.’’ See § 876.1(e) for the avail- through the abdominal wall into the ability of this guidance document. urinary bladder with the aid of a trocar and cannula. The device is used to pass [69 FR 77623, Dec. 28, 2004] fluids to and from the urinary tract. This generic type of device includes the § 876.5025 Vibrator for climax control suprapubic catheter and tube, Malecot of premature ejaculation. catheter, catheter punch instrument, (a) Identification. A vibrator for cli- suprapubic drainage tube, and the max control of premature ejaculation suprapubic cannula and trocar. is used for males who suffer from pre- (b) Classification. (1) Class II (per- mature ejaculation. It is designed to formance standards). increase the time between arousal and (2) Class I for the catheter punch in- ejaculation using the stimulating vi- strument, nondisposable cannula and bratory effects of the device on the trocar, and gastro-urological trocar. penis. The devices subject to this paragraph (b) Classification. Class II (special (b)(2) are exempt from the premarket controls). The special controls for this notification procedures in subpart E of device are: part 807 of this chapter subject to the (1) The labeling must include specific limitations in § 876.9. instructions regarding the proper placement and use of the device. [48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, (2) The portions of the device that 2001] contact the patient must be demonstrated to be biocompatible. § 876.5130 Urological catheter and ac- (3) Appropriate analysis/testing must cessories. demonstrate electromagnetic compat- (a) Identification. A urological cath- ibility safety, electrical safety, and eter and accessories is a flexible tubu- thermal safety of the device. lar device that is inserted through the (4) Mechanical safety testing must urethra and used to pass fluids to or demonstrate that the device will with- from the urinary tract. This generic stand forces encountered during use. type of device includes radiopaque [80 FR 30355, May 28, 2015] urological catheters, ureteral catheters, urethral catheters, coude´ cath- § 876.5030 Continent ileostomy catheters, balloon retention type catheters, eter. straight catheters, upper urinary tract (a) Identification. A continent ileos- catheters, double lumen female tomy catheter is a flexible tubular de- urethrographic catheters, disposable

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ureteral catheters, male tions of use. The following performance urethrographic catheters, and characteristics must be tested: urological catheter accessories includ- (i) Urine flow rate testing. ing ureteral catheter stylets, ureteral (ii) Valve integrity testing. catheter adapters, ureteral catheter (iii) Bladder neck retention force holders, ureteral catheter stylets, testing. ureteral catheterization trays, and the (iv) Pump/valve endurance testing. gastro-urological irrigation tray (for (v) Encrustation testing. urological use). (vi) Remote control reliability, me- (b) Classification. (1) Class II (per- chanical integrity, and battery life formance standards). testing. (2) Class I for the ureteral stylet (5) Clinical testing must demonstrate (guidewire), stylet for gastrourological safe and effective use, document the catheter, ureteral catheter adapter, device acceptance rate and the adverse ureteral catheter connector, and event profile associated with clinical ureteral catheter holder. The devices use, and demonstrate that the device subject to this paragraph (b)(2) are ex- performs as intended under anticipated empt from the premarket notification conditions of use. procedures in subpart E of part 807 of (6) Labeling must include: this chapter subject to the limitations (i) Specific instructions, contra- in § 876.9. indications, warnings, cautions, limitations, and the clinical training needed [48 FR 53023, Nov. 23, 1983, as amended at 61 FR 1122, Jan. 16, 1996; 66 FR 38801, July 25, for the safe use of the device. 2001] (ii) Statement of the maximum insert indwelling period. § 876.5140 Urethral insert with pump (iii) Information on the patient edu- for bladder drainage. cation and support program prior to (a) Identification. A urethral insert and during initial device use. with pump for bladder drainage is a (iv) Information on the patient popu- catheter-like device with internal lation for which the device has been pump mechanism that is placed in the demonstrated to be safe and effective. urethra. Under patient control the in- (v) Information on how the device op- ternal pump draws urine out of the erates and the recommended treatment bladder when voiding is desired, and regimen. blocks urine flow when continence is (vi) A detailed summary of the desired. The device is intended for use device- and procedure-related com- by women who cannot empty their plications or adverse events pertinent bladder due to impaired detrusor con- to use of the device. tractility. (vii) An expiration date/shelf life. (b) Classification. Class II (special (7) Patient labeling must be provided controls). The special controls for this and must include: device are: (i) Relevant contraindications, warn- (1) The elements of the device that ings, precautions, and adverse events/ may contact the urinary tract must be complications. demonstrated to be biocompatible. (ii) Information on how the device (2) Performance data must dem- operates and the recommended treat- onstrate the sterility of the device ment regimen. components that contact the urinary (iii) Information on the patient edu- tract. cation and support program prior to and during initial device use. (3) Performance data must support (iv) Information on the patient popu- shelf life by demonstrating continued lation for which there is clinical evi- sterility of the device (or the sterile dence of safety and effectiveness. components), package integrity, and device functionality over the requested (v) The potential risks and benefits shelf life. associated with the use of the device. (vi) Post-insertion care instructions. (4) Non-clinical testing data must (vii) Alternative treatments. demonstrate that the device performs as intended under anticipated condi- [80 FR 18309, Apr. 6, 2015]

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§ 876.5160 Urological clamp for males. zle to be controlled. The device may in- (a) Identification. A urological clamp clude a console-type toilet and nec- for males is a device used to close the essary fittings to allow the device to be urethra of a male to control urinary in- connected to water and sewer pipes. continence or to hold anesthetic or ra- The device may use electrical power to diography contrast media in the ure- heat the water. The device does not in- thra temporarily. It is an external clude the enema kit (§ 876.5210). clamp. (b) Classification. (1) Class II (per- (b) Classification. Class I (general conformance standards) when the device is trols). Except when intended for inter- intended for colon cleansing when nal use or use on females, the device is medically indicated, such as before ra- exempt from the premarket notifica- diological or endoscopic examinations. tion procedures in subpart E of part 807 (2) Class III (premarket approval) of this chapter subject to § 876.9. when the device is intended for other uses, including colon cleansing rou- [48 FR 53023, Nov. 23, 1963, as amended at 65 tinely for general well being. FR 2317, Jan. 14, 2000] (c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of § 876.5210 Enema kit. completion of a PDP is required to be (a) Identification. An enema kit is a filed with the Food and Drug Adminis- device intended to instill water or tration on or before December 26, 1996 other fluids into the colon through a for any colonic irrigation system de- nozzle inserted into the rectum to pro- scribed in paragraph (b)(2) of this sec- mote evacuation of the contents of the tion that was in commercial distribu- lower colon. The device consists of a tion before May 28, 1976, or that has, on container for fluid connected to the or before December 26, 1996 been found nozzle either directly or via tubing. to be substantially equivalent to a co- This device does not include the colonic irrigation system described in lonic irrigation system (§ 876.5220). paragraph (b)(2) of this section that (b) Classification. Class I (general con- was in commercial distribution before trols). The device is exempt from the May 28, 1976. Any other colonic irriga- premarket notification procedures in tion system shall have an approved subpart E of part 807 of this chapter PMA in effect before being placed in subject to § 876.9. The device is exempt commercial distribution. from the current good manufacturing practice requirements of the quality [48 FR 53023, Nov. 23, 1983, as amended at 52 system regulation in part 820 of this FR 17738, May 11, 1987; 61 FR 50707, Sept. 27, 1996] chapter, with the exception of § 820.180 of this chapter, with respect to general § 876.5250 Urine collector and acces- requirements concerning records, and sories. § 820.198 of this chapter, with respect to (a) Identification. A urine collector complaint files. and accessories is a device intended to [48 FR 53023, Nov. 23, 1963, as amended at 65 collect urine. The device and acces- FR 2317, Jan. 14, 2000] sories consist of tubing, a suitable receptacle, connectors, mechanical sup- § 876.5220 Colonic irrigation system. ports, and may include a means to pre- (a) Identification. A colonic irrigation vent the backflow of urine or ascent of system is a device intended to instill infection. The two kinds of urine col- water into the colon through a nozzle lectors are: inserted into the rectum to cleanse (1) A urine collector and accessories (evacuate) the contents of the lower intended to be connected to an indwell- colon. The system is designed to allow ing catheter, which includes the uri- evacuation of the contents of the colon nary drainage collection kit and the during the administration of the co- closed urine drainage system and lonic irrigation. The device consists of drainage bag; and a container for fluid connected to the (2) A urine collector and accessories nozzle via tubing and includes a system not intended to be connected to an in- which enables the pressure, tempera- dwelling catheter, which includes the ture, or flow of water through the noz- corrugated rubber sheath, pediatric

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urine collector, leg bag for external continence device shall have an ap- use, urosheath type incontinence de- proved PMA or a declared completed vice, and the paste-on device for incon- PDP in effect before being placed in tinence. commercial distribution. (b) Classification—(1) Class II (special [48 FR 53023, Nov. 23, 1983, as amended at 52 controls) for a urine collector and acces- FR 17738, May 11, 1987; 61 FR 50707, Sept. 27, sories intended to be connected to an in- 1996] dwelling catheter. The device is exempt from the premarket notification proce- § 876.5280 Implanted mechanical/hy- dures in subpart E of part 807 of this draulic urinary continence device. chapter subject to § 876.9. (a) Identification. An implanted me- (2) Class I (general controls). For a chanical/hydraulic urinary continence urine collector and accessories not in- device is a device used to treat urinary tended to be connected to an indwell- incontinence by the application of con- ing catheter, the device is exempt from tinuous or intermittent pressure to oc- the premarket notification procedures clude the urethra. The totally im- in subpart E of part 807 of this chapter planted device may consist of a static subject to the limitations in § 876.9. If pressure pad, or a system with a con- the device is not labeled or otherwise tainer of radiopaque fluid in the abdo- represented as sterile, it is exempt men and a manual pump and valve from the current good manufacturing under the skin surface that is con- practice requirements of the quality nected by tubing to an adjustable pres- system regulation in part 820 of this sure pad or to a cuff around the ure- chapter, with the exception of § 820.180, thra. The fluid is pumped as needed with respect to general requirements from the container to inflate the pad or concerning records, and § 820.198, with cuff to pass on the urethra. respect to complaint files. (b) Classification. Class III (premarket approval). [48 FR 53023, Nov. 23, 1983, as amended at 63 FR 59228, Nov. 3, 1998; 65 FR 2317, Jan. 14, (c) Date PMA or notice of completion of 2000; 66 FR 38802, July 25, 2001; 73 FR 34860, a PDP is required. A PMA or a notice of June 19, 2008] completion of a PDP is required to be filed with the Food and Drug Adminis- § 876.5270 Implanted electrical urinary tration on or before December 26, 2000, continence device. for any implanted mechanical/hydrau- (a) Identification. An implanted elec- lic urinary continence device that was trical urinary device is a device in- in commercial distribution before May tended for treatment of urinary incon- 28, 1976, or that has, on or before De- tinence that consists of a receiver im- cember 26, 2000, been found to be sub- planted in the abdomen with electrodes stantially equivalent to an implanted for pulsed-stimulation that are im- mechanical/hydraulic urinary con- planted either in the bladder wall or in tinence device that was in commercial the pelvic floor, and a battery-powered distribution before May 28, 1976. Any transmitter outside the body. other implanted mechanical/hydraulic (b) Classification. Class III (premarket urinary continence device shall have approval). an approved PMA or a declared com- (c) Date PMA or notice of completion of pleted PDP in effect before being a PDP is required. A PMA or a notice of placed in commercial distribution. completion of a PDP is required to be [48 FR 53023, Nov. 23, 1983, as amended at 52 filed with the Food and Drug Adminis- FR 17738, May 11, 1987; 65 FR 57731, Sept. 26, tration on or before December 26, 1996 2000] for any implanted electrical urinary continence device that was in commer- § 876.5310 Nonimplanted, peripheral cial distribution before May 28, 1976, or electrical continence device. that has, on or before December 26, 1996 (a) Identification. A nonimplanted, pe- been found to be substantially equiva- ripheral electrical continence device is lent to an implanted electrical urinary a device that consists of an electrode continence device that was in commer- that is connected by an electrical cable cial distribution before May 28, 1976. to a battery-powered pulse source. The Any other implanted electrical urinary electrode is placed onto or inserted

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into the body at a peripheral location § 876.5450 Rectal dilator. and used to stimulate the nerves asso- (a) Identification. A rectal dilator is a ciated with pelvic floor function to device designed to dilate the anal maintain urinary continence. When sphincter and canal when the size of necessary, the electrode may be re- the anal opening may interfere with its moved by the user. function or the passage of an exam- (b) Class II, subject to Classification. ining instrument. the following special controls: (b) Classification. Class I (general con- (1) That sale, distribution, and use of trols). The device is exempt from the this device are restricted to prescrip- premarket notification procedures in tion use in accordance with § 801.109 of subpart E of part 807 of this chapter this chapter. subject to the limitations in § 876.9. (2) That the labeling must bear all information required for the safe and ef- [48 FR 53023, Nov. 23, 1983, as amended at 61 fective use of the device as outlined in FR 1122, Jan. 16, 1996; 66 FR 38802, July 25, § 801.109(c) of this chapter, including a 2001] detailed summary of the clinical infor- § 876.5470 Ureteral dilator. mation upon which the instructions are based. (a) Identification. A ureteral dilator is a device that consists of a specially [65 FR 18237, Apr. 7, 2000] shaped catheter or bougie and is used to dilate the ureter at the place where § 876.5320 Nonimplanted electrical continence device. a stone has become lodged or to dilate a ureteral stricture. (a) Identification. A nonimplanted (b) Classification. Class II (perform- electrical continence device is a device ance standards). that consists of a pair of electrodes on a plug or a pessary that are connected § 876.5520 Urethral dilator. by an electrical cable to a battery-pow- (a) A urethral dilator is ered pulse source. The plug or pessary Identification. is inserted into the rectum or into the a device that consists of a slender hol- vagina and used to stimulate the mus- low or solid instrument made of metal, cles of the pelvic floor to maintain uri- plastic, or other suitable material in a nary or fecal continence. When nec- cylindrical form and in a range of sizes essary, the plug or pessary may be re- and flexibilities. The device may in- moved by the user. This device exclude a mechanism to expand the por- cludes an AC-powered nonimplanted tion of the device in the urethra and electrical continence device and the indicate the degree of expansion on a powered vaginal muscle stimulator for dial. It is used to dilate the urethra. therapeutic use (§ 884.5940). This generic type of device includes the (b) Classification. Class II (perform- mechanical urethral dilator, urological ance standards). bougies, metal or plastic urethral sound, urethrometer, filiform, and fili- § 876.5365 Esophageal dilator. form follower. (b) Classification. (1) Class II (per- (a) Identification. An esophageal dila- formance standards). tor is a device that consists of a cylindrical instrument that may be hollow (2) Class I for the urethrometer, and weighted with mercury or a metal urological bougie, filiform and filiform olive-shaped weight that slides on a follower, and metal or plastic urethral guide, such as a string or wire and is sound. The devices subject to this para- used to dilate a stricture of the esoph- graph (b)(2) are exempt from the pre- agus. This generic type of device in- market notification procedures in sub- cludes esophageal or gastrointestinal part E of part 807 of this chapter sub- bougies and the esophageal dilator ject to the limitations in § 876.9. (metal olive). [48 FR 53023, Nov. 23, 1983, as amended at 61 (b) Classification. Class II (perform- FR 1122, Jan. 16, 1996; 66 FR 38802, July 25, ance standards). 2001]

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§ 876.5530 Implantable transprostatic (ii) Implant migration must be con- tissue retractor system. ducted. (a) Identification. An implantable (7) Labeling must bear all informa- transprostatic tissue retractor system tion required for safe and effective use of the device, and must include: is a prescription use device that con- (i) Specific instructions, warnings, sists of a delivery device and implant. cautions, limitations, and the clinical The delivery device is inserted training needed for the safe use of the transurethrally and deploys the im- device. plant through the prostate. It is de- (ii) Information on the patient popu- signed to increase prostatic urethral lation for which the device has been patency by providing prostate lobe tis- demonstrated to be effective. sue retraction while preserving the po- (iii) A detailed summary of the de- tential for future prostate procedures vice technical parameters. and is intended for the treatment of (iv) Information on how the device symptoms due to urinary outflow ob- operates and the typical course of struction secondary to benign prostatic treatment. hyperplasia in men. (v) An expiration date/shelf life. (b) Classification. Class II (special (vi) A detailed summary of the controls). The special controls for this device- and procedure-related com- device are: plications or adverse events pertinent (1) The elements of the device that to use of the device. may contact the patient must be demonstrated to be biocompatible. [79 FR 43249, July 25, 2014] (2) Performance data must dem- § 876.5540 Blood access device and ac- onstrate the sterility of the patient- cessories. contacting components of the device. (a) Identification. A blood access de- (3) Performance data must support vice and accessories is a device in- shelf life by demonstrating continued tended to provide access to a patient’s sterility of the device (of the patient- blood for hemodialysis or other chronic contacting components), package in- uses. When used in hemodialysis, it is tegrity, and device functionality over part of an artificial kidney system for the requested shelf life. the treatment of patients with renal (4) Non-clinical testing data must failure or toxemic conditions and pro- demonstrate that the device performs vides access to a patient’s blood for as intended under anticipated condi- hemodialysis. The device includes im- tions of use. The following performance planted blood access devices, non- characteristics must be tested: implanted blood access devices, and ac- (i) Deployment testing must be con- cessories for both the implanted and ducted. nonimplanted blood access devices. (ii) Mechanical strength must be con- (1) The implanted blood access device ducted. is a prescription device and consists of (iii) Resistance-to-degradation test- various flexible or rigid tubes, such as ing must be conducted. catheters, or cannulae, which are sur- (5) Non-clinical testing must evalu- gically implanted in appropriate blood ate the compatibility of the device in a vessels, may come through the skin, magnetic resonance environment. and are intended to remain in the body (6) In vivo testing must demonstrate for 30 days or more. This generic type safe and effective use, assess the im- of device includes various catheters, pact of the implants on the ability to shunts, and connectors specifically de- perform subsequent treatments, docu- signed to provide access to blood. Ex- ment the adverse event profile associ- amples include single and double ated with clinical use, and demonstrate lumen catheters with cuff(s), fully sub- that the device performs as intended cutaneous port-catheter systems, and under anticipated conditions of use. A–V shunt cannulae (with vessel tips). The following performance characteris- The implanted blood access device may tics must be tested: also contain coatings or additives (i) Deployment testing must be con- which may provide additional ducted. functionality to the device.

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(2) The nonimplanted blood access vice must be conducted, and retested device consists of various flexible or for leakage. rigid tubes, such as catheters, cannulae (G) Mechanical hemolysis testing or hollow needles, which are inserted must be conducted for new or altered into appropriate blood vessels or a vas- device designs that affect the blood cular graft prosthesis (§§ 870.3450 and flow pattern. 870.3460), and are intended to remain in (H) Chemical tolerance of the device the body for less than 30 days. This ge- to repeated exposure to commonly used neric type of device includes fistula disinfection agents must be estab- needles, the single needle dialysis set lished. (coaxial flow needle), and the single (iii) Performance data must dem- needle dialysis set (alternating flow onstrate the sterility of the device. needle). (iv) Performance data must support (3) Accessories common to either the shelf life of the device for contin- type include the shunt adaptor, ued sterility, package integrity, and cannula clamp, shunt connector, shunt functionality over the requested shelf stabilizer, vessel dilator, disconnect life that must include tensile, repeated forceps, shunt guard, crimp plier, tube clamping, and leakage testing. plier, crimp ring, joint ring, fistula (v) Labeling of implanted blood ac- adaptor, and declotting tray (including cess devices for hemodialysis must in- contents). clude the following: (b) Classification. (1) Class II (special (A) Labeling must provide arterial controls) for the implanted blood ac- and venous pressure versus flow rates, cess device. The special controls for either in tabular or graphical format. this device are: The fluid and its viscosity used during (i) Components of the device that testing must be stated. come into human contact must be dem- (B) Labeling must specify the for- onstrated to be biocompatible. Mate- ward and reverse recirculation rates. rial names and specific designation (C) Labeling must provide the arte- numbers must be provided. rial and venous priming volumes. (ii) Performance data must dem- (D) Labeling must specify an expira- onstrate that the device performs as tion date. intended under anticipated conditions (E) Labeling must identify any dis- of use. The following performance infecting agents that cannot be used to characteristics must be tested: clean any components of the device. (A) Pressure versus flow rates for (F) Any contraindicated disinfecting both arterial and venous lumens, from agents due to material incompatibility the minimum flow rate to the max- must be identified by printing a warn- imum flow rate in 100 milliliter per ing on the catheter. Alternatively, con- minute increments, must be estab- traindicated disinfecting agents must lished. The fluid and its viscosity used be identified by a label affixed to the during testing must be stated. patient’s medical record and with writ- (B) Recirculation rates for both for- ten instructions provided directly to ward and reverse flow configurations the patient. must be established, along with the (G) Labeling must include a patient protocol used to perform the assay, implant card. which must be provided. (H) The labeling must contain com- (C) Priming volumes must be estab- prehensive instructions for the fol- lished. lowing: (D) Tensile testing of joints and ma- (1) Preparation and insertion of the terials must be conducted. The min- device, including recommended site of imum acceptance criteria must be ade- insertion, method of insertion, and a quate for its intended use. reference on the proper location for tip (E) Air leakage testing and liquid placement; leakage testing must be conducted. (2) Proper care and maintenance of (F) Testing of the repeated clamping the device and device exit site; of the extensions of the catheter that (3) Removal of the device; simulates use over the life of the de- (4) Anticoagulation;

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(5) Management of obstruction and (B) Labeling must include Warning thrombus formation; and Statements to address the potential for (6) Qualifications for clinical pro- vascular access steal syndrome, arte- viders performing the insertion, main- rial stenosis, arterial thrombosis, and tenance, and removal of the devices. hemorrhage including exsanguination (vi) In addition to Special Controls in given that the device accesses the arte- paragraphs (b)(1)(i) through (v) of this rial circulation. section, implanted blood access devices (C) Clinical performance testing that include subcutaneous ports must must demonstrate safe and effective include the following: use and capture any adverse events ob- (A) Labeling must include the rec- served during clinical use. ommended type of needle for access as (2) Class II (performance standards) well as detailed instructions for care for the nonimplanted blood access de- and maintenance of the port, subcuta- vice. neous pocket, and skin overlying the (3) Class II (performance standards) port. for accessories for both the implanted (B) Performance testing must include and the nonimplanted blood access de- results on repeated use of the ports vices not listed in paragraph (b)(4) of that simulates use over the intended this section. life of the device. (4) Class I for the cannula clamp, dis- (C) Clinical performance testing connect forceps, crimp plier, tube plier, must demonstrate safe and effective crimp ring, and joint ring, accessories use and capture any adverse events ob- for both the implanted and non- served during clinical use. implanted blood access device. The de- (vii) In addition to Special Controls vices subject to this paragraph (b)(4) in paragraphs (b)(1)(i) through (v) of are exempt from the premarket notifi- this section, implanted blood access de- cation procedures in subpart E of part vices with coatings or additives must 807 of this chapter subject to the limi- include the following: tations in § 876.9. (A) A description and material characterization of the coating or additive [48 FR 53023, Nov. 23, 1983, as amended at 52 FR 17738, May 11, 1987; 61 FR 1122, Jan. 16, material, the purpose of the coating or 1996; 66 FR 38802, July 25, 2001; 79 FR 43245, additive, duration of effectiveness, and July 25, 2014] how and where the coating is applied. (B) An identification in the labeling § 876.5600 Sorbent regenerated of any coatings or additives and a sum- dialysate delivery system for hemo- mary of the results of performance dialysis. testing for any coating or material (a) Identification. A sorbent regen- with special characteristics, such as erated dialysate delivery system for decreased thrombus formation or anti- hemodialysis is a device that is part of microbial properties. an artificial kidney system for the (C) A Warning Statement in the la- treatment of patients with renal fail- beling for potential allergic reactions ure or toxemic conditions, and that including anaphylaxis if the coating or consists of a sorbent cartridge and the additive contains known allergens. means to circulate dialysate through (D) Performance data must dem- this cartridge and the dialysate com- onstrate efficacy of the coating or ad- partment of the dialyzer. The device is ditive and the duration of effective- used with the extracorporeal blood sys- ness. tem and the dialyzer of the hemo- (viii) The following must be included dialysis system and accessories for A–V shunt cannulae (with vessel (§ 876.5820). The device includes the tips): means to maintain the temperature, (A) The device must comply with conductivity, electrolyte balance, flow Special Controls in paragraphs (b)(1)(i) rate and pressure of the dialysate, and through (v) of this section with the ex- alarms to indicate abnormal dialysate ception of paragraphs (b)(1)(ii)(B), conditions. The sorbent cartridge may (b)(1)(ii)(C), (b)(1)(v)(B), and (b)(1)(v)(C), include absorbent, ion exchange and which do not apply. catalytic materials.

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(b) Classification. Class II (perform- centrate and sterile purified water (for ance standards). automatic peritoneal dialysate delivery systems or ‘‘reverse osmosis’’ sys- § 876.5630 Peritoneal dialysis system tems). Prepackaged dialysate intended and accessories. for use with either of the peritoneal (a) Identification. (1) A peritoneal di- dialysate delivery systems is regulated alysis system and accessories is a de- by FDA as a drug. vice that is used as an artificial kidney (b) Classification. Class II (perform- system for the treatment of patients ance standards). with renal failure or toxemic conditions, and that consists of a peritoneal § 876.5665 Water purification system access device, an administration set for for hemodialysis. peritoneal dialysis, a source of (a) Identification. A water purification dialysate, and, in some cases, a water purification mechanism. After the system for hemodialysis is a device dialysate is instilled into the patient’s that is intended for use with a hemo- peritoneal cavity, it is allowed to dwell dialysis system and that is intended to there so that undesirable substances remove organic and inorganic sub- from the patient’s blood pass through stances and microbial contaminants the lining membrane of the peritoneal from water used to dilute dialysate cavity into this dialysate. These sub- concentrate to form dialysate. This ge- stances are then removed when the neric type of device may include a dialysate is drained from the patient. water softener, sediment filter, carbon The peritoneal dialysis system may filter, and water distillation system. regulate and monitor the dialysate (b) Classification. Class II (perform- temperature, volume, and delivery rate ance standards). together with the time course of each cycle of filling, dwell time, and drain- § 876.5820 Hemodialysis system and ac- ing of the peritoneal cavity or manual cessories. controls may be used. This generic de- (a) Identification. A hemodialysis sys- vice includes the semiautomatic and tem and accessories is a device that is the automatic peritoneal delivery sys- used as an artificial kidney system for tem. the treatment of patients with renal (2) The peritoneal access device is a failure or toxemic conditions and that flexible tube that is implanted through consists of an extracorporeal blood sys- the abdominal wall into the peritoneal tem, a conventional dialyzer, a cavity and that may have attached dialysate delivery system, and acces- cuffs to provide anchoring and a skin sories. Blood from a patient flows seal. The device is either a single use through the tubing of the peritioneal catheter, intended to re- extracorporeal blood system and acces- main in the peritoneal cavity for less than 30 days, or a long term peritoneal sories to the blood compartment of the catheter. Accessories include stylets dialyzer, then returns through further and trocars to aid in the insertion of tubing of the extracorporeal blood sys- the catheter and an obturator to main- tem to the patient. The dialyzer has tain the patency of the surgical fistula two compartments that are separated in the abdominal wall between treat- by a semipermeable membrane. While ments. the blood is in the blood compartment, (3) The disposable administration set undesirable substances in the blood for peritoneal dialysis consists of tub- pass through the semipermeable mem- ing, an optional reservoir bag, and ap- brane into the dialysate in the propriate connectors. It may include a dialysate compartment. The dialysate peritoneal dialysate filter to trap and delivery system controls and monitors remove contaminating particles. the dialysate circulating through the (4) The source of dialysate may be dialysate compartment of the dialyzer. sterile prepackaged dialysate (for semi- (1) The extracorporeal blood system automatic peritoneal dialysate deliv- and accessories consists of tubing, ery systems or ‘‘cycler systems’’) or pumps, pressure monitors, air foam or dialysate prepared from dialysate con- bubble detectors, and alarms to keep

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blood moving safely from the blood ac- empt from the premarket notification cess device and accessories for hemo- procedures in subpart E of part 807 of dialysis (§ 876.5540) to the blood com- this chapter subject to the limitations partment of the dialyzer and back to in § 876.9. the patient. [48 FR 53023, Nov. 23, 1983, as amended at 54 (2) The conventional dialyzer allows FR 25050, June 12, 1989; 66 FR 38802, July 25, a transfer of water and solutes between 2001] the blood and the dialysate through the semipermeable membrane. The § 876.5830 Hemodialyzer with dispos- semipermeable membrane of the con- able insert (Kiil type). ventional dialyzer has a sufficiently (a) Identification. A hemodialyzer low permeability to water that an with disposable inserts (Kiil type) is a ultrafiltration controller is not re- device that is used as a part of an arti- quired to prevent excessive loss of ficial kidney system for the treatment water from the patient’s blood. This of patients with renal failure or tox- conventional dialyzer does not include emic conditions and that includes dis- hemodialyzers with the disposable in- posable inserts consisting of layers of serts (Kiil type) (§ 876.5830) or dialyzers semipermeable membranes which are of high permeability (§ 876.5860). sandwiched between support plates. (3) The dialysate delivery system The device is used with the consists of mechanisms that monitor extracorporeal blood system and the and control the temperature, conduc- dialysate delivery system of the hemo- tivity, flow rate, and pressure of the dialysis system and accessories dialysate and circulates dialysate (§ 876.5820). through the dialysate compartment of (b) Classification. Class II (perform- the dialyzer. The dialysate delivery ance standards). system includes the dialysate concentrate for hemodialysis (liquid or [48 FR 53023, Nov. 23, 1983, as amended at 53 powder) and alarms to indicate abnor- FR 11253, Apr. 6, 1988] mal dialysate conditions. This dialysate delivery system does not in- § 876.5860 High permeability hemo- clude the sorbent regenerated dialysate dialysis system. delivery system for hemodialysis (a) Identification. A high permeability (§ 876.5600), the dialysate delivery sys- hemodialysis system is a device in- tem of the peritoneal dialysis system tended for use as an artificial kidney and accessories (§ 876.5630), or the con- system for the treatment of patients trolled dialysate delivery system of the with renal failure, fluid overload, or high permeability hemodialysis system toxemic conditions by performing such § 876.5860). therapies as hemodialysis, (4) Remote accessories to the hemo- hemofiltration, hemoconcentration, dialysis system include the unpowered and hemodiafiltration. Using a dialysis chair without a scale, the pow- hemodialyzer with a semipermeable ered dialysis chair without a scale, the membrane that is more permeable to dialyzer holder set, dialysis tie gun and water than the semipermeable mem- ties, and hemodialysis start/stop tray. brane of the conventional hemodialysis (b) Classification. (1) Class II (per- system (§ 876.5820), the high perme- formance standards) for hemodialysis ability hemodialysis system removes systems and all accessories directly as- toxins or excess fluid from the pa- sociated with the extracorporeal blood tient’s blood using the principles of system and the dialysate delivery sys- convection (via a high ultrafiltration tem. rate) and/or diffusion (via a concentra- (2) Class I for other accessories of the tion gradient in dialysate). During hemodialysis system remote from the treatment, blood is circulated from the extracorporeal blood system and the patient through the hemodialyzer’s dialysate delivery system, such as the blood compartment, while the unpowered dialysis chair, hemodialysis dialysate solution flows countercurrent start/stop tray, dialyzer holder set, and through the dialysate compartment. In dialysis tie gun and ties. The devices this process, toxins and/or fluid are subject to this paragraph (b)(2) are ex- transferred across the membrane from

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the blood to the dialysate compart- § 876.5870 Sorbent hemoperfusion sys- ment. The hemodialysis delivery ma- tem. chine controls and monitors the pa- (a) Identification. A sorbent rameters related to this processing, in- hemoperfusion system is a prescription cluding the rate at which blood and device that consists of an dialysate are pumped through the sys- extracorporeal blood system similar to tem, and the rate at which fluid is re- that identified in the hemodialysis sys- moved from the patient. The high per- tem and accessories (§ 876.5820) and a meability hemodialysis system con- container filled with adsorbent mate- sists of the following devices: rial that removes a wide range of sub- (1) The hemodialyzer consists of a stances, both toxic and normal, from semipermeable membrane with an in blood flowing through it. The adsorb- vitro ultrafiltration coefficient (Kuf) ent materials are usually activated- greater than 8 milliliters per hour per carbon or resins which may be coated conventional millimeter of mercury, as or immobilized to prevent fine par- measured with bovine or expired ticles entering the patient’s blood. The human blood, and is used with either generic type of device may include an automated ultrafiltration controller lines and filters specifically designed or anther method of ultrafiltration to connect the device to the control to prevent fluid imbalance. extracorporeal blood system. The de- (2) The hemodialysis delivery ma- vice is used in the treatment of poi- chine is similar to the extracorporeal soning, drug overdose, hepatic coma, or blood system and dialysate delivery metabolic disturbances. system of the hemodialysis system and (b) Classification. (1) Class II (special accessories (§ 876.5820), with the addi- controls) when the device is intended tion of an ultrafiltration controller and for the treatment of poisoning and mechanisms that monitor and/or con- drug overdose. The special controls for trol such parameters as fluid balance, this device are: dialysate composition, and patient (i) The device must be demonstrated treatment parameters (e.g., blood pres- to be biocompatible; sure, hematocrit, urea, etc.). (ii) Performance data must dem- (3) The high permeability hemo- onstrate the mechanical integrity of dialysis system accessories include, the device (e.g., tensile, flexural, and but are not limited to, tubing lines and structural strength), including testing various treatment related monitors for the possibility of leaks, ruptures, (e.g., dialysate pH, blood pressure, release of particles, and/or disconnec- hematocrit, and blood recirculation tions under anticipated conditions of monitors). use; (b) Classification. Class II. The special (iii) Performance data must dem- controls for this device are FDA’s: onstrate device sterility and shelf life; (1) ‘‘Use of International Standard (iv) Bench performance testing must ISO 10993 ‘Biological Evaluation of demonstrate device functionality in Medical Device—Part I: Evaluation and terms of substances, toxins, and drugs Testing,’ ’’ removed by the device, and the extent (2) ‘‘Guidance for the Content of that these are removed when the device 510(k)s for Conventional and High Per- is used according to its labeling, and to meability Hemodialyzers,’’ validate the device’s safeguards; (3) ‘‘Guidance for Industry and CDRH (v) A summary of clinical experience Reviewers on the Content of Pre- with the device that discusses and ana- market Notifications for Hemodialysis lyzes device safety and performance, Delivery Systems,’’ including a list of adverse events ob- (4) ‘‘Guidance for the Content of Pre- served during the testing, must be pro- market Notifications for Water Purifi- vided; cation Components and Systems for (vi) Labeling must include the fol- Hemodialysis,’’ and lowing: (A) A detailed summary of the de- (5) ‘‘Guidance for Hemodialyzer vice-related and procedure-related Reuse Labeling.’’ complications pertinent to the use of [65 FR 17145, Mar. 31, 2000] the device;

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(B) A summary of the performance (b) Classification. Class II (perform- data provided for the device, including ance standards). a list of the drugs and/or poisons the device has been demonstrated to re- § 876.5885 Tissue culture media for move, and the extent for removal/de- human ex vivo tissue and cell cul- pletion; and ture processing applications. (vii) For those devices that incor- (a) Identification. Tissue culture porate electrical components, appro- media for human ex vivo tissue and cell priate analysis and testing must be culture processing applications consist conducted to verify electrical safety of cell and tissue culture media and and electromagnetic compatibility of components that are composed of the device. chemically defined components (e.g., (2) Class III (premarket approval) amino acids, vitamins, inorganic salts) when the device is intended for the that are essential for the ex vivo devel- treatment of hepatic coma and meta- opment, survival, and maintenance of bolic disturbances. tissues and cells of human origin. The (c) Date premarket approval application solutions are indicated for use in (PMA) or notice of completion of product human ex vivo tissue and cell culture development protocol (PDP) is required. A processing applications. PMA or notice of completion of a PDP (b) Classification. Class II (special is required to be filed with FDA by controls): FDA guidance document, April 17, 2014, for any sorbent ‘‘Class II Special Controls Guidance hemoperfusion system indicated for Document: Tissue Culture Media for treatment of hepatic coma or meta- Human Ex Vivo Processing Applica- bolic disturbances that was in commer- tions; Final Guidance for Industry and cial distribution before May 28, 1976, or FDA Reviewers.’’ that has, by April 17, 2014, been found [66 FR 27025, May 16, 2001] to be substantially equivalent to any sorbent hemoperfusion device indicated § 876.5895 Ostomy irrigator. for treatment of hepatic coma or meta- (a) Identification. An ostomy irrigator bolic disturbances that was in commer- is a device that consists of a container cial distribution before May 28, 1976. for fluid, tubing with a cone-shaped tip Any other sorbent hemoperfusion sys- or a soft and flexible catheter with a tem device indicated for treatment of retention shield and that is used to hepatic coma or metabolic disturb- wash out the colon through a colos- ances shall have an approved PMA or tomy, a surgically created opening of declared completed PDP in effect be- the colon on the surface of the body. fore being placed in commercial dis- (b) Classification. Class II (perform- tribution. ance standards). [79 FR 3094, Jan. 17, 2014] § 876.5900 Ostomy pouch and acces- § 876.5880 Isolated kidney perfusion sories. and transport system and acces- (a) Identification. An ostomy pouch sories. and accessories is a device that con- (a) Identification. An isolated kidney sists of a bag that is attached to the perfusion and transport system and ac- patient’s skin by an adhesive material cessories is a device that is used to sup- and that is intended for use as a recep- port a donated or a cadaver kidney and tacle for collection of fecal material or to maintain the organ in a near-normal urine following an ileostomy, colos- physiologic state until it is trans- tomy, or ureterostomy (a surgically planted into a recipient patient. This created opening of the small intestine, generic type of device may include tub- large intestine, or the ureter on the ing, catheters, connectors, an ice stor- surface of the body). This generic type age or freezing container with or with- of device and its accessories includes out bag or preservatives, pulsatile or the ostomy pouch, ostomy adhesive, nonpulsatile hypothermic isolated the disposable colostomy appliance, organ perfusion apparatus with or ostomy collector, colostomy pouch, without oxygenator, and disposable urinary ileostomy bag, urine collecting perfusion set. ureterostomy bag, ostomy drainage

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bag with adhesive, stomal bag, ostomy device performs as intended under an- protector, and the ostomy size selector, ticipated conditions of use. but excludes ostomy pouches which in- (2) The elements of the device that corporate arsenic-containing com- contact vaginal tissue must be dem- pounds. onstrated to be biocompatible. (b) Classification. Class I (general con- (3) The cleaning and disinfection in- trols). The device is exempt from the structions for the device must be vali- premarket notification procedures in dated. subpart E of part 807 of this chapter (4) Non-clinical (bench) testing must subject to the limitations in § 876.9. demonstrate that the device performs as intended under anticipated condi- [48 FR 53023, Nov. 23, 1983, as amended at 54 FR 25050, June 12, 1989; 66 FR 38802, July 25, tions of use. 2001] (5) Non-clinical (bench) testing must demonstrate that the device does not: § 876.5920 Protective garment for in- (i) Enhance the growth of Staphy- continence. lococcus aureus. (a) Identification. A protective gar- (ii) Increase production of Toxic ment for incontinence is a device that Shock Syndrome Toxin-1 by S. aureus. consists of absorbent padding and a (iii) Alter the growth of normal vag- fluid barrier and that is intended to inal flora. protect an incontinent patient’s gar- (6) Labeling must include: ment from the patient’s excreta. This (i) Specific instructions, contra- generic type of device does not include indications, warnings, cautions, limita- diapers for infants. tions, and the clinical training needed (b) Classification. Class I (general con- for the safe use of the device. trols). The device is exempt from the (ii) The intended patient population premarket notification procedures in and the intended use environment. subpart E of part 807 of this chapter (iii) Information on how the device is subject to the limitations in § 876.9. The to be fitted, how the device operates, device is also exempt from the current and recommendations on device main- good manufacturing practice require- tenance. ments of the quality system regulation (iv) A detailed summary of the clin- in part 820 of this chapter, with the ex- ical testing pertinent to the use of the ception of § 820.180, regarding general device, including a summary of the requirements concerning records, and device- and procedure-related com- § 820.198, regarding complaint files. plications or adverse events related to use of the device, as well as relevant [48 FR 53023, Nov. 23, 1983, as amended at 54 safety and performance information. FR 25050, June 12, 1989; 66 FR 38802, July 25, 2001] (7) Patient labeling must be provided and must include: § 876.5930 Rectal control system. (i) Relevant contraindications, warnings, precautions, and adverse events/ (a) Identification. A rectal control complications. system is a prescription device in- (ii) Information on how the device tended to treat fecal incontinence by operates and the recommended device controlling the size of the rectal maintenance (i.e., care instructions), lumen. The device is inserted in the va- including cleaning and disinfection. gina and includes a portion that ex- (iii) Information on the patient popu- pands to reduce the rectal lumen to lation for which there was a favorable prevent stool leakage and retracts to benefit/risk assessment. allow normal passage of stool. The de- (iv) The potential risks and benefits vice includes an external regulator to associated with the use of the device. control the state of expansion. (b) Classification. Class II (special [80 FR 30933, June 1, 2015] controls). The special controls for this device are: § 876.5955 Peritoneo-venous shunt. (1) Clinical testing must document (a) Identification. A peritoneo-venous the device acceptance data and the ad- shunt is an implanted device that con- verse event profile associated with sists of a catheter and a pressure acti- clinical use, and demonstrate that the vated one-way valve. The catheter is

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implanted with one end in the peri- tric, colonic, etc.), rectal catheter, toneal cavity and the other in a large sterile infant gavage set, gastro- vein. This device enables ascitic fluid intestinal string and tubes to locate in- in the peritoneal cavity to flow into ternal bleeding, double lumen tube for the venous system for the treatment of intestinal decompression or intubation, intractable ascites. feeding tube, gastroenterostomy tube, (b) Classification. Class II. The special Levine tube, nasogastric tube, single controls for this device are FDA’s: lumen tube with mercury weight bal- (1) ‘‘Use of International Standard loon for intestinal intubation or de- ISO 10993 ‘Biological Evaluation of compression, and gastro-urological ir- Medical Devices—Part I: Evaluation rigation tray (for gastrological use). and Testing,’ ’’ (b) Classification. (1) Class II (special (2) ‘‘510(k) Sterility Review Guidance controls). The barium enema retention of 2/12/90 (K90–1),’’ and catheter and tip with or without a bag (3) Backflow specification and testing that is a gastrointestinal tube and ac- to prevent reflux of blood into the cessory is exempt from the premarket shunt. notification procedures in subpart E of [48 FR 53023, Nov. 23, 1983, as amended at 52 this part subject to the limitations in FR 17738, May 11, 1987; 65 FR 17145, Mar. 31, § 876.9. 2000] (2) Class I (general controls) for the § 876.5970 Hernia support. dissolvable nasogastric feed tube guide for the nasogastric tube. The class I de- (a) Identification. A hernia support is vice is exempt from the premarket no- a device, usually made of elastic, can- tification procedures in subpart E of vas, leather, or metal, that is intended part 807 of this chapter subject to to be placed over a hernial opening (a § 876.9. weakness in the abdominal wall) to prevent protrusion of the abdominal [49 FR 573, Jan. 5, 1984, as amended at 65 FR contents. This generic type of device 2317, Jan. 14, 2000; 65 FR 76932, Dec. 8, 2000] includes the umbilical truss. (b) Classification. Class I (general con- § 876.5990 Extracorporeal shock wave trols). The device is exempt from the lithotripter. premarket notification procedures in (a) Identification. An extracorporeal subpart E of part 807 of this chapter shock wave lithotripter is a device that subject to the limitations in § 876.9. The focuses ultrasonic shock waves into the device is also exempt from the current body to noninvasively fragment uri- good manufacturing practice require- nary calculi within the kidney or urements of the quality system regulation ter. The primary components of the de- in part 820 of this chapter, with the ex- vice are a shock wave generator, high ception of § 820.180, regarding general voltage generator, control console, im- requirements concerning records, and aging/localization system, and patient § 820.198, regarding complaint files. table. Prior to treatment, the urinary [48 FR 53023, Nov. 23, 1983, as amended at 59 stone is targeted using either an inte- FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, gral or stand-alone localization/imag- 2001] ing system. Shock waves are typically generated using electrostatic spark dis- § 876.5980 Gastrointestinal tube and charge (spark gap), electromagneti- accessories. cally repelled membranes, or piezo- (a) Identification. A gastrointestinal electric crystal arrays, and focused tube and accessories is a device that onto the stone with either a specially consists of flexible or semi-rigid tubing designed reflector, dish, or acoustic used for instilling fluids into, with- lens. The shock waves are created drawing fluids from, splinting, or sup- under water within the shock wave pressing bleeding of the alimentary generator, and are transferred to the tract. This device may incorporate an patient’s body using an appropriate integral inflatable balloon for reten- acoustic interface. After the stone has tion or hemostasis. This generic type been fragmented by the focused shock of device includes the hemostatic bag, waves, the fragments pass out of the irrigation and aspiration catheter (gas- body with the patient’s urine.

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(b) Classification. Class II (special 878.4022 Hydrogel wound dressing and burn controls) (FDA guidance document: dressing. ‘‘Guidance for the Content of Pre- 878.4025 Silicone sheeting. 878.4040 Surgical apparel. market Notifications (510(k)’s) for 878.4100 Organ bag. Extracorporeal Shock Wave 878.4160 Surgical camera and accessories. Lithotripters Indicated for the Frag- 878.4200 Introduction/drainage catheter and mentation of Kidney and Ureteral accessories. Calculi.’’) 878.4300 Implantable clip. 878.4320 Removable skin clip. [65 FR 48612, Aug. 9, 2000] 878.4340 Contact cooling system for aesthetic use. PART 878—GENERAL AND PLASTIC 878.4350 Cryosurgical unit and accessories. 878.4360 Scalp cooling system to reduce the SURGERY DEVICES likelihood of chemotherapy-induced alopecia. Subpart A—General Provisions 878.4370 Surgical drape and drape accessories. Sec. 878.4380 Drape adhesive. 878.1 Scope. 878.4400 Electrosurgical cutting and coagu- 878.3 Effective dates of requirement for pre- lation device and accessories. market approval. 878.4410 Low energy ultrasound wound 878.9 Limitations of exemptions from sec- cleaner. tion 510(k) of the Federal Food, Drug, 878.4420 Electrosurgical device for over-the- and Cosmetic Act (the act). counter aesthetic use. 878.4440 Eye pad. Subpart B—Diagnostic Devices 878.4450 Nonabsorbable gauze for internal use. 878.1800 Speculum and accessories. 878.4452 Nonabsorbable expandable hemostatic sponge for temporary internal use. Subpart C [Reserved] 878.4460 Non-powdered surgeon’s glove. 878.4470 Surgeon’s gloving cream. Subpart D—Prosthetic Devices 878.4490 Absorbable hemostatic agent and dressing. 878.3250 External facial fracture fixation ap- 878.4493 Absorbable poly(glycolide/l-lactide) pliance. surgical suture. 878.3300 Surgical mesh. 878.4494 Absorbable poly(hydroxybutyrate) 878.3500 Polytetrafluoroethylene with car- surgical suture produced by recombinant bon fibers composite implant material. DNA technology. 878.3530 Silicone inflatable breast pros- 878.4495 Stainless steel suture. thesis. 878.4520 Polytetrafluoroethylene injectable. 878.3540 Silicone gel-filled breast prosthesis. 878.4580 Surgical lamp. 878.3550 Chin prosthesis. 878.4590 Focused ultrasound stimulator sys- 878.3590 Ear prosthesis. tem for aesthetic use. 878.3610 Esophageal prosthesis. 878.4630 Ultraviolet lamp for dermatologic 878.3680 Nose prosthesis. disorders. 878.3720 Tracheal prosthesls. 878.4635 Sunlamp products and ultraviolet 878.3750 External prosthesis adhesive. lamps intended for use in sunlamp prod- 878.3800 External aesthetic restoration pros- ucts. thesis. 878.4660 Skin marker. 878.3900 Inflatable extremity splint. 878.4670 Internal tissue marker. 878.3910 Noninflatable extremity splint. 878.4680 Nonpowered, single patient, port- 878.3925 Plastic surgery kit and accessories. able suction apparatus. 878.4683 Non-Powered suction apparatus de- Subpart E—Surgical Devices vice intended for negative pressure wound therapy. 878.4010 Tissue adhesive. 878.4700 Surgical microscope and acces- 878.4011 Tissue adhesive with adjunct wound sories. closure device for topical approximation 878.4730 Surgical skin degreaser or adhesive of skin. tape solvent. 878.4014 Nonresorbable gauze/sponge for ex- 878.4750 Implantable staple. ternal use. 878.4755 Absorbable lung biopsy plug. 878.4015 Wound dressing with poly (diallyl 878.4760 Removable skin staple. dimethyl ammonium chloride) 878.4780 Powered suction pump. (pDADMAC) additive. 878.4790 Powered surgical instrument for 878.4018 Hydrophilic wound dressing. improvement in the appearance of 878.4020 Occlusive wound dressing. cellulite.

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878.4800 Manual surgical instrument for merely that the device is accurately general use. described by the section title and iden- 878.4810 Laser surgical instrument for use in tification provision of a regulation in general and plastic surgery and in dermatology. this part, but shall state why the de- 878.4815 Magnetic surgical instrument sys- vice is substantially equivalent to tem. other devices, as required by § 807.87 of 878.4820 Surgical instrument motors and ac- this chapter. cessories/attachments. (c) To avoid duplicative listings, a 878.4830 Absorbable surgical gut suture. general and plastic surgery device that 878.4840 Absorbable polydioxanone surgical has two or more types of uses (e.g., suture. 878.4930 Suture retention device. used both as a diagnostic device and as 878.4950 Manual operating table and acces- a therapeutic device) is listed in one sories and manual operating chair and subpart only. accessories. (d) References in this part to regu- 878.4960 Operating tables and accessories latory sections of the Code of Federal and operating chairs and accessories. Regulations are to chapter I of title 21 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture. unless otherwise noted. 878.5010 Nonabsorbable polypropylene sur- (e) Guidance documents referenced in gical suture. this part are available on the Internet 878.5020 Nonabsorbable polyamide surgical at http://www.fda.gov/MedicalDevices/ suture. DeviceRegulationandGuidance/ 878.5030 Natural nonabsorbable silk surgical GuidanceDocuments/default.htm.. suture. 878.5035 Nonabsorbable expanded polytetra- [53 FR 23872, June 24, 1988, as amended at 67 fluoroethylene surgical suture. FR 77676, Dec. 19, 2002; 78 FR 18233, Mar. 26, 878.5040 Suction lipoplasty system. 2013]

Subpart F—Therapeutic Devices § 878.3 Effective dates of requirement for premarket approval. 878.5070 Air-handling apparatus for a surgical operating room. A device included in this part that is 878.5350 Needle-type epilator. classified into class III (premarket ap- 878.5360 Tweezer-type epilator. proval) shall not be commercially dis- 878.5400 Low level laser system for aesthetic tributed after the date shown in the use regulation classifying the device unless 878.5650 Topical oxygen chamber for extremities. the manufacturer has an approval 878.5900 Nonpneumatic tourniquet. under section 515 of the act (unless an 878.5910 Pneumatic tourniquet. exemption has been granted under section 520(g)(2) of the act). An approval AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. under section 515 of the act consists of FDA’s issuance of an order approving SOURCE: 53 FR 23872, June 24, 1988, unless an application for premarket approval otherwise noted. (PMA) for the device or declaring com- EDITORIAL NOTE: Nomenclature changes to pleted a product development protocol part 878 appear at 73 FR 35341, June 23, 2008. (PDP) for the device. (a) Before FDA requires that a device Subpart A—General Provisions commercially distributed before the enactment date of the amendments, or § 878.1 Scope. a device that has been found substan- (a) This part sets forth the classifica- tially equivalent to such a device, has tion of general and plastic surgery de- an approval under section 515 of the vices intended for human use that are act, FDA must promulgate a regula- in commercial distribution. tion under section 515(b) of the act re- (b) The identification of a device in a quiring such approval, except as pro- regulation in this part is not a precise vided in paragraphs (b) and (c) of this description of every device that is, or section. Such a regulation under sec- will be, subject to the regulation. A tion 515(b) of the act shall not be effec- manufacturer who submits a pre- tive during the grace period ending on market notification submission for a the 90th day after its promulgation or device under part 807 cannot show on the last day of the 30th full calendar

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month after the regulation that classi- § 878.9 Limitations of exemptions from fies the device into class III is effec- section 510(k) of the Federal Food, tive, whichever is later. See section Drug, and Cosmetic Act (the act). 501(f)(2)(B) of the act. Accordingly, un- The exemption from the requirement less an effective date of the require- of premarket notification (section ment for premarket approval is shown 510(k) of the act) for a generic type of in the regulation for a device classified class I or II device is only to the extent into class III in this part, the device that the device has existing or reason- may be commercially distributed with- ably foreseeable characteristics of out FDA’s issuance of an order approv- commercially distributed devices with- ing a PMA or declaring completed a in that generic type or, in the case of PDP for the device. If FDA promul- in vitro diagnostic devices, only to the gates a regulation under section 515(b) extent that misdiagnosis as a result of using the device would not be associ- of the act requiring premarket ap- ated with high morbidity or mortality. proval for a device, section 501(f)(1)(A) Accordingly, manufacturers of any of the act applies to the device. commercially distributed class I or II (b) Any new, not substantially equiv- device for which FDA has granted an alent, device introduced into commer- exemption from the requirement of cial distribution on or after May 28, premarket notification must still sub- 1976, including a device formerly mar- mit a premarket notification to FDA keted that has been substantially al- before introducing or delivering for in- tered, is classified by statute (section troduction into interstate commerce 513(f) of the act) into class III without for commercial distribution the device any grace period and FDA must have when: issued an order approving a PMA or de- (a) The device is intended for a use claring completed a PDP for the device different from the intended use of a le- before the device is commercially dis- gally marketed device in that generic tributed unless it is reclassified. If type of device; e.g., the device is in- FDA knows that a device being com- tended for a different medical purpose, mercially distributed may be a ‘‘new’’ or the device is intended for lay use device as defined in this section be- where the former intended use was by cause of any new intended use or other health care professionals only; reasons, FDA may codify the statutory (b) The modified device operates classification of the device into class using a different fundamental scientific technology than a legally mar- III for such new use. Accordingly, the keted device in that generic type of de- regulation for such a class III device vice; e.g., a surgical instrument cuts states that as of the enactment date of tissue with a laser beam rather than the amendments, May 28, 1976, the de- with a sharpened metal blade, or an in vice must have an approval under sec- vitro diagnostic device detects or iden- tion 515 of the act before commercial tifies infectious agents by using distribution. deoxyribonucleic acid (DNA) probe or (c) A device identified in a regulation nucleic acid hybridization technology in this part that is classified into class rather than culture or immunoassay III and that is subject to the transi- technology; or tional provisions of section 520(l) of the (c) The device is an in vitro device act is automatically classified by stat- that is intended: ute into class III and must have an ap- (1) For use in the diagnosis, moni- proval under section 515 of the act be- toring, or screening of neoplastic dis- fore being commercially distributed. eases with the exception of Accordingly, the regulation for such a immunohistochemical devices; class III transitional device states that (2) For use in screening or diagnosis as of the enactment date of the amend- of familial or acquired genetic dis- ments, May 28, 1976, the device must orders, including inborn errors of me- have an approval under section 515 of tabolism; (3) For measuring an analyte that the act before commercial distribution. serves as a surrogate marker for screening, diagnosis, or monitoring

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life-threatening diseases such as ac- subpart E of part 807 of this chapter quired immune deficiency syndrome subject to § 878.9. (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or [53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, to monitor therapy; 2000] (4) For assessing the risk of cardiovascular diseases; § 878.3300 Surgical mesh. (5) For use in diabetes management; (6) For identifying or inferring the (a) Identification. Surgical mesh is a identity of a microorganism directly metallic or polymeric screen intended from clinical material; to be implanted to reinforce soft tissue (7) For detection of antibodies to or bone where weakness exists. Exam- microorganisms other than ples of surgical mesh are metallic and immunoglobulin G (IgG) or IgG assays polymeric mesh for hernia repair, and when the results are not qualitative, or acetabular and cement restrictor mesh are used to determine immunity, or the used during orthopedic surgery. assay is intended for use in matrices (b) Classification. Class II. other than serum or plasma; (8) For noninvasive testing as defined § 878.3500 Polytetrafluoroethylene in § 812.3(k) of this chapter; and with carbon fibers composite implant material. (9) For near patient testing (point of care). (a) Identification. A polytetrafluoroethylene with carbon fibers composite [65 FR 2317, Jan. 14, 2000] implant material is a porous device material intended to be implanted dur- Subpart B—Diagnostic Devices ing surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The § 878.1800 Speculum and accessories. device material serves as a space-occu- (a) Identification. A speculum is a de- pying substance and is shaped and vice intended to be inserted into a body formed by the surgeon to conform to cavity to aid observation. It is either the patient’s need. nonilluminated or illuminated and (b) Classification. Class II. may have various accessories. (b) Classification. Class I (general con- § 878.3530 Silicone inflatable breast trols). The device is exempt from the prosthesis. premarket notification procedures in (a) Identification. A silicone inflatable subpart E of part 807 of this chapter, breast prosthesis is a silicone rubber subject to the limitations in § 878.9. shell made of polysiloxane(s), such as [53 FR 23872, June 24, 1988, as amended at 54 polydimethylsiloxane and FR 13827, Apr. 5, 1989; 59 FR 63010, Dec. 7, polydiphenylsiloxane, that is inflated 1994; 66 FR 38802, July 25, 2001] to the desired size with sterile isotonic saline before or after implantation. Subpart C [Reserved] The device is intended to be implanted to augment or reconstruct the female Subpart D—Prosthetic Devices breast. (b) Classification. Class III. § 878.3250 External facial fracture fixa- (c) Date PMA or notice of completion of tion appliance. a PDP is required. A PMA or a notice of (a) Identification. An external facial completion of a PDP is required to be fracture fixation appliance is a metal filed with the Food and Drug Adminis- apparatus intended to be used during tration on or before November 17, 1999, surgical reconstruction and repair to for any silicone inflatable breast pros- immobilize maxillofacial bone frag- thesis that was in commercial distribu- ments in their proper facial relation- tion before May 28, 1976, or that has, on ship. or before November 17, 1999, been found (b) Classification. Class I (general con- to be substantially equivalent to a sili- trols). The device is exempt from the cone inflatable breast prosthesis that premarket notification procedures in was in commercial distribution before

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May 28, 1976. Any other silicone inflat- be filed with the Food and Drug Ad- able breast prosthesis shall have an ap- ministration on or before July 9, 1991 proved PMA or a declared completed for any silicone gel-filled breast pros- PDP in effect before being placed in thesis that was in commercial distribu- commercial distribution. tion before May 28, 1976, or that has on [53 FR 23872, June 24, 1988, as amended at 64 or before July 9, 1991 been found to be FR 45161, Aug. 19, 1999] substantially equivalent to a silicone gel-filled breast prosthesis that was in § 878.3540 Silicone gel-filled breast commercial distribution before May 28, prosthesis. 1976. Any other silicone gel-filled (a) Identification—(1) Single-lumen sili- breast prosthesis shall have an ap- cone gel-filled breast prosthesis. A single- proved PMA in effect before being lumen silicone gel-filled breast pros- placed in commercial distribution. thesis is a silicone rubber shell made of [53 FR 23872, June 24, 1988, as amended at 56 polysiloxane(s), such as FR 14627, Apr. 10, 1991] polydimethylsiloxane and polydiphenylsiloxane. The shell either § 878.3550 Chin prosthesis. contains a fixed amount cross-linked (a) Identification. A chin prosthesis is polymerized silicone gel, filler, and sta- a silicone rubber solid device intended bilizers or is filled to the desired size to be implanted to augment or recon- with injectable silicone gel at time of struct the chin. implantation. The device is intended to (b) Classification. Class II. be implanted to augment or reconstruct the female breast. § 878.3590 Ear prosthesis. (2) Double-lumen silicone gel-filled (a) Identification. An ear prosthesis is breast prosthesis. A double lumen sili- a silicone rubber solid device intended cone gel-filled breast prosthesis is a sil- to be implanted to reconstruct the ex- icone rubber inner shell and a silicone ternal ear. rubber outer shell, both shells made of (b) Classification. Class II. polysiloxane(s), such as polydimethylsiloxane and § 878.3610 Esophageal prosthesis. polydiphenylsiloxane. The inner shell (a) Identification. An esophageal pros- contains fixed amounts of cross-linked thesis is a rigid, flexible, or expandable polymerized silicone gel, fillers, and tubular device made of a plastic, stabilizers. The outer shell is inflated metal, or polymeric material that is to the desired size with sterile isotonic intended to be implanted to restore the saline before or after implantation. structure and/or function of the esoph- The device is intended to be implanted agus. The metal esophageal prosthesis to augment or reconstruct the female may be uncovered or covered with a breast. polymeric material. This device may (3) Polyurethane covered silicone gel- also include a device delivery system. filled breast prosthesis. A polyurethane (b) Classification. Class II. The special covered silicone gel-filled breast pros- control for this device is FDA’s ‘‘Guid- thesis is an inner silicone rubber shell ance for the Content of Premarket No- made of polysiloxane(s), such as tification Submissions for Esophageal polydimethylsiloxane and and Tracheal Prostheses.’’ polydiphenylsiloxane, with an outer silicone adhesive layer and an outer [65 FR 17145, Mar. 31, 2000] covering of polyurethane; contained within the inner shell is a fixed amount § 878.3680 Nose prosthesis. of cross-linked polymerized silicone (a) Identification. A nose prosthesis is gel, fillers, and stabilizers and an inert a silicone rubber solid device intended support structure compartmentalizing to be implanted to augment or recon- the silicone gel. The device is intended struct the nasal dorsum. to be implanted to augment or recon- (b) Classification. Class II. struct the female breast. (b) Classification. Class III. § 878.3720 Tracheal prosthesis. (c) Date premarket approval application (a) Identification. The tracheal pros- (PMA) is required. A PMA is required to thesis is a rigid, flexible, or expandable

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tubular device made of a silicone, concerning records, and § 820.198, with metal, or polymeric material that is respect to complaint files. intended to be implanted to restore the structure and/or function of the tra- [53 FR 23872, June 24, 1988, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, chea or trachealbronchial tree. It may 2001] be unbranched or contain one or two branches. The metal tracheal pros- § 878.3900 Inflatable extremity splint. thesis may be uncovered or covered with a polymeric material. This device (a) Identification. An inflatable ex- may also include a device delivery sys- tremity splint is a device intended to tem. be inflated to immobilize a limb or an (b) Classification. Class II. The special extremity. control for this device is FDA’s ‘‘Guid- (b) Classification. Class I (general con- ance for the Content of Premarket No- trols). The device is exempt from the tification Submissions for Esophageal premarket notification procedures in and Tracheal Prostheses.’’ subpart E of part 807 of this chapter, subject to the limitations in § 878.9. [65 FR 17146, Mar. 31, 2000] [53 FR 23872, June 24, 1988, as amended at 59 § 878.3750 External prosthesis adhe- FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, sive. 2001] (a) Identification. An external prosthesis adhesive is a silicone-type adhe- § 878.3910 Noninflatable extremity sive intended to be used to fasten to splint. the body an external aesthetic restora- (a) Identification. A noninflatable ex- tion prosthesis, such as an artificial tremity splint is a device intended to nose. immobilize a limb or an extremity. It (b) Classification. Class I (general con- is not inflatable. trols). The device is exempt from the (b) Classification. Class I (general con- premarket notification procedures in trols). The device is exempt from the subpart E of part 807 of this chapter, premarket notification procedures in subject to the limitations in § 878.9. subpart E of part 807 of this chapter [53 FR 23872, June 24, 1988, as amended at 59 subject to § 878.9. If the device is not la- FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, beled or otherwise represented as ster- 2001] ile, it is exempt from the current good manufacturing practice requirements § 878.3800 External aesthetic restora- of the quality system regulation in tion prosthesis. part 820 of this chapter, with the excep- (a) Identification. An external aes- tion of § 820.180 of this chapter, with re- thetic restoration prosthesis is a device spect to general requirements con- intended to be used to construct an ex- cerning records, and § 820.198 of this ternal artificial body structure, such as chapter, with respect to complaint an ear, breast, or nose. Usually the de- files. vice is made of silicone rubber and it may be fastened to the body with an [53 FR 23872, June 24, 1988, as amended at 54 external prosthesis adhesive. The de- FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, vice is not intended to be implanted. 2000] (b) Classification. Class I (general controls). The device is exempt from the § 878.3925 Plastic surgery kit and accessories. premarket notification procedures in subpart E of part 807 of this chapter, (a) Identification. A plastic surgery subject to the limitations in § 878.9. If kit and accessories is a device intended the device is intended for use without to be used to reconstruct maxillofacial an external prosthesis adhesive to fas- deficiencies. The kit contains surgical ten it to the body, the device is exempt instruments and materials used to from the current good manufacturing make maxillofacial impressions before practice requirements of the quality molding an external prosthesis. system regulation in part 820 of this (b) Classification. Class I (general con- chapter, with the exception of § 820.180, trols). The device is exempt from the with respect to general requirements premarket notification procedures in

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subpart E of part 807 of this chapter It may be used in conjunction with, but subject to § 878.9. not in place of, deep dermal stitches. Additionally, the adjunct wound clo- [53 FR 23872, June 24, 1988, as amended at 54 FR 13827, Apr. 5, 1989; 65 FR 2317, Jan. 14, sure device component maintains tem- 2000] porary skin edge alignment along the length of wound during application of Subpart E—Surgical Devices the liquid adhesive. (b) Classification. Class II (special § 878.4010 Tissue adhesive. controls). The special control for this device is FDA’s ‘‘Guidance for Industry (a) Tissue adhesive for the topical ap- and FDA Staff; Class II Special Con- proximation of skin—(1) Identification. A trols Guidance Document: Tissue Adhe- tissue adhesive for the topical approxi- sive with Adjunct Wound Closure De- mation of skin is a device intended for vice Intended for the Topical Approxi- topical closure of surgical incisions, in- mation of Skin.’’ See § 878.1(e) for the cluding laparoscopic incisions, and availability of this guidance document. simple traumatic lacerations that have easily approximated skin edges. Tissue [75 FR 68794, Nov. 10, 2010] adhesives for the topical approximation of skin may be used in conjunction § 878.4014 Nonresorbable gauze/sponge with, but not in place of, deep dermal for external use. stitches. (a) Identification. A nonresorbable (2) Classification. Class II (special con- gauze/sponge for external use is a ster- trols). The special control for this de- ile or nonsterile device intended for vice is FDA’s ‘‘Class II Special Controls medical purposes, such as to be placed Guidance Document: ‘‘Tissue Adhesive directly on a patient’s wound to absorb for the Topical Approximation of exudate. It consists of a strip, piece, or Skin.’’ See § 878.1(e) of this chapter for pad made from open woven or the availability of this guidance docu- nonwoven mesh cotton cellulose or a ment. simple chemical derivative of cellulose. (b) Tissue adhesive for non-topical This classification does not include a use—(1) Identification. A tissue adhesive nonresorbable gauze/sponge for exter- for non-topical use, including adhesives nal use that contains added drugs such intended for use in the embolization of as antimicrobial agents, added bio- brain arteriovenous malformation or logics such as growth factors, or is for use in ophthalmic surgery, is a de- composed of materials derived from vice used for adhesion of internal tis- animal sources. sues and vessels. (b) Classification. Class I (general con- (2) Classification. Class III (premarket trols). The device is exempt from the approval). As of May 28, 1976, an ap- premarket notification procedures in proval under section 515 of the act is part 807, subpart E of this chapter sub- required before this device may be ject to the limitations in § 878.9. commercially distributed. See § 878.3 of [64 FR 53929, Oct. 5, 1999] this chapter. [73 FR 31033, May 30, 2008] § 878.4015 Wound dressing with poly (diallyl dimethyl ammonium chlo- § 878.4011 Tissue adhesive with ad- ride) (pDADMAC) additive. junct wound closure device for top- (a) Identification. A wound dressing ical approximation of skin. with pDADMAC additive is intended (a) Identification. A tissue adhesive for use as a primary dressing for exud- with adjunct wound closure device ining wounds, 1st and 2d degree burns, tended for the topical approximation of and surgical wounds, to secure and pre- skin is a device indicated for topical vent movement of a primary dressing, application only to hold closed easily and as a wound packing. approximated skin edges of wounds (b) Classification. Class II (special from surgical incisions, including controls). The special control is: the punctures from minimally invasive FDA guidance document entitled surgery, and simple, thoroughly ‘‘Class II Special Controls Guidance cleansed, trauma-induced lacerations. Document: Wound Dressing With Poly

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(Diallyl Dimethyl Ammonium Chlo- sorb wound exudate, to control bleed- ride) (pDADMAC) Additive.’’ See ing or fluid loss, and to protect against § 878.1(e) for availability of this guid- abrasion, friction, desiccation, and con- ance document. tamination. It consists of a nonresorbable matrix made of hydro- [74 FR 53167, Oct. 16, 2009] philic polymers or other material in § 878.4018 Hydrophilic wound dress- combination with water (at least 50 ing. percent) and capable of absorbing (a) Identification. A hydrophilic exudate. This classification does not wound dressing is a sterile or non-ster- include a hydrogel wound dressing that ile device intended to cover a wound contains added drugs such as anti- and to absorb exudate. It consists of microbial agents, added biologics such nonresorbable materials with hydro- as growth factors, or is composed of philic properties that are capable of ab- materials derived from animal sources. sorbing exudate (e.g., cotton, cotton (b) Classification. Class I (general con- derivatives, alginates, dextran, and trols). The device is exempt from the rayon). This classification does not in- premarket notification procedures in clude a hydrophilic wound dressing part 807, subpart E of this chapter sub- that contains added drugs such as anti- ject to the limitations in § 878.9. microbial agents, added biologics such [64 FR 53929, Oct. 5, 1999] as growth factors, or is composed of materials derived from animal sources. § 878.4025 Silicone sheeting. (b) Classification. Class I (general con- (a) Identification. Silicone sheeting is trols). The device is exempt from the intended for use in the management of premarket notification procedures in closed hyperproliferative (hypertrophic part 807, subpart E of this chapter sub- and keloid) scars. ject to the limitations in § 878.9. (b) Classification. Class I (general con- [64 FR 53929, Oct. 5, 1999] trols). The device is exempt from the premarket notification procedures in § 878.4020 Occlusive wound dressing. subpart E of part 807 of this chapter (a) Identification. An occlusive wound subject to the limitations in § 878.9. dressing is a nonresorbable, sterile or [69 FR 48148, Aug. 9, 2004] non-sterile device intended to cover a wound, to provide or support a moist § 878.4040 Surgical apparel. wound environment, and to allow the (a) Identification. Surgical apparel are exchange of gases such as oxygen and devices that are intended to be worn by water vapor through the device. It con- operating room personnel during sur- sists of a piece of synthetic polymeric gical procedures to protect both the material, such as polyurethane, with or surgical patient and the operating without an adhesive backing. This clas- room personnel from transfer of micro- sification does not include an occlusive organisms, body fluids, and particulate wound dressing that contains added material. Examples include surgical drugs such as antimicrobial agents, caps, hoods, masks, gowns, operating added biologics such as growth factors, room shoes and shoe covers, and isola- or is composed of materials derived tion masks and gowns. Surgical suits from animal sources. and dresses, commonly known as scrub (b) Classification. Class I (general con- suits, are excluded. trols). The device is exempt from the (b) Classification. (1) Class II (special premarket notification procedures in controls) for surgical gowns and sur- part 807, subpart E of this chapter sub- gical masks. ject to the limitations in § 878.9. (2) Class I (general controls) for sur- [64 FR 53929, Oct. 5, 1999] gical apparel other than surgical gowns and surgical masks. The class I device § 878.4022 Hydrogel wound dressing is exempt from the premarket notifica- and burn dressing. tion procedures in subpart E of part 807 (a) Identification. A hydrogel wound of this chapter subject to § 878.9. dressing is a sterile or non-sterile de- [53 FR 23872, June 24, 1988, as amended at 65 vice intended to cover a wound, to ab- FR 2317, Jan. 14, 2000]

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§ 878.4100 Organ bag. § 878.4300 Implantable clip. (a) Identification. An organ bag is a (a) Identification. An implantable clip device that is a flexible plastic bag in- is a clip-like device intended to con- tended to be used as a temporary recep- nect internal tissues to aid healing. It tacle for an organ during surgical pro- is not absorbable. cedures to prevent moisture loss. (b) Classification. Class II. (b) Classification. Class I (general con- § 878.4320 Removable skin clip. trols). The device is exempt from the premarket notification procedures in (a) Identification. A removable skin clip is a clip-like device intended to subpart E of part 807 of this chapter connect skin tissues temporarily to aid subject to § 878.9. healing. It is not absorbable. [53 FR 23872, June 24, 1988, as amended at 59 (b) Classification. Class I (general con- FR 63010, Dec. 7, 1994; 65 FR 2318, Jan. 14, trols). The device is exempt from the 2000] premarket notification procedures in subpart E of part 807 of this chapter § 878.4160 Surgical camera and acces- subject to § 878.9. sories. [53 FR 23872, June 24, 1988, as amended at 65 (a) Identification. A surgical camera FR 2318, Jan. 14, 2000] and accessories is a device intended to be used to record operative procedures. § 878.4340 Contact cooling system for (b) Classification. Class I (general con- aesthetic use. trols). The device is exempt from the (a) Identification. A contact cooling premarket notification procedures in system for aesthetic use is a device subpart E of part 807 of this chapter, that is a combination of a cooling pad subject to the limitations in § 878.9. associated with a vacuum or mechanical massager intended for the disrup- [53 FR 23872, June 24, 1988, as amended at 54 tion of adipocyte cells intended for FR 13827, Apr. 5, 1989; 66 FR 38802, July 25, non-invasive aesthetic use. 2001] (b) Classification. Class II (special controls). The special controls for this § 878.4200 Introduction/drainage cath- device is FDA’s ‘‘Guidance for Industry eter and accessories. and FDA Staff; Class II Special Con- (a) Identification. An introduction/ trols Guidance Document: Contact drainage catheter is a device that is a Cooling System for Aesthetic Use.’’ See flexible single or multilumen tube in- § 878.1(e) for the availability of this tended to be used to introduce nondrug guidance document. fluids into body cavities other than [76 FR 6553, Feb. 7, 2011] blood vessels, drain fluids from body cavities, or evaluate certain physio- § 878.4350 Cryosurgical unit and acces- logic conditions. Examples include irri- sories. gation and drainage catheters, pedi- (a) Identification—(1) Cryosurgical unit atric catheters, peritoneal catheters with a liquid nitrogen cooled cryoprobe (including dialysis), and other general and accessories. A cryosurgical unit surgical catheters. An introduction/ with a liquid nitrogen cooled cryoprobe drainage catheter accessory is intended and accessories is a device intended to to aid in the manipulation of or inser- destroy tissue during surgical proce- tion of the device into the body. Exam- dures by applying extreme cold. ples of accessories include adaptors, (2) Cryosurgical unit with a nitrous connectors, and catheter needles. oxide cooled cryoprobe and accessories. A (b) Classification. Class I (general con- cryosurgical unit with a nitrous oxide trols). The device is exempt from the cooled cryoprobe and accessories is a device intended to destroy tissue dur- premarket notification procedures in ing surgical procedures, including subpart E of part 807 of this chapter urological applications, by applying ex- subject to § 878.9. treme cold. [53 FR 23872, June 24, 1988, as amended at 65 (3) Cryosurgical unit with a carbon di- FR 2318, Jan. 14, 2000] oxide cooled cryoprobe or a carbon dioxide

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dry ice applicator and accessories. A (iii) A summary of the non-clinical cryosurgical unit with a carbon dioxide and/or clinical testing pertinent to use cooled cryoprobe or a carbon dioxide of the device. dry ice applicator and accessories is a (iv) A summary of the device tech- device intended to destroy tissue dur- nical parameters, including tempera- ing surgical procedures by applying ex- ture cooling range and duration of treme cold. The device is intended to cooling. treat disease conditions such as tu- (v) A summary of the device- and pro- mors, skin cancers, acne scars, or cedure-related adverse events pertinent hemangiomas (benign tumors con- to use of the device. sisting of newly formed blood vessels) (vi) Information on how the device and various benign or malignant gyne- operates and the typical course of cological conditions affecting vulvar, treatment. vaginal, or cervical tissue. The device (6) Patient labeling must be provided is not intended for urological applica- and must include: tions. (i) Relevant contraindications, warn- (b) Classification. Class II. ings, precautions, and adverse effects/ complications. § 878.4360 Scalp cooling system to re- (ii) Information on how the device duce the likelihood of chemo- operates and the typical course of therapy-induced alopecia. treatment. (a) Identification. A scalp cooling sys- (iii) Information on the patient popu- tem to reduce the likelihood of chemo- lation for which there is clinical evi- therapy-induced alopecia is a prescrip- dence of effectiveness. tion device intended to reduce the fre- (iv) The potential risks and benefits quency and severity of alopecia during associated with use of the device. chemotherapy in which alopecia-induc- (v) Postoperative care instructions. ing chemotherapeutic agents are used. (vi) A statement describing the po- (b) Classification—Class II (special tential risk of developing scalp metas- controls). The special controls for this tasis. device are: [81 FR 7453, Feb. 12, 2016] (1) Non-clinical performance testing must demonstrate that the device § 878.4370 Surgical drape and drape meets all design specifications and per- accessories. formance requirements, and that the (a) Identification. A surgical drape device performs as intended under an- and drape accessories is a device made ticipated conditions of use. This infor- of natural or synthetic materials in- mation must include testing to dem- tended to be used as a protective pa- onstrate accuracy of the temperature tient covering, such as to isolate a site control mechanism. of surgical incision from microbial and (2) Performance testing must dem- other contamination. The device in- onstrate the electromagnetic compat- cludes a plastic wound protector that ibility and electrical safety of the de- may adhere to the skin around a sur- vice. gical incision or be placed in a wound (3) Software verification, validation, to cover its exposed edges, and a latex and hazard analysis must be performed. drape with a self-retaining finger cot (4) The patient contacting compo- that is intended to allow repeated in- nents of the device must be dem- sertion of the surgeon’s finger into the onstrated to be biocompatible. Mate- rectum during performance of a rial names must be provided. transurethral prostatectomy. (5) Labeling must include the fol- (b) Classification. Class II. lowing: (i) A statement describing the poten- § 878.4380 Drape adhesive. tial risk of developing scalp metas- (a) Identification. A drape adhesive is tasis. a device intended to be placed on the (ii) Information on the patient popu- skin to attach a surgical drape. lation and chemotherapeutic agents/ (b) Classification. Class I (general con- regimen for which the device has been trols). The device is exempt from the demonstrated to be effective. premarket notification procedures in

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subpart E of part 807 of this chapter, package labeling and correctly choose subject to the limitations in § 878.9. the device for the indicated aesthetic [53 FR 23872, June 24, 1988, as amended at 59 use. FR 63010, Dec. 7, 1994; 66 FR 38802, July 25, (3) Usability performance evaluation 2001] must demonstrate that the over-the- counter user can correctly use the de- § 878.4400 Electrosurgical cutting and vice, based solely on reading the direc- coagulation device and accessories. tions for use, to treat the indicated (a) Identification. An electrosurgical aesthetic use. cutting and coagulation device and ac- (4) Clinical performance evaluation cessories is a device intended to re- must demonstrate that the device per- move tissue and control bleeding by forms as intended under anticipated use of high-frequency electrical cur- conditions of use to achieve the in- rent. tended aesthetic results. (b) Classification. Class II. (5) The patient-contacting compo- § 878.4410 Low energy ultrasound nents of the device must be dem- wound cleaner. onstrated to be biocompatible. (a) Identification. A low energy (6) Instructions for cleaning the de- ultrasound wound cleaner is a device vice must be validated. that uses ultrasound energy to vapor- (7) Performance data must be pro- ize a solution and generate a mist that vided to demonstrate the electro- is used for the cleaning and mainte- magnetic compatibility and electrical nance debridement of wounds. Low lev- safety, including the mechanical integ- els of ultrasound energy may be carried rity, of the device. to the wound by the saline mist. (8) Software verification, validation, (b) Classification. Class II (special and hazard analysis must be performed. controls). The special control is FDA’s (9) Labeling must include: guidance document entitled ‘‘Class II (i) Warnings, precautions, and con- Special Controls Guidance Document: traindications to ensure the safe use of Low Energy Ultrasound Wound Clean- the device for the over-the-counter er.’’ See § 878.1(e) for the availability of users. this guidance document. (ii) A statement that the safety and [70 FR 67355, Nov. 7, 2005] effectiveness of the device’s use for uses other than the indicated aesthetic § 878.4420 Electrosurgical device for use are not known. over-the-counter aesthetic use. (iii) A summary of the clinical infor- (a) Identification. An electrosurgical mation used to establish effectiveness device for over-the-counter aesthetic for each indicated aesthetic usage and use is a device using radiofrequency en- observed adverse events. ergy to produce localized heating within tissues for non-invasive aesthetic [81 FR 42244, June 29, 2016] use. (b) Classification. Class II (special § 878.4440 Eye pad. controls). The special controls for this (a) Identification. An eye pad is a de- device are: vice that consists of a pad made of var- (1) Non-clinical performance data ious materials, such as gauze and cot- must demonstrate that the device ton, intended for use as a bandage over meets all design specifications and per- the eye for protection or absorption of formance requirements. The following secretions. performance characteristics must be (b) Classification. Class I (general con- tested: Over-heating, power accuracy trols). The device is exempt from the radiofrequency, pulse cycle, waveform, pulse duration, and device character- premarket notification procedures in ization parameters. subpart E of part 807 of this chapter, (2) Label comprehension and self-se- subject to the limitations in § 878.9. lection performance evaluation must [53 FR 23872, June 24, 1988, as amended at 59 demonstrate that the intended over- FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, the-counter users can understand the 2001]

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§ 878.4450 Nonabsorbable gauze for in- functionality over the requested shelf ternal use. life. (a) Identification. Nonabsorbable (4) Assessment of material character- gauze for internal use is a device made istics must be sufficient to support of an open mesh fabric intended to be safety under anticipated conditions of used inside the body or a surgical inci- use. Assessments must include the fol- sion or applied to internal organs or lowing: structures, to control bleeding, absorb (i) Material specifications. fluid, or protect organs or structures (ii) Immunogenicity. from abrasion, drying, or contamina- (iii) Viral inactivation for animal-de- tion. The device is woven from mate- rived materials. rial made of not less than 50 percent by (5) Non-clinical performance data mass cotton, cellulose, or a simple must demonstrate that the device per- chemical derivative of cellulose, and forms as intended under anticipated contains x-ray detectable elements. conditions of use. The following per- (b) Classification. Class I (general conformance characteristics must be test- trols). The device is exempt from the ed: premarket notification procedures in (i) Absorption capacity. subpart E of part 807 of this chapter, subject to the limitations in § 878.9. (ii) Extent of swelling. (iii) Mechanical properties. [53 FR 23872, June 24, 1988, as amended at 61 (iv) Expansion force/pressure. FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001] (v) Radiopacity. (vi) Deployment/applicator § 878.4452 Nonabsorbable expandable functionality. hemostatic sponge for temporary (6) In vivo performance data must internal use. demonstrate safe and effective use by (a) Identification. A nonabsorbable ex- verifying that the device performs as pandable hemostatic sponge for tem- intended under anticipated conditions porary internal use is a prescription of use. Appropriate analysis/testing device intended to be placed tempo- must demonstrate that the product: rarily into junctional, non-compress- Controls bleeding, does not promote ible wounds, which are not amenable to adverse local or systemic effects, and tourniquet use, to control bleeding can be completely removed from the until surgical care is acquired. The wound. The following performance sponges expand upon contact with characteristics must be tested: blood to fill the wound cavity and pro- (i) Deployment. vide a physical barrier and pressure (ii) Control of bleeding. that facilitates formation of a clot. (iii) Radiopacity. The device consists of sterile, non- (iv) Retrieval. absorbable radiopaque compressed (v) Assessment of local and systemic sponges and may include an applicator effects. to facilitate delivery into a wound. (b) Classification. Class II (special (7) Human factors testing and anal- controls). The special controls for this ysis must validate that the device de- device are: sign and labeling are sufficient for ap- (1) Performance data must dem- propriate use by emergency responders onstrate the biocompatibility of pa- deploying the device as well as sur- tient-contacting components. geons retrieving the device from (2) Performance data must dem- wounds. onstrate the sterility of patient-con- (8) Labeling must include: tacting components including (i) Specific instructions for deploy- endotoxin and pyrogenicity assessment by emergency responders and re- ments. trieval by surgeons. (3) Performance data must support (ii) Warnings, cautions, and limita- device stability by demonstrating con- tions needed for safe use of the device. tinued sterility of the patient-con- (iii) Information on how the device tacting components of the device, operates and the typical course of package integrity, and device treatment.

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(iv) A detailed summary of the in (PGL suture) is an absorbable sterile, vivo and human factors testing perti- flexible strand as prepared and syn- nent to use of the device. thesized from homopolymers of (v) Appropriate imaging information glycolide and copolymers made from 90 to ensure complete retrieval of device. percent glycolide and 10 percent l- (vi) An expiration date/shelf life. lactide, and is indicated for use in soft tissue approximation. A PGL suture [79 FR 34224, June 16, 2014] meets United States Pharmacopeia § 878.4460 Non-powdered surgeon’s (U.S.P.) requirements as described in glove. the U.S.P. ‘‘Monograph for Absorbable Surgical Sutures;’’ it may be (a) Identification. A non-powdered surgeon’s glove is a device intended to be monofilament or multifilament (braid- worn on the hands of operating room ed) in form; it may be uncoated or personnel to protect a surgical wound coated; and it may be undyed or dyed from contamination. A non-powdered with an FDA-approved color additive. surgeon’s glove does not incorporate Also, the suture may be provided with powder for purposes other than manu- or without a standard needle attached. facturing. The final finished glove in- (b) Classification. Class II (special cludes only residual powder from man- controls). The special control for this ufacturing. device is FDA’s ‘‘Class II Special Con- (b) Classification. Class I (general controls Guidance Document: Surgical Su- trols). tures; Guidance for Industry and FDA.’’ See § 878.1(e) for the availability [53 FR 23872, June 24, 1988, as amended at 66 of this guidance document. FR 46952, Sept. 10, 2001; 81 FR 91730, Dec. 19, 2016] [56 FR 47151, Sept. 18, 1991, as amended at 68 FR 32984, June 3, 2003] § 878.4470 Surgeon’s gloving cream. § 878.4494 Absorbable (a) Identification. Surgeon’s gloving poly(hydroxybutyrate) surgical su- cream is an ointment intended to be ture produced by recombinant DNA used to lubricate the user’s hand before technology. putting on a surgeon’s glove. (a) Identification. An absorbable (b) Classification. Class I (general con- poly(hydroxybutyrate) surgical suture trols). The device is exempt from the is an absorbable surgical suture made premarket notification procedures in of material isolated from prokaryotic subpart E of part 807 of this chapter, cells produced by recombinant subject to the limitations in § 878.9. deoxyribonucleic acid (DNA) tech- [53 FR 23872, June 24, 1988, as amended at 59 nology. The device is intended for use FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, in general soft tissue approximation 2001] and ligation. (b) Classification. Class II (special § 878.4490 Absorbable hemostatic agent and dressing. controls). The special control for this device is the FDA guidance document (a) Identification. An absorbable he- entitled ‘‘Class II Special Controls mostatic agent or dressing is a device Guidance Document: Absorbable intended to produce hemostasis by ac- Poly(hydroxybutyrate) Surgical Suture celerating the clotting process of Produced by Recombinant DNA Tech- blood. It is absorbable. nology.’’ For the availability of this (b) Classification. Class III. guidance document see § 878.1(e). (c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an [72 FR 43146, Aug. 3, 2007] approval under section 515 of the act is required before this device may be § 878.4495 Stainless steel suture. commercially distributed. See § 878.3. (a) Identification. A stainless steel suture is a needled or unneedled non- § 878.4493 Absorbable poly(glycolide/l- absorbable surgical suture composed of lactide) surgical suture. 316L stainless steel, in USP sizes 12–0 (a) Identification. An absorbable through 10, or a substantially equiva- poly(glycolide/l-lactide) surgical suture lent stainless steel suture, intended for

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use in abdominal wound closure, intes- § 878.4630 Ultraviolet lamp for der- tinal anastomosis, hernia repair, and matologic disorders. sternal closure. (a) Identification. An ultraviolet lamp (b) Classification. Class II (special for dermatologic disorders is a device controls). The special control for this (including a fixture) intended to pro- device is FDA’s ‘‘Class II Special Con- vide ultraviolet radiation of the body trols Guidance Document: Surgical Su- to photoactivate a drug in the treat- tures; Guidance for Industry and ment of a dermatologic disorder if the FDA.’’ See § 878.1(e) for the availability labeling of the drug intended for use of this guidance document. with the device bears adequate directions for the device’s use with that [65 FR 19836, Apr. 13, 2000, as amended at 68 drug. FR 32984, June 3, 2003] (b) Classification. Class II.

§ 878.4520 Polytetrafluoroethylene § 878.4635 Sunlamp products and ul- injectable. traviolet lamps intended for use in (a) Identification. Polytetrafluoro- sunlamp products. ethylene injectable is an injectable (a) Identification. A sunlamp product paste prosthetic device composed of is any device designed to incorporate polytetrafluoroethylene intended to be one or more ultraviolet (UV) lamps in- used to augment or reconstruct a vocal tended for irradiation of any part of cord. the living human body, by UV radi- (b) Classification. Class III. ation with wavelengths in air between (c) Date PMA or notice of completion of 200 and 400 nanometers, to induce skin tanning. This definition includes tan- a PDP is required. As of May 28, 1976, an ning beds and tanning booths. A UV approval under section 515 of the act is lamp intended for use in sunlamp prod- required before this device may be ucts is any lamp that produces UV ra- commercially distributed. See § 878.3. diation in the wavelength interval of 200 to 400 nanometers in air. § 878.4580 Surgical lamp. (b) Classification. Class II (special (a) Identification. A surgical lamp (in- controls). The special controls for sun- cluding a fixture) is a device intended lamp products and UV lamps intended to be used to provide visible illumina- for use in sunlamp products are: tion of the surgical field or the patient. (1) Conduct performance testing that (b) Classification. Class II. demonstrates the following: (i) Device meets appropriate output § 878.4590 Focused ultrasound stimu- performance specifications such as lator system for aesthetic use. wavelengths, energy density, and lamp (a) Identification. A Focused life; and Ultrasound Stimulator System for Aes- (ii) Device’s safety features, such as timers to limit UV exposure and thetic Use is a device using focused alarms, function properly. ultrasound to produce localized, me- (2) Demonstrate that device is mechanical motion within tissues and chanically safe to prevent user injury. cells for the purpose of producing ei- (3) Demonstrate software ther localized heating for tissue coagu- verification, validation, and hazard lation or for mechanical cellular mem- analysis. brane disruption intended for (4) Demonstrate that device is bio- noninvasive aesthetic use. compatible. (b) Classification. Class II (special (5) Demonstrate that device is elec- controls). The special control for this trically safe and electromagnetically device is FDA’s ‘‘Class II Special Con- compatible in its intended use environ- trols Guidance Document: Focused ment. Ultrasound Stimulator System for Aes- (6) Labeling—(i) Sunlamp products. (A) thetic Use.’’ See § 878.1(e) for the avail- The warning statement below must ap- ability of this guidance document. pear on all sunlamp products and must be placed in a black box. This state- [76 FR 43121, July 20, 2011] ment must be permanently affixed or

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inscribed on the product when fully as- § 878.4660 Skin marker. sembled for use so as to be legible and (a) Identification. A skin marker is a readily accessible to view by the person pen-like device intended to be used to who will be exposed to UV radiation write on the patient’s skin, e.g., to out- immediately before the use of the prod- line surgical incision sites or mark an- uct. It shall be of sufficient durability atomical sites for accurate blood pres- to remain legible throughout the ex- sure measurement. pected lifetime of the product. It shall appear on a part or panel displayed (b) Classification. Class I (general con- prominently under normal conditions trols). The device is exempt from the of use so that it is readily accessible to premarket notification procedures in view whether the tanning bed canopy subpart E of part 807 of this chapter, (or tanning booth door) is open or subject to the limitations in § 878.9. closed when the person who will be ex- [53 FR 23872, June 24, 1988, as amended at 59 posed approaches the equipment and FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, the text shall be at least 10 millimeters 2001] (height). Labeling on the device must include the following statement: § 878.4670 Internal tissue marker. (a) Identification. An internal tissue Attention: This sunlamp product should not be marker is a prescription use device used on persons under the age of 18 years. that is intended for use prior to or during general surgical procedures to de- (B) Manufacturers shall provide vali- marcate selected sites on internal tis- dated instructions on cleaning and dis- sues. infection of sunlamp products between (b) Classification. Class II (special uses in the user instructions. controls). The special controls for this (ii) Sunlamp products and UV lamps in- device are: tended for use in sunlamp products. Man- (1) The device must be demonstrated ufacturers of sunlamp products and UV to be biocompatible. Material names lamps intended for use in sunlamp and specific designation numbers must products shall provide or cause to be be provided. provided in the user instructions, as (2) Performance testing must dem- well as all consumer-directed catalogs, onstrate that the device performs as specification sheets, descriptive bro- intended to mark the tissue for which chures, and Web pages in which sun- it is indicated. lamp products or UV lamps intended (3) Performance data must dem- for use in sunlamp products are offered onstrate the sterility of the device. for sale, the following contraindication (4) Performance data must support and warning statements: the shelf life of the device by dem- (A) ‘‘Contraindication: This product onstrating sterility, package integrity, is contraindicated for use on persons device functionality, and material sta- under the age of 18 years.’’ bility over the requested shelf life. (B) ‘‘Contraindication: This product (5) Labeling must include: must not be used if skin lesions or open (i) A warning that the device must wounds are present.’’ not be used on a non-sterile surface (C) ‘‘Warning: This product should prior to use internally. not be used on individuals who have (ii) An expiration date/shelf life. had skin cancer or have a family his- (iii) Single use only labeling must be tory of skin cancer.’’ labeled directly on the device. (D) ‘‘Warning: Persons repeatedly exposed to UV radiation should be regu- [80 FR 46486, Aug. 5, 2015] larly evaluated for skin cancer.’’ § 878.4680 Nonpowered, single patient, (c) Performance standard. Sunlamp portable suction apparatus. products and UV lamps intended for use in sunlamp products are subject to (a) Identification. A nonpowered, sin- the electronic product performance gle patient, portable suction apparatus standard at § 1040.20 of this chapter. is a device that consists of a manually operated plastic, disposable evacuation [79 FR 31213, June 2, 2014] system intended to provide a vacuum

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for suction drainage of surgical tended to be used to dissolve surface wounds. skin oil or adhesive tape. (b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter, subject to § 878.9. subject to the limitations in § 878.9. [53 FR 23872, June 24, 1988, as amended at 65 [53 FR 23872, June 24, 1988, as amended at 59 FR 2318, Jan. 14, 2000] FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001] § 878.4683 Non-Powered suction apparatus device intended for negative § 878.4750 Implantable staple. pressure wound therapy. (a) Identification. An implantable sta- (a) Identification. A non-powered suc- ple is a staple-like device intended to tion apparatus device intended for neg- connect internal tissues to aid healing. ative pressure wound therapy is a de- It is not absorbable. vice that is indicated for wound man- (b) Classification. Class II. agement via application of negative § 878.4755 Absorbable lung biopsy pressure to the wound for removal of plug. fluids, including wound exudate, irriga- (a) Identification. A preformed (po- tion fluids, and infectious materials. It lymerized) absorbable lung biopsy plug is further indicated for management of is intended to provide accuracy in wounds, burns, flaps, and grafts. marking a biopsy location for visual- (b) Classification. Class II (special ization during surgical resection and controls). The special control for this closure of pleural punctures associated device is FDA’s ‘‘Class II Special Con- with percutaneous, transthoracic nee- trols Guidance Document: Non-powered dle lung biopsies. Upon deployment Suction Apparatus Device Intended for into the biopsy tract, the plug expands Negative Pressure Wound Therapy to fill the biopsy void and remains in (NPWT).’’ See § 878.1(e) for the avail- place until resorbed. ability of this guidance document. (b) Classification. Class II (special [75 FR 70114, Nov. 17, 2010] controls). The special controls for this device are: § 878.4700 Surgical microscope and ac- (1) The design characteristics of the cessories. device must ensure that the geometry (a) Identification. A surgical micro- and material composition are con- scope and accessories is an AC-powered sistent with the intended use. device intended for use during surgery (2) Performance testing must dem- to provide a magnified view of the sur- onstrate deployment as indicated in gical field. the accompanying labeling, including the indicated introducer needles, and (b) Classification. Class I (general controls). The device is exempt from the demonstrate expansion and resorption premarket notification procedures in characteristics in a clinically relevant subpart E of part 807 of this chapter, environment. (3) In vivo evaluation must dem- subject to the limitations in § 878.9. onstrate performance characteristics [55 FR 48440, Nov. 20, 1990, as amended at 59 of the device, including the ability of FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, the plug to not prematurely resorb or 2001] migrate and the rate of pneumothorax. (4) Sterility testing must dem- § 878.4730 Surgical skin degreaser or onstrate the sterility of the device and adhesive tape solvent. the effects of the sterilization process (a) Identification. A surgical skin on the physical characteristics of the degreaser or an adhesive tape solvent is plug. a device that consists of a liquid such (5) Shelf-life testing must dem- as 1,1,2-trichloro-1,2,2-trifluoroethane; onstrate the shelf-life of the device in- 1,1,1-trichloroethane; and 1,1,1-tri- cluding the physical characteristics of chloroethane with mineral spirits in- the plug.

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(6) The device must be demonstrated formance requirements, and to dem- to be biocompatible. onstrate durability and mechanical in- (7) Labeling must include a detailed tegrity of the device. summary of the device-related and pro- (2) In vivo evaluation of the device cedure-related complications pertinent must demonstrate device performance, to the use of the device and appropriate including the safety of the release warnings. Labeling must include iden- methodology and blood loss at the tification of compatible introducer treatment sites. needles. (3) All elements of the device that may contact the patient must be dem- [79 FR 13219, Mar. 10, 2014] onstrated to be biocompatible. (4) Electrical safety and electro- § 878.4760 Removable skin staple. magnetic compatibility of the device (a) Identification. A removable skin must be demonstrated. staple is a staple-like device intended (5) The labeling must include a sum- to connect external tissues temporarily mary of in vivo evaluation data and all to aid healing. It is not absorbable. the device specific warnings, pre- (b) Classification. Class I (general con- cautions, and/or contraindications. trols). The device is exempt from the (6) Sterility and shelf-life testing for premarket notification procedures in the device must demonstrate the ste- subpart E of part 807 of this chapter rility of patient contacting compo- subject to § 878.9. nents and the shelf life of these compo- [53 FR 23872, June 24, 1988, as amended at 65 nents. FR 2318, Jan. 14, 2000] [79 FR 31861, June 3, 2014]

§ 878.4780 Powered suction pump. § 878.4800 Manual surgical instrument (a) Identification. A powered suction for general use. pump is a portable, AC-powered or (a) Identification. A manual surgical compressed air-powered device in- instrument for general use is a non- tended to be used to remove infectious powered, hand-held, or hand-manipu- materials from wounds or fluids from a lated device, either reusable or dispos- patient’s airway or respiratory support able, intended to be used in various system. The device may be used during general surgical procedures. The device surgery in the operating room or at the includes the applicator, clip applier, bi- patient’s bedside. The device may in- opsy brush, manual dermabrasion clude a microbial filter. brush, scrub brush, cannula, ligature (b) Classification. Class II. carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin § 878.4790 Powered surgical instru- graft expander, file, forceps, gouge, in- ment for improvement in the ap- strument guide, needle guide, hammer, pearance of cellulite. hemostat, amputation hook, ligature (a) Identification. A powered surgical passing and knot-tying instrument, instrument for improvement in the ap- knife, blood lancet, mallet, disposable pearance of cellulite is a prescription or reusable aspiration and injection device that is used for the controlled needle, disposable or reusable suturing release of subcutaneous tissue for im- needle, osteotome, pliers, rasp, re- provement in the appearance of tainer, retractor, saw, scalpel blade, cellulite. The device consists of a cut- scalpel handle, one-piece scalpel, snare, ting tool powered by a motor and a spatula, stapler, disposable or reusable means for instrument guidance to con- stripper, stylet, suturing apparatus for trol the areas of subcutaneous tissue the stomach and intestine, measuring cutting underneath the cellulite de- tape, and calipers. A surgical instru- pressions or dimples. ment that has specialized uses in a spe- (b) Classification. Class II (special cific medical specialty is classified in controls). The special controls for this separate regulations in parts 868 device are: through 892. (1) Non-clinical testing must be per- (b) Classification. Class I (general con- formed to demonstrate that the device trols). The device is exempt from the meets all design specifications and per- premarket notification procedures in

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subpart E of part 807 of this chapter, conditions of use. The following per- subject to the limitations in § 878.9. formance characteristics must be tested: [53 FR 23872, June 24, 1988, as amended at 54 FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, (i) Magnetic field strength testing 1994; 66 FR 38803, July 25, 2001] characterization to identify the distances from the magnet that are safe § 878.4810 Laser surgical instrument for patients and users with ferromag- for use in general and plastic sur- netic implants, devices, or objects. gery and in dermatology. (ii) Ability of the internal surgical (a) Identification. (1) A carbon dioxide instrument(s) to be coupled, de-cou- laser for use in general surgery and in pled, and re-coupled with the external dermatology is a laser device intended magnet over the external magnet use to cut, destroy, or remove tissue by life. light energy emitted by carbon dioxide. (3) The patient-contacting compo- (2) An argon laser for use in derma- nents of the device must be dem- tology is a laser device intended to de- onstrated to be biocompatible. stroy or coagulate tissue by light en- (4) Performance data must dem- ergy emitted by argon. onstrate the sterility of the device (b) Classification. (1) Class II. components that are patient-con- (2) Class I for special laser gas mix- tacting. tures used as a lasing medium for this (5) Methods and instructions for re- class of lasers. The devices subject to processing reusable components must this paragraph (b)(2) are exempt from be validated. the premarket notification procedures (6) Performance data must support in subpart E of part 807 of this chapter, shelf life by demonstrating continued subject to the limitations in § 878.9. sterility of the device or the sterile components and device functionality [53 FR 23872, June 24, 1988, as amended at 61 over the labeled shelf life. FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 2001] (7) Training must be developed and validated by human factors testing and § 878.4815 Magnetic surgical instru- analysis to ensure users can follow the ment system. instructions for use to allow safe use of (a) Identification. A magnetic surgical the device. instrument system is a prescription de- (8) Labeling must include: vice used in laparoscopic surgical pro- (i) Magnetic field safe zones. cedures consisting of several compo- (ii) Instructions for proper device nents, such as surgical instruments, use. and a magnetic controller. The mag- (iii) A screening checklist to ensure netic controller is provided separately that all patients and operating staff from the surgical instrument and is are screened from bringing ferromag- used outside the patient. The external netic implants, devices, or objects near magnetic controller is magnetically the external magnet. coupled with the internal surgical in- (iv) Reprocessing instructions for any strument(s) at the surgical site to reusable components. grasp, hold, retract, mobilize, or ma- (v) Shelf life. nipulate soft tissue and organs. (vi) Use life. (b) Classification. Class II (special [81 FR 64763, Sept. 21, 2016] controls). The special controls for this device are: § 878.4820 Surgical instrument motors (1) In vivo performance data must and accessories/attachments. demonstrate that the device performs (a) Identification. Surgical instrument as intended under anticipated condi- motors and accessories are AC-pow- tions of use. Testing must demonstrate ered, battery-powered, or air-powered the ability of the device to grasp, hold, devices intended for use during surgical retract, mobilize, or manipulate soft procedures to provide power to operate tissue and organs. various accessories or attachments to (2) Non-clinical performance data cut hard tissue or bone and soft tissue. must demonstrate that the system per- Accessories or attachments may informs as intended under anticipated clude a bur, chisel (osteotome),

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dermabrasion brush, dermatome, drill bolster, intended to aid wound healing bit, hammerhead, pin driver, and saw by distributing suture tension over a blade. larger area in the patient. (b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter subpart E of part 807 of this chapter, subject to § 878.9. subject to the limitations in § 878.9. [55 FR 48440, Nov. 20, 1990, as amended at 65 [53 FR 23872, June 24, 1988, as amended at 59 FR 2318, 2000] FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, 2001] § 878.4830 Absorbable surgical gut suture. § 878.4950 Manual operating table and (a) Identification. An absorbable sur- accessories and manual operating gical gut suture, both plain and chro- chair and accessories. mic, is an absorbable, sterile, flexible (a) Identification. A manual operating thread prepared from either the serosal table and accessories and a manual op- connective tissue layer of beef (bovine) erating chair and accessories are non- or the submucosal fibrous tissue of powered devices, usually with movable sheep (ovine) intestine, and is intended components, intended to be used to for use in soft tissue approximation. support a patient during diagnostic ex- (b) Classification. Class II (special aminations or surgical procedures. controls). The special control for this (b) Classification. Class I (general con- device is FDA’s ‘‘Class II Special Con- trols). The device is exempt from the trols Guidance Document: Surgical Su- premarket notification procedures in tures; Guidance for Industry and subpart E of part 807 of this chapter, FDA.’’ See § 878.1(e) for the availability subject to the limitations in § 878.9. of this guidance document. [53 FR 23872, June 24, 1988, as amended at 54 [54 FR 50738, Dec. 11, 1989, as amended at 68 FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, FR 32984, June 3, 2003] 1994; 66 FR 38803, July 25, 2001]

§ 878.4840 Absorbable polydioxanone § 878.4960 Operating tables and acces- surgical suture. sories and operating chairs and ac- (a) Identification. An absorbable cessories. polydioxanone surgical suture is an ab- (a) Identification. Operating tables sorbable, flexible, sterile, and accessories and operating chairs monofilament thread prepared from and accessories are AC-powered or air- polyester polymer poly (p-dioxanone) powered devices, usually with movable and is intended for use in soft tissue components, intended for use during di- approximation, including pediatric car- agnostic examinations or surgical pro- diovascular tissue where growth is ex- cedures to support and position a pa- pected to occur, and ophthalmic sur- tient. gery. It may be coated or uncoated, (b) Classification. Class I (general con- undyed or dyed, and with or without a trols). The device is exempt from the standard needle attached. premarket notification procedures in (b) Classification. Class II (special subpart E of part 807 of this chapter controls). The special control for the subject to § 878.9. device is FDA’s ‘‘Class II Special Con- trols Guidance Document: Surgical Su- [55 FR 48440, Nov. 20, 1990, as amended at 65 tures; Guidance for Industry and FR 2318, Jan. 14, 2000] FDA.’’ See § 878.1(e) for the availability § 878.5000 Nonabsorbable of this guidance document. poly(ethylene terephthalate) sur- [67 FR 77676, Dec. 19, 2002] gical suture. (a) Identification. Nonabsorbable § 878.4930 Suture retention device. poly(ethylene terephthalate) surgical (a) Identification. A suture retention suture is a multifilament, nonabsorb- device is a device, such as a retention able, sterile, flexible thread prepared bridge, a surgical button, or a suture from fibers of high molecular weight,

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long-chain, linear polyesters having re- United States Pharmacopeia (U.S.P.) current aromatic rings as an integral requirements as described in the U.S.P. component and is indicated for use in monograph for nonabsorbable surgical soft tissue approximation. The sutures; it may be monofilament or poly(ethylene terephthalate) surgical multifilament in form; it may be pro- suture meets U.S.P. requirements as vided uncoated or coated; and it may described in the U.S.P. Monograph for be undyed or dyed with an appropriate Nonabsorbable Surgical Sutures; it FDA listed color additive. Also, the su- may be provided uncoated or coated; ture may be provided with or without a and it may be undyed or dyed with an standard needle attached. appropriate FDA listed color additive. (b) Classification. Class II (special Also, the suture may be provided with controls). The special control for this or without a standard needle attached. device is FDA’s ‘‘Class II Special Con- (b) Classification. Class II (special trols Guidance Document: Surgical Su- controls). The special control for this tures; Guidance for Industry and device is FDA’s ‘‘Class II Special Con- FDA.’’ See § 878.1(e) for the availability trols Guidance Document: Surgical Su- of this guidance document. tures; Guidance for Industry and [56 FR 24685, May 31, 1991, as amended at 68 FDA.’’ See § 878.1(e) for the availability FR 32985, June 3, 2003] of this guidance document. [56 FR 24685, May 31, 1991, as amended at 68 § 878.5030 Natural nonabsorbable silk FR 32984, June 3, 2003] surgical suture. (a) Identification. Natural nonabsorb- § 878.5010 Nonabsorbable poly- able silk surgical suture is a non- propylene surgical suture. absorbable, sterile, flexible multifila- (a) Identification. Nonabsorbable poly- ment thread composed of an organic propylene surgical suture is a protein called fibroin. This protein is monofilament, nonabsorbable, sterile, derived from the domesticated species flexible thread prepared from long- Bombyx mori (B. mori) of the family chain polyolefin polymer known as Bombycidae. Natural nonabsorbable silk polypropylene and is indicated for use surgical suture is indicated for use in in soft tissue approximation. The poly- soft tissue approximation. Natural propylene surgical suture meets United nonabsorbable silk surgical suture States Pharmacopeia (U.S.P.) require- meets the United States Pharmacopeia ments as described in the U.S.P. Mono- (U.S.P.) monograph requirements for graph for Nonabsorbable Surgical Su- Nonabsorbable Surgical Suture (class tures; it may be undyed or dyed with I). Natural nonabsorbable silk surgical an FDA approved color additive; and suture may be braided or twisted; it the suture may be provided with or may be provided uncoated or coated; without a standard needle attached. and it may be undyed or dyed with an (b) Classification. Class II (special FDA listed color additive. controls). The special control for this (b) Classification. Class II (special device is FDA’s ‘‘Class II Special Con- controls). The special control for this trols Guidance Document: Surgical Su- device is FDA’s ‘‘Class II Special Con- tures; Guidance for Industry and trols Guidance Document: Surgical Su- FDA.’’ See § 878.1(e) for the availability tures; Guidance for Industry and of this guidance document. FDA.’’ See § 878.1(e) for the availability [56 FR 24685, May 31, 1991, as amended at 68 of this guidance document. FR 32984, June 3, 2003] [58 FR 57558, Oct. 26, 1993, as amended at 68 FR 32985, June 3, 2003] § 878.5020 Nonabsorbable polyamide surgical suture. § 878.5035 Nonabsorbable expanded (a) Identification. Nonabsorbable poly- polytetrafluoroethylene surgical su- amide surgical suture is a nonabsorb- ture. able, sterile, flexible thread prepared (a) Identification. Nonabsorbable ex- from long-chain aliphatic polymers panded polytetrafluoroethylene Nylon 6 and Nylon 6,6 and is indicated (ePTFE) surgical suture is a for use in soft tissue approximation. monofilament, nonabsorbable, sterile, The polyamide surgical suture meets flexible thread prepared from ePTFE

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and is intended for use in soft tissue § 878.5350 Needle-type epilator. approximation and ligation, including (a) Identification. A needle-type epila- cardiovascular surgery. It may be undyed or dyed with an approved color tor is a device intended to destroy the additive and may be provided with or dermal papilla of a hair by applying without an attached needle(s). electric current at the tip of a fine nee- (b) Classification. Class II (special dle that has been inserted close to the controls). The special control for this hair shaft, under the skin, and into the device is FDA’s ‘‘Class II Special Con- dermal papilla. The electric current trols Guidance Document: Surgical Su- may be high-frequency AC current, tures; Guidance for Industry and high-frequency AC combined with DC FDA.’’ See § 878.1(e) for the availability current, or DC current only. of this guidance document. (b) Classification. Class I (general controls). The device is exempt from the [65 FR 20735, Apr. 18, 2000, as amended at 68 FR 32985, June 3, 2003] premarket notification procedures in subpart E of part 807 of this chapter, § 878.5040 Suction lipoplasty system. subject to the limitations in § 878.9. (a) Identification. A suction lipoplasty [53 FR 23872, June 24, 1988, as amended at 61 system is a device intended for aes- FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, thetic body contouring. The device 2001] consists of a powered suction pump (containing a microbial filter on the § 878.5360 Tweezer-type epilator. exhaust and a microbial in-line filter (a) Identification. The tweezer-type in the connecting tubing between the epilator is an electrical device intended collection bottle and the safety trap), to remove hair. The energy provided at collection bottle, cannula, and con- the tip of the tweezer used to remove necting tube. The microbial filters, hair may be radio frequency, galvanic tubing, collection bottle, and cannula (direct current), or a combination of must be capable of being changed be- radio frequency and galvanic energy. tween patients. The powered suction (b) Classification. Class I (general con- pump has a motor with a minimum of trols). The device is exempt from pre- 1⁄3 horsepower, a variable vacuum range market notification procedures in sub- from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacu- part E of part 807 of this chapter sub- um with accompanying vacuum ject to § 878.9. gauges, a single or double rotary vane [63 FR 57060, Oct. 26, 1998] (with or without oil), a single or double diaphragm, a single or double piston, § 878.5400 Low level laser system for and a safety trap. aesthetic use (b) Classification. Class II (special (a) Identification. A Low Level Laser controls). Consensus standards and la- System for Aesthetic Use is a device beling restrictions. using low level laser energy for the dis- [63 FR 7705, Feb. 17, 1998] ruption of adipocyte cells within the fat layer for the release of fat and Subpart F—Therapeutic Devices lipids from these cells for noninvasive aesthetic use. § 878.5070 Air-handling apparatus for (b) Classification. Class II (special a surgical operating room. controls). The special control for this (a) Identification. Air-handling appa- device is the FDA guidance document ratus for a surgical operating room is a entitled ‘‘Guidance for Industry and device intended to produce a directed, Food and Drug Administration Staff; nonturbulent flow of air that has been Class II Special Controls Guidance filtered to remove particulate matter Document: Low Level Laser System for and microorganisms to provide an area Aesthetic Use.’’ See § 878.1(e) for the free of contaminants to reduce the pos- availability of this guidance document. sibility of infection in the patient. [76 FR 20842, Apr. 14, 2011] (b) Classification. Class II.

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§ 878.5650 Topical oxygen chamber for PART 880—GENERAL HOSPITAL extremities. AND PERSONAL USE DEVICES (a) Identification. A topical oxygen chamber for extremities is a device Subpart A—General Provisions that is intended to surround a patient’s Sec. limb and apply humidified oxygen topi- 880.1 Scope. cally at a pressure slightly greater 880.3 Effective dates of requirement for pre- than atmospheric pressure to aid heal- market approval. ing of chronic skin ulcers such as bed- 880.9 Limitations of exemptions from sec- sores. tion 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). (b) Classification. Class II (special controls). The special control for this Subpart B [Reserved] device is FDA’s ‘‘Class II Special Con- trols Guidance: Topical Oxygen Cham- Subpart C—General Hospital and Personal ber for Extremities.’’ See § 878.1(e) for Use Monitoring Devices the availability of this guidance docu- 880.2200 Liquid crystal forehead tempera- ment. ture strip. 880.2400 Bed-patient monitor. [76 FR 22807, Apr. 25, 2011] 880.2420 Electronic monitor for gravity flow infusion systems. § 878.5900 Nonpneumatic tourniquet. 880.2460 Electrically powered spinal fluid (a) Identification. A nonpneumatic pressure monitor. tourniquet is a device consisting of a 880.2500 Spinal fluid manometer. 880.2700 Stand-on patient scale. strap or tubing intended to be wrapped 880.2720 Patient scale. around a patient’s limb and tightened 880.2740 Surgical sponge scale. to reduce circulation. 880.2800 Sterilization process indicator. (b) Classification. Class I (general con- 880.2900 Clinical color change thermometer. trols). The device is exempt from the 880.2910 Clinical electronic thermometer. 880.2920 Clinical mercury thermometer. premarket notification procedures in 880.2930 Apgar timer. subpart E of part 807 of this chapter, subject to the limitations in § 878.9. Subparts D–E [Reserved] [53 FR 23872, June 24, 1988, as amended at 54 Subpart F—General Hospital and Personal FR 13828, Apr. 5, 1989; 59 FR 63010, Dec. 7, Use Therapeutic Devices 1994; 66 FR 38803, July 25, 2001] 880.5025 I.V. container. § 878.5910 Pneumatic tourniquet. 880.5045 Medical recirculating air cleaner. 880.5075 Elastic bandage. (a) Identification. A pneumatic tour- 880.5090 Liquid bandage. niquet is an air-powered device con- 880.5100 AC-powered adjustable hospital bed. sisting of a pressure-regulating unit, 880.5110 Hydraulic adjustable hospital bed. connecting tubing, and an inflatable 880.5120 Manual adjustable hospital bed. cuff. The cuff is intended to be wrapped 880.5130 Infant radiant warmer. around a patient’s limb and inflated to 880.5140 Pediatric medical crib. 880.5145 Medical bassinet. reduce or totally occlude circulation 880.5150 Nonpowered flotation therapy mat- during surgery. tress. (b) Classification. Class I (general con- 880.5160 Therapeutic medical binder. trols). The device is exempt from the 880.5180 Burn sheet. premarket notification procedures in 880.5200 Intravascular catheter. 880.5210 Intravascular catheter securement subpart E of part 807 of this chapter, device. subject to the limitations in § 878.9. 880.5240 Medical adhesive tape and adhesive bandage. [53 FR 23872, June 24, 1988, as amended at 61 880.5270 Neonatal eye pad. FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, 880.5300 Medical absorbent fiber. 2001] 880.5400 Neonatal incubator. 880.5410 Neonatal transport incubator. 880.5420 Pressure infusor for an I.V. bag. 880.5430 Nonelectrically powered fluid injector.

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880.5440 Intravascular administration set. 880.6350 Battery-powered medical examina- 880.5445 Intravascular administration set, tion light. automated air removal system. 880.6375 Patient lubricant. 880.5450 Patient care reverse isolation 880.6430 Liquid medication dispenser. chamber. 880.6450 Skin pressure protectors. 880.5475 Jet lavage. 880.6500 Medical ultraviolet air purifier. 880.5500 AC-powered patient lift. 880.6600 Ultraviolet (UV) radiation chamber 880.5510 Non-AC-powered patient lift. disinfection device. 880.5550 Alternating pressure air flotation 880.6710 Medical ultraviolet water purifier. mattress. 880.6730 Body waste receptacle. 880.5560 Temperature regulated water mattress. 880.6740 Vacuum-powered body fluid suction 880.5570 Hypodermic single lumen needle. apparatus. 880.5580 Acupuncture needle. 880.6760 Protective restraint. 880.5630 Nipple shield. 880.6775 Powered patient transfer device. 880.5640 Lamb feeding nipple. 880.6785 Manual patient transfer device. 880.5680 Pediatric position holder. 880.6800 Washers for body waste receptacles. 880.5700 Neonatal phototherapy unit. 880.6820 Medical disposable scissors. 880.5725 Infusion pump. 880.6850 Sterilization wrap. 880.5740 Suction snakebite kit. 880.6860 Ethylene oxide gas sterilizer. 880.5760 Chemical cold pack snakebite kit. 880.6870 Dry-heat sterilizer. 880.5780 Medical support stocking. 880.6880 Steam sterilizer. 880.5820 Therapeutic scrotal support. 880.6885 Liquid chemical sterilants/high 880.5860 Piston syringe. level disinfectants. 880.5950 Umbilical occlusion device. 880.6890 General purpose disinfectants. 880.5960 Lice removal kit. 880.6900 Hand-carried stretcher. 880.5965 Subcutaneous, implanted, 880.6910 Wheeled stretcher. intravascular infusion port and catheter. 880.6920 Syringe needle introducer. 880.5970 Percutaneous, implanted, long-term intravascular catheter. 880.6960 Irrigating syringe. 880.6970 Liquid crystal vein locator. Subpart G—General Hospital and Personal 880.6980 Vein stabilizer. Use Miscellaneous Devices 880.6990 Infusion stand. 880.6991 Medical washer. 880.6025 Absorbent tipped applicator. 880.6992 Medical washer-disinfector. 880.6050 Ice bag. AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 880.6060 Medical disposable bedding. 360j, 371. 880.6070 Bed board. 880.6080 Cardiopulmonary resuscitation SOURCE: 45 FR 69682, Oct. 21, 1980, unless board. otherwise noted. 880.6085 Hot/cold water bottle. 880.6100 Ethylene oxide gas aerator cabinet. EDITORIAL NOTE: Nomenclature changes to 880.6140 Medical chair and table. part 880 appear at 73 FR 35341, June 23, 2008. 880.6150 Ultrasonic cleaner for medical instruments. Subpart A—General Provisions 880.6175 [Reserved] 880.6185 Cast cover. § 880.1 Scope. 880.6190 Mattress cover for medical purposes. (a) This part sets forth the classifica- 880.6200 Ring cutter. tion of general hospital and personal 880.6230 Tongue depressor. use devices intended for human use 880.6250 Non-powdered patient examination that are in commercial distribution. glove. (b) The identification of a device in a 880.6260 Filtering facepiece respirator for use by the general public in public health regulation in this part is not a precise medical emergencies. description of every device that is, or 880.6265 Examination gown. will be, subject to the regulation. A 880.6280 Medical insole. manufacturer who submits a pre- 880.6300 Implantable radiofrequency trans- market notification submission for a ponder system for patient identification device under part 807 may not show and health information. merely that the device is accurately 880.6305 Ingestible event marker. described by the section title and iden- 880.6310 Medical device data system. 880.6315 Remote medication management tification provisions of a regulation in system. this part, but shall state why the de- 880.6320 AC-powered medical examination vice is substantially equivalent to light. other devices, as required by § 807.87.

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(c) To avoid duplicative listings, a mercially distributed without FDA’s general hospital and personal use de- issuance of an order approving a PMA vice that has two or more types of uses or declaring completed a PDP for the (e.g., used both as a diagnostic device device. If FDA promulgates a regula- and as a therapeutic device) is listed tion under section 515(b) of the act re- only in one subpart. quiring premarket approval for a de- (d) References in this part to regu- vice, section 501(f)(1)(A) of the act ap- latory sections of the Code of Federal plies to the device. Regulations are to chapter I of title 21, (b) Any new, not substantially equiv- unless otherwise noted. alent, device introduced into commer- (e) Guidance documents referenced in cial distribution on or after May 28, this part are available on the Internet 1976, including a device formerly mar- at http://www.fda.gov/MedicalDevices/ keted that has been substantially al- DeviceRegulationandGuidance/ tered, is classified by statute (section GuidanceDocuments/default.htm.. 513(f) of the act) into class III without [52 FR 17738, May 11, 1987, as amended at 69 any grace period and FDA must have FR 71704, Dec. 8, 2004; 78 FR 18233, Mar. 26, issued an order approving a PMA or de- 2013] claring completed a PDP for the device before the device is commercially dis- § 880.3 Effective dates of requirement tributed unless it is reclassified. If for premarket approval. FDA knows that a device being com- A device included in this part that is mercially distributed may be a ‘‘new’’ classified into class III (premarket ap- devices defined in this section because proval) shall not be commercially dis- of any new intended use or other rea- tributed after the date shown in the sons, FDA may codify the statutory regulation classifying the device unless classification of the device into class the manufacturer has an approval III for such new use. Accordingly, the under section 515 of the act (unless an regulation for such a class III device exemption has been granted under sec- states that as of the enactment date of tion 520(g)(2) of the act). An approval the amendments, May 28, 1976, the de- under section 515 of the act consists of vice must have an approval under sec- FDA’s issuance of an order approving tion 515 of the act before commercial an application for premarket approval distribution. (PMA) for the device or declaring completed a product development protocol [52 FR 17738, May 11, 1987] (PDP) for the device. (a) Before FDA requires that a device § 880.9 Limitations of exemptions from commercially distributed before the section 510(k) of the Federal Food, enactment date of the amendments, or Drug, and Cosmetic Act (the act). a device that has been found substan- The exemption from the requirement tially equivalent to such a device, has of premarket notification (section an approval under section 515 of the act 510(k) of the act) for a generic type of FDA must promulgate a regulation class I or II device is only to the extent under section 515(b) of the act requir- that the device has existing or reason- ing such approval, except as provided ably foreseeable characteristics of in paragraph (b) of this section. Such a commercially distributed devices with- regulation under section 515(b) of the in that generic type or, in the case of act shall not be effective during the in vitro diagnostic devices, only to the grace period ending on the 90th day extent that misdiagnosis as a result of after its promulgation or on the last using the device would not be associ- day of the 30th full calendar month ated with high morbidity or mortality. after the regulation that classifies the Accordingly, manufacturers of any device into class III is effective, which- commercially distributed class I or II ever is later. See section 501(f)(2)(B) of device for which FDA has granted an the act. Accordingly, unless an effec- exemption from the requirement of tive date of the requirement for pre- premarket notification must still sub- market approval is shown in the regu- mit a premarket notification to FDA lation for a device classified into class before introducing or delivering for in- III in this part, the device may be com- troduction into interstate commerce

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for commercial distribution the device Subpart B [Reserved] when: (a) The device is intended for a use Subpart C—General Hospital and different from the intended use of a legally marketed device in that generic Personal Use Monitoring Devices type of device; e.g., the device is in- § 880.2200 Liquid crystal forehead tem- tended for a different medical purpose, perature strip. or the device is intended for lay use where the former intended use was by (a) Identification. A liquid crystal health care professionals only; forehead temperature strip is a device (b) The modified device operates applied to the forehead that is used to using a different fundamental sci- indicate the presence or absence of entific technology than a legally mar- fever, or to monitor body temperature keted device in that generic type of de- changes. The device displays the color vice; e.g., a surgical instrument cuts changes of heat sensitive liquid crys- tissue with a laser beam rather than tals corresponding to the variation in with a sharpened metal blade, or an in the surface temperature of the skin. vitro diagnostic device detects or iden- The liquid crystals, which are cho- tifies infectious agents by using lesteric esters, are sealed in plastic. deoxyribonucleic acid (DNA) probe or (b) Classification. Class II (special nucleic acid hybridization technology controls). The device is exempt from rather than culture or immunoassay the premarket notification procedures technology; or in subpart E of part 807 of this chapter (c) The device is an in vitro device subject to § 880.9. that is intended: [45 FR 69682, Oct. 21, 1980, as amended at 63 (1) For use in the diagnosis, moni- FR 59228, Nov. 3, 1998] toring, or screening of neoplastic diseases with the exception of § 880.2400 Bed-patient monitor. immunohistochemical devices; (a) Identification. A bed-patient mon- (2) For use in screening or diagnosis itor is a battery-powered device placed of familial or acquired genetic dis- under a mattress and used to indicate orders, including inborn errors of me- by an alarm or other signal when a pa- tabolism; tient attempts to leave the bed. (3) For measuring an analyte that (b) Classification. Class I (general con- serves as a surrogate marker for trols). The device is exempt from the screening, diagnosis, or monitoring premarket notification procedures in life-threatening diseases such as ac- subpart E of part 807 of this chapter quired immune deficiency syndrome subject to the limitations in § 880.9. (AIDS), chronic or active hepatitis, tuberculosis, or myocardial infarction or [45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63010, Dec. 7, 1994; 66 FR 38803, July 25, to monitor therapy; 2001] (4) For assessing the risk of cardiovascular diseases; § 880.2420 Electronic monitor for grav- (5) For use in diabetes management; ity flow infusion systems. (6) For identifying or inferring the (a) Identification. An electronic mon- identity of a microorganism directly itor for gravity flow infusion systems from clinical material; is a device used to monitor the amount (7) For detection of antibodies to of fluid being infused into a patient. microorganisms other than The device consists of an electronic immunoglobulin G (IgG) or IgG assays transducer and equipment for signal when the results are not qualitative, or amplification, conditioning, and dis- are used to determine immunity, or the play. assay is intended for use in matrices (b) Classification. Class II (perform- other than serum or plasma; ance standards). (8) For noninvasive testing as defined in § 812.3(k) of this chapter; and § 880.2460 Electrically powered spinal (9) For near patient testing (point of fluid pressure monitor. care). (a) Identification. An electrically pow- [65 FR 2318, Jan. 14, 2000] ered spinal fluid pressure monitor is an

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electrically powered device used to cation, conditioning and display equip- measure spinal fluid pressure by the ment. use of a transducer which converts spi- (b) Classification. Class I (general con- nal fluid pressure into an electrical sig- trols). The device is exempt from the nal. The device includes signal amplifi- premarket notification procedures in cation, conditioning, and display equip- subpart E of part 807 of this chapter ment. subject to the limitations in § 880.9. (b) Classification. Class II (performance standards). [45 FR 69682, Oct. 21, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38803, July 25, § 880.2500 Spinal fluid manometer. 2001] (a) Identification. A spinal fluid ma- § 880.2740 Surgical sponge scale. nometer is a device used to measure spinal fluid pressure. The device uses a (a) Identification. A surgical sponge hollow needle, which is inserted into scale is a nonelectrically powered de- the spinal column fluid space, to con- vice used to weigh surgical sponges nect the spinal fluid to a graduated col- that have been used to absorb blood umn so that the pressure can be meas- during surgery so that, by comparison ured by reading the height of the fluid. with the known dry weight of the (b) Classification. Class II (perform- sponges, an estimate may be made of ance standards). the blood lost by the patient during surgery. § 880.2700 Stand-on patient scale. (b) Classification. Class I (general con- (a) Identification. A stand-on patient trols). The device is exempt from the scale is a device intended for medical premarket notification procedures in purposes that is used to weigh a pa- subpart E of part 807 of this chapter, tient who is able to stand on the scale subject to the limitations in § 880.9. The platform. device also is exempt from the current (b) Classification. Class I (general con- good manufacturing practice require- trols). The device is exempt from the ments of the quality system regulation premarket notification procedures in in part 820 of this chapter, with the ex- subpart E of part 807 of this chapter, ception of § 820.180, with respect to gen- subject to the limitations in § 880.9. The eral requirements concerning records, device also is exempt from the current and § 820.198, with respect to complaint good manufacturing practice require- files. ments of the quality system regulation in part 820 of this chapter, with the ex- [45 FR 69682, Oct. 21, 1980, as amended at 66 ception of § 820.180, with respect to gen- FR 38804, July 25, 2001] eral requirements concerning records, and § 820.198, with respect to complaint § 880.2800 Sterilization process indi- files. cator. (a) Biological sterilization process indi- [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38803, July 25, 2001] cator—(1) Identification. A biological sterilization process indicator is a de- § 880.2720 Patient scale. vice intended for use by a health care (a) Identification. A patient scale is a provider to accompany products being device intended for medical purposes sterilized through a sterilization proce- that is used to measure the weight of a dure and to monitor adequacy of steri- patient who cannot stand on a scale. lization. The device consists of a This generic device includes devices known number of microorganisms, of placed under a bed or chair to weigh known resistance to the mode of steri- both the support and the patient, de- lization, in or on a carrier and enclosed vices where the patient is lifted by a in a protective package. Subsequent sling from a bed to be weighed, and de- growth or failure of the microorga- vices where the patient is placed on the nisms to grow under suitable condi- scale platform to be weighed. The de- tions indicates the adequacy of steri- vice may be mechanical, battery pow- lization. ered, or AC-powered and may include (2) Classification. Class II (perform- transducers, electronic signal amplifi- ance standards).

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(b) Physical/chemical sterilization proc- in subpart E of part 807 of this chapter ess indicator—(1) Identification. A phys- subject to § 880.9. ical/chemical sterilization process indi- [45 FR 69682, Oct. 21, 1980, as amended at 63 cator is a device intended for use by a FR 59228, Nov. 3, 1998] health care provider to accompany products being sterilized through a § 880.2930 Apgar timer. sterilization procedure and to monitor (a) Identification. The Apgar timer is one or more parameters of the steri- a device intended to alert a health care lization process. The adequacy of the provider to take the Apgar score of a sterilization conditions as measured by newborn infant. these parameters is indicated by a visi- (b) Classification. Class I (general con- ble change in the device. trols). The device is exempt from the (2) Classification. Class II (perform- premarket notification procedures in ance standards). subpart E of part 807 of this chapter subject to the limitations in § 880.9. The § 880.2900 Clinical color change thermometer. device is also exempt from the current good manufacturing practice require- (a) Identification. A clinical color ments in part 820 of this chapter, with change thermometer is a disposable de- the exception of § 820.180 of this chap- vice used to measure a patient’s oral, ter, with respect to general require- rectal, or axillary (armpit) body tem- ments concerning records, and § 820.198 perature. The device records body tem- of this chapter, with respect to com- perature by use of heat sensitive plaint files. chemicals which are sealed at the end of a plastic or metal strip. Body heat [63 FR 59718, Nov. 5, 1998] causes a stable color change in the heat sensitive chemicals. Subparts D–E [Reserved] (b) Classification. Class I (general controls). The device is exempt from the Subpart F—General Hospital and premarket notification procedures in Personal Use Therapeutic Devices subpart E of part 807 of this chapter, subject to the limitations in § 880.9. § 880.5025 I.V. container. [45 FR 69682, Oct. 21, 1980, as amended at 61 (a) Identification. An I.V. container is FR 1123, Jan. 16, 1996; 66 FR 38804, July 25, a container made of plastic or glass 2001] used to hold a fluid mixture to be administered to a patient through an § 880.2910 Clinical electronic thermom- intravascular administration set. eter. (b) Classification. Class II (perform- (a) Identification. A clinical electronic ance standards). thermometer is a device used to measure the body temperature of a patient § 880.5045 Medical recirculating air by means of a transducer coupled with cleaner. an electronic signal amplification, con- (a) Identification. A medical recircu- ditioning, and display unit. The trans- lating air cleaner is a device used to re- ducer may be in a detachable probe move particles from the air for medical with or without a disposable cover. purposes. The device may function by (b) Classification. Class II (perform- electrostatic precipitation or filtra- ance standards). tion. (b) Classification. Class II (perform- § 880.2920 Clinical mercury thermom- ance standards). eter. (a) Identification. A clinical mercury § 880.5075 Elastic bandage. thermometer is a device used to meas- (a) Identification. An elastic bandage ure oral, rectal, or axillary (armpit) is a device consisting of either a long body temperature using the thermal flat strip or a tube of elasticized mate- expansion of mercury. rial that is used to support and com- (b) Classification. Class II (special press a part of a patient’s body. controls). The device is exempt from (b) Classification. Class I (general con- the premarket notification procedures trols). The device is exempt from the

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premarket notification procedures in The device includes movable and subpart E of part 807 of this chapter, latchable side rails. subject to the limitations in § 880.9. The (b) Classification. Class I (general con- device also is exempt from the current trols). The device is exempt from the good manufacturing practice require- premarket notification procedures in ments of the quality system regulation subpart E of part 807 of this chapter, in part 820 of this chapter, with the ex- subject to the limitations in § 880.9. ception of § 820.180, with respect to general requirements concerning records, [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38804, July 25, 2001] and § 820.198, with respect to complaint files. § 880.5120 Manual adjustable hospital [45 FR 69682, Oct. 21, 1980, as amended at 66 bed. FR 38804, July 25, 2001] (a) Identification. A manual adjustable hospital bed is a device intended § 880.5090 Liquid bandage. for medical purposes that consists of a (a) Identification. A liquid bandage is bed with a manual mechanism operated a sterile device that is a liquid, by an attendant to adjust the height semiliquid, or powder and liquid com- and surface contour of the bed. The de- bination used to cover an opening in vice includes movable and latchable the skin or as a dressing for burns. The side rails. device is also used as a topical skin (b) Classification. Class I (general con- protectant. trols). The device is exempt from the (b) Classification. Class I (general con- premarket notification procedures in trols). When used only as a skin pro- subpart E of part 807 of this chapter, tectant, the device is exempt from the subject to the limitations in § 880.9. The premarket notification procedures in device is also exempt from the current subpart E of part 807 of this chapter good manufacturing practice require- subject to § 880.9. ments of the quality system regulation [45 FR 69682, Oct. 21, 1980, as amended at 65 in part 820 of this chapter, with the ex- FR 2318, Jan. 14, 2000] ception of § 820.180, with respect to general requirements concerning records, § 880.5100 AC-powered adjustable hos- and § 820.198, with respect to complaint pital bed. files. (a) Identification. An AC-powered ad- [45 FR 69682, Oct. 21, 1980, as amended at 54 justable hospital bed is a device in- FR 25050, June 12, 1989; 66 FR 38804, July 25, tended for medical purposes that con- 2001] sists of a bed with a built-in electric motor and remote controls that can be § 880.5130 Infant radiant warmer. operated by the patient to adjust the (a) Identification. The infant radiant height and surface contour of the bed. warmer is a device consisting of an in- The device includes movable and frared heating element intended to be latchable side rails. placed over an infant to maintain the (b) Classification. Class II (special infant’s body temperature by means of controls). The device is exempt from radiant heat. The device may also con- the premarket notification procedures tain a temperature monitoring sensor, in subpart E of part 807 of this chapter a heat output control mechanism, and subject to § 880.9. an alarm system (infant temperature, [45 FR 69682, Oct. 21, 1980, as amended at 63 manual mode if present, and failure FR 59229, Nov. 3, 1998] alarms) to alert operators of a temperature condition over or under the § 880.5110 Hydraulic adjustable hos- set temperature, manual mode time pital bed. limits, and device component failure, (a) Identification. A hydraulic adjust- respectively. The device may be placed able hospital bed is a device intended over a pediatric hospital bed or it may for medical purposes that consists of a be built into the bed as a complete bed with a hydraulic mechanism oper- unit. ated by an attendant to adjust the (b) Classification. Class II (Special height and surface contour of the bed. Controls):

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(1) The Association for the Advance- (6) The mattress must fit tightly ment of Medical Instrumentation around all four sides of the crib base, (AAMI) Voluntary Standard for the In- such that entrapment or impingement fant Radiant Warmer; of occupant is prevented; (2) A prescription statement in ac- (7) The mattress for the crib shall cordance with § 801.109 of this chapter meet the Consumer Product Safety (restricted to use by or upon the order Commission (CPSC) Standard for the of qualified practitioners as deter- flammability of mattresses and mat- mined by the States); and tress pads (FF 4–72, amended) and (3) Labeling for use only in health Standard for the flammability (open care facilities and only by persons with flame) of mattress sets, 16 CFR parts specific training and experience in the 1632 and 1633, respectively; and use of the device. (8) Each device must have the fol- [62 FR 33350, June 19, 1997] lowing label(s) affixed: (i) Adequate instructions for users to § 880.5140 Pediatric medical crib. care for, maintain, and clean the crib; (a) Identification. A pediatric medical and crib is a prescription device intended (ii) A warning label on at least two for medical purposes for use with a pe- sides of the medical crib with the fol- diatric patient that consists of an open lowing language in text of at least 9 crib, fixed end rails, movable and millimeters in height: latchable side rail components, and WARNING: Never leave a child unsu- possibly an accompanying mattress. pervised when the moveable side is The contour of the crib surface may be open or not secured. adjustable. (b) Classification. Class II (special [81 FR 91737, Dec. 19, 2016] controls). The device is exempt from § 880.5145 Medical bassinet. the premarket notification procedures in subpart E of part 807 of this chapter (a) Identification. A medical bassinet subject to § 880.9. The special controls is a prescription device that is a small for this device are: bed intended for use with pediatric pa- (1) Crib design and performance test- tients, generally from birth to approxi- ing shall demonstrate the mechanical mately 5 months of age. It is intended and structural stability of the crib for medical purposes for use in a nurs- under expected conditions of use, in- ery, labor and delivery unit, or patient cluding the security of latches and room, but may also be used outside of other locking mechanisms when en- traditional health care settings. A gaged; medical bassinet is a non-powered de- (2) Materials used shall be appro- vice that consists of two components: priate for the conditions of use, allow The plastic basket or bed component for proper sanitation, and be free from and a durable frame with wheels, which surface defects that could result in in- holds the basket or bed component. juries; The basket or bed component is a box- (3) The height of the rail and end like structure, generally made of a panel as measured from the top of the clear, high impact-resistant plastic rail or panel in its highest position to material, with an open top and four the top of the mattress support in its stationary walls to hold the pediatric lowest position shall be at least 26 patient. The frame can include draw- inches (66 centimeters). Any mattress ers, shelving, or cabinetry that pro- used in this crib must not exceed a vides space to hold infant care items. thickness of 6 inches; The wheels or casters allow the bassi- (4) Hardware and fasteners shall be net to transport the infant throughout designed and constructed to eliminate the care setting. mechanical hazards to the patient; (b) Classification. Class II (special (5) The distance between components controls). The device is exempt from of the side rail (i.e., slats, spindles, and the premarket notification procedures corner posts) shall not be greater than in subpart E of part 807 of this chapter 23⁄8 inches (6 centimeters) apart at any subject to § 880.9. The special controls point; for this device are:

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(1) The manufacturer must conduct and § 820.198, with respect to complaint performance testing to determine ma- files. terial compatibility with cleansing [45 FR 69682, Oct. 21, 1980, as amended at 66 products labeled to clean the device. FR 38804, July 25, 2001] Testing must demonstrate that the cleaning instructions provided by the § 880.5160 Therapeutic medical binder. manufacturer do not cause crazing, (a) Identification. A therapeutic med- cracking, or deterioration of the de- ical binder is a device, usually made of vice; cloth, that is intended for medical pur- (2) Manufacturers shall conduct per- poses and that can be secured by ties so formance testing to ensure the me- that it supports the underlying part of chanical and structural stability of the the body or holds a dressing in place. bassinet under expected conditions of This generic type of device includes the use, including transport of patients in abdominal binder, breast binder, and the bassinet. Testing must dem- perineal binder. onstrate that failures such as wheel or (b) Classification. Class I (general con- caster breakage do not occur and that trols). The device is exempt from the the device does not present a tipping premarket notification procedures in hazard due to any mechanical failures subpart E of part 807 of this chapter, under expected conditions of use; and subject to the limitations in § 880.9. If (3) Each device must have the fol- the device is not labeled or otherwise lowing label(s) affixed: represented as sterile, it is also exempt (i) Adequate instructions for users to from the current good manufacturing care for, maintain, and clean the bassi- practice requirements of the quality net; and system regulation in part 820 of this (ii) A warning label on at least two chapter, with the exception of § 820.180, sides of the plastic basket or bed com- with respect to general requirements ponent with the following language in concerning records, and § 820.198, with text of at least 9 millimeters in height: respect to complaint files. WARNING: To avoid tipping hazards of [45 FR 69682, Oct. 21, 1980, as amended at 66 this device, make sure that the bas- FR 38804, July 25, 2001] ket or bed component sits firmly in the base and that all doors, drawers, § 880.5180 Burn sheet. and casters are secure. (a) Identification. A burn sheet is a de- [81 FR 91737, Dec. 19, 2016] vice made of a porous material that is wrapped aroung a burn victim to retain § 880.5150 Nonpowered flotation ther- body heat, to absorb wound exudate, apy mattress. and to serve as a barrier against con- (a) Identification. A nonpowered flota- taminants. tion therapy mattress is a mattress in- (b) Classification. Class I (general con- tended for medical purposes which controls). The device is exempt from the tains air, fluid, or other materials that premarket notification procedures in have the functionally equivalent effect subpart E of part 807 of this chapter, of supporting a patient and avoiding subject to the limitations in § 880.9. excess pressure on local body areas. [45 FR 69682, Oct. 21, 1980, as amended at 59 The device is intended to treat or pre- FR 63011, Dec. 7, 1994; 66 FR 38804, July 25, vent decubitus ulcers (bed sores). 2001] (b) Classification. Class I (general controls). The device is exempt from the § 880.5200 Intravascular catheter. premarket notification procedures in (a) Identification. An intravascular subpart E of part 807 of this chapter, catheter is a device that consists of a subject to the limitations in § 880.9. The slender tube and any necessary con- device also is exempt from the current necting fittings and that is inserted good manufacturing practice require- into the patient’s vascular system for ments of the quality system regulation short term use (less than 30 days) to in part 820 of this chapter, with the ex- sample blood, monitor blood pressure, ception of § 820.180, with respect to gen- or administer fluids intravenously. The eral requirements concerning records, device may be constructed of metal,

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rubber, plastic, or a combination of manufacturing practice requirements these materials. of the quality system regulation in (b) Classification. Class II (perform- part 820 of this chapter, with the excep- ance standards). tion of § 820.180 of this chapter, with respect to general requirements con- § 880.5210 Intravascular catheter securement device. cerning records, and § 820.198 of this chapter, with respect to complaint (a) Identification. An intravascular files. catheter securement device is a device with an adhesive backing that is placed [45 FR 69682, Oct. 21, 1980, as amended at 65 over a needle or catheter and is used to FR 2318, Jan. 14, 2000] keep the hub of the needle or the catheter flat and securely anchored to the § 880.5300 Medical absorbent fiber. skin. (a) Identification. A medical absorbent (b) Classification. Class I (general con- fiber is a device intended for medical trols). The device is exempt from the purposes that is made from cotton or premarket notification procedures in synthetic fiber in the shape of a ball or subpart E of part 807 of this chapter, a pad and that is used for applying subject to the limitations in § 880.9. medication to, or absorbing small [45 FR 69682, Oct. 21, 1980, as amended at 59 amounts of body fluids from, a pa- FR 63011, Dec. 7, 1994; 66 FR 38804, July 25, tient’s body surface. Absorbent fibers 2001] intended solely for cosmetic purposes § 880.5240 Medical adhesive tape and are not included in this generic device adhesive bandage. category. (a) Identification. A medical adhesive (b) Classification. Class I (general con- tape or adhesive bandage is a device in- trols). The device is exempt from the tended for medical purposes that con- premarket notification procedures in sists of a strip of fabric material or subpart E of part 807 of this chapter, plastic, coated on one side with an ad- subject to the limitations in § 880.9. If hesive, and may include a pad of sur- the device is not labeled or otherwise gical dressing without a disinfectant. represented as sterile, it is also exempt The device is used to cover and protect from the current good manufacturing wounds, to hold together the skin practice requirements of the quality edges of a wound, to support an injured system regulation in part 820 of this part of the body, or to secure objects to chapter, with the exception of § 820.180, the skin. with respect to general requirements (b) Classification. Class I (general con- concerning records, and § 820.198, with trols). The device is exempt from the respect to complaint files. premarket notification procedures in subpart E of part 807 of this chapter, [45 FR 69682, Oct. 21, 1980, as amended at 66 subject to the limitations in § 880.9. FR 38804, July 25, 2001]

[45 FR 69682, Oct. 21, 1980, as amended at 59 § 880.5400 Neonatal incubator. FR 63011, Dec. 7, 1994; 66 FR 38804, July 25, 2001] (a) Identification. A neonatal incubator is a device consisting of a rigid § 880.5270 Neonatal eye pad. boxlike enclosure in which an infant (a) Identification. A neonatal eye pad may be kept in a controlled environ- is an opaque device used to cover and ment for medical care. The device may protect the eye of an infant during include an AC-powered heater, a fan to therapeutic procedures, such as circulate the warmed air, a container phototherapy. for water to add humidity, a control (b) Classification. Class I (general con- valve through which oxygen may be trols). The device is exempt from the added, and access ports for nursing premarket notification procedures in care. subpart E of part 807 of this chapter (b) Classification. Class II (perform- subject to § 880.9. If the device is not la- ance standards). beled or otherwise represented as sterile, it is exempt from the current good

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§ 880.5410 Neonatal transport incu- I.V. set stopcock, fluid delivery tubing, bator. connectors between parts of the set, a (a) Identification. A neonatal trans- side tube with a cap to serve as an in- port incubator is a device consisting of jection site, and a hollow spike to pen- a portable rigid boxlike enclosure with etrate and connect the tubing to an insulated walls in which an infant may I.V. bag or other infusion fluid con- be kept in a controlled environment tainer. while being transported for medical (b) Classification. Class II (special care. The device may include straps to controls). The special control for phar- secure the infant, a battery-operated macy compounding systems within this heater, an AC-powered battery charger, classification is the FDA guidance doc- a fan to circulate the warmed air, a ument entitled ‘‘Class II Special Con- container for water to add humidity, trols Guidance Document: Pharmacy and provision for a portable oxygen Compounding Systems; Final Guidance bottle. for Industry and FDA Reviewers.’’ (b) Classification. Class II (perform- Pharmacy compounding systems clas- ance standards). sified within the intravascular administration set are exempt from the pre- § 880.5420 Pressure infusor for an I.V. market notification procedures in sub- bag. part E of this part and subject to the (a) Identification. A pressure infusor limitations in § 880.9. for an I.V. bag is a device consisting of [45 FR 69682, Oct. 21, 1980, as amended at 66 an inflatable cuff which is placed FR 15798, Mar. 21, 2001] around an I.V. bag. When the device is inflated, it increases the pressure on § 880.5445 Intravascular administra- the I.V. bag to assist the infusion of tion set, automated air removal sys- the fluid. tem. (b) Classification. Class I (general con- (a) Identification. An intravascular trols). The device is exempt from the administration set, automated air re- premarket notification procedures in moval system, is a prescription device subpart E of part 807 of this chapter used to detect and automatically re- subject to § 880.9. move air from an intravascular admin- [45 FR 69682, Oct. 21, 1980, as amended at 65 istration set with minimal to no inter- FR 2318, Jan. 14, 2000] ruption in the flow of the intravascular fluid. The device may include an air § 880.5430 Nonelectrically powered identification mechanism, software, an fluid injector. air removal mechanism, tubing, appa- (a) Identification. A nonelectrically ratus to collect removed air, and safety powered fluid injector is a nonelec- control mechanisms to address haz- trically powered device used by a ardous situations. health care provider to give a hypo- (b) Classification. Class II (special dermic injection by means of a narrow, controls). The special controls for this high velocity jet of fluid which can device are: penetrate the surface of the skin and (1) Provide an argument dem- deliver the fluid to the body. It may be onstrating that all reasonably foresee- used for mass inoculations. able hazards have been adequately ad- (b) Classification. Class II (perform- dressed with respect to the persons for ance standards). whose use the device is represented or intended and the conditions of use for § 880.5440 Intravascular administra- the device, which includes the fol- tion set. lowing: (a) Identification. An intravascular (i) Description of the device indica- administration set is a device used to tions for use, design, and technology, administer fluids from a container to a use environments, and users in suffi- patient’s vascular system through a cient detail to determine that the de- needle or catheter inserted into a vein. vice complies with all special controls. The device may include the needle or (ii) Demonstrate that controls are catheter, tubing, a flow regulator, a implemented to address device system drip chamber, an infusion line filter, an hazards and their causes.

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(iii) Include a justification sup- § 880.5450 Patient care reverse isola- porting the acceptability criteria for tion chamber. each hazard control. (a) Identification. A patient care re- (iv) A traceability analysis dem- verse isolation chamber is a device onstrating that all credible hazards consisting of a roomlike enclosure de- have at least one corresponding control signed to prevent the entry of harmful and that all controls have been verified airborne material. This device protects and validated in the final device de- a patient who is undergoing treatment sign. for burns or is lacking a normal im- (2) Appropriate software verification, munosuppressive defense due to ther- validation, and hazard analysis must apy or congenital abnormality. The de- be performed. vice includes fans and air filters which (3) The device parts that directly or maintain an atmosphere of clean air at indirectly contact the patient must be a pressure greater than the air pressure demonstrated to be biocompatible. outside the enclosure. (4) Performance data must dem- (b) Classification. Class II (perform- onstrate the sterility of fluid path con- ance standards). tacting components and the shelf life § 880.5475 Jet lavage. of these components. (5) The device must be designed and (a) Identification. A jet lavage is a de- tested for electrical safety and electro- vice used to clean a wound by a magnetic compatibility (EMC). pulsatile jet of sterile fluid. The device (6) Nonclinical performance testing consists of the pulsing head, tubing to data must demonstrate that the device connect to a container of sterile fluid, performs as intended under anticipated and a means of propelling the fluid through the tubing, such as an electric conditions of use. The following per- roller pump. formance characteristics must be test- (b) Classification. Class II (special ed: controls). The device is exempt from (i) Device system and component re- the premarket notification procedures liability testing must be conducted. in subpart E of part 807 of this chapter (ii) Fluid ingress protection testing subject to § 880.9. must be conducted. (iii) Testing of safety controls must [45 FR 69682, Oct. 21, 1980, as amended at 63 be performed to demonstrate adequate FR 59229, Nov. 3, 1998] mitigation of hazardous situations, in- § 880.5500 AC-powered patient lift. cluding sensor failure, flow control failure, improper device position, de- (a) Identification. An AC-powered lift vice malfunction, infusion delivery is an electrically powered device either error, and release of air to the patient. fixed or mobile, used to lift and trans- (7) A human factors validation study port patients in the horizontal or other must demonstrate that use hazards are required position from one place to an- adequately addressed. other, as from a bed to a bath. The device includes straps and slings to sup- (8) The labeling must include the fol- port the patient. lowing: (b) Classification. Class II (special (i) The device’s air identification and controls). The device is exempt from removal response time. the premarket notification procedures (ii) The device’s minimum air volume in subpart E of part 807 of this chapter identification sensitivity. subject to § 880.9. (iii) The minimum and maximum flow rates at which the device is capa- [45 FR 69682, Oct. 21, 1980, as amended at 63 ble of reliably detecting and removing FR 59229, Nov. 3, 1998] air. § 880.5510 Non-AC-powered patient (iv) Quantification of any fluid loss lift. during device air removal operations as (a) Identification. A non-AC-powered a function of flow rate. patient lift is a hydraulic, battery, or [79 FR 28406, May 16, 2014] mechanically powered device, either

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fixed or mobile, used to lift and trans- § 880.5570 Hypodermic single lumen port a patient in the horizontal or needle. other required position from one place (a) Identification. A hypodermic single to another, as from a bed to a bath. lumen needle is a device intended to in- The device includes straps and a sling ject fluids into, or withdraw fluids to support the patient. from, parts of the body below the sur- (b) Classification. Class I (general con- face of the skin. The device consists of trols). The device is exempt from the a metal tube that is sharpened at one premarket notification procedures in end and at the other end joined to a fe- subpart E of part 807 of this chapter, male connector (hub) designed to mate subject to the limitations in § 880.9. with a male connector (nozzle) of a piston syringe or an intravascular admin- [45 FR 69682, Oct. 21, 1980, as amended at 54 istration set. FR 25050, June 12, 1989; 66 FR 38804, July 25, (b) Classification. Class II (perform- 2001] ance standards).

§ 880.5550 Alternating pressure air flo- § 880.5580 Acupuncture needle. tation mattress. (a) Identification. An acupuncture (a) Identification. An alternating pres- needle is a device intended to pierce sure air flotation mattress is a device the skin in the practice of acupunc- intended for medical purposes that con- ture. The device consists of a solid, sists of a mattress with multiple air stainless steel needle. The device may cells that can be filled and emptied in have a handle attached to the needle to an alternating pattern by an associated facilitate the delivery of acupuncture control unit to provide regular, fre- treatment. quent, and automatic changes in the (b) Classification. Class II (special distribution of body pressure. The de- controls). Acupuncture needles must vice is used to prevent and treat comply with the following special con- decubitus ulcers (bed sores). trols: (b) Classification. Class II (special (1) Labeling for single use only and controls). The device is exempt from conformance to the requirements for the premarket notification procedures prescription devices set out in 21 CFR in subpart E of part 807 of this chapter 801.109, subject to § 880.9. (2) Device material biocompatibility, and [45 FR 69682, Oct. 21, 1980, as amended at 63 (3) Device sterility. FR 59229, Nov. 3, 1998] [61 FR 64617, Dec. 6, 1996] § 880.5560 Temperature regulated water mattress. § 880.5630 Nipple shield. (a) Identification. A nipple shield is a (a) Identification. A temperature regu- device consisting of a cover used to lated water mattress is a device in- protect the nipple of a nursing woman. tended for medical purposes that con- This generic device does not include sists of a mattress of suitable size, nursing pads intended solely to protect filled with water which can be heated the clothing of a nursing woman from or in some cases cooled. The device in- milk. cludes electrical heating and water cir- (b) Classification. Class I (general con- culating components, and an optional trols). The device is exempt from the cooling component. The temperature premarket notification procedures in control may be manual or automatic. subpart E of part 807 of this chapter, (b) Classification. Class I (general con- subject to the limitations in § 880.9. trols). The device is exempt from the premarket notification procedures in [45 FR 69682, Oct. 21, 1980, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 33804, July 25, subpart E of part 807 of this chapter, 2001] subject to the limitations in § 880.9. § 880.5640 Lamb feeding nipple. [45 FR 69682, Oct. 21, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38804, July 25, (a) Identification. A lamb feeding nip- 2001] ple is a device intended for use as a

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feeding nipple for infants with oral or piston pump, a roller pump, or a peri- facial abnormalities. staltic pump and may be powered elec- (b) Classification. Class I (general con- trically or mechanically. The device trols). The device is exempt from the may also operate using a constant premarket notification procedures in force to propel the fluid through a nar- subpart E of part 807 of this chapter, row tube which determines the flow subject to the limitations in § 880.9. If rate. The device may include means to the device is not labeled or otherwise detect a fault condition, such as air in, represented as sterile, it is also exempt or blockage of, the infusion line and to from the current good manufacturing activate an alarm. practice requirements of the quality (b) Classification. Class II (perform- system regulation in part 820 of this ance standards). chapter, with the exception of § 820.180, with respect to general requirements § 880.5740 Suction snakebite kit. concerning records, and § 820.198, with respect to complaint files. (a) Identification. A suction snakebite kit is a device consisting of a knife, [45 FR 69682, Oct. 21, 1980, as amended at 66 suction device, and tourniquet used for FR 38804, July 25, 2001] first-aid treatment of snakebites by removing venom from the wound. § 880.5680 Pediatric position holder. (b) Classification. Class I (general con- (a) Identification. A pediatric position trols). The device is exempt from the holder is a device used to hold an in- premarket notification procedures in fant or a child in a desired position for subpart E of part 807 of this chapter, therapeutic or diagnostic purposes, subject to the limitations in § 880.9. e.g., in a crib under a radiant warmer, or to restrain a child while an [45 FR 69682, Oct. 21, 1980, as amended at 59 intravascular injection is adminis- FR 63011, Dec. 7, 1994; 66 FR 38805, July 25, tered. 2001] (b) Classification. Class I (general con- § 880.5760 Chemical cold pack snake- trols). The device is exempt from the bite kit. good manufacturing practice regulation in part 820 of this chapter, with (a) Identification. A chemical cold the exception of § 820.180, with respect pack snakebit kit is a device consisting to general requirements concerning of a chemical cold pack and tourniquet records, and § 820.198, with respect to used for first-aid treatment of complaint files. snakebites. (b) Classification. Class III (premarket [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 46952, Sept. 10, 2001] approval). (c) Date PMA or notice of completion of § 880.5700 Neonatal phototherapy unit. a PDP is required. A PMA or a notice of (a) Identification. A neonatal completion of a PDP is required to be phototherapy unit is a device used to filed with the Food and Drug Adminis- treat or prevent hyperbilirubinemia tration on or before December 26, 1996 (elevated serum bilirubin level). The for any chemical cold pack snakebite device consists of one or more lamps kit that was in commercial distribu- that emit a specific spectral band of tion before May 28, 1976, or that has, on light, under which an infant is placed or before December 26, 1996 been found for therapy. This generic type of device to be substantially equivalent to a may include supports for the patient chemical cold pack snakebite kit that and equipment and component parts. was in commercial distribution before (b) Classification. Class II (perform- May 28, 1976. Any other chemical cold ance standards). pack snakebite kit shall have an approved PMA or a declared completed § 880.5725 Infusion pump. PDP in effect before being placed in (a) Identification. An infusion pump is commercial distribution. a device used in a health care facility [45 FR 69682, Oct. 21, 1980, as amended at 52 to pump fluids into a patient in a con- FR 17739, May 11, 1987; 61 FR 50708, Sept. 27, trolled manner. The device may use a 1996]

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§ 880.5780 Medical support stocking. and § 820.198, with respect to complaint files. (a) Medical support stocking to prevent the pooling of blood in the legs—(1) Iden- [45 FR 69682, Oct. 21, 1980, as amended at 66 tification. A medical support stocking FR 38805, July 25, 2001] to prevent the pooling of blood in the § 880.5860 Piston syringe. legs is a device that is constructed of elastic material and designed to apply (a) Identification. A piston syringe is controlled pressure to the leg and that a device intended for medical purposes is intended for use in the prevention of that consists of a calibrated hollow pooling of blood in the leg. barrel and a movable plunger. At one end of the barrel there is a male con- (2) Classification. Class II (perform- nector (nozzle) for fitting the female ance standards). connector (hub) of a hypodermic single (b) Medical support stocking for general lumen needle. The device is used to in- medical purposes—(1) Identification. A ject fluids into, or withdraw fluids medical support stocking for general from, the body. medical purposes is a device that is (b) Classification. Class II (perform- constructed of elastic material and de- ance standards). signed to apply controlled pressure to the leg and that is intended for medical § 880.5950 Umbilical occlusion device. purposes other than the prevention of (a) Identification. An umbilical occlu- pooling of blood in the leg. sion device is a clip, tie, tape, or other (2) Classification. Class I. The device article used to close the blood vessels is exempt from the premarket notifica- in the umbilical cord of a newborn in- tion procedures in subpart E of part 807 fant. of this chapter, subject to the limita- (b) Classification. Class I (general con- tions in § 880.9. The device is also ex- trols). The device is exempt from the empt from the current good manufac- premarket notification procedures in turing practice requirements of the subpart E of part 807 of this chapter, quality system regulation in part 820 of subject to the limitations in § 880.9. this chapter, with the exception of [45 FR 69682, Oct. 21, 1980, as amended at 59 § 820.180, with respect to general re- FR 63011, Dec. 7, 1994; 66 FR 38805, July 25, quirements concerning records, and 2001] § 820.198, with respect to complaint files. § 880.5960 Lice removal kit. (a) Identification. The lice removal [45 FR 69682, Oct. 21, 1980, as amended at 59 kit is a comb or comb-like device in- FR 63011, Dec. 7, 1994; 66 FR 38805, July 25, tended to remove and/or kill lice and 2001] nits from head and body hair. It may or § 880.5820 Therapeutic scrotal support. may not be battery operated. (b) Classification. Class I (general con- (a) Identification. A therapeutic scro- trols). The device is exempt from the tal support is a device intended for premarket notification procedures in medical purposes that consist of a subpart E of part 807 of this chapter pouch attached to an elastic waistband subject to the limitations in § 880.9. and that is used to support the scrotum (the sac that contains the testicles). [63 FR 59718, Nov. 5, 1998] (b) Classification. Class I (general con- § 880.5965 Subcutaneous, implanted, trols). The device is exempt from the intravascular infusion port and premarket notification procedures in catheter. subpart E of part 807 of this chapter, (a) Identification. A subcutaneous, im- subject to the limitations in § 880.9. The planted, intravascular infusion port device also is exempt from the current and catheter is a device that consists good manufacturing practice require- of a subcutaneous, implanted reservoir ments of the quality system regulation that connects to a long-term in part 820 of this chapter, with the ex- intravascular catheter. The device al- ception of § 820.180, with respect to gen- lows for repeated access to the vascular eral requirements concerning records, system for the infusion of fluids and

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medications and the sampling of blood. (b) Classification. Class I (general con- The device consists of a portal body trols). The device is exempt from the with a resealable septum and outlet premarket notification procedures in made of metal, plastic, or combination subpart E of part 807 of this chapter, of these materials and a long-term subject to the limitations in § 880.9. If intravascular catheter is either the device is not labeled or otherwise preattached to the port or attached to represented as sterile, it is also exempt the port at the time of device place- from the current good manufacturing ment. The device is available in var- practice requirements of the quality ious profiles and sizes and can be of a system regulation in part 820 of this single or multiple lumen design. chapter, with the exception of § 820.180, (b) Classification. Class II (special with respect to general requirements controls) Guidance Document: ‘‘Guid- concerning records, and § 820.198, with ance on 510(k) Submissions for Im- respect to complaint files. planted Infusion Ports,’’ FDA October 1990. [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38805, July 25, 2001] [65 FR 37043, June 13, 2000] § 880.6050 Ice bag. § 880.5970 Percutaneous, implanted, (a) Identification. An ice bag is a de- long-term intravascular catheter. vice intended for medical purposes that (a) Identification. A percutaneous, im- is in the form of a container intended planted, long-term intravascular cath- to be filled with ice that is used to eter is a device that consists of a slen- apply dry cold therapy to an area of der tube and any necessary connecting the body. The device may include a fittings, such as luer hubs, and acces- holder that keeps the bag in place sories that facilitate the placement of against an external area of the patient. the device. The device allows for re- (b) Classification. Class I (general con- peated access to the vascular system trols). The device is exempt from the for long-term use of 30 days or more, premarket notification procedures in and it is intended for administration of subpart E of part 807 of this chapter, fluids, medications, and nutrients; the subject to the limitations in § 880.9. If sampling of blood; and monitoring the device is not labeled or otherwise blood pressure and temperature. The represented as sterile, it is also exempt device may be constructed of metal, from the current good manufacturing rubber, plastic, composite materials, or practice requirements of the quality any combination of these materials system regulation in part 820 of this and may be of single or multiple lumen chapter, with the exception of § 820.180, design. with respect to general requirements (b) Classification. Class II (special concerning records, and § 820.198, with controls) Guidance Document: ‘‘Guid- respect to complaint files. ance on Premarket Notification [510(k)] Submission for Short-Term and [45 FR 69682, Oct. 21, 1980, as amended at 66 Long-Term Intravascular Catheters.’’ FR 38805, July 25, 2001] [65 FR 37043, June 13, 2000] § 880.6060 Medical disposable bedding. (a) Identification. Medical disposable Subpart G—General Hospital and bedding is a device intended for med- Personal Use Miscellaneous ical purposes to be used by one patient Devices for a period of time and then discarded. This generic type of device may in- § 880.6025 Absorbent tipped appli- clude disposable bedsheets, bedpads, cator. pillows and pillowcases, blankets, (a) Identification. An absorbent tipped emergency rescue blankets, or water- applicator is a device intended for med- proof sheets. ical purposes that consists of an ab- (b) Classification. Class I (general con- sorbent swab on a wooden, paper, or trols). The device is exempt from the plastic stick. The device is used to premarket notification procedures in apply medications to, or to take speci- subpart E of part 807 of this chapter, mens from, a patient. subject to the limitations in § 880.9. If

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the device is not labeled or otherwise § 880.6085 Hot/cold water bottle. represented as sterile, it is also exempt (a) Identification. A hot/cold water from the current good manufacturing bottle is a device intended for medical practice requirements of the quality purposes that is in the form of a con- system regulation in part 820 of this tainer intended to be filled with hot or chapter, with the exception of § 820.180, cold water to apply heat or cold to an with respect to general requirements area of the body. concerning records, and § 820.198, with (b) Classification. Class I (general con- respect to complaint files. trols). The device is exempt from the [45 FR 69682, Oct. 21, 1980, as amended at 59 premarket notification procedures in FR 63011, Dec. 7, 1994; 66 FR 38805, July 25, subpart E of part 807 of this chapter, 2001] subject to the limitations in § 880.9. The device is also exempt from the current § 880.6070 Bed board. good manufacturing practice requirements of the quality system regulation (a) Identification. A bed board is a de- in part 820 of this chapter, with the ex- vice intended for medical purposes that ception of § 820.180, with respect to gen- consists of a stiff board used to in- eral requirements concerning records, crease the firmness of a bed. and § 820.198, with respect to complaint (b) Classification. Class I (general con- files. trols). The device is exempt from the premarket notification procedures in [45 FR 69682, Oct. 21, 1980, as amended at 66 subpart E of part 807 of this chapter, FR 38805, July 25, 2001] subject to the limitations in § 880.9. The § 880.6100 Ethylene oxide gas aerator device is also exempt from the current cabinet. good manufacturing practice require- (a) Identification. An ethyene oxide ments of the quality system regulation gas aerator cabinet is a device that is in part 820 of this chapter, with the ex- intended for use by a health care pro- ception of § 820.180, with respect to gen- vider and consists of a cabinet with a eral requirements concerning records, ventilation system designed to cir- and § 820.198, with respect to complaint culate and exchange the air in the cabi- files. net to shorten the time required to re- [45 FR 69682, Oct. 21, 1980, as amended at 66 move residual ethylene oxide (ETO) FR 38805, July 25, 2001] from wrapped medical devices that have undergone ETO sterilization. The § 880.6080 Cardiopulmonary resuscita- device may include a heater to warm tion board. the circulating air. (a) Identification. A cardiopulmonary (b) Classification. Class II (perform- resuscitation board is a device con- ance standards). sisting of a rigid board which is placed § 880.6140 Medical chair and table. under a patient to act as a support during cardiopulmonary resuscitation. (a) Identification. A medical chair or (b) Classification. Class I (general con- table is a device intended for medical trols). The device is exempt from the purposes that consists of a chair or premarket notification procedures in table without wheels and not elec- subpart E of part 807 of this chapter, trically powered which, by reason of subject to the limitations in § 880.9. The special shape or attachments, such as device is also exempt from the current food trays or headrests, or special fea- good manufacturing practice require- tures such as a built-in raising and lowering mechanism or removable ments of the quality system regulation arms, is intended for use of blood do- in part 820 of this chapter, with the ex- nors, geriatric patients, or patients un- ception of § 820.180, with respect to gen- dergoing treatment or examination. eral requirements concerning records, (b) Classification. Class I (general con- and § 820.198, with respect to complaint trols). The device is exempt from the files. premarket notification procedures in [45 FR 69682, Oct. 21, 1980, as amended at 66 subpart E of part 807 of this chapter, FR 38805, July 25, 2001] subject to the limitations in § 880.9. The

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device is also exempt from the current § 880.6190 Mattress cover for medical good manufacturing practice require- purposes. ments of the quality system regulation (a) Identification. A mattress cover in part 820 of this chapter, with the ex- for medical purposes is a device in- ception of § 820.180, with respect to gen- tended for medical purposes that is eral requirements concerning records, used to protect a mattress. It may be and § 820.198, with respect to complaint electrically conductive or contain a files. germicide. (b) Classification. Class I (general con- [45 FR 69682, Oct. 21, 1980, as amended at 66 trols). The device is exempt from the FR 38805, July 25, 2001] premarket notification procedures in § 880.6150 Ultrasonic cleaner for med- subpart E of part 807 of this chapter, ical instruments. subject to the limitations in § 880.9. If the device is not labeled or otherwise (a) Identification. An ultrasonic clean- represented as sterile, it is also exempt er for medical instruments is a device from the current good manufacturing intended for cleaning medical instru- practice requirements of the quality ments by the emission of high fre- system regulation in part 820 of this quency soundwaves. chapter, with the exception of § 820.180, (b) Classification. Class I. The device, with respect to general requirements including any solutions intended for concerning records, and § 820.198, with use with the device for cleaning and respect to complaint files. sanitizing the instruments, is exempt [45 FR 69682, Oct. 21, 1980, as amended at 59 from the premarket notification proce- FR 63011, Dec. 7, 1994; 66 FR 38806, July 25, dures in subpart E of part 807 of this 2001] chapter, subject to the limitations in § 880.9. § 880.6200 Ring cutter. (a) Identification. A ring cutter is a [45 FR 69682, Oct. 21, 1980, as amended at 54 device intended for medical purposes FR 25050, June 12, 1989; 59 FR 63011, Dec. 7, 1994; 66 FR 38805, July 25, 2001] that is used to cut a ring on a patient’s finger so that the ring can be removed. § 880.6175 [Reserved] The device incorporates a guard to prevent injury to the patient’s finger. § 880.6185 Cast cover. (b) Classification. Class I (general controls). The device is exempt from the (a) Identification. A cast cover is a de- premarket notification procedures in vice intended for medical purposes that subpart E of part 807 of this chapter, is made of waterproof material and subject to the limitations in § 880.9. The placed over a cast to protect it from device also is exempt from the current getting wet during a shower or a bath. good manufacturing practice require- (b) Classification. Class I (general con- ments of the quality system regulation trols). The device is exempt from the in part 820 of this chapter, with the ex- premarket notification procedures in ception of § 820.180, with respect to gen- subpart E of part 807 of this chapter, eral requirements concerning records, subject to the limitations in § 880.9. If and § 820.198, with respect to complaint the device is not labeled or otherwise files. represented as sterile, it is also exempt [45 FR 69682, Oct. 21, 1980, as amended at 66 from the current good manufacturing FR 38806, July 25, 2001] practice requirements of the quality system regulation in part 820 of this § 880.6230 Tongue depressor. chapter, with the exception of § 820.180, (a) Identification. A tongue depressor with respect to general requirements is a device intended to displace the concerning records, and § 820.198, with tongue to facilitate examination of the respect to complaint files. surrounding organs and tissues. (b) Classification. Class I (general con- [45 FR 69682, Oct. 21, 1980, as amended at 66 trols). The device is exempt from the FR 38806, July 25, 2001] premarket notification procedures in subpart E of part 807 of this chapter,

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subject to the limitations in § 880.9. If (2) The FDA guidance document enti- the device is not labeled or otherwise tled: ‘‘Guidance for Industry and Food represented as sterile, it is also exempt and Drug Administration Staff; Class II from the current good manufacturing Special Controls Guidance Document: practice requirements of the quality Filtering Facepiece Respirator for use system regulation in part 820 of this by the General Public in Public Health chapter, with the exception of § 820.180, Medical Emergencies.’’ See § 880.1(e) for with respect to general requirements information on obtaining a copy of this concerning records, and § 820.198, with guidance document. respect to complaint files. [72 FR 36362, July 3, 2007] [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001] § 880.6265 Examination gown. (a) Identification. An examination § 880.6250 Non-powdered patient examination glove. gown is a device intended for medical purposes that is made of cloth, paper, (a) Identification. A non-powdered pa- or other material that is draped over or tient examination glove is a disposable worn by a patient as a body covering device intended for medical purposes during a medical examination. that is worn on the examiner’s hand or (b) Classification. Class I (general con- finger to prevent contamination be- trols). The device is exempt from the tween patient and examiner. A non- premarket notification procedures in powdered patient examination glove subpart E of part 807 of this chapter, does not incorporate powder for pur- subject to the limitations in § 880.9. If poses other than manufacturing. The the device is not labeled or otherwise final finished glove includes only resid- represented as sterile, it is also exempt ual powder from manufacturing. from the current good manufacturing (b) Class I (general con- Classification. practice requirements of the quality trols). system regulation in part 820 of this [45 FR 69682, Oct. 21, 1980, as amended at 54 chapter, with the exception of § 820.180, FR 1604, Jan. 13, 1989; 66 FR 46952, Sept. 10, with respect to general requirements 2001; 81 FR 91730, Dec. 19, 2016] concerning records, and § 820.198, with respect to complaint files. § 880.6260 Filtering facepiece respirator for use by the general pub- [45 FR 69682, Oct. 21, 1980, as amended at 66 lic in public health medical emer- FR 38806, July 25, 2001] gencies. (a) Identification. A filtering facepiece § 880.6280 Medical insole. respirator for use by the general public (a) Identification. A medical insole is in public health medical emergencies is a device intended for medical purposes a device that is a disposable half-face- that is placed inside a shoe to relieve piece non-powered air-purifying partic- the symptoms of athlete’s foot infec- ulate respirator intended for use to tion by absorbing moisture. cover the nose and mouth of the wearer (b) Classification. Class I (general con- to help reduce wearer exposure to path- trols). The device is exempt from the ogenic biological airborne particulates premarket notification procedures in during a public health medical emer- subpart E of part 807 of this chapter, gency. The device is made of polymeric subject to the limitations in § 880.9. materials and is intended to fit closely [45 FR 69682, Oct. 21, 1980, as amended at 54 to the face and to function by filtering FR 25050, June 12, 1989; 66 FR 38806, July 25, particulate material. 2001] (b) Classification. Class II (special controls). The special controls are: § 880.6300 Implantable radiofrequency (1) Certification by the National In- transponder system for patient stitute for Occupational Safety and identification and health informa- Health (NIOSH) as a non-powered air- tion. purifying particulate respirator with a (a) Identification. An implantable ra- minimum filtration efficiency classi- diofrequency transponder system for fication of N95, in accordance with 42 patient identification and health infor- CFR part 84. mation is a device intended to enable

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access to secure patient identification vice and the maximum number of daily and corresponding health information. device ingestions. This system may include a passive im- [78 FR 28734, May 16, 2013] planted transponder, inserter, and scanner. The implanted transponder is § 880.6310 Medical device data system. used only to store a unique electronic (a) Identification. (1) A medical device identification code that is read by the data system (MDDS) is a device that is scanner. The identification code is used intended to provide one or more of the to access patient identity and cor- following uses, without controlling or responding health information stored altering the functions or parameters of in a database. any connected medical devices: (b) Classification. Class II (special (i) The electronic transfer of medical controls). The special control is FDA’s device data; guidance document entitled ‘‘Class II (ii) The electronic storage of medical Special Controls Guidance Document: device data; Implantable Radiofrequency Trans- (iii) The electronic conversion of ponder System for Patient Identifica- medical device data from one format to tion and Health Information.’’ See another format in accordance with a § 880.1(e) for the availability of this preset specification; or guidance document. This device is ex- (iv) The electronic display of medical empt from the premarket notification device data. procedures in subpart E of part 807 of (2) An MDDS may include software, this chapter subject to the limitations electronic or electrical hardware such in § 880.9. as a physical communications medium (including wireless hardware), modems, [69 FR 71704, Dec. 10, 2004] interfaces, and a communications protocol. This identification does not in- § 880.6305 Ingestible event marker. clude devices intended to be used in (a) Identification. An ingestible event connection with active patient moni- marker is a prescription device used to toring. record time-stamped, patient-logged (b) Classification. Class I (general con- events. The ingestible component links trols). The device is exempt from the wirelessly through intrabody commu- premarket notification procedures in nication to an external recorder which subpart E of part 807 of this chapter, records the date and time of ingestion subject to the limitations in § 880.9. as well as the unique serial number of [76 FR 8649, Feb. 15, 2011] the ingestible device. (b) Classification. Class II (special § 880.6315 Remote Medication Manage- ment System. controls). The special controls for this device are: (a) Identification. A remote medica- (1) The device must be demonstrated tion management system is a device to be biocompatible and non-toxic; composed of clinical and communica- (2) Nonclinical, animal, and clinical tions software, a medication delivery unit, and medication packaging. The testing must provide a reasonable as- system is intended to store the pa- surance of safety and effectiveness, in- tient’s prescribed medications in a de- cluding device performance, durability, livery unit, to permit a health care compatibility, usability (human fac- professional to remotely schedule the tors testing), event recording, and patient’s prescribed medications, to proper excretion of the device; notify the patient when the prescribed (3) Appropriate analysis and nonclin- medications are due to be taken, to re- ical testing must validate electro- lease the prescribed medications to a magnetic compatibility performance, tray of the delivery unit accessible to wireless performance, and electrical the patient on the patient’s command, safety; and and to record a history of the event for (4) Labeling must include a detailed the health care professional. The sys- summary of the nonclinical and clin- tem is intended for use as an aid to ical testing pertinent to use of the de- health care professionals in managing

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therapeutic regimens for patients in orifice to facilitate entry of a diag- the home or clinic. nostic or therapeutic device. (b) Classification. Class II (special (b) Classification. Class I (general con- controls). The special control is: The trols). FDA guidance document entitled ‘‘Guidance for Industry and Food and [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 46952, Sept. 10, 2001] Drug Administration Staff; Class II Special Controls Guidance Document: § 880.6430 Liquid medication dis- Remote Medication Management Sys- penser. tem.’’ See § 880.1(e) for availability of this guidance document. (a) Identification. A Liquid medication dispenser is a device intended for [72 FR 59177, Oct. 19, 2007] medical purposes that is used to issue a measured amount of liquid medication. § 880.6320 AC-powered medical examination light. (b) Classification. Class I (general controls). The device is exempt from the (a) Identification. An AC-powered premarket notification procedures in medical examination light is an AC- subpart E of part 807 of this chapter, powered device intended for medical subject to the limitations in § 880.9. The purposes that is used to illuminate device is also exempt from the current body surfaces and cavities during a good manufacturing practice require- medical examination. ments of the quality system regulation (b) Classification. Class I (general con- in part 820 of this chapter, with the ex- trols). The device is exempt from the ception of § 820.180, with respect to gen- premarket notification procedures in eral requirements concerning records, subpart E of part 807 of this chapter, and § 820.198, with respect to complaint subject to the limitations in § 880.9. files. [45 FR 69682, Oct. 21, 1980, as amended at 61 [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 1123, Jan. 16, 1996; 66 FR 38806, July 25, FR 38806, July 25, 2001] 2001]

§ 880.6350 Battery-powered medical § 880.6450 Skin pressure protectors. examination light. (a) Identification. A skin pressure pro- (a) Identification. A battery-powered tector is a device intended for medical medical examination light is a battery- purposes that is used to reduce pres- powered device intended for medical sure on the skin over a bony promi- purposes that is used to illuminate nence to reduce the likelihood of the body surfaces and cavities during a patient’s developing decubitus ulcers medical examination. (bedsores). (b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter, subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The subject to the limitations in § 880.9. The device also is exempt from the current device is also exempt from the current good manufacturing practice require- good manufacturing practice requirements of the quality system regulation ments of the quality system regulation in part 820 of this chapter, with the ex- in part 820 of this chapter, with the exception of § 820.180, with respect to gen- ception of § 820.180, with respect to general requirements concerning records, eral requirements concerning records, and § 820.198, with respect to complaint and § 820.198, with respect to complaint files. files. [45 FR 69682, Oct. 21, 1980, as amended at 66 [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38806, July 25, 2001] FR 38806, July 25, 2001]

§ 880.6375 Patient lubricant. § 880.6500 Medical ultraviolet air puri- (a) Identification. A patient lubricant fier. is a device intended for medical pur- (a) Identification. A medical ultra- poses that is used to lubricate a body violet air purifier is a device intended

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for medical purposes that is used to de- for procedures on replacement of the stroy bacteria in the air by exposure to UV lamp when needed. ultraviolet radiation. (vii) Procedures to follow in case of (b) Classification. Class II (perform- UV lamp malfunction or failure. ance standards). (viii) Procedures for disposing of mercury-containing UV lamps, if appli- § 880.6600 Ultraviolet (UV) radiation cable. chamber disinfection device. (ix) Identification of specific equip- (a) Identification. An ultraviolet (UV) ment that is compatible with the UV radiation chamber disinfection device radiation dose generated by the device is intended for the low-level surface and that can safely undergo UV radi- disinfection of non-porous equipment ation low-level disinfection in the surfaces by dose-controlled UV irradia- chamber device. tion. This classification does not in- (x) Description of the required prepa- clude self-contained open chamber UV ration of equipment for disinfection in radiation disinfection devices intended the UV radiation chamber device. for whole room disinfection in a health (xi) Identification of the specific mi- care environment. crobes used in successful performance (b) Classification—Class II (special testing of the device. controls). The special controls for this (xii) Validated instructions for clean- device are: ing and disinfection of the device. (1) Performance testing must dem- [80 FR 72588, Nov. 20, 2015] onstrate the following: (i) The chamber’s ability to control § 880.6710 Medical ultraviolet water the UV radiation dose during oper- purifier. ation. (a) Identification. A medical ultra- (ii) The chamber’s disinfection per- violet water purifier is a device in- formance through microbial challenge tended for medical purposes that is testing. used to destroy bacteria in water by (iii) Evidence that the equipment in- exposure to ultraviolet radiation. tended to be processed is UV compat- (b) Classification. Class II (perform- ible. ance standards). (iv) Validation of the cleaning and disinfection procedures. § 880.6730 Body waste receptacle. (v) The ability of the device to continue to perform to all specification (a) Identification. A body waste recep- after cleaning and disinfection. tacle is a device intended for medical (vi) Whether the device generates purposes that is not attached to the ozone (if so, 21 CFR 801.415, Maximum body and that is used to collect the acceptable level of ozone, applies). body wastes of a bed patient. (2) Appropriate software verification, (b) Classification. Class I (general con- validation, and hazard analysis must trols). The device is exempt from the be performed. premarket notification procedures in (3) Appropriate analysis and/or test- subpart E of part 807 of this chapter, ing must validate electrical safety, me- subject to the limitations in § 880.9. The chanical safety, and electromagnetic device also is exempt from the current compatibility of the device in its in- good manufacturing practice require- tended use environment. ments of the quality system regulation (4) The labeling must include: in part 820 of this chapter, with the ex- (i) UV hazard warning labels. ception of § 820.180, with respect to gen- (ii) Explanation of all displays and/or eral requirements concerning records, labeling on user interface. and § 820.198, with respect to complaint (iii) Explanation of device safety files. interlocks. [66 FR 38806, July 25, 2001] (iv) Explanation of all disinfection cycle signals, cautions and warnings. § 880.6740 Vacuum-powered body fluid (v) Device operating procedures. suction apparatus. (vi) Identification of the expected UV (a) Identification. A vacuum-powered lamp operational life and instructions body fluid suction apparatus is a device

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used to aspirate, remove, or sample that the patient can be transferred body fluids. The device is powered by with minimal disturbance in a hori- an external source of vacuum. This ge- zontal position to the stretcher. neric type of device includes vacuum (b) Classification. Class I (general con- regulators, vacuum collection bottles, trols). The device is exempt from the suction catheters and tips, connecting premarket notification procedures in flexible aspirating tubes, rigid suction subpart E of part 807 of this chapter, tips, specimen traps, noninvasive tub- subject to the limitations in § 880.9. The ing, and suction regulators (with device is also exempt from the current gauge). good manufacturing practice require- (b) Classification. Class II (special ments of the quality system regulation controls). The device is exempt from in part 820 of this chapter, with the ex- the premarket notification procedures ception of § 820.180, with respect to gen- in subpart E of part 807 of this chapter eral requirements concerning records, subject to § 880.9. and § 820.198, with respect to complaint [45 FR 69682, Oct. 21, 1980, as amended at 63 files. FR 59229, Nov. 3, 1998] [45 FR 69682, Oct. 21, 1980, as amended at 66 § 880.6760 Protective restraint. FR 38807, July 25, 2001] (a) Identification. A protective re- § 880.6800 Washers for body waste restraint is a device, including but not ceptacles. limited to a wristlet, anklet, vest, (a) Identification. A washer for body mitt, straight jacket, body/limb holder, waste receptacles is a device intended or other type of strap, that is intended for medical purposes that is used to for medical purposes and that limits clean and sanitize a body waste recep- the patient’s movements to the extent tacle, such as a bedpan. The device con- necessary for treatment, examination, sists of a wall-mounted plumbing fix- or protection of the patient or others. ture with a door through which a body (b) Classification. Class I (general controls). waste receptacle is inserted. When the door is closed the body waste recep- [61 FR 8439, Mar. 4, 1996, as amended at 66 FR tacle is cleaned by hot water, steam, or 46952, Sept. 10, 2001] germicide. (b) Classification. Class I (general con- § 880.6775 Powered patient transfer device. trols). The device is exempt from the premarket notification procedures in (a) Identification. A powered patient subpart E of part 807 of this chapter, transfer device is a device consisting of subject to the limitations in § 880.9. The a wheeled stretcher and a powered device also is exempt from the current mechanism that has a broad, flexible good manufacturing practice require- band stretched over long rollers that ments of the quality system regulation can advance itself under a patient and in part 820 of this chapter, with the ex- transfer the patient with minimal dis- ception of § 820.180, with respect to gen- turbance in a horizontal position to the eral requirements concerning records, stretcher. and § 820.198, with respect to complaint (b) Classification. Class II (special files. controls). The device is exempt from the premarket notification procedures [45 FR 69682, Oct. 21, 1980, as amended at 66 in subpart E of part 807 of this chapter FR 38807, July 25, 2001] subject to § 880.9. § 880.6820 Medical disposable scissors. [45 FR 69682, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998] (a) Identification. Medical disposable scissors are disposable type general § 880.6785 Manual patient transfer de- cutting devices intended for medical vice. purposes. This generic type of device (a) Identification. A manual patient does not include surgical scissors. transfer device is a device consisting of (b) Classification. Class I (general con- a wheeled stretcher and a mechanism trols). The device is exempt from the on which a patient can be placed so premarket notification procedures in

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subpart E of part 807 of this chapter, Format of Premarket Notification subject to the limitations in § 880.9. (510(k)) Submissions for Liquid Chem- ical Sterilants/High Level Disinfect- [45 FR 69682, Oct. 21, 1980, as amended at 66 FR 38807, July 25, 2001] ants, and user information and training. § 880.6850 Sterilization wrap. [65 FR 36325, June 8, 2000] (a) Identification. A sterilization wrap (pack, sterilization wrapper, bag, or ac- § 880.6890 General purpose disinfect- cessories, is a device intended to be ants. used to enclose another medical device (a) Identification. A general purpose that is to be sterilized by a health care disinfectant is a germicide intended to provider. It is intended to allow steri- process noncritical medical devices and lization of the enclosed medical device equipment surfaces. A general purpose and also to maintain sterility of the disinfectant can be used to preclean or enclosed device until used. decontaminate critical or semicritical (b) Classification. Class II (perform- medical devices prior to terminal steri- ance standards). lization or high level disinfection. Non- § 880.6860 Ethylene oxide gas steri- critical medical devices make only top- lizer. ical contact with intact skin. (b) Classification. Class I (general con- (a) Identification. An ethylene gas trols). The device is exempt from the sterilizer is a nonportable device intended for use by a health care pro- premarket notification procedures in vider that uses ethylene oxide (ETO) to subpart E of part 807 of this chapter sterilize medical products. subject to the limitations in § 880.9. (b) Classification. Class II (perform- [65 FR 36326, June 8, 2000] ance standards). § 880.6900 Hand-carried stretcher. § 880.6870 Dry-heat sterilizer. (a) Identification. A hand-carried (a) Identification. A dry-heat sterilizer stretcher is a device consisting of a is a device that is intended for use by lightweight frame, or of two poles with a health care provider to sterilize med- a cloth or metal platform, on which a ical products by means of dry heat. patient can be carried. (b) Classification. Class II (perform- (b) Classification. Class I (general con- ance standards). trols). The device is exempt from the § 880.6880 Steam sterilizer. premarket notification procedures in subpart E of part 807 of this chapter, (a) Identification. A steam sterilizer subject to the limitations in § 880.9. The (autoclave) is a device that is intended device is also exempt from the current for use by a health care provider to good manufacturing practice require- sterilize medical products by means of ments of the quality system regulation pressurized steam. in part 820 of this chapter, with the ex- (b) Classification. Class II (perform- ception of § 820.180, with respect to gen- ance standards). eral requirements concerning records, § 880.6885 Liquid chemical sterilants/ and § 820.198, with respect to complaint high level disinfectants. files. (a) Identification. A liquid chemical [45 FR 69682, Oct. 21, 1980, as amended at 59 sterilant/high level disinfectant is a FR 63011, Dec. 7, 1994; 66 FR 38807, July 25, germicide that is intended for use as 2001] the terminal step in processing critical and semicritical medical devices prior § 880.6910 Wheeled stretcher. to patient use. Critical devices make (a) Identification. A wheeled stretcher contact with normally sterile tissue or is a device consisting of a platform body spaces during use. Semicritical mounted on a wheeled frame that is de- devices make contact during use with signed to transport patients in a hori- mucous membranes or nonintact skin. zontal position. The device may have (b) Classification. Class II (special side rails, supports for fluid infusion controls). Guidance on the Content and equipment, and patient securement

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straps. The frame may be fixed or col- subpart E of part 807 of this chapter, lapsible for use in an ambulance. subject to the limitations in § 880.9. (b) Classification. Class II (special [45 FR 69682, Oct. 21, 1980, as amended at 54 controls). The device is exempt from FR 25050, June 12, 1989; 66 FR 38807, July 25, the premarket notification procedures 2001] in subpart E of part 807 of this chapter subject to § 880.9. § 880.6980 Vein stabilizer. (a) Identification. A vein stabilizer is [45 FR 69682, Oct. 21, 1980, as amended at 63 a device consisting of a flat piece of FR 59229, Nov. 3, 1998] plastic with two noninvasive prongs. § 880.6920 Syringe needle introducer. The device is placed on the skin so that the prongs are on either side of a vein (a) Identification. A syringe needle in- and hold it stable while a hypodermic troducer is a device that uses a spring- needle is inserted into the vein. loaded mechanism to drive a hypo- (b) Classification. Class I (general con- dermic needle into a patient to a pre- trols). The device is exempt from the determined depth below the skin sur- premarket notification procedures in face. subpart E of part 807 of this chapter, (b) Classification. Class II (perform- subject to the limitations in § 880.9. If ance standards). the device is not labeled or otherwise represented as sterile, it is also exempt § 880.6960 Irrigating syringe. from the current good manufacturing (a) Identification. An irrigating sy- practice requirements of the quality ringe is a device intended for medical system regulation in part 820 of this purposes that consists of a bulb or a chapter, with the exception of § 820.180, piston syringe with an integral or a de- with respect to general requirements tachable tube. The device is used to ir- concerning records, and § 820.198, with rigate, withdraw fluid from, or instill respect to complaint files. fluid into, a body cavity or wound. [45 FR 69682, Oct. 21, 1980, as amended at 66 (b) Classification. Class I (general con- FR 38807, July 25, 2001] trols). The device is exempt from the § 880.6990 Infusion stand. premarket notification procedures in subpart E of part 807 of this chapter, (a) Identification. The infusion stand subject to the limitations in § 880.9. If is a stationary or movable stand in- the device is not labeled or otherwise tended to hold infusion liquids, infu- represented as sterile, it is also exempt sion accessories, and other medical de- from the current good manufacturing vices. practice requirements of the quality (b) Classification. Class I (general con- system regulation in part 820 of this trols). The device is exempt from the chapter, with the exception of § 820.180, premarket notification procedures in with respect to general requirements subpart E of part 807 of this chapter concerning records, and § 820.198, with subject to the limitations in § 880.9. respect to complaint files. [63 FR 59718, Nov. 5, 1998] [45 FR 69682, Oct. 21, 1980, as amended at 66 § 880.6991 Medical washer. FR 38807, July 25, 2001] (a) Identification. A medical washer is § 880.6970 Liquid crystal vein locator. a device that is intended for general medical purposes to clean and dry sur- (a) Identification. A liquid crystal gical instruments, anesthesia equip- vein locator is a device used to indicate ment, hollowware, and other medical the location of a vein by revealing vari- devices. ations in the surface temperature of (b) Classification. Class II (special the skin by displaying the color controls). The special control for this changes of heat sensitive liquid crys- device is the FDA guidance document tals (cholesteric esters). entitled ‘‘Class II Special Controls (b) Classification. Class I (general con- Guidance Document: Medical Washers trols). The device is exempt from the and Medical Washer-Disinfectors.’’ The premarket notification procedures in device is exempt from the premarket

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notification procedures in subpart E of 882.1400 Electroencephalograph. part 807 of this chapter subject to 882.1410 Electroencephalograph electrode/ § 880.9. lead tester. 882.1420 Electroencephalogram (EEG) signal [67 FR 69121, Nov. 15, 2002] spectrum analyzer. 882.1430 Electroencephalograph test signal § 880.6992 Medical washer-disinfector. generator. (a) Identification. A medical washer- 882.1440 Neuropsychiatric interpretive electroencephalograph assessment aid. disinfector is a device that is intended 882.1450 Brain injury adjunctive interpre- for general medical purposes to clean, tive electroencephalograph assessment decontaminate, disinfect, and dry sur- aid. gical instruments, anesthesia equip- 882.1460 Nystagmograph. ment, hollowware, and other medical 882.1470 Computerized cognitive assessment devices. aid. (b) Classification. Class II (special 882.1471 Computerized cognitive assessment controls). The special control for this aid for concussion. 882.1480 Neurological endoscope. device is the FDA guidance document 882.1500 Esthesiometer. entitled ‘‘Class II Special Controls 882.1525 Tuning fork. Guidance Document: Medical Washers 882.1540 Galvanic skin response measure- and Medical Washer-Disinfectors.’’ ment device. (1) Medical washer-disinfectors that 882.1550 Nerve conduction velocity measure- are intended to clean, high level dis- ment device. infect, and dry surgical instruments, 882.1560 Skin potential measurement de- anesthesia equipment, hollowware, and vice. 882.1561 Evoked photon image capture de- other medical devices. vice. (2) Medical washer-disinfectors that 882.1570 Powered direct-contact tempera- are intended to clean, low or inter- ture measurement device. mediate level disinfect, and dry sur- 882.1610 Alpha monitor. gical instruments, anesthesia equip- 882.1620 Intracranial pressure monitoring ment, hollowware, and other medical device. devices are exempt from the premarket 882.1700 Percussor. 882.1750 Pinwheel. notification procedures in subpart E of 882.1790 Ocular plethysmograph. part 807 of this chapter subject to 882.1825 Rheoencephalograph. § 880.9. 882.1835 Physiological signal amplifier. 882.1845 Physiological signal conditioner. [67 FR 69121, Nov. 15, 2002] 882.1855 Electroencephalogram (EEG) telemetry system. PART 882—NEUROLOGICAL 882.1870 Evoked response electrical stimu- DEVICES lator. 882.1880 Evoked response mechanical stimu- Subpart A—General Provisions lator. 882.1890 Evoked response photic stimulator. Sec. 882.1900 Evoked response auditory stimu- 882.1 Scope. lator. 882.3 Effective dates of requirement for pre- 882.1925 Ultrasonic scanner calibration test market approval. block. 882.9 Limitations of exemptions from sec- 882.1935 Near Infrared (NIR) Brain Hema- tion 510(k) of the Federal Food, Drug, toma Detector. and Cosmetic Act (the act). 882.1950 Tremor transducer.

Subpart B—Neurological Diagnostic Subparts C–D [Reserved] Devices Subpart E—Neurological Surgical Devices 882.1020 Rigidity analyzer. 882.1030 Ataxiagraph. 882.4030 Skull plate anvil. 882.1200 Two-point discriminator. 882.4060 Ventricular cannula. 882.1240 Echoencephalograph. 882.4100 Ventricular catheter. 882.1275 Electroconductive media. 882.4125 Neurosurgical chair. 882.1310 Cortical electrode. 882.4150 Scalp clip. 882.1320 Cutaneous electrode. 882.4175 Aneurysm clip applier. 882.1330 Depth electrode. 882.4190 Clip forming/cutting instrument. 882.1340 Nasopharyngeal electrode. 882.4200 Clip removal instrument. 882.1350 Needle electrode. 882.4215 Clip rack.

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882.4250 Cryogenic surgical device. 882.5810 External functional neuromuscular 882.4275 Dowel cutting instrument. stimulator. 882.4300 Manual cranial drills, burrs, 882.5820 Implanted cerebellar stimulator. trephines, and their accessories. 882.5830 Implanted diaphragmatic/phrenic 882.4305 Powered compound cranial drills, nerve stimulator. burrs, trephines, and their accessories. 882.5840 Implanted intracerebral/subcortical 882.4310 Powered simple cranial drills, stimulator for pain relief. burrs, trephines, and their accessories. 882.5850 Implanted spinal cord stimulator 882.4325 Cranial drill handpiece (brace). for bladder evacuation. 882.4360 Electric cranial drill motor. 882.5860 Implanted neuromuscular stimu- 882.4370 Pneumatic cranial drill motor. lator. 882.4400 Radiofrequency lesion generator. 882.5870 Implanted peripheral nerve stimu- 882.4440 Neurosurgical headrests. lator for pain relief. 882.4460 Neurosurgical head holder (skull 882.5880 Implanted spinal cord stimulator clamp). for pain relief. 882.4500 Cranioplasty material forming in- 882.5890 Transcutaneous electrical nerve strument. stimulator for pain relief. 882.4525 Microsurgical instrument. 882.5891 Transcutaneous electrical nerve 882.4535 Nonpowered neurosurgical instru- stimulator to treat headache. ment. 882.5900 Preformed craniosynostosis strip. 882.4545 Shunt system implantation instru- 882.5894 Limited output transcutaneous pi- ment. ezoelectric stimulator for skin reactions 882.4560 Stereotaxic instrument. associated with insect bites. 882.4600 Leukotome. 882.5895 Vibratory counter-stimulation de- 882.4650 Neurosurgical suture needle. vice. 882.4700 Neurosurgical paddie. 882.4725 Radiofrequency lesion probe. 882.5910 Dura substitute. 882.4750 Skull punch. 882.5940 Electroconvulsive therapy device. 882.4800 Self-retaining retractor for neuro- 882.5950 Neurovascular embolization device. surgery. 882.5960 Skull tongs for traction. 882.4840 Manual rongeur. 882.5970 Cranial orthosis. 882.4845 Powered rongeur. 882.5975 Human dura mater. 882.4900 Skullplate screwdriver. AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. Subpart F—Neurological Therapeutic Devices SOURCE: 44 FR 51730, Sept. 4, 1979, unless otherwise noted. 882.5030 Methyl methacrylate for EDITORIAL NOTE: Nomenclature changes to aneurysmorrhaphy. part 882 appear at 73 FR 35341, June 23, 2008. 882.5050 Biofeedback device. 882.5070 Bite block. 882.5150 Intravascular occluding catheter. Subpart A—General Provisions 882.5175 Carotid artery clamp. 882.5200 Aneurysm clip. § 882.1 Scope. 882.5225 Implanted malleable clip. (a) This part sets forth the classifica- 882.5235 Aversive conditioning device. 882.5250 Burr hole cover. tion of neurological devices intended 882.5275 Nerve cuff. for human use that are in commercial 882.5300 Methyl methacrylate for distribution. cranioplasty. (b) The identification of a device in a 882.5320 Preformed alterable cranioplasty regulation in this part is not a precise plate. description of every device that is, or 882.5330 Preformed nonalterable will be, subject to the regulation. A cranioplasty plate. 882.5360 Cranioplasty plate fastener. manufacturer who submits a pre- 882.5500 Lesion temperature monitor. market notification submission for a 882.5550 Central nervous system fluid shunt device under part 807 may not show and components. merely that the device is accurately 882.5600 Neurovascular mechanical described by the section title and iden- thrombectomy device for acute ischemic tification provisions of a regulation in stroke treatment. this part, but shall state why the de- 882.5700 Thermal system for insomnia. vice is substantially equivalent to 882.5800 Cranial electrotherapy stimulator. 882.5805 Repetitive transcranial magnetic other devices, as required by § 807.87. stimulation system. (c) To avoid duplicative listings, a 882.5808 Transcranial magnetic stimulator neurological device that has two or for headache. more types of uses (e.g., used both as a

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diagnostic device and as a therapeutic tion under section 515(b) of the act re- device) is listed only in one subpart. quiring premarket approval for a de- (d) References in this part to regu- vice, section, 501(f)(1)(A) of the act ap- latory sections of the Code of Federal plies to the device. Regulations are to chapter I of title 21, (b) Any new, not substantially equiv- unless otherwise noted. alent, device introduced into commer- (e) Guidance documents referenced in cial distribution on or after May 28, this part are available on the Internet 1976, including a device formerly mar- at http://www.fda.gov/MedicalDevices/ keted that has been substantially al- DeviceRegulationandGuidance/ tered, is classified by statute (section GuidanceDocuments/default.htm.. 513(f) of the act) into class III without any grace period and FDA must have [52 FR 17739, May 11, 1987, as amended at 68 FR 70436, Dec. 18, 2003; 78 FR 18233, Mar. 26, issued an order approving a PMA or de- 2013] claring completed a PDP for the device before the device is commercially dis- § 882.3 Effective dates of requirement tributed unless it is reclassified. If for premarket approval. FDA knows that a device being com- A device included in this part that is mercially distributed may be a ‘‘new’’ classified into class III (premarket ap- device as defined in this section be- proval) shall not be commercially dis- cause of any new intended use or other tributed after the date shown in the reasons, FDA may codify the statutory regulation classifying the device unless classification of the device into class the manufacturer has an approval III for such new use. Accordingly, the under section 515 of the act (unless an regulation for such a class III device exemption has been granted under sec- states that as of the enactment date of tion 520(g)(2) of the act). An approval the amendments, May 28, 1976, the de- under section 515 of the act consists of vice must have an approval under sec- FDA’s issuance of an order approving tion 515 of the act before commercial an application for premarket approval distribution. (PMA) for the device or declaring com- [52 FR 17739, May 11, 1987] pleted a product development protocol (PDP) for the device. § 882.9 Limitations of exemptions from (a) Before FDA requires that a device section 510(k) of the Federal Food, commercially distributed before the Drug, and Cosmetic Act (the act). enactment date of the amendments, or The exemption from the requirement a device that has been found substan- of premarket notification (section tially equivalent to such a device, has 510(k) of the act) for a generic type of an approval under section 515 of the act class I or II device is only to the extent FDA must promulgate a regulation that the device has existing or reason- under section 515(b) of the act requir- ably foreseeable characteristics of ing such approval, except as provided commercially distributed devices within paragraph (b) of this section. Such a in that generic type or, in the case of regulation under section 515(b) of the in vitro diagnostic devices, only to the act shall not be effective during the extent that misdiagnosis as a result of grace period ending on the 90th day using the device would not be associ- after its promulgation or on the last ated with high morbidity or mortality. day of the 30th full calendar month Accordingly, manufacturers of any after the regulation that classifies the commercially distributed class I or II device into class III is effective, which- device for which FDA has granted an ever is later. See section 501(f)(2)(B) of exemption from the requirement of the act. Accordingly, unless an effec- premarket notification must still sub- tive date of the requirement for pre- mit a premarket notification to FDA market approval is shown in the regu- before introducing or delivering for in- lation for a device classified into class troduction into interstate commerce III in this part, the device may be com- for commercial distribution the device mercially distributed without FDA’s when: issuance of an order approving a PMA (a) The device is intended for a use or declaring completed a PDP for the different from the intended use of a le- device. If FDA promulgates a regula- gally marketed device in that generic

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type of device; e.g., the device is in- Subpart B—Neurological tended for a different medical purpose, Diagnostic Devices or the device is intended for lay use where the former intended use was by § 882.1020 Rigidity analyzer. health care professionals only; (a) Identification. A rigidity analyzer (b) The modified device operates is a device for quantifying the extent of using a different fundamental sci- the rigidity of a patient’s limb to de- entific technology than a legally mar- termine the effectiveness of drugs or keted device in that generic type of de- other treatments. vice; e.g., a surgical instrument cuts (b) Classification. Class II (perform- tissue with a laser beam rather than ance standards). with a sharpened metal blade, or an in vitro diagnostic device detects or iden- § 882.1030 Ataxiagraph. tifies infectious agents by using (a) Identification. An ataxiagraph is a deoxyribonucleic acid (DNA) probe or device used to determine the extent of nucleic acid hybridization technology ataxia (failure of muscular coordina- rather than culture or immunoassay tion) by measuring the amount of technology; or swaying of the body when the patient (c) The device is an in vitro device is standing erect and with eyes closed. that is intended: (b) Classification. Class I (general con- (1) For use in the diagnosis, moni- trols). toring, or screening of neoplastic diseases with the exception of [44 FR 51730, Sept. 4, 1979, as amended at 66 FR 46952, Sept. 10, 2001] immunohistochemical devices; (2) For use in screening or diagnosis § 882.1200 Two-point discriminator. of familial or acquired genetic disorders, including inborn errors of me- (a) Identification. A two-point dis- tabolism; criminator is a device with points used for testing a patient’s touch discrimi- (3) For measuring an analyte that nation. serves as a surrogate marker for (b) Classification. Class I (general con- screening, diagnosis, or monitoring trols). The device is exempt from the life-threatening diseases such as ac- premarket notification procedures in quired immune deficiency syndrome subpart E of part 807 of this chapter (AIDS), chronic or active hepatitis, tu- subject to § 882.9. The device is also ex- berculosis, or myocardial infarction or empt from the current good manufac- to monitor therapy; turing practice requirements of the (4) For assessing the risk of cardio- quality system regulation in part 820 of vascular diseases; this chapter, with the exception of (5) For use in diabetes management; § 820.180 of this chapter, with respect to (6) For identifying or inferring the general requirements concerning identity of a microorganism directly records, and § 820.198 of this chapter, from clinical material; with respect to complaint files. (7) For detection of antibodies to [44 FR 51730, Sept. 4, 1979, as amended at 54 microorganisms other than FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, immunoglobulin G (IgG) or IgG assays 2000] when the results are not qualitative, or are used to determine immunity, or the § 882.1240 Echoencephalograph. assay is intended for use in matrices (a) Identification. An other than serum or plasma; echoencephalograph is an ultrasonic (8) For noninvasive testing as defined scanning device (including A-scan, B- in § 812.3(k) of this chapter; and scan, and doppler systems) that uses (9) For near patient testing (point of noninvasive transducers for measuring care). intracranial interfaces and blood flow velocity to and in the head. [65 FR 2319, Jan. 14, 2000] (b) Classification. Class II (performance standards).

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§ 882.1275 Electroconductive media. to measure and record the electrical activity of the patient’s brain obtained (a) Identification. Electroconductive by placing two or more electrodes on media are the conductive creams or the head. gels used with external electrodes to (b) Classification. Class II (perform- reduce the impedance (resistance to al- ance standards). ternating current) of the contact between the electrode surface and the § 882.1410 Electroencephalograph elec- skin. trode/lead tester. (b) Classification. Class II (perform- (a) Identification. An ance standards). electroencephalograph electrode/lead § 882.1310 Cortical electrode. tester is a device used for testing the impedance (resistance to alternating (a) Identification. A cortical electrode current) of the electrode and lead sys- is an electrode which is temporarily tem of an electroencephalograph to as- placed on the surface of the brain for sure that an adequate contact is made stimulating the brain or recording the between the electrode and the skin. brain’s electrical activity. (b) Classification. Class I (general con- (b) Classification. Class II (perform- trols). The device is exempt from the ance standards). premarket notification procedures in subpart E of part 807 of this chapter § 882.1320 Cutaneous electrode. subject to the limitations in § 882.9. (a) Identification. A cutaneous electrode is an electrode that is applied di- [44 FR 51730, Sept. 4, 1979, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38807, July 25, rectly to a patient’s skin either to 2001] record physiological signals (e.g., the electroencephalogram) or to apply § 882.1420 Electroencephalogram electrical stimulation. (EEG) signal spectrum analyzer. (b) Classification. Class II (perform- (a) Identification. An electroencepha- ance standards). logram (EEG) signal spectrum analyzer is a device used to display the fre- § 882.1330 Depth electrode. quency content or power spectral den- (a) Identification. A depth electrode is sity of the electroencephalogram an electrode used for temporary stimu- (EEG) signal. lation of, or recording electrical sig- (b) Classification. Class I (general con- nals at, subsurface levels of the brain. trols). (b) Classification. Class II (perform- [44 FR 51730, Sept. 4, 1979, as amended at 66 ance standards). FR 46953, Sept. 10, 2001]

§ 882.1340 Nasopharyngeal electrode. § 882.1430 Electroencephalograph test (a) Identification. A nasopharyngeal signal generator. electrode is an electrode which is tem- (a) Identification. An porarily placed in the nasopharyngeal electroencephalograph test signal gen- region for the purpose of recording erator is a device used to test or cali- electrical activity. brate an electroencephalograph. (b) Classification. Class II (perform- (b) Classification. Class I (general con- ance standards). trols). The device is exempt from the premarket notification procedures in § 882.1350 Needle electrode. subpart E of part 807 of this chapter (a) Identification. A needle electrode subject to the limitations in § 882.9. is a device which is placed [44 FR 51730, Sept. 4, 1979, as amended at 59 subcutaneously to stimulate or to FR 63011, Dec. 7, 1994; 66 FR 38807, July 25, record electrical signals. 2001] (b) Classification. Class II (performance standards). § 882.1440 Neuropsychiatric interpretive electroencephalograph assess- § 882.1400 Electroencephalograph. ment aid. (a) Identification. An (a) Identification. The electroencephalograph is a device used neuropsychiatric interpretive

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electroencephalograph assessment aid (6) The device design must include is a prescription device that uses a pa- safeguards to prevent use of the device tient’s electroencephalograph (EEG) to as a stand-alone diagnostic. provide an interpretation of the pa- (7) The labeling must include the fol- tient’s neuropsychiatric condition. The lowing information: neuropsychiatric interpretive EEG as- (i) A warning that the device is not sessment aid is used only as an assess- to be used as a stand-alone diagnostic. ment aid for a medical condition for (ii) A detailed summary of the clin- which there exists other valid methods ical performance testing, including any of diagnosis. adverse events and complications. (b) Classification. Class II (special (iii) The qualifications and training controls). The special controls for this requirements for device users including device are: technicians and clinicians. (1) The technical parameters of the (iv) The intended use population and device, hardware and software, must be the intended use environment. fully characterized and must dem- (v) Any instructions technicians onstrate a reasonable assurance of should convey to patients regarding safety and effectiveness. the collection of EEG data. (i) Hardware specifications must be (vi) Information allowing clinicians provided. Appropriate verification, val- to gauge clinical risk associated with idation, and hazard analysis must be integrating the EEG interpretive as- performed. sessment aid into their diagnostic (ii) Software, including any propri- pathway. etary algorithm(s) used by the device (vii) Where appropriate, validated to arrive at its interpretation of the methods and instructions for reprocess- patient’s condition, must be described ing of any reusable components. in detail in the software requirements [79 FR 9085, Feb. 18, 2014] specification and software design specification. Appropriate software § 882.1450 Brain injury adjunctive in- verification, validation, and hazard terpretive electroencephalograph analysis must be performed. assessment aid. (2) The device parts that contact the (a) Identification. A brain injury ad- patient must be demonstrated to be junctive interpretive biocompatible. electroencephalograph assessment aid (3) The device must be designed and is a prescription device that uses a pa- tested for electrical safety, electro- tient’s electroencephalograph (EEG) to magnetic compatibility, thermal, and provide an interpretation of the struc- mechanical safety. tural condition of the patient’s brain in (4) Clinical performance testing must the setting of trauma. A brain injury demonstrate the accuracy, precision, adjunctive interpretive EEG assess- reproducibility, of determining the ment aid is for use as an adjunct to EEG-based interpretation, including standard clinical practice only as an any specified equivocal zones (cutoffs). assessment aid for a medical condition (5) Clinical performance testing must for which there exists other valid demonstrate the ability of the device methods of diagnosis. to function as an assessment aid for (b) Classification. Class II (special the medical condition for which the de- controls). The special controls for this vice is indicated. Performance meas- device are: ures must demonstrate device perform- (1) The technical parameters of the ance characteristics per the intended device, hardware and software, must be use in the intended use environment. fully characterized and include the fol- Performance measurements must in- lowing information: clude sensitivity, specificity, positive (i) Hardware specifications must be predictive value, and negative pre- provided. Appropriate verification, val- dictive value per the device intended idation, and hazard analysis must be use. Repeatability of measurements performed. must be demonstrated using interclass (ii) Software, including any propri- correlation coefficients and illustrated etary algorithm(s) used by the device by qualitative scatter plot(s). to arrive at its interpretation of the

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patient’s condition, must be described way when the device is unable to pro- in detail in the software requirements vide a classification or final result. specification (SRS) and software design [80 FR 16268, Mar. 27, 2015] specification (SDS). Appropriate software verification, validation, and haz- § 882.1460 Nystagmograph. ard analysis must be performed. (a) Identification. A nystagmograph is (2) The device parts that contact the a device used to measure, record, or patient must be demonstrated to be visually display the involuntary move- biocompatible. ments (nystagmus) of the eyeball. (3) The device must be designed and (b) Classification. Class II (perform- tested for electrical safety, electro- ance standards). magnetic compatibility (EMC), thermal, and mechanical safety. § 882.1470 Computerized cognitive as- (4) Clinical performance testing must sessment aid. demonstrate the accuracy, precision- (a) Identification. The computerized repeatability and reproducibility, of cognitive assessment aid is a prescrip- determining the EEG-based interpretation device that uses an individual’s tion, including any specified equivocal score(s) on a battery of cognitive tasks zones (cutoffs). to provide an interpretation of the cur- (5) Clinical performance testing must rent level of cognitive function. The demonstrate the ability of the device computerized cognitive assessment aid to function as an assessment aid for is used only as an assessment aid to de- the medical condition for which the determine level of cognitive functioning vice is indicated. Performance meas- for which there exists other valid ures must demonstrate device perform- methods of cognitive assessment and ance characteristics per the intended does not identify the presence or abuse in the intended use environment. sence of clinical diagnoses. The com- Performance measurements must in- puterized cognitive assessment aid is clude sensitivity, specificity, positive not intended as a stand-alone or ad- predictive value (PPV), and negative junctive diagnostic device. predictive value (NPV) with respect to (b) Classification. Class II (special the study prevalence per the device in- controls). The special control(s) for tended use. this device are: (6) The device design must include (1) The technical parameters of the safeguards to ensure appropriate clin- device’s hardware and software must be ical interpretation of the device output fully characterized and be accompanied (e.g., use in appropriate patient popu- by appropriate non-clinical testing: lation, or for appropriate clinical deci- (i) Hardware specifications must be sion). provided. Appropriate verification, val- (7) The labeling and training infor- idation, and hazard analysis must be mation must include: performed. (i) A warning that the device is not (ii) Software, including any propri- to be used as a stand-alone diagnostic. etary algorithm(s) used by the device (ii) A detailed summary of the clin- to arrive at its interpretation of the ical performance testing, including any patient’s cognitive function, must be adverse events and complications. described in detail in the software re- (iii) The intended use population and quirements specification (SRS) and the intended use environment. software design specification (SDS). (iv) Any instructions technicians Appropriate software verification, vali- should convey to patients regarding dation, and hazard analysis must be the collection of EEG data. performed. (v) Information allowing clinicians to (2) The device must be designed and gauge clinical risk associated with in- tested for electrical safety. tegrating the EEG interpretive assess- (3) The labeling must include: ment aid into their diagnostic path- (i) A summary of any testing con- way. ducted to demonstrate how the device (vi) Information allowing clinicians functions as an interpretation of the to understand how to integrate the de- current level of cognitive function. The vice output into their diagnostic path- summary of testing must include the

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following, if available: Any expected or the current level of cognitive function observed adverse events and complica- in an individual that has recently re- tions; any performance measurements ceived an injury that causes concern including sensitivity, specificity, posi- about a possible concussion. The test- tive predictive value (PPV), and nega- ing must: tive predictive value (NPV) per the de- (i) Evaluate device output and clin- vices intended use; a description of the ical interpretation. repeatability of measurements; a de- (ii) Evaluate device test-retest reli- scription of how the cut-off values for ability of the device output. categorization of measurements were (iii) Evaluate construct validity of determined; and a description of the the device cognitive assessments. construct validity of the device. (iv) Describe the construction of the (ii) A warning that the device does normative database, which includes the not identify the presence or absence of following: clinical diagnoses. (A) How the clinical workup was (iii) A warning that the device is not completed to establish a ‘‘normal’’ pop- a stand-alone diagnostic. ulation, including the establishment of (iv) The intended use population and inclusion and exclusion criteria. the intended use environment. (B) Statistical methods and model (v) Any instructions technicians assumptions used. must convey to patients regarding the (3) The labeling must include: administration of the test and collec- (i) A summary of any clinical testing tion of cognitive test data. conducted to demonstrate how the de- [80 FR 49138, Aug. 17, 2015] vice functions as an interpretation of the current level of cognitive function § 882.1471 Computerized cognitive as- in a patient that has recently received sessment aid for concussion. an injury that causes concern about a (a) Identification. The computerized possible concussion. The summary of cognitive assessment aid for concus- testing must include the following: sion is a prescription device that uses (A) Device output and clinical inter- an individual’s score(s) on a battery of pretation. cognitive tasks to provide an indica- (B) Device test-retest reliability of tion of the current level of cognitive the device output. function in response to concussion. The (C) Construct validity of the device computerized cognitive assessment aid cognitive assessments. for concussion is used only as an as- (D) A description of the normative sessment aid in the management of database, which includes the following: concussion to determine cognitive (1) How the clinical workup was com- function for patients after a potential pleted to establish a ‘‘normal’’ popu- concussive event where other diag- lation, including the establishment of nostic tools are available and does not inclusion and exclusion criteria. identify the presence or absence of con- (2) How normal values will be re- cussion. It is not intended as a stand- ported to the user. alone diagnostic device. (3) Representative screen shots and (b) Classification. Class II (special reports that will be generated to pro- controls). The special controls for this vide the user results and normative device are: data. (1) Software, including any propri- (4) Statistical methods and model as- etary algorithm(s) used by the device sumptions used. to arrive at its interpretation of the (5) Whether or not the normative patient’s cognitive function, must be database was adjusted due to dif- described in detail in the software references in age and gender. quirements specification (SRS) and (ii) A warning that the device should software design specification (SDS). only be used by health care profes- Software verification, validation, and sionals who are trained in concussion hazard analysis must be performed. management. (2) Clinical performance data must be (iii) A warning that the device does provided that demonstrates how the not identify the presence or absence of device functions as an interpretation of concussion or other clinical diagnoses.

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(iv) A warning that the device is not cerning records, and § 820.198, with re- a stand-alone diagnostic. spect to complaint files. (v) Any instructions technicians must convey to patients regarding the [44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 66 FR 38807, July 25, administration of the test and collec- 2001] tion of cognitive test data. [81 FR 87811, Dec. 6, 2016] § 882.1540 Galvanic skin response measurement device. § 882.1480 Neurological endoscope. (a) Identification. A galvanic skin re- (a) Identification. A neurological en- sponse measurement device is a device doscope is an instrument with a light used to determine autonomic responses source used to view the inside of the as psychological indicators by meas- ventricles of the brain. uring the electrical resistance of the (b) Classification. Class II (perform- skin and the tissue path between two ance standards). electrodes applied to the skin. (b) Classification. Class II (perform- § 882.1500 Esthesiometer. ance standards). (a) Identification. An esthesiometer is a mechanical device which usually con- § 882.1550 Nerve conduction velocity sists of a single rod or fiber which is measurement device. held in the fingers of the physician or (a) Identification. A nerve conduction other examiner and which is used to velocity measurement device is a de- determine whether a patient has tac- vice which measures nerve conduction tile sensitivity. time by applying a stimulus, usually to (b) Classification. Class I (general con- a patient’s peripheral nerve. This de- trols). The device is exempt from the vice includes the stimulator and the premarket notification procedures in electronic processing equipment for subpart E of part 807 of this chapter measuring and displaying the nerve subject to § 882.9. The device is also ex- conduction time. empt from the current good manufacturing practice requirements of the (b) Classification. Class II (perform- quality system regulation in part 820 of ance standards). this chapter, with the exception of § 882.1560 Skin potential measurement § 820.180 of this chapter, with respect to device. general requirements concerning records, and § 820.198 of this chapter, (a) Identification. A skin potential with respect to complaint files. measurement device is a general diagnostic device used to measure skin [44 FR 51730, Sept. 4, 1979, as amended at 54 voltage by means of surface skin elec- FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, 2000] trodes. (b) Classification. Class II (perform- § 882.1525 Tuning fork. ance standards). (a) Identification. A tuning fork is a § 882.1561 Evoked photon image cap- mechanical device which resonates at a ture device. given frequency and is used to diagnose hearing disorders and to test for vibra- (a) Identification. An evoked photon tory sense. image capture device is a prescription, (b) Classification. Class I (general con- electrically powered device intended trols). The device is exempt from the for use as a noninvasive measurement premarket notification procedures in tool that applies electricity to detect subpart E of part 807 of this chapter electrophysiological signals emanating subject to the limitations in § 882.9. The from the skin, which are reported nu- device is also exempt from the current merically and as images without clin- good manufacturing practice require- ical interpretation. The device is not ments of the quality system regulation intended for diagnostic purposes. in part 820 of this chapter, of this chap- (b) Classification. Class I (general con- ter, with the exception of § 820.180, with trols). The device is exempt from the respect to general requirements con- premarket notification procedures in

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subpart E of part 807 of this chapter, and § 820.198, with respect to complaint subject to the limitations in § 882.9. files. [81 FR 67155, Sept. 30, 2016] [44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 59 FR 63011, Dec. 7, § 882.1570 Powered direct-contact tem- 1994; 66 FR 38807, July 25, 2001] perature measurement device. § 882.1750 Pinwheel. (a) Identification. A powered direct- (a) Identification. A pinwheel is a de- contact temperature measurement device with sharp points on a rotating vice is a device which contains a power wheel used for testing pain sensation. source and is used to measure dif- (b) Classification. Class I (general con- ferences in temperature between two trols). The device is exempt from the points on the body. premarket notification procedures in (b) Classification. Class II (perform- subpart E of part 807 of this chapter ance standards). subject to § 882.9. § 882.1610 Alpha monitor. [44 FR 51730, Sept. 4, 1979, as amended at 54 FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, (a) Identification. An alpha monitor is 2000] a device with electrodes that are placed on a patient’s scalp to monitor § 882.1790 Ocular plethysmograph. that portion of the electroencepha- (a) Identification. An ocular logram which is referred to as the plethysmograph is a device used to alpha wave. measure or detect volume changes in (b) Classification. Class II (perform- the eye produced by pulsations of the ance standards). artery, to diagnose carotid artery occlusive disease (restrictions on blood § 882.1620 Intracranial pressure moni- flow in the carotid artery). toring device. (b) Classification. Class III (premarket (a) Identification. An intracranial approval). pressure monitoring device is a device (c) Date PMA or notice of completion used for short-term monitoring and re- of PDP is required. A PMA or notice of completion of a PDP is required to be cording of intracranial pressures and filed with the Food and Drug Adminis- pressure trends. The device includes tration on or before September 21, 2004, the transducer, monitor, and inter- for any ocular plethysmograph that connecting hardware. was in commercial distribution before (b) Classification. Class II (perform- May 28, 1976. Any other ocular ance standards). plethysmograph shall have an approved PMA or declared completed PDP in ef- § 882.1700 Percussor. fect before being placed in commercial (a) Identification. A percussor is a distribution. small hammerlike device used by a [44 FR 51730, Sept. 4, 1979, as amended at 52 physician to provide light blows to a FR 17739, May 11, 1987; 69 FR 34920, June 23, body part. A percussor is used as a di- 2004] agnostic aid during physical examinations. § 882.1825 Rheoencephalograph. (b) Classification. Class I (general con- (a) Identification. A trols). The device is exempt from the rheoencephalograph is a device used to premarket notification procedures in estimate a patient’s cerebral circula- subpart E of part 807 of this chapter tion (blood flow in the brain) by elec- subject to the limitations in § 882.9. The trical impedance methods with direct device is also exempt from the current electrical connections to the scalp or good manufacturing practice require- neck area. ments of the quality system regulation (b) Classification. Class III (premarket in part 820 of this chapter, with the ex- approval). ception of § 820.180, with respect to gen- (c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of eral requirements concerning records, completion of a PDP is required to be

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filed with the Food and Drug Adminis- (b) Classification. Class II (perform- tration on or before December 26, 1996 ance standards). for any rheoencephalograph that was in commercial distribution before May § 882.1880 Evoked response mechan- 28, 1976, or that has, on or before De- ical stimulator. cember 26, 1996 been found to be sub- (a) Identification. An evoked response stantially equivalent to a mechanical stimulator is a device used rheoencephalograph that was in com- to produce a mechanical stimulus or a mercial distribution before May 28, series of mechanical stimuli for the 1976. Any other rheoencephalograph purpose of measuring a patient’s shall have an approved PMA or a de- evoked response. clared completed PDP in effect before (b) Classification. Class II (perform- being placed in commercial distribu- ance standards). tion. [44 FR 51730, Sept. 4, 1979, as amended at 52 § 882.1890 Evoked response photic FR 17740, May 11, 1987; 61 FR 50708, Sept. 27, stimulator. 1996] (a) Identification. An evoked response photic stimulator is a device used to § 882.1835 Physiological signal ampli- generate and display a shifting pattern fier. or to apply a brief light stimulus to a (a) Identification. A physiological sig- patient’s eye for use in evoked response nal amplifier is a general purpose de- measurements or for electroencepha- vice used to electrically amplify sig- logram (EEG) activation. nals derived from various physiological (b) Classification. Class II (perform- sources (e.g., the electroencepha- ance standards). logram). (b) Classification. Class II (perform- § 882.1900 Evoked response auditory ance standards). stimulator. (a) Identification. An evoked response § 882.1845 Physiological signal conditioner. auditory stimulator is a device that produces a sound stimulus for use in (a) Identification. A physiological sig- evoked response measurements or elec- nal conditioner is a device such as an troencephalogram activation. integrator or differentiator used to (b) Classification. Class II (perform- modify physiological signals for re- ance standards). cording and processing. (b) Classification. Class II (perform- § 882.1925 Ultrasonic scanner calibra- ance standards). tion test block. § 882.1855 Electroencephalogram (a) Identification. An ultrasonic scan- (EEG) telemetry system. ner calibration test block is a block of (a) Identification. An electroencepha- material with known properties used to logram (EEG) telemetry system con- calibrate ultrasonic scanning devices sists of transmitters, receivers, and (e.g., the echoencephalograph). other components used for remotely (b) Classification. Class I (general con- monitoring or measuring EEG signals trols). The device is exempt from the by means of radio or telephone trans- premarket notification procedures in mission systems. subpart E of part 807 of this chapter (b) Classification. Class II (perform- subject to the limitations in § 882.9. ance standards). [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63011, Dec. 7, 1994; 66 FR 38807, July 25, § 882.1870 Evoked response electrical 2001] stimulator. (a) Identification. An evoked response § 882.1935 Near Infrared (NIR) Brain electrical stimulator is a device used Hematoma Detector. to apply an electrical stimulus to a pa- (a) Identification. A Near Infrared tient by means of skin electrodes for (NIR) Brain Hematoma Detector is a the purpose of measuring the evoked noninvasive device that employs near- response. infrared spectroscopy that is intended

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to be used to evaluate suspected brain tion or for injection. This device is fre- hematomas. quently referred to as a ventricular (b) Classification. Class II (special needle. controls). The special controls for this (b) Classification. Class I (general con- device are: trols). When made only of surgical (1) The sale, distribution, and use of grade stainless steel, the device is ex- this device are restricted to prescrip- empt from the premarket notification tion use in accordance with § 801.109 of procedures in subpart E of part 807 of this chapter; this chapter subject to § 882.9. (2) The labeling must include specific instructions and the clinical training [44 FR 51730, Sept. 4, 1979, as amended at 65 needed for the safe use of this device; FR 2319, Jan. 14, 2000] (3) Appropriate analysis/testing should validate electromagnetic com- § 882.4100 Ventricular catheter. patibility (EMC), electrical safety, and (a) Identification. A ventricular cath- battery characteristics; eter is a device used to gain access to (4) Performance data should validate the cavities of the brain for injection accuracy and precision and safety fea- of material into, or removal of mate- tures; rial from, the brain. (5) Any elements of the device that (b) Classification. Class II (perform- may contact the patient should be ance standards). demonstrated to be biocompatible; and, (6) Appropriate software verification, § 882.4125 Neurosurgical chair. validation, and hazard analysis should be performed. (a) Identification. A neurosurgical chair is an operating room chair used [77 FR 16927, Mar. 23, 2012] to position and support a patient during neurosurgery. § 882.1950 Tremor transducer. (b) Classification. Class I (general con- (a) Identification. A tremor trans- trols). The device is exempt from the ducer is a device used to measure the premarket notification procedures in degree of tremor caused by certain dis- subpart E of part 807 of this chapter eases. subject to the limitations in § 882.9. (b) Classification. Class II (performance standards). [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, Subparts C–D [Reserved] 2001] § 882.4150 Scalp clip. Subpart E—Neurological Surgical Devices (a) Identification. A scalp clip is a plastic or metal clip used to stop bleed- § 882.4030 Skull plate anvil. ing during surgery on the scalp. (a) Identification. A skull plate anvil (b) Classification. Class II (perform- is a device used to form alterable skull ance standards). plates in the proper shape to fit the § 882.4175 Aneurysm clip applier. curvature of a patient’s skull. (b) Classification. Class I (general con- (a) Identification. An aneurysm clip trols). The device is exempt from the applier is a device used by the surgeon premarket notification procedures in for holding and applying intracranial subpart E of part 807 of this chapter aneurysm clips. subject to the limitations in § 882.9. (b) Classification. Class II (perform- [44 FR 51730, Sept. 4, 1979, as amended at 59 ance standards). FR 63011, Dec. 7, 1994; 66 FR 38808, July 25, 2001] § 882.4190 Clip forming/cutting instrument. § 882.4060 Ventricular cannula. (a) Identification. A clip forming/cut- (a) Identification. A ventricular ting instrument is a device used by the cannula is a device used to puncture physician to make tissue clips from the ventricles of the brain for aspira- wire stock.

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(b) Classification. Class I. The device § 882.4305 Powered compound cranial is exempt from the premarket notifica- drills, burrs, trephines, and their tion procedures in subpart E of part 807 accessories. of this chapter. (a) Identification. Powered compound [44 FR 51730, Sept. 4, 1979, as amended at 59 cranial drills, burrs, trephines, and FR 63012, Dec. 7, 1994] their accessories are bone cutting and drilling instruments used on a pa- § 882.4200 Clip removal instrument. tient’s skull. The instruments employ (a) Identification. A clip removal in- a clutch mechanism to disengage the strument is a device used to remove tip of the instrument after penetrating surgical clips from the patient. the skull to prevent plunging of the tip (b) Classification. Class I (general con- into the brain. trols). The device is exempt from the (b) Classification. Class II (perform- premarket notification procedures in ance standards). subpart E of part 807 of this chapter subject to the limitations in § 882.9. § 882.4310 Powered simple cranial drills, burrs, trephines, and their [44 FR 51730, Sept. 4, 1979, as amended at 59 accessories. FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001] (a) Identification. Powered simple cranial drills, burrs, trephines, and their § 882.4215 Clip rack. accessories are bone cutting and drill- (a) Identification. A clip rack is a de- ing instruments used on a patient’s vice used to hold or store surgical clips skull. The instruments are used with a during surgery. power source but do not have a clutch (b) Classification. Class I (general con- mechanism to disengage the tip after trols). The device is exempt from the penetrating the skull. premarket notification procedures in (b) Classification. Class II (perform- subpart E of part 807 of this chapter ance standards). subject to the limitations in § 882.9. § 882.4325 Cranial drill handpiece [44 FR 51730, Sept. 4, 1979, as amended at 54 (brace). FR 25051, June 12, 1989; 59 FR 63012, Dec. 7, (a) Identification. A cranial drill hand- 1994; 66 FR 38808, July 25, 2001] piece (brace) is a hand holder, which is § 882.4250 Cryogenic surgical device. used without a power source, for drills, burrs, trephines, or other cutting tools (a) Identification. A cryogenic sur- that are used on a patient’s skull. gical device is a device used to destroy (b) Classification. Class I (general con- nervous tissue or produce lesions in trols). The device is exempt from the nervous tissue by the application of ex- premarket notification procedures in treme cold to the selected site. subpart E of part 807 of this chapter (b) Classification. Class II (perform- subject to the limitations in § 882.9. ance standards). [44 FR 51730, Sept. 4, 1979, as amended at 61 § 882.4275 Dowel cutting instrument. FR 1123, Jan. 16, 1996; 66 FR 38808, July 25, (a) Identification. A dowel cutting in- 2001] strument is a device used to cut dowels § 882.4360 Electric cranial drill motor. of bone for bone grafting. (b) Classification. Class II (perform- (a) Identification. An electric cranial ance standards). drill motor is an electrically operated power source used with removable ro- § 882.4300 Manual cranial drills, burrs, tating surgical cutting tools or drill trephines, and their accessories bits on a patient’s skull. (a) Identification. Manual cranial (b) Classification. Class II (perform- drills, burrs, trephines, and their acces- ance standards). sories are bone cutting and drilling instruments that are used without a § 882.4370 Pneumatic cranial drill power source on a patient’s skull. motor. (b) Classification. Class II (perform- (a) Identification. A pneumatic cranial ance standards). drill motor is a pneumatically operated

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power source used with removable ro- strument used in neurological micro- tating surgical cutting tools or drill surgery procedures. bits on a patient’s skull. (b) Classification. Class I (general con- (b) Classification. Class II (perform- trols). The device is exempt from the ance standards). premarket notification procedures in subpart E of part 807 of this chapter § 882.4400 Radiofrequency lesion gen- subject to the limitations in § 882.9. erator. (a) Identification. A radiofrequency le- [44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, sion generator is a device used to 2001] produce lesions in the nervous system or other tissue by the direct applica- § 882.4535 Nonpowered neurosurgical tion of radiofrequency currents to se- instrument. lected sites. (a) Identification. A nonpowered (b) Classification. Class II (perform- neurosurgical instrument is a hand in- ance standards). strument or an accessory to a hand in- § 882.4440 Neurosurgical headrests. strument used during neurosurgical procedures to cut, hold, or manipulate (a) Identification. A neurosurgical tissue. It includes specialized chisels, headrest is a device used to support the osteotomes, curettes, dissectors, ele- patient’s head during a surgical proce- vators, forceps, gouges, hooks, surgical dure. knives, rasps, scissors, separators, (b) Classification. Class I (general con- spatulas, spoons, blades, blade holders, trols). The device is exempt from the blade breakers, probes, etc. premarket notification procedures in (b) Classification. Class I (general con- subpart E of part 807 of this chapter trols). The device is exempt from the subject to the limitations in § 882.9. premarket notification procedures in [44 FR 51730, Sept. 4, 1979, as amended at 59 subpart E of part 807 of this chapter FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, subject to the limitations in § 882.9. 2001] [44 FR 51730, Sept. 4, 1979, as amended at 59 § 882.4460 Neurosurgical head holder FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, (skull clamp). 2001] (a) Identification. A neurosurgical § 882.4545 Shunt system implantation head holder (skull clamp) is a device instrument. used to clamp the patient’s skull to hold head and neck in a particular po- (a) Identification. A shunt system im- sition during surgical procedures. plantation instrument is an instru- (b) Classification. Class II (perform- ment used in the implantation of cere- ance standards). brospinal fluid shunts, and includes tunneling instruments for passing § 882.4500 Cranioplasty material form- shunt components under the skin. ing instrument. (b) Classification. Class I (general con- (a) Identification. A cranioplasty ma- trols). When made only of surgical terial forming instrument is a roller grade stainless steel, the device is ex- used in the preparation and forming of empt from the premarket notification cranioplasty (skull repair) materials. procedures in subpart E of part 807 of (b) Classification. Class I (general con- this chapter subject to § 882.9. trols). The device is exempt from the [44 FR 51730, Sept. 4, 1979, as amended at 65 premarket notification procedures in FR 2319, Jan. 14, 2000] subpart E of part 807 of this chapter subject to the limitations in § 882.9. § 882.4560 Stereotaxic instrument. [44 FR 51730, Sept. 4, 1979, as amended at 59 (a) Identification. A stereotaxic in- FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, strument is a device consisting of a 2001] rigid frame with a calibrated guide mechanism for precisely positioning § 882.4525 Microsurgical instrument. probes or other devices within a pa- (a) Identification. A microsurgical in- tient’s brain, spinal cord, or other part strument is a nonpowered surgical in- of the nervous system.

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(b) Classification. Class II (perform- (b) Classification. Class I (general con- ance standards). trols). The device is exempt from the premarket notification procedures in § 882.4600 Leukotome. subpart E of part 807 of this chapter (a) Identification. A leukotome is a subject to § 882.9. This exemption does device used to cut sections out of the not apply to powered compound cranial brain. drills, burrs, trephines, and their acces- (b) Classification. Class I (general con- sories classified under § 882.4305. trols). The device is exempt from the premarket notification procedures in [44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000] subpart E of part 807 of this chapter subject to the limitations in § 882.9. § 882.4800 Self-retaining retractor for [44 FR 51730, Sept. 4, 1979, as amended at 59 neurosurgery. FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, (a) Identification. A self-retaining re- 2001] tractor for neurosurgery is a self-lock- § 882.4650 Neurosurgical suture nee- ing device used to hold the edges of a dle. wound open during neurosurgery. (b) Classification. Class II (perform- (a) Identification. A neurosurgical suture needle is a needle used in suturing ance standards). during neurosurgical procedures or in § 882.4840 Manual rongeur. the repair of nervous tissue. (b) Classification. Class I (general con- (a) Identification. A manual rongeur is trols). The device is exempt from the a manually operated instrument used premarket notification procedures in for cutting or biting bone during sur- subpart E of part 807 of this chapter gery involving the skull or spinal col- subject to § 882.9. umn. [44 FR 51730, Sept. 4, 1979, as amended at 54 (b) Classification. Class II (perform- FR 25051, June 12, 1989; 65 FR 2319, Jan. 14, ance standards). 2000] § 882.4845 Powered rongeur. § 882.4700 Neurosurgical paddie. (a) Identification. A powered rongeur (a) A neurosurgical paddie is a pad is a powered instrument used for cut- used during surgery to protect nervous ting or biting bone during surgery in- tissue, absorb fluids, or stop bleeding. volving the skull or spinal column. (b) Classification. Class II (perform- (b) Classification. Class II (performance standards). ance standards). [44 FR 51730, Sept. 4, 1979, as amended at 69 FR 10332, Mar. 5, 2004] § 882.4900 Skullplate screwdriver. (a) Identification. A skullplate screw- § 882.4725 Radiofrequency lesion driver is a tool used by the surgeon to probe. fasten cranioplasty plates or (a) Identification. A radiofrequency le- skullplates to a patient’s skull by sion probe is a device connected to a screws. radiofrequency (RF) lesion generator (b) Classification. Class I (general con- to deliver the RF energy to the site trols). The device is exempt from the within the nervous system where a le- premarket notification procedures in sion is desired. subpart E of part 807 of this chapter (b) Classification. Class II (perform- subject to the limitations in § 882.9. ance standards). [44 FR 51730, Sept. 4, 1979, as amended at 59 § 882.4750 Skull punch. FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, (a) Identification. A skull punch is a 2001] device used to punch holes through a patient’s skull to allow fixation of cranioplasty plates or bone flaps by wire or other means.

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Subpart F—Neurological (c) Date PMA or notice of completion of Therapeutic Devices a PDP is required. A PMA or a notice of completion of a PDP is required to be § 882.5030 Methyl methacrylate for filed with the Food and Drug Adminis- aneurysmorrhaphy. tration on or before December 26, 1996 for any intravascular occluding cath- (a) Identification. Methyl methacry- eter that was in commercial distribu- late for aneurysmorrhaphy (repair of tion before May 28, 1976, or that has, on aneurysms, which are balloonlike sacs or before December 26, 1996 been found formed on blood vessels) is a self-cur- to be substantially equivalent to an ing acrylic used to encase and reinforce intravascular occluding catheter that intracranial aneurysms that are not was in commercial distribution before amenable to conservative manage- May 28, 1976. Any other intravascular ment, removal, or obliteration by an- occluding catheter shall have an ap- eurysm clip. proved PMA or a declared completed (b) Classification. Class II (perform- PDP in effect before being placed in ance standards). commercial distribution. § 882.5050 Biofeedback device. [44 FR 51730, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987; 61 FR 50708, Sept. 27, (a) Identification. A biofeedback de- 1996] vice is an instrument that provides a visual or auditory signal corresponding § 882.5175 Carotid artery clamp. to the status of one or more of a pa- (a) Identification. A carotid artery tient’s physiological parameters (e.g., clamp is a device that is surgically brain alpha wave activity, muscle ac- placed around a patient’s carotid ar- tivity, skin temperature, etc.) so that tery (the principal artery in the neck the patient can control voluntarily that supplies blood to the brain) and these physiological parameters. has a removable adjusting mechanism (b) Classification. Class II (special that protrudes through the skin of the controls). The device is exempt from patient’s neck. The clamp is used to oc- the premarket notification procedures clude the patient’s carotid artery to in subpart E of part 807 of this chapter treat intracranial aneurysms when it is a prescription battery pow- (balloonlike sacs formed on blood ves- ered device that is indicated for relax- sels) or other intracranial vascular ation training and muscle reeducation malformations that are difficult to at- and prescription use, subject to § 882.9. tach directly by reducing the blood pressure and blood flow to the aneu- [44 FR 51730, Sept. 4, 1979, as amended at 63 rysm or malformation. FR 59229, Nov. 3, 1998] (b) Classification. Class II (perform- § 882.5070 Bite block. ance standards). (a) Identification. A bite block is a de- § 882.5200 Aneurysm clip. vice inserted into a patient’s mouth to (a) Identification. An aneurysm clip is protect the tongue and teeth while the a device used to occlude an patient is having convulsions. intracranial aneurysm (a balloonlike (b) Classification. Class II (perform- sac formed on a blood vessel) to pre- ance standards). vent it from bleeding or bursting. (b) Classification. Class II (perform- § 882.5150 Intravascular occluding ance standards). catheter. (a) Identification. An intravascular § 882.5225 Implanted malleable clip. occluding catheter is a catheter with (a) Identification. An implanted mal- an inflatable or detachable balloon tip leable clip is a bent wire or staple that that is used to block a blood vessel to is forcibly closed with a special instru- treat malformations, e.g., aneurysms ment to occlude an intracranial blood (balloonlike sacs formed on blood ves- vessel or aneurysm (a balloonlike sac sels) of intracranial blood vessels. formed on a blood vessel), stop bleed- (b) Classification. Class III (premarket ing, or hold tissue or a mechanical de- approval). vice in place in a patient.

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(b) Classification. Class II (perform- § 882.5330 Preformed nonalterable ance standards). cranioplasty plate. § 882.5235 Aversive conditioning de- (a) Identification. A preformed vice. nonalterable cranioplasty plate is a de- (a) Identification. An aversive condi- vice that is implanted in a patient to tioning device is an instrument used to repair a skull defect and is constructed administer an electrical shock or other of a material, e.g., stainless steel or noxious stimulus to a patient to mod- vitallium, that cannot be altered or re- ify undesirable behavioral characteris- shaped at the time of surgery without tics. changing the chemical behavior of the (b) Classification. Class II (perform- material. ance standards). (b) Classification. Class II (performance standards). § 882.5250 Burr hole cover. (a) Identification. A burr hole cover is § 882.5360 Cranioplasty plate fastener. a plastic or metal device used to cover (a) Identification. A cranioplasty plate or plug holes drilled into the skull dur- fastener is a screw, wire, or other arti- ing surgery and to reattach cranial cle made of tantalum, vitallium, or bone removed during surgery. stainless steel used to secure a plate to (b) Classification. Class II (perform- the patient’s skull to repair a skull de- ance standards). fect. § 882.5275 Nerve cuff. (b) Classification. Class II (performance standards). (a) Identification. A nerve cuff is a tubular silicone rubber sheath used to en- § 882.5500 Lesion temperature mon- case a nerve for aid in repairing the itor. nerve (e.g., to prevent ingrowth of scar tissue) and for capping the end of the (a) Identification. A lesion tempera- nerve to prevent the formation of ture monitor is a device used to mon- neuroma (tumors). itor the tissue temperature at the site (b) Classification. Class II (perform- where a lesion (tissue destruction) is to ance standards). be made when a surgeon uses a radiofrequency (RF) lesion generator and § 882.5300 Methyl methacrylate for probe. cranioplasty. (b) Classification. Class II (perform- (a) Identification. Methyl methacry- ance standards). late for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses § 882.5550 Central nervous system to repair a skull defect in a patient. At fluid shunt and components. the time of surgery, the surgeon initi- (a) Identification. A central nervous ates polymerization of the material system fluid shunt is a device or com- and forms it into a plate or other ap- bination of devices used to divert fluid propriate shape to repair the defect. from the brain or other part of the cen- (b) Classification. Class II (performance standards). tral nervous system to an internal delivery site or an external receptacle for § 882.5320 Preformed alterable the purpose of relieving elevated cranioplasty plate. intracranial pressure or fluid volume (a) Identification. A preformed (e.g., due to hydrocephalus). Compo- alterable cranioplasty plate is a device nents of a central nervous system that is implanted into a patient to re- shunt include catheters, valved cath- pair a skull defect. It is constructed of eters, valves, connectors, and other ac- a material, e.g., tantalum, that can be cessory components intended to facili- altered or reshaped at the time of sur- tate use of the shunt or evaluation of a gery without changing the chemical patient with a shunt. behavior of the material. (b) Classification. Class II (perform- (b) Classification. Class II (performance standards). ance standards).

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§ 882.5600 Neurovascular mechanical vice performs as intended for use in the thrombectomy device for acute treatment of acute ischemic stroke and ischemic stroke treatment. must capture any adverse events asso- (a) Identification. A neurovascular ciated with the device and procedure. mechanical thrombectomy device for (6) The labeling must include: acute ischemic stroke treatment is a (i) Information on the specific pa- prescription device used in the treat- tient population for which the device is ment of acute ischemic stroke to im- intended for use in the treatment of prove clinical outcomes. The device is acute ischemic stroke, including but delivered into the neurovasculature not limited to, specifying time from with an endovascular approach, me- symptom onset, vessels or location of chanically removes thrombus from the the neurovasculature that can be body, and restores blood flow in the accessed for treatment, and limitations neurovasculature. on core infarct size. (b) Classification. Class II (special (ii) Detailed instructions on proper controls). The special controls for this device preparation and use for throm- device are: bus retrieval from the (1) The patient contacting compo- neurovasculature. nents of the device must be dem- (iii) A summary of the clinical test- onstrated to be biocompatible. ing results, including a detailed sum- (2) Non-clinical performance testing mary of the device- and procedure-re- must demonstrate that the device per- lated complications and adverse forms as intended under anticipated events. conditions of use, including: (iv) A shelf life. (i) Mechanical testing to dem- [81 FR 94253, Dec. 23, 2016] onstrate the device can withstand anticipated tensile, torsional, and com- § 882.5700 Thermal system for insom- pressive forces. nia. (ii) Mechanical testing to evaluate (a) Identification. A thermal system the radial forces exerted by the device. for insomnia is a prescription device (iii) Non-clinical testing to verify the for use in patients with insomnia that dimensions of the device. is used to apply a specified tempera- (iv) Non-clinical testing must dem- ture to the skin surface. onstrate the device can be delivered to (b) Classification. Class II (special the target location in the controls). The special controls for this neurovasculature and retrieve simu- device are: lated thrombus under simulated use (1) The patient-contacting compo- conditions. nents of the device must be dem- (v) Non-clinical testing must demonstrated to be biocompatible. onstrate the device is radiopaque and (2) Performance testing must dem- can be visualized. onstrate electromagnetic compat- (vi) Non-clinical testing must evalu- ibility and electrical safety. ate the coating integrity and particu- (3) Non-clinical performance testing lates under simulated use conditions. must demonstrate that the device per- (vii) Animal testing must evaluate forms as intended under anticipated the safety of the device, including dam- conditions of use. The following per- age to the vessels or tissue under an- formance characteristics must be eval- ticipated use conditions. uated: (3) Performance data must support (i) Thermal performance of the de- the sterility and pyrogenicity of the vice, including maintenance of the tar- patient contacting components of the get temperature, must be evaluated device. under simulated use conditions. (4) Performance data must support (ii) Mechanical testing to dem- the shelf-life of the device by demonstrate the device can withstand onstrating continued sterility, package forces under anticipated use condi- integrity, and device functionality tions. over the specified shelf-life. (iii) Mechanical testing to dem- (5) Clinical performance testing of onstrate the device is resistant to leak- the device must demonstrate the de- age under anticipated use conditions.

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(4) Software verification, validation, brain to induce electrical currents for and hazard analysis must be performed. the treatment of headache. (5) Patient labeling must be provided (b) Classification. Class II (special to convey information regarding safe controls). The special controls for this use of the device, including instruc- device are: tions for assembly. (1) Appropriate analysis/testing must [81 FR 44772, July 11, 2016] demonstrate electromagnetic compatibility, electrical safety, and thermal § 882.5800 Cranial electrotherapy stim- safety. ulator. (2) Appropriate verification, valida- (a) Identification. A cranial tion, and hazard analysis must be per- electrotherapy stimulator is a device formed on the device software and that applies electrical current to a pa- firmware. tient’s head to treat insomnia, depres- (3) The elements of the device that sion, or anxiety. contact the patient must be assessed to (b) Classification. Class III (premarket be biocompatible. approval). (4) Non-clinical testing data must (c) Date a PMA or notice of completion demonstrate that the device performs of a PDP is required. No effective date has been established of the require- as intended under anticipated condi- ment for premarket approval. See tions of use. This includes full charac- § 882.3. terization of the magnetic pulse output and resulting magnetic field map. This [44 FR 51730, Sept. 4, 1979, as amended at 52 also includes characterization of the FR 17740, May 11, 1987; 60 FR 43969, Aug. 24, sound level of the device during use. 1995; 62 FR 30457, June 4, 1997; 73 FR 34860, June 19, 2008] (5) Clinical testing must demonstrate that the device is safe and effective for § 882.5805 Repetitive transcranial mag- treating headache in the indicated pa- netic stimulation system. tient population. (a) Identification. A repetitive (6) The physician and patient label- transcranial magnetic stimulation sys- ing must include the following: tem is an external device that delivers (i) A summary of the clinical per- transcranial repetitive pulsed mag- formance testing, including any ad- netic fields of sufficient magnitude to verse events and complications. induce neural action potentials in the (ii) The intended use population in prefrontal cortex to treat the symp- terms of the types of headaches appro- toms of major depressive disorder with- priate for use with the device. out inducing seizure in patients who (iii) Information on how to report ad- have failed at least one antidepressant verse events and device malfunctions. medication and are currently not on any antidepressant therapy. (iv) A diagram or picture depicting (b) Classification. Class II (special the proper placement of the device on controls). The special control is FDA’s the user. ‘‘Class II Special Controls Guidance [78 FR 38458, July 8, 2014] Document: Repetitive Transcranial Magnetic Stimulation System.’’ See § 882.5810 External functional neuro- § 882.1(e) for the availability of this muscular stimulator. guidance document. (a) Identification. An external func- [76 FR 44491, July 26, 2011] tional neuromuscular stimulator is an electrical stimulator that uses external § 882.5808 Transcranial magnetic stim- electrodes for stimulating muscles in ulator for headache. the leg and ankle of partially paralyzed (a) Identification. A transcranial mag- patients (e.g., after stroke) to provide netic stimulator device for headache is flexion of the foot and thus improve a device that delivers brief duration, the patient’s gait. rapidly alternating, or pulsed, mag- (b) Classification. Class II (perform- netic fields that are externally directed ance standards). at spatially discrete regions of the

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§ 882.5820 Implanted cerebellar stimu- (c) Date premarket approval application lator. (PMA) or notice of completion of a prod- (a) Identification. An implanted cere- uct development protocol (PDP) is re- bellar stimulator is a device used to quired. A PMA or a notice of comple- stimulate electrically a patient’s cere- tion of a PDP is required to be filed bellar cortex for the treatment of in- with the Food and Drug Administra- tractable epilepsy, spasticity, and some tion on or before July 7, 1986 for any movement disorders. The stimulator implanted diaphragmatic/phrenic nerve consists of an implanted receiver with stimulator that was in commercial dis- electrodes that are placed on the pa- tribution before May 28, 1976, or that tient’s cerebellum and an external has on or before July 7, 1986 been found transmitter for transmitting the stim- to be substantially equivalent to an ulating pulses across the patient’s skin implanted diaphragmatic/phrenic nerve to the implanted receiver. stimulator that was in commercial dis- (b) Classification. Class III (premarket tribution before May 28, 1976. Any approval). other implanted diaphragmatic/phrenic (c) Date premarket approval application nerve stimulator shall have an ap- (PMA) or notice of completion of a prod- proved PMA or a declared completed uct development protocol (PDP) is re- PDP in effect before being placed in quired. A PMA or notice of completion commercial distribution. of a PDP is required to be filed with [44 FR 51730, Sept. 4, 1979, as amended at 51 the Food and Drug Administration on FR 12101, Apr. 8, 1986] or before September 26, 1984. Any implanted cerebellar stimulator that was not in commercial distribution before § 882.5840 Implanted intracerebral/ May 28, 1976, or that has not on or be- subcortical stimulator for pain re- fore September 26, 1984 been found by lief. FDA to be substantially equivalent to (a) Identification. An implanted an implanted cerebellar stimulator intracerebral/subcortical stimulator that was in commercial distribution for pain relief is a device that applies before May 28, 1976 shall have an ap- electrical current to subsurface areas proved PMA or declared completed of a patient’s brain to treat severe in- PDP in effect before beginning com- tractable pain. The stimulator consists mercial distribution. of an implanted receiver with elec- [44 FR 51730, Sept. 4, 1979, as amended at 49 trodes that are placed within a pa- FR 26574, June 28, 1984] tient’s brain and an external transmitter for transmitting the stimu- § 882.5830 Implanted diaphragmatic/ lating pulses across the patient’s skin phrenic nerve stimulator. to the implanted receiver. (a) Identification. An implanted dia- (b) Classification. Class III (premarket phragmatic/phrenic nerve stimulator is approval). a device that provides electrical stimu- (c) Date premarket approval application lation of a patient’s phrenic nerve to (PMA) or notice of completion of a prod- contract the diaphragm rhythmically uct development protocol (PDP) is re- and produce breathing in patients who quired. A PMA or a notice of comple- have hypoventilation (a state in which tion of a PDP is required to be filed an abnormally low amount of air en- with the Food and Drug Administra- ters the lungs) caused by brain stem tion on or before March 1, 1989, for any disease, high cervical spinal cord in- implanted intracerebral/subcortical jury, or chronic lung disease. The stim- stimulator for pain relief that was in ulator consists of an implanted re- commercial distribution before May 28, ceiver with electrodes that are placed 1976, or that has on or before March 1, around the patient’s phrenic nerve and 1989, been found to be substantially an external transmitter for transmit- equivalent to an implanted ting the stimulating pulses across the intracerebral/subcortical stimulator patient’s skin to the implanted re- for pain relief that was in commercial ceiver. distribution before May 28, 1976. Any (b) Classification. Class III (premarket other implanted intracerebral/subcor- approval). tical stimulator for pain relief shall

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have an approved PMA or a declared electrodes that are placed around a pa- completed PDP in effect before being tient’s nerve and an external trans- placed in commercial distribution. mitter for transmitting the stimu- [44 FR 51730, Sept. 4, 1979, as amended at 53 lating pulses across the patient’s skin FR 48621, Dec. 1, 1988] to the implanted receiver. The external transmitter is activated by a switch in § 882.5850 Implanted spinal cord stim- the heel in the patient’s shoe. ulator for bladder evacuation. (b) Classification. Class III (premarket (a) Identification. An implanted spinal approval). cord stimulator for bladder evacuation (c) Date PMA or notice of completion of is an electrical stimulator used to PDP is required. A PMA or notice of empty the bladder of a paraplegic pa- completion of a PDP for a device de- tient who has a complete transection scribed in paragraph (b) of this section of the spinal cord and who is unable to is required to be filed with the Food empty his or her bladder by reflex means or by the intermittent use of and Drug Administration on or before catheters. The stimulator consists of July 13, 1999 for any implanted neuro- an implanted receiver with electrodes muscular stimulator that was in com- that are placed on the conus medullaris mercial distribution before May 28, portion of the patient’s spinal cord and 1976, or that has, on or before July 13, an external transmitter for transmit- 1999, been found to be substantially ting the stimulating pulses across the equivalent to an implanted neuro- patient’s skin to the implanted re- muscular stimulator that was in com- ceiver. mercial distribution before May 28, (b) Classification. Class III (premarket 1976. Any other implanted neuro- approval). muscular stimulator shall have an ap- (c) Date PMA or notice of completion of proved PMA or declared completed a PDP is required. A PMA or a notice of PDP in effect before being placed in completion of a PDP is required to be commercial distribution. filed with the Food and Drug Adminis- tration on or before December 26, 1996 [44 FR 51730, Sept. 4, 1979, as amended at 52 for any implanted spinal cord stimu- FR 17740, May 11, 1987; 64 FR 18329, Apr. 14, lator for bladder evacuation that was 1999] in commercial distribution before May 28, 1976, or that has, on or before De- § 882.5870 Implanted peripheral nerve cember 26, 1996 been found to be sub- stimulator for pain relief. stantially equivalent to an implanted (a) Identification. An implanted pe- spinal cord stimulator for bladder ripheral nerve stimulator for pain re- evacuation that was in commercial dis- lief is a device that is used to stimulate tribution before May 28, 1976. Any electrically a peripheral nerve in a pa- other implanted spinal cord stimulator tient to relieve severe intractable pain. for bladder evacuation shall have an The stimulator consists of an im- approved PMA or a declared completed planted receiver with electrodes that PDP in effect before being placed in are placed around a peripheral nerve commercial distribution. and an external transmitter for trans- [44 FR 51730, Sept. 4, 1979, as amended at 52 mitting the stimulating pulses across FR 17740, May 11, 1987; 61 FR 50708, Sept. 27, the patient’s skin to the implanted re- 1996] ceiver. § 882.5860 Implanted neuromuscular (b) Classification. Class II (perform- stimulator. ance standards). (a) Identification. An implanted neu- [44 FR 51730, Sept. 4, 1979, as amended at 78 romuscular stimulator is a device that FR 18234, Mar. 26, 2013] provides electrical stimulation to a patient’s peroneal or femoral nerve to cause muscles in the leg to contract, thus improving the gait in a patient with a paralyzed leg. The stimulator consists of an implanted receiver with

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§ 882.5880 Implanted spinal cord stim- current distribution testing of the elec- ulator for pain relief. trodes must be conducted. (a) Identification. An implanted spinal (5) Appropriate software verification, cord stimulator for pain relief is a de- validation, and hazard analysis must vice that is used to stimulate elec- be performed. trically a patient’s spinal cord to re- (6) Clinical performance data must lieve severe intractable pain. The stim- demonstrate that the device is safe and ulator consists of an implanted re- effective as a treatment for headache ceiver with electrodes that are placed in the indicated patient population. on the patient’s spinal cord and an ex- (7) Labeling must include the fol- ternal transmitter for transmitting the lowing: stimulating pulses across the patient’s (i) Appropriate contraindications skin to the implanted receiver. such as not for use in subjects with an (b) Classification. Class II (perform- implanted metallic or electronic device ance standards). in the head, a cardiac pacemaker, or an implanted or wearable defibrillator. § 882.5890 Transcutaneous electrical (ii) Appropriate warnings such as not nerve stimulator for pain relief. to apply the device on the neck or (a) Identification. A transcutaneous chest, not to use the device in the pres- electrical nerve stimulator for pain re- ence of electronic monitoring equip- lief is a device used to apply an elec- ment, not to use in the bath or shower, trical current to electrodes on a pa- not to use while sleeping, not to use tient’s skin to treat pain. while driving, not to use while oper- (b) Classification. Class II (perform- ating machinery. ance standards). (iii) Appropriate precautions such as the long-term effects of chronic use of § 882.5891 Transcutaneous electrical the device are unknown. nerve stimulator to treat headache. (iv) A summary of the expected risks (a) Identification. A transcutaneous and benefits of using the device. electrical nerve stimulator to treat (v) A summary of the clinical per- headache is a device used to apply an formance data, including information electrical current to a patient’s cra- on the patient population for which the nium through electrodes placed on the device has and has not been dem- skin. onstrated to be effective, and any ad- (b) Classification. Class II (special verse events and complications. controls). The special controls for this (vi) Information on how the device device are: operates and the typical sensations ex- (1) The patient-contacting compo- perienced during treatment. nents of the device must be dem- (vii) A detailed summary of the de- onstrated to be biocompatible. vice technical parameters. (2) Appropriate analysis/testing must (viii) An expiration date/shelf life for validate electromagnetic compatibility the electrodes and the number of times and electrical, mechanical, and ther- they can be reused. mal safety. (ix) Disposal instructions. (3) The technical parameters of the [79 FR 37948, July 3, 2014] device, including waveform, output modes, maximum output voltage and § 882.5894 Limited output trans- current (with 500, 2,000, and 10,000 ohm cutaneous piezoelectric stimulator loads), pulse duration, frequency, net for skin reactions associated with charge (μC) per pulse, maximum phase insect bites. charge at 500 ohms, maximum current (a) Identification. A limited output density (mA/cm2, r.m.s.), maximum av- transcutaneous piezoelectric stimu- erage current (mA), maximum average lator for skin reactions associated with power density (W/cm2), and the type of insect bites is a device intended to al- impedance monitoring system must be leviate skin reactions associated with fully characterized. insect bites via cutaneous, piezo- (4) Electrical performance, adhesive electric stimulation at the local site of integrity, shelf life, reusability, and the bite.

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(b) Classification. Class II (special (2) If the device contains software or controls). The special controls for this firmware, appropriate verification, val- device are: idation, and hazard analysis must be (1) Appropriate testing to charac- performed. terize the electrical output specifica- (3) The elements of the device that tions of the device (i.e., total charge de- contact the patient must be assessed to livered, maximum instantaneous out- be biocompatible. put current, maximum instantaneous (4) Non-clinical testing data (includ- output voltage, pulse duration, charge ing vibration frequency, amplitude, density) must be conducted. and acceleration) must demonstrate (2) Mechanical bench testing must that the device performs as intended demonstrate that the device will with- under anticipated conditions of use. stand the labeled number duration of (5) Labeling must include: uses. (i) Specific information pertinent to (3) All elements of the device that use of the device by the intended pa- may contact the patient must be as- tient population and the treatment sessed to be biocompatible. regimen; (4) Labeling must include: (ii) Warning to only use the device on (i) Validated instructions which ad- normal, intact, clean, healthy skin; (iii) Warning to not use the device if dresses the following: the user has leg skin disorders, such as (A) Identification of areas of the body eczema, psoriasis, cellulitis, non-heal- which are appropriate and not appro- ing wounds; priate for contact with the device. (iv) Warning to discontinue use if (B) Whether use of the device in con- Restless Leg Syndrome symptoms junction with flammable materials worsen; and (e.g., insect repellent) is appropriate. (v) Instructions for end users to con- (C) Use of the device on or near im- tact the device manufacturer and planted devices. MedWatch in case they experience any (D) How to identify the correct type adverse events when using this device. of skin condition. (ii) Technical parameters of the de- [82 FR 13554, Mar. 14, 2017] vice (maximum output voltage (instan- § 882.5900 Preformed craniosynostosis taneous), maximum output current (in- strip. stantaneous), and pulse duration). (iii) Language to direct end users to (a) Identification. A preformed contact the device manufacturer and craniosynostosis strip is a plastic strip MedWatch if they experience any ad- used to cover bone edges of craniec- verse events with this device. tomy sites (sites where the skull has (iv) The anticipated number of device been cut) to prevent the bone from re- uses prior to failure. growing in patients whose skull sutures are abnormally fused together. [80 FR 15165, Mar. 23, 2015] (b) Classification. Class II (performance standards). § 882.5895 Vibratory counter-stimulation device. § 882.5910 Dura substitute. (a) Identification. A vibratory (a) Identification. A dura substitute is counter-stimulation device is a pre- a sheet or material that is used to re- scription device that provides elec- pair the dura mater (the membrane trically powered mechanical vibration surrounding the brain). to improve the quality of sleep in pa- (b) Classification. Class II (perform- tients with primary Restless Legs Syn- ance standards). drome. (b) Classification. Class II (special § 882.5940 Electroconvulsive therapy controls). The special controls for this device. device are: (a) Identification. An (1) Appropriate analysis/testing must electroconvulsive therapy device is a demonstrate electromagnetic compat- device used for treating severe psy- ibility (EMC), electrical safety, and chiatric disturbances (e.g., severe de- thermal safety. pression) by inducing in the patient a

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major motor seizure by applying a brief plagiocephaly, including infants with intense electrical current to the pa- plagiocephalic-, brachycephalic-, and tient’s head. scaphocephalic-shaped heads. (b) Classification. Class III (premarket (b) Classification. Class II (special approval). controls) (prescription use in accord- (c) Date PMA or notice of completion of ance with § 801.109 of this chapter, bio- a PDP is required. No effective date has compatibility testing, and labeling been established of the requirement for (contraindications, warnings, pre- premarket approval. See § 882.3. cautions, adverse events, instructions for physicians and parents)). [44 FR 51730, Sept. 4, 1979, as amended at 52 FR 17740, May 11, 1987] [63 FR 40651, July 30, 1998]

§ 882.5950 Neurovascular embolization § 882.5975 Human dura mater. device. (a) Identification. Human dura mater (a) Identification. A neurovascular is human pachymeninx tissue intended embolization device is an intravascular to repair defects in human dura mater. implant intended to permanently oc- (b) Classification. Class II (special clude blood flow to cerebral aneurysms controls). The special control for this and cerebral ateriovenous malforma- device is the FDA guidance document tions. This does not include entitled ‘‘Class II Special Controls cyanoacrylates and other embolic Guidance Document: Human Dura agents, which act by polymerization or Mater.’’ See § 882.1(e) for the avail- precipitation. Embolization devices ability of this guidance. used in other vascular applications are (c) Scope. The classification set forth also not included in this classification, in this section is only applicable to see § 870.3300. human dura mater recovered prior to (b) Classification. Class II (special May 25, 2005. controls.) The special control for this [68 FR 70436, Dec. 18, 2003, as amended at 76 device is the FDA guidance document FR 36993, June 24, 2011] entitled ‘‘Class II Special Controls Guidance Document: Vascular and PART 884—OBSTETRICAL AND Neurovascular Embolization Devices.’’ For availability of this guidance docu- GYNECOLOGICAL DEVICES ment, see § 882.1(e). Subpart A—General Provisions [69 FR 77900, Dec. 29, 2004] Sec. § 882.5960 Skull tongs for traction. 884.1 Scope. 884.3 Effective dates of requirement for pre- (a) Identification. Skull tongs for market approval. traction is an instrument used to im- 884.9 Limitations of exemptions from sec- mobilize a patient with a cervical spine tion 510(k) of the Federal Food, Drug, injury (e.g., fracture or dislocation). and Cosmetic Act (the act). The device is caliper shaped with tips Subpart B—Obstetrical and Gynecological that penetrate the skin. It is anchored Diagnostic Devices to the skull and has a heavy weight attached to it that maintains, by trac- 884.1040 Viscometer for cervical mucus. tion, the patient’s position. 884.1050 Endocervical aspirator. (b) Classification. Class II (perform- 884.1060 Endometrial aspirator. ance standards). 884.1100 Endometrial brush. 884.1175 Endometrial suction curette and § 882.5970 Cranial orthosis. accessories. 884.1185 Endometrial washer. (a) Identification. A cranial orthosis is 884.1300 Uterotubal carbon dioxide a device that is intended for medical insufflator and accessories. purposes to apply pressure to promi- 884.1425 Perineometer. nent regions of an infant’s cranium in 884.1550 Amniotic fluid sampler (amniocentesis tray). order to improve cranial symmetry 884.1560 Fetal blood sampler. and/or shape in infants from 3 to 18 884.1600 Transabdominal amnioscope months of age, with moderate to severe (fetoscope) and accessories. nonsynostotic positional 884.1630 Colposcope.

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884.1640 Culdoscope and accessories. 884.4260 Hygroscopic Laminaria cervical di- 884.1660 Transcervical endoscope lator. (amnioscope) and accessories. 884.4270 Vibratory cervical dilators. 884.1690 Hysteroscope and accessories. 884.4340 Fetal vacuum extractor. 884.1700 Hysteroscopic insufflator. 884.4400 Obstetric forceps. 884.1720 Gynecologic laparoscope and acces- 884.4500 Obstetric fetal destructive instru- sories. ment. 884.1730 Laparoscopic insufflator. 884.4520 Obstetric-gynecologic general manual instrument. Subpart C—Obstetrical and Gynecological 884.4530 Obstetric-gynecologic specialized Monitoring Devices manual instrument. 884.4550 Gynecologic surgical laser. 884.2050 Obstetric data analyzer. 884.4900 Obstetric table and accessories. 884.2225 Obstetric-gynecologic ultrasonic 884.4910 Specialized surgical instrumenta- imager. tion for use with urogynecologic surgical 884.2600 Fetal cardiac monitor. mesh. 884.2620 Fetal electroencephalographic monitor. Subpart F—Obstetrical and Gynecological 884.2640 Fetal phonocardiographic monitor Therapeutic Devices and accessories. 884.2660 Fetal ultrasonic monitor and acces- 884.5050 Metreurynter-balloon abortion sys- sories. tem. 884.5070 Vacuum abortion system. 884.2675 Fetal scalp circular (spiral) elec- 884.5100 Obstetric anesthesia set. trode and applicator. 884.5150 Nonpowered breast pump. 884.2685 Fetal scalp clip electrode and appli- 884.5160 Powered breast pump. cator. 884.5200 Hemorrhoid prevention pressure 884.2700 Intrauterine pressure monitor and wedge. accessories. 884.5225 Abdominal decompression chamber. 884.2720 External uterine contraction mon- 884.5250 Cervical cap. itor and accessories. 884.5300 Condom. 884.2730 Home uterine activity monitor. 884.5310 Condom with spermicidal lubricant. 884.2740 Perinatal monitoring system and 884.5320 Glans sheath. accessories. 884.5330 Female condom. 884.2800 Computerized labor monitoring sys- 884.5350 Contraceptive diaphragm and acces- tem. sories. 884.2900 Fetal stethoscope. 884.5360 Contraceptive intrauterine device 884.2960 Obstetric ultrasonic transducer and (IUD) and introducer. accessories. 884.5380 Contraceptive tubal occlusion de- 884.2980 Telethermographic system. vice (TOD) and introducer. 884.2982 Liquid crystal thermographic sys- 884.5390 Perineal heater. tem. 884.5400 Menstrual cup. 884.2990 Breast lesion documentation sys- 884.5425 Scented or scented deodorized men- tem. strual pad. 884.5435 Unscented menstrual pad. Subpart D—Obstetrical and Gynecological 884.5460 Scented or scented deodorized men- Prosthetic Devices strual tampon. 884.5470 Unscented menstrual tampon. 884.3200 Cervical drain. 884.5900 Therapeutic vaginal douche appa- 884.3575 Vaginal pessary. ratus. 884.3650 Fallopian tube prosthesis. 884.5920 Vaginal insufflator. 884.3900 Vaginal stent. 884.5940 Powered vaginal muscle stimulator for therapeutic use. Subpart E—Obstetrical and Gynecological 884.5960 Genital vibrator for therapeutic Surgical Devices use. 884.5970 Clitoral engorgement device. 884.4050 Gynecologic laparoscopic power 884.5980 Surgical mesh for transvaginal pel- morcellation containment system. vic organ prolapse repair. 884.4100 Endoscopic electrocautery and accessories. Subpart G—Assisted Reproduction Devices 884.4120 Gynecologic electrocautery and accessories. 884.6100 Assisted reproduction needles. 884.4150 Bipolar endoscopic coagulator-cut- 884.6110 Assisted reproduction catheters. ter and accessories. 884.6120 Assisted reproduction accessories. 884.4160 Unipolar endoscopic coagulator- 884.6130 Assisted reproduction microtools. cutter and accessories. 884.6140 Assisted reproduction micropipette 884.4250 Expandable cervical dilator. fabrication instruments.

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884.6150 Assisted reproduction micro- § 884.3 Effective dates of requirement manipulators and microinjectors. for premarket approval. 884.6160 Assisted reproduction labware. 884.6165 Intravaginal culture system. A device included in this part that is 884.6170 Assisted reproduction water and classified into class III (premarket ap- water purification systems. proval) shall not be commercially dis- 884.6180 Reproductive media and supple- tributed after the date shown in the ments. regulation classifying the device unless 884.6190 Assisted reproductive microscopes the manufacturer has an approval and microscope accessories. under section 515 of the act (unless an 884.6195 Assisted reproduction embryo exemption has been granted under sec- image assessment system. tion 520(g)(2) of the act). An approval 884.6200 Assisted reproduction laser system. under section 515 of the act consists of AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, FDA’s issuance of an order approving 360j, 371. an application for premarket approval (PMA) for the device or declaring com- SOURCE: 45 FR 12684, Feb. 26, 1980, unless pleted a product development protocol otherwise noted. (PDP) for the device. (a) Before FDA requires that a device Subpart A—General Provisions commercially distributed before the enactment date of the amendments, or § 884.1 Scope. a device that has been found substan- (a) This part sets forth the classifica- tially equivalent to such a device, has tion of obstetrical and gynecological an approval under section 515 of the act devices intended for human use that FDA must promulgate a regulation are in commercial distribution. under section 515(b) of the act requir- (b) The identification of a device in a ing such approval, except as provided regulation in this part is not a precise in paragraph (b) of this section. Such a description of every device that is, or regulation under section 515(b) of the will be, subject to the regulation. A act shall not be effective during the manufacturer who submits a pre- grace period ending on the 90th day market notification submission for a after its promulgation or on the last device under part 807 may not show day of the 30th full calendar month merely that the device is accurately after the regulation that classifies the described by the section title and iden- device into class III is effective, whichever is later. See section 501(f)(2)(B) of tification provisions of a regulation in the act. Accordingly, unless an effec- this part, but shall state why the de- tive date of the requirement for pre- vice is substantially equivalent to market approval is shown in the regu- other devices, as required by § 807.87. lation for a device classified into class (c) To avoid duplicative listings, an III in this part, the device may be com- obstetrical and gynecological device mercially distributed without FDA’s that has two or more types of uses issuance of an order approving a PMA (e.g., used both as a diagnostic device or declaring completed a PDP for the and as a therapeutic device) is listed device. If FDA promulgates a regula- only in one subpart. tion under section 515(b) of the act re- (d) References in this part to regu- quiring premarket approval for a de- latory sections of the Code of Federal vice, section 501(f)(1)(A) of the act ap- Regulations are to chapter I of title 21, plies to the device. unless otherwise noted. (b) Any new, not substantially equiv- (e) Guidance documents referenced in alent, device introduced into commer- this part are available on the Internet cial distribution on or after May 28, at http://www.fda.gov/MedicalDevices/ 1976, including a device formerly mar- DeviceRegulationandGuidance/ keted that has been substantially al- GuidanceDocuments/default.htm. tered, is classified by statute (section 513(f) of the act) into class III without [52 FR 17740, May 11, 1987, as amended at 68 any grace period and FDA must have FR 44415, Aug. 27, 2003; 78 FR 18233, Mar. 26, issued an order approving a PMA or de- 2013] claring completed a PDP for the device

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before the device is commercially dis- deoxyribonucleic acid (DNA) probe or tributed unless it is reclassified. If nucleic acid hybridization technology FDA knows that a device being com- rather than culture or immunoassay mercially distributed may be a ‘‘new’’ technology; or device as defined in this section be- (c) The device is an in vitro device cause of any new intended use or other that is intended: reasons, FDA may codify the statutory (1) For use in the diagnosis, moni- classification of the device into class toring, or screening of neoplastic dis- III for such new use. Accordingly, the eases with the exception of regulation for such a class III device immunohistochemical devices; states that as of the enactment date of (2) For use in screening or diagnosis the amendments, May 28, 1976, the de- of familial or acquired genetic dis- vice must have an approval under sec- orders, including inborn errors of me- tion 515 of the act before commercial tabolism; distribution. (3) For measuring an analyte that serves as a surrogate marker for [52 FR 17740, May 11, 1987] screening, diagnosis, or monitoring § 884.9 Limitations of exemptions from life-threatening diseases such as ac- section 510(k) of the Federal Food, quired immune deficiency syndrome Drug, and Cosmetic Act (the act). (AIDS), chronic or active hepatitis, tu- The exemption from the requirement berculosis, or myocardial infarction or of premarket notification (section to monitor therapy; 510(k) of the act) for a generic type of (4) For assessing the risk of cardio- class I or II device is only to the extent vascular diseases; that the device has existing or reason- (5) For use in diabetes management; ably foreseeable characteristics of (6) For identifying or inferring the commercially distributed devices with- identity of a microorganism directly in that generic type or, in the case of from clinical material; (7) For detection of antibodies to in vitro diagnostic devices, only to the microorganisms other than extent that misdiagnosis as a result of immunoglobulin G (IgG) or IgG assays using the device would not be associ- when the results are not qualitative, or ated with high morbidity or mortality. are used to determine immunity, or the Accordingly, manufacturers of any assay is intended for use in matrices commercially distributed class I or II other than serum or plasma; device for which FDA has granted an (8) For noninvasive testing as defined exemption from the requirement of in § 812.3(k) of this chapter; and premarket notification must still sub- (9) For near patient testing (point of mit a premarket notification to FDA care). before introducing or delivering for introduction into interstate commerce [65 FR 2319, Jan. 14, 2000] for commercial distribution the device when: Subpart B—Obstetrical and Gyne- (a) The device is intended for a use cological Diagnostic Devices different from the intended use of a legally marketed device in that generic § 884.1040 Viscometer for cervical type of device; e.g., the device is in- mucus. tended for a different medical purpose, (a) Identification. A viscometer for or the device is intended for lay use cervical mucus is a device that is in- where the former intended use was by tended to measure the relative health care professionals only; viscoelasticity of cervical mucus col- (b) The modified device operates lected from a female patient. Measure- using a different fundamental sci- ments of relative viscoelasticity are in- entific technology than a legally mar- tended for use as an adjunct in the keted device in that generic type of de- clinical evaluation of a female with vice; e.g., a surgical instrument cuts chronic infertility, to determine the tissue with a laser beam rather than time of ovulation and the penetrability with a sharpened metal blade, or an in of cervical mucus to motile sperm. vitro diagnostic device detects or iden- (b) Classification. Class I (general con- tifies infectious agents by using trols). The device is exempt from the

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premarket notification procedures in (i) ‘‘Use of International Standard subpart E of part 807 of this chapter ISO 10993 ‘Biological Evaluation of subject to § 884.9. Medical Devices—Part I: Evaluation and Testing,’ ’’ and [47 FR 14706, Apr. 6, 1982, as amended at 65 FR 2320, Jan. 14, 2000] (ii) ‘‘510(k) Sterility Review Guidance of 2/12/90 (K90–1),’’ § 884.1050 Endocervical aspirator. (2) Labeling: (a) Identification. An endocervical as- (i) Indication: Only to evaluate the pirator is a device designed to remove endometrium, and tissue from the endocervix (mucous (ii) Contraindications: Pregnancy, membrane lining the canal of the cer- history of uterine perforation, or a re- vix of the uterus) by suction with a sy- cent cesarean section, and ringe, bulb and pipette, or catheter. (3) Design and testing: This device is used to evaluate (i) The sampling component is cov- endocervical tissue to detect malig- ered within the vagina, and nant and premalignant lesions. (ii) For adherence of the bristles and (b) Classification. Class II (perform- brush head. ance standards). [45 FR 12684, Feb. 26, 1980, as amended at 52 § 884.1060 Endometrial aspirator. FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, 2000] (a) Identification. An endometrial aspirator is a device designed to remove § 884.1175 Endometrial suction curette materials from the endometrium (the and accessories. mucosal lining of the uterus) by suc- (a) Identification. An endometrial suction with a syringe, bulb and pipette, tion curette is a device used to remove or catheter. This device is used to material from the uterus and from the study endometrial cytology (cells). mucosal lining of the uterus by scrap- (b) Classification. Class II. The special ing and vacuum suction. This device is controls for this device are: used to obtain tissue for biopsy or for (1) FDA’s: menstrual extraction. This generic (i) ‘‘Use of International Standard type of device may include catheters, ISO 10993 ‘Biological Evaluation of syringes, and tissue filters or traps. Medical Devices—Part I: Evaluation (b) Classification. Class II (perform- and Testing,’ ’’ and ance standards). (ii) ‘‘510(k) Sterility Review Guidance of 2/12/90 (K90–1),’’ § 884.1185 Endometrial washer. (2) Labeling: (i) Indication: Only to evaluate the (a) Identification. An endometrial endometrium, and washer is a device used to remove ma- (ii) Contraindications: Pregnancy, terials from the endometrium (the history of uterine perforation, or a re- mucosal lining of the uterus) by wash- cent cesarean section, and ing with water or saline solution and (3) The sampling component is cov- then aspirating with negative pressure. ered within vagina. This device is used to study endometrial cytology (cells). [45 FR 12684, Feb. 26, 1980, as amended at 52 (b) Classification. Class II. The special FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, 2000] controls for this device are: (1) FDA’s: § 884.1100 Endometrial brush. (i) ‘‘Use of International Organiza- (a) Identification. An endometrial tion for Standardization’s ISO 10993 brush is a device designed to remove ‘Biological Evaluation of Medical De- samples of the endometrium (the vices—Part I: Evaluation and Test- mucosal lining of the uterus) by brush- ing,’ ’’ and ing its surface. This device is used to (ii) ‘‘510(k) Sterility Review Guidance study endometrial cytology (cells). of 2/12/90 (K90–1),’’ (b) Classification. Class II. The special (2) Labeling: controls for this device are: (i) Indication: Only to evaluate the (1) FDA’s: endometrium,

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(ii) Contraindications: Pregnancy, (b) Classification. Class I (general con- history of uterine perforation, or a re- trols). The device is exempt from the cent cesarean section, and premarket notification procedures in (iii) Warning: Do not attach to a wall subpart E of part 807 of this chapter or any external suction, and subject to the limitations in § 884.9. (3) Design and Testing: [61 FR 1123, Jan. 16, 1996, as amended at 66 (i) The sampling component is cov- FR 33808, July 25, 2001] ered within the vagina, and (ii) Intrauterine pressure should not § 884.1560 Fetal blood sampler. exceed 50 millimeters of mercury. (a) Identification. A fetal blood sam- [45 FR 12684, Feb. 26, 1980, as amended at 52 pler is a device used to obtain fetal FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, blood transcervically through an endo- 2000] scope by puncturing the fetal skin with a short blade and drawing blood into a § 884.1300 Uterotubal carbon dioxide insufflator and accessories. heparinized tube. The fetal blood pH is determined and used in the diagnosis of (a) Identification. A uterotubal carbon fetal distress and fetal hypoxia. dioxide insufflator and accessories is a (b) Classification. Class II (perform- device used to test the patency (lack of ance standards). obstruction) of the fallopian tubes by pressurizing the uterus and fallopian § 884.1600 Transabdominal amnioscope tubes and filling them with carbon di- (fetoscope) and accessories. oxide gas. (b) Classification. Class II (perform- (a) Identification. A transabdominal ance standards). amnioscope is a device designed to permit direct visual examination of the § 884.1425 Perineometer. fetus by a telescopic system via abdominal entry. The device is used to (a) Identification. A perineometer is a ascertain fetal abnormalities, to obtain device consisting of a fluid-filled sack fetal blood samples, or to obtain fetal for intravaginal use that is attached to an external manometer. The devices tissue. This generic type of device may measure the strength of the perineal include the following accessories: tro- muscles by offering resistence to a pa- car and cannula, instruments used tient’s voluntary contractions of these through an operating channel or muscles and is used to diagnose and to through a separate cannula associated correct, through exercise, uninary in- with the amnioscope, light source and continence or sexual dysfunction. cables, and component parts. (b) Classification. Class II (perform- (b) Classification. Class III (premarket ance standards). approval). (c) Date premarket approval application § 884.1550 Amniotic fluid sampler (PMA) or notice of completion of a prod- (amniocentesis tray). uct development protocol (PDP) is re- (a) Identification. The amniotic fluid quired. A PMA or a notice of comple- sampler (amniocentesis tray) is a col- tion of a PDP is required to be filed lection of devices used to aspirate with the Food and Drug Administra- amniotic fluid from the amniotic sac tion on or before January 29, 1987 for via a transabdominal approach. Com- any transabdominal amnioscope ponents of the amniocentesis tray in- (fetoscope) and accessories that was in clude a disposable 3 inch 20 gauge nee- commercial distribution before May 28, dle with stylet and a 30 cc. syringe, as 1976, or that has on or before January well as the various sample collection 29, 1987 been found to be substantially accessories, such as vials, specimen equivalent to a transabdominal containers, medium, drapes, etc. The amnioscope (fetoscope) and accessories device is used at 16–18 weeks gestation that was in commercial distribution for antepartum diagnosis of certain before May 28, 1976. Any other congenital abnormalities or anytime transabdominal amnioscope (fetoscope) after 24 weeks gestation when used to and accessories shall have an approved assess fetal maturity. PMA or a declared completed PDP in

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effect before being placed in commer- subpart E of part 807 of this chapter, cial distribution. subject to the limitations in § 884.9. [45 FR 12684, Feb. 26, 1980, as amended at 51 [45 FR 12684, Feb. 26, 1980, as amended at 61 FR 39845, Oct. 31, 1986] FR 1123, Jan. 16, 1996; 66 FR 38808, July 25, 2001] § 884.1630 Colposcope. (a) Identification. A colposcope is a § 884.1660 Transcervical endoscope (amnioscope) and accessories. device designed to permit direct viewing of the tissues of the vagina and cer- (a) Identification. A transcervical en- vix by a telescopic system located out- doscope is a device designed to permit side the vagina. It is used to diagnose direct viewing of the fetus and abnormalities and select areas for bi- amniotic sac by means of an open tube opsy. This generic type of device may introduced into the uterus through the include a light source, cables, and com- cervix. The device may be used to vis- ponent parts. ualize the fetus or amniotic fluid and (b) Classification. Class II (perform- to sample fetal blood or amniotic fluid. ance standards). This generic type of device may include obturators, instruments used § 884.1640 Culdoscope and accessories. through an operating channel, light (a) Identification. A culdoscope is a sources and cables, and component device designed to permit direct view- parts. ing of the organs within the peri- (b) Classification. Class II (perform- toneum by a telescopic system intro- ance standards). duced into the pelvic cavity through § 884.1690 Hysteroscope and acces- the posterior vaginal fornix. It is used sories. to perform diagnostic and surgical procedures on the female genital organs. (a) Identification. A hysteroscope is a This generic type of device may in- device used to permit direct viewing of clude trocar and cannula, instruments the cervical canal and the uterine cav- used through an operating channel, ity by a telescopic system introduced scope preheaters, light source and ca- into the uterus through the cervix. It is bles, and component parts. used to perform diagnostic and surgical (b) Classification. (1) Class II (per- procedures other than sterilization. formance standards). This generic type of device may in- (2) Class I for culdoscope accessories clude obturators and sheaths, instru- that are not part of a specialized in- ments used through an operating chan- strument or device delivery system; do nel, scope preheaters, light sources and not have adapters, connectors, chan- cables, and component parts. nels, or do not have portals for (b) Classification. (1) Class II (per- electrosurgical, laser, or other power formance standards). sources. Such culdoscope accessory in- (2) Class I for hysteroscope acces- struments include: lens cleaning brush, sories that are not part of a specialized biopsy brush, clip applier (without instrument or device delivery system; clips), applicator, cannula (without do not have adapters, connectors, chan- trocar or valves), ligature carrier/nee- nels, or do not have portals for dle holder, clamp/hemostat/grasper, cu- electrosurgical, laser, or other power rette, instrument guide, ligature pass- sources. Such hysteroscope accessory ing and knotting instrument, suture instruments include: lens cleaning needle (without suture), retractor, me- brush, cannula (without trocar or chanical (noninflatable), snare, stylet, valves), clamp/hemostat/grasper, cu- forceps, dissector, mechanical (non- rette, instrument guide, forceps, dis- inflatable) scissors, and suction/irriga- sector, mechanical (noninflatable), and tion probe. The devices subject to this scissors. The devices subject to this paragraph (b)(2) are exempt from the paragraph (b)(2) are exempt from the premarket notification procedures in premarket notification procedures in

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subpart E of part 807 of this chapter, ing and knotting instrument, suture subject to the limitations in § 884.9. needle (without suture), retractor, mechanical (noninflatable), snare, stylet, [45 FR 12684, Feb. 26, 1980, as amended at 61 FR 1123, Jan. 16, 1996; 66 FR 38808, July 25, forceps, dissector, mechanical (non- 2001] inflatable), scissors, and suction/irrigation probe. The devices subject to this § 884.1700 Hysteroscopic insufflator. paragraph (b)(2) are exempt from the (a) Identification. A hysteroscopic premarket notification procedures in insufflator is a device designed to dis- subpart E of part 807 of this chapter, tend the uterus by filling the uterine subject to the limitations in § 884.9. cavity with a liquid or gas to facilitate [45 FR 12684, Feb. 26, 1980, as amended at 61 viewing with a hysteroscope. FR 1124, Jan. 16, 1996; 66 FR 38808, July 25, (b) Classification. (1) Class II (per- 2001] formance standards). (2) Class I for tubing and tubing/filter § 884.1730 Laparoscopic insufflator. fits which only include accessory in- (a) Identification. A laparoscopic struments that are not used to effect insufflator is a device used to facilitate intrauterine access, e.g., hysteroscopic the use of the laparoscope by filling the introducer sheaths, etc.; and single-use peritoneal cavity with gas to distend tubing kits used for only intrauterine it. insufflation. The devices subject to this (b) Classification. (1) Class II (per- paragraph (b)(2) are exempt from the formance standards). premarket notification procedures in (2) Class I for tubing and tubing/filter subpart E of part 807 of this chapter, kits which include accessory instru- subject to the limitations in § 884.9. ments that are not used to effect intra- [45 FR 12684, Feb. 26, 1980, as amended at 61 abdominal insufflation FR 1124, Jan. 16, 1996; 66 FR 38808, July 25, (pneumoperitoneum). The devices sub- 2001] ject to this paragraph (b)(2) are exempt from the premarket notification proce- § 884.1720 Gynecologic laparoscope dures in subpart E of part 807 of this and accessories. chapter, subject to the limitations in (a) Identification. A gynecologic § 884.9. laparoscope is a device used to permit direct viewing of the organs within the [45 FR 12684, Feb. 26, 1980, as amended at 61 peritoneum by a telescopic system in- FR 1124, Jan. 16, 1996; 66 FR 38809, July 25, 2001] troduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female gen- Subpart C—Obstetrical and Gyne- ital organs. This generic type of device cological Monitoring Devices may include: Trocar and cannula, instruments used through an operating § 884.2050 Obstetric data analyzer. channel, scope preheater, light source (a) Identification. An obstetric data and cables, and component parts. analyzer (fetal status data analyzer) is (b) Classification. (1) Class II (per- a device used during labor to analyze formance standards). electronic signal data obtained from (2) Class I for gynecologic fetal and maternal monitors. The ob- laparoscope accessories that are not stetric data analyzer provides clinical part of a specialized instrument or de- diagnosis of fetal status and rec- vice delivery system, do not have ommendations for labor management adapters, connector channels, or do not and clinical interventions. This generic have portals for electrosurgical, lasers, type of device may include signal anal- or other power sources. Such ysis and display equipment, electronic gynecologic laparosope accessory in- interfaces for other equipment, and struments include: the lens cleaning power supplies and component parts. brush, biopsy brush, clip applier (with- (b) Classification: Class III (premarket out clips), applicator, cannula (without approval). trocar or valves), ligature carrier/nee- (c) Date PMA or notice of completion of dle holder, clamp/hemostat/grasper, cu- PDP is required. A PMA or a notice of rette, instrument guide, ligature pass- completion of a PDP is required to be

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filed with the Food and Drug Adminis- the ‘‘fetal electrocardiographic mon- tration on or before October 3, 2000, for itor.’’ any obstetric data analyzer described (b) Classification. Class II (perform- in paragraph (a) of this section that ance standards). was in commercial distribution before May 28, 1976, or that has been found, on § 884.2620 Fetal or before October 3, 2000, to be substan- electroencephalographic monitor. tially equivalent to an obstetric data (a) Identification. A fetal analyzer described in paragraph (a) of electroencephalographic monitor is a this section that was in commercial distribution before May 28, 1976. Any device used to detect, measure, and other obstetric data analyzer described record in graphic form (by means of in paragraph (a) of this section shall one or more electrodes placed have an approved PMA or declared transcervically on the fetal scalp dur- completed PDP in effect before being ing labor) the rhythmically varying placed in commercial distribution. electrical skin potentials produced by the fetal brain. [65 FR 41332, July 5, 2000] (b) Classification. Class III (premarket § 884.2225 Obstetric-gynecologic ultra- approval). sonic imager. (c) Date PMA or notice of completion of (a) Identification. An obstetric- a PDP is required. A PMA or a notice of gynecologic ultrasonic imager is a de- completion of a PDP is required to be vice designed to transmit and receive filed with the Food and Drug Adminis- ultrasonic energy into and from a fe- tration on or before December 26, 1996 male patient by pulsed echoscopy. This for any fetal electroencephalographic device is used to provide a visual rep- monitor that was in commercial dis- resentation of some physiological or tribution before May 28, 1976, or that artificial structure, or of a fetus, for di- has, on or before December 26, 1996 agnostic purposes during a limited pe- been found to be substantially equiva- riod of time. This generic type of de- lent to a fetal electroencephalographic vice may include the following: signal monitor in commercial distribution be- analysis and display equipment, elec- fore May 28, 1976. Any other fetal tronic interfaces for other equipment, electroencephalographic monitor shall patient and equipment supports, cou- have an approved PMA or a declared pling gel, and component parts. This generic type of device does not include completed PDP in effect before being devices used to monitor the changes in placed in commercial distribution. some physiological condition over long [45 FR 12684, Feb. 26, 1980, as amended at 52 periods of time. FR 17741, May 11, 1987; 61 FR 50708, Sept. 27, (b) Classification. Class II (perform- 1996] ance standards). § 884.2640 Fetal phonocardiographic § 884.2600 Fetal cardiac monitor. monitor and accessories. (a) Identification. A fetal cardiac (a) Identification. A fetal monitor is a device used to ascertain phonocardiographic monitor is a device fetal heart activity during pregnancy designed to detect, measure, and record and labor. The device is designed to fetal heart sounds electronically, in separate fetal heart signals from ma- graphic form, and noninvasively, to as- ternal heart signals by analyzing elec- certain fetal condition during labor. trocardiographic signals (electrical potentials generated during contraction This generic type of device includes the and relaxation of heart muscle) ob- following accessories: signal analysis tained from the maternal abdomen and display equipment, patient and with external electrodes. This generic equipment supports, and other compo- type of device may include an alarm nent parts. that signals when the heart rate (b) Classification. Class II (perform- crosses a preset threshold. This generic ance standards). type of device includes the ‘‘fetal cardiotachometer (with sensors)’’ and

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§ 884.2660 Fetal ultrasonic monitor (b) Classification. Class III (premarket and accessories. approval). (a) Identification. A fetal ultrasonic (c) Date PMA or notice of completion of monitor is a device designed to trans- a PDP is required. A PMA or a notice of mit and receive ultrasonic energy into completion of a PDP is required to be and from the pregnant woman, usually filed with the Food and Drug Adminis- by means of continuous wave (doppler) tration on or before December 26, 1996 echoscopy. The device is used to rep- for any fetal scalp clip electrode and resent some physiological condition or applicator that was in commercial dis- characteristic in a measured value over tribution before May 28, 1976, or that a period of time (e.g., perinatal moni- has, on or before December 26, 1996 toring during labor) or in an imme- been found to be substantially equiva- diately perceptible form (e.g., use of lent to a fetal scalp clip electrode and the ultrasonic stethoscope). This ge- applicator that was in commercial dis- neric type of device may include the tribution before May 28, 1976. Any following accessories: signal analysis other fetal scalp clip electrode and ap- and display equipment, electronic plicator shall have an approved PMA or interfaces for other equipment, patient a declared completed PDP in effect be- and equipment supports, and compo- fore being placed in commercial dis- nent parts. This generic type of device tribution. does not include devices used to image some relatively unchanging physio- [45 FR 12684, Feb. 26, 1980, as amended at 52 logical structure or interpret a physio- FR 17741, May 11, 1987; 61 FR 50708, Sept. 27, logical condition, but does include de- 1996] vices which may be set to alarm automatically at a predetermined threshold § 884.2700 Intrauterine pressure mon- value. itor and accessories. (b) Classification. Class II (perform- (a) Identification. An intrauterine ance standards). pressure monitor is a device designed to detect and measure intrauterine and § 884.2675 Fetal scalp circular (spiral) amniotic fluid pressure with a catheter electrode and applicator. placed transcervically into the uterine (a) Identification. A fetal scalp cir- cavity. The device is used to monitor cular (spiral) electrode and applicator intensity, duration, and frequency of is a device used to obtain a fetal elec- uterine contractions during labor. This trocardiogram during labor and deliv- generic type of device may include the ery. It establishes electrical contact following accessories: signal analysis between fetal skin and an external and display equipment, patient and monitoring device by a shallow sub- equipment supports, and component cutaneous puncture of fetal scalp tis- parts. sue with a curved needle or needles. (b) Classification. Class II (perform- This generic type of device includes ance standards). nonreusable spiral electrodes and reusable circular electrodes. § 884.2720 External uterine contrac- (b) Classification. Class II (perform- tion monitor and accessories. ance standards). (a) Identification. An external uterine § 884.2685 Fetal scalp clip electrode contraction monitor (i.e., the and applicator. tokodynamometer) is a device used to (a) Identification. A fetal scalp clip monitor the progress of labor. It meas- electrode and applicator is a device de- ures the duration, frequency, and rel- signed to establish electrical contact ative pressure of uterine contractions between fetal skin and an external with a transducer strapped to the ma- monitoring device by means of pinch- ternal abdomen. This generic type of ing skin tissue with a nonreusable clip. device may include an external pres- This device is used to obtain a fetal sure transducer, support straps, and electrocardiogram. This generic type of other patient and equipment supports. device may include a clip electrode ap- (b) Classification. Class II (perform- plicator. ance standards).

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§ 884.2730 Home uterine activity mon- the maternal abdomen and cervix and itor. on the fetal scalp to provide the matrix (a) Identification. A home uterine ac- of measurements used to produce the tivity monitor (HUAM) is an electronic display. system for at home antepartum meas- (b) Classification. Class II (special urement of uterine contractions, data controls). The special controls are the transmission by telephone to a clinical FDA guidance document entitled: setting, and for receipt and display of ‘‘Guidance for Industry and Food and the uterine contraction data at the Drug Administration Staff; Class II clinic. The HUAM system comprises a Special Controls Guidance Document: tocotransducer, an at-home recorder, a Computerized Labor Monitoring Sys- modem, and a computer and monitor tems.’’ See § 884.1(e) for availability of that receive, process, and display data. this guidance document. This device is intended for use in [72 FR 20227, Apr. 24, 2007] women with a previous preterm delivery to aid in the detection of preterm § 884.2900 Fetal stethoscope. labor. (b) Classification. Class II (special (a) Identification. A fetal stethoscope controls); guidance document (Class II is a device used for listening to fetal Special Controls Guidance for Home heart sounds. It is designed to transmit Uterine Activity Monitors). the fetal heart sounds not only through sound channels by air conduction, but [66 FR 14076, Mar. 9, 2001] also through the user’s head by tissue conduction into the user’s ears. It does § 884.2740 Perinatal monitoring system not use ultrasonic energy. This device and accessories. is designed to eliminate noise inter- (a) Identification. A perinatal moni- ference commonly caused by handling toring system is a device used to show conventional stethoscopes. graphically the relationship between (b) Classification. Class I (general con- maternal labor and the fetal heart rate trols). The device is exempt from the by means of combining and coordi- premarket notification procedures in nating uterine contraction and fetal subpart E of part 807 of this chapter, heart monitors with appropriate dis- subject to the limitations in § 884.9. plays of the well-being of the fetus during pregnancy, labor, and delivery. [45 FR 12684, Feb. 26, 1980, as amended at 66 This generic type of device may in- FR 38809, July 25, 2001] clude any of the devices subject to §§ 884.2600, 884.2640, 884.2660, 884.2675, § 884.2960 Obstetric ultrasonic trans- 884.2700, and 884.2720. This generic type ducer and accessories. of device may include the following ac- (a) Identification. An obstetric ultra- cessories: Central monitoring system sonic transducer is a device used to and remote repeaters, signal analysis apply ultrasonic energy to, and to re- and display equipment, patient and ceive ultrasonic energy from, the body equipment supports, and component in conjunction with an obstetric mon- parts. itor or imager. The device converts (b) Classification. Class II (perform- electrical signals into ultrasonic en- ance standards). ergy, and vice versa, by means of an assembly distinct from an ultrasonic gen- § 884.2800 Computerized Labor Moni- erator. This generic type of device may toring System. include the following accessories: cou- (a) Identification. A computerized pling gel, preamplifiers, amplifiers, sig- labor monitoring system is a system nal conditioners with their power sup- intended to continuously measure cer- ply, connecting cables, and component vical dilation and fetal head descent parts. This generic type of device does and provide a display that indicates not include devices used to generate the progress of labor. The computerized the ultrasonic frequency electrical sig- labor monitoring system includes a nals for application. monitor and ultrasound transducers. (b) Classification. Class II (perform- Ultrasound transducers are placed on ance standards).

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§ 884.2980 Telethermographic system. physical palpation or mammography in (a) Telethermographic system intended diagnostic screening for detection of for adjunctive diagnostic screening for de- breast cancer or other uses is a non- tection of breast cancer or other uses—(1) electrically powered or an AC-powered Identification. A telethermographic sys- device applied to the skin that displays tem for adjunctive diagnostic screen- the color patterns of heat sensitive ing for detection of breast cancer or cholesteric liquid crystals that respond other uses is an electrically powered to temperature variations of the sur- device with a detector that is intended face of the body. This generic type of to measure, without touching the pa- device may include patient and equip- tient’s skin, the self-emanating infra- ment supports, a means to ensure ther- red radiation that reveals the tempera- mal contact between the patient’s skin ture variations of the surface of the and the liquid crystals, component body. This generic type of device may parts, and accessories. include signal analysis and display (2) Classification. Class I (general con- equipment, patient and equipment sup- trols). ports, component parts, and acces- (b) A nonelectrically powered or an sories. AC-powered liquid crystal thermo- (2) Classification. Class I (general con- graphic system intended for use alone trols). in diagnostic screening for detection of (b) Telethermographic system intended breast cancer or other uses— for use alone in diagnostic screening for (1) Identification. A nonelectrically detection of breast cancer or other uses— powered or an AC-powered liquid crys- (1) Identification. A telethermographic tal thermographic system intended for system for use as the sole diagnostic use as the sole diagnostic screening screening tool for detection of breast tool for detection of breast cancer or cancer or other uses is an electrically other uses is a nonelectrically powered powered device with a detector that is or an AC-powered device applied to the intended to measure, without touching skin that displays the color patterns of the patient’s skin, the self-emanating heat sensitive cholesteric liquid crys- infrared radiation that reveals the tals that respond to temperature vari- temperature variations of the surface ations of the surface of the body. This of the body. This generic type of device generic type of device may include may include signal analysis and dis- image display and recording equip- play equipment, patient and equipment ment, patient and equipment supports, supports, component parts, and acces- a means to ensure thermal contact be- sories. tween the patient’s skin and the liquid (2) Classification. Class III. crystals, component parts, and acces- (3) Date PMA or notice of completion of sories. a PDP is required. As of the enactment (2) Classification. Class III. date of the amendments, May 28, 1976, (3) Date PMA or notice of completion of an approval under section 515 of the act a PDP is required. As of the enactment is required before the device described date of the amendments, May 28, 1976, in paragraph (b)(1) may be commer- an approval under section 515 of the act cially distributed. See § 884.3. is required before the device described in paragraph (b)(1) may be commer- [53 FR 1566, Jan. 20, 1988, as amended at 55 FR 48440, Nov. 20, 1990; 66 FR 46953, Sept. 10, cially distributed. See § 884.3. 2001] [53 FR 1566, Jan. 20, 1988, as amended at 55 FR 48441, Nov. 20, 1990; 66 FR 46953, Sept. 10, § 884.2982 Liquid crystal thermo- 2001] graphic system. (a) A nonelectrically powered or an AC- § 884.2990 Breast lesion documentation powered liquid crystal thermographic sys- system. tem intended for adjunctive use in diag- (a) Identification. A breast lesion doc- nostic screening for detection of breast umentation system is a device for use cancer or other uses—(1) Identification. A in producing a surface map of the nonelectrically powered or an AC-pow- breast as an aid to document palpable ered liquid crystal thermographic sys- breast lesions identified during a clin- tem intended for use as an adjunct to ical breast examination.

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(b) Classification. Class II (special vice consisting of an instrument port controls). The special control is FDA’s and tissue containment method that guidance entitled ‘‘Class II Special creates a working space allowing for Controls Guidance Document: Breast direct visualization during a power Lesion Documentation System.’’ See morcellation procedure following a § 884.1(e) for the availability of this laparoscopic procedure for the excision guidance document. of benign gynecologic tissue that is not [68 FR 44415, Aug. 27, 2003] suspected to contain malignancy. (b) Classification. Class II (special Subpart D—Obstetrical and controls). The special controls for this device are: Gynecological Prosthetic Devices (1) The patient-contacting compo- § 884.3200 Cervical drain. nents of the device must be demonstrated to be biocompatible; (a) Identification. A cervical drain is a (2) Device components that are la- device designed to provide an exit beled sterile must be validated to a ste- channel for draining discharge from rility assurance level of 10¥6; the cervix after pelvic surgery. (b) Classification. Class II (perform- (3) Performance data must support ance standards). shelf life by demonstrating continued sterility of the device or the sterile § 884.3575 Vaginal pessary. components, package integrity, and de- (a) Identification. A vaginal pessary is vice functionality over the intended a removable structure placed in the va- shelf life; gina to support the pelvic organs and is (4) Non-clinical performance data used to treat conditions such as uter- must demonstrate that the device ine prolapse (falling down of uterus), meets all design specifications and per- uterine retroposition (backward dis- formance requirements. The following placement), or gynecologic hernia. performance characteristics must be (b) Classification. Class II (perform- tested: ance standards). (i) Demonstration of the device im- permeability to tissue, cells, and § 884.3650 Fallopian tube prosthesis. fluids; (a) Identification. A fallopian tube (ii) Demonstration that the device al- prosthesis is a device designed to main- lows for the insertion and withdrawal tain the patency (openness) of the fal- of laparoscopic instruments while lopian tube and is used after recon- maintaining pneumoperitoneum; structive surgery. (iii) Demonstration that the contain- (b) Classification. Class II (perform- ment system provides adequate space ance standards). to perform morcellation and adequate visualization of the laparoscopic in- § 884.3900 Vaginal stent. struments and tissue specimen relative (a) Identification. A vaginal stent is a to the external viscera; device used to enlarge the vagina by (iv) Demonstration that intended stretching, or to support the vagina laparoscopic instruments and and to hold a skin graft after recon- morcellators do not compromise the structive surgery. integrity of the containment system; (b) Classification. Class II (perform- and ance standards). (v) Demonstration that intended users can adequately deploy the device, Subpart E—Obstetrical and morcellate a specimen without com- Gynecological Surgical Devices promising the integrity of the device, and remove the device without spillage § 884.4050 Gynecologic laparoscopic of contents; power morcellation containment (5) Training must be developed and system. validated to ensure users can follow (a) Identification. A gynecologic the instructions for use; and laparoscopic power morcellation con- (6) Labeling must include the fol- tainment system is a prescription de- lowing:

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(i) A contraindication for use in Equipment—Part 1: General Require- gynecologic surgery in which the tissue ments for Safety,’’ to be morcellated is known or sus- (3) American National Standards In- pected to contain malignancy; stitute/American Association for Med- (ii) Unless clinical performance data ical Instrumentation’s HF–18, 1993, demonstrates that it can be removed or ‘‘Electrosurgical Devices,’’ modified, a contraindication for re- (4) Labeling: moval of uterine tissue containing sus- (i) Indication: For female tubal steri- pected fibroids in patients who are: lization, and Peri- or postmenopausal, or candidates (ii) Instructions for use: for en bloc tissue removal, for example, (A) Destroy at least 2 centimeters of through the vagina or via a mini-lapa- the fallopian tubes, rotomy incision; (B) Use a cut or undampened sinus- (iii) The following boxed warning: oidal waveform, ‘‘Warning: Information regarding the (C) Use a minimum power of 25 watts, potential risks of a procedure with this and device should be shared with patients. (D) For devices with ammeters: con- Uterine tissue may contain tinue electrode activation for 5 seconds unsuspected cancer. The use of after the visual endpoint (tissue laparoscopic power morcellators during blanching) is reached or current flow fibroid surgery may spread cancer. The ceases indicating adequate tissue de- use of this containment system has not struction. been clinically demonstrated to reduce [45 FR 12684, Feb. 26, 1980, as amended at 52 this risk.’’ FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, (iv) A statement limiting use of de- 2000] vice to physicians who have completed the training program; and § 884.4120 Gynecologic electrocautery (v) An expiration date or shelf life. and accessories. (a) Identification. A gynecologic [81 FR 40183, June 21, 2016] electrocautery is a device designed to destroy tissue with high temperatures § 884.4100 Endoscopic electrocautery and accessories. by tissue contact with an electrically heated probe. It is used to excise cer- (a) Identification. An endoscopic vical lesions, perform biopsies, or treat electrocautery is a device used to per- chronic cervicitis under direct visual form female sterilization under observation. This generic type of de- endoscopic observation. It is designed vice may include the following acces- to coagulate fallopian tube tissue with sories: an electrical generator, a probe, a probe heated by low-voltage energy. and electrical cables. This generic type of device may in- (b) Classification. Class II (perform- clude the following accessories: elec- ance standards). trical generators, probes, and electrical cables. § 884.4150 Bipolar endoscopic coagu- (b) Classification. Class II. The special lator-cutter and accessories. controls for this device are: (a) Identification. A bipolar (1) FDA’s: endoscopic coagulator-cutter is a de- (i) ‘‘Use of International Standard vice used to perform female steriliza- ISO 10993 ‘Biological Evaluation of tion and other operative procedures Medical Devices—Part I: Evaluation under endoscopic observation. It de- and Testing,’ ’’ stroys tissue with high temperatures (ii) ‘‘510(k) Sterility Review Guidance by directing a high frequency electrical 2/12/90 (K–90),’’ and current through tissue between two (iii) ‘‘Guidance (‘Guidelines’) for electrical contacts of a probe. This ge- Evaluation of Laproscopic Bipolar and neric type of device may include the Thermal Coagulators (and Acces- following accessories: an electrical sories),’’ generator, probes, and electrical ca- (2) International Electrotechnical bles. Commission’s IEC 60601–1–AM2 (1995– (b) Classification. Class II. The special 03), Amendment 2, ‘‘Medical Electrical controls for this device are:

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(1) FDA’s: (b) Classification. Class II (perform- (i) ‘‘Use of International Standard ance standards). ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation § 884.4250 Expandable cervical dilator. and Testing,’ ’’ (a) Identification. An expandable cer- (ii) ‘‘510(k) Sterility Review Guidance vical dilator is an instrument with two 2/12/90 (K–90),’’ and handles and two opposing blades used (iii) ‘‘Guidance (‘Guidelines’) for manually to dilate (stretch open) the Evaluation of Laproscopic Bipolar and cervical os. Thermal Coagulators (and Acces- (b) Classification. Class III (premarket sories),’’ approval). (2) International Electrotechnical (c) Date PMA or notice of completion of Commission’s IEC 60601–1–AM2 (1995– a PDP is required. A PMA or a notice of 03), Amendment 2, ‘‘Medical Electrical completion of a PDP is required to be Equipment—Part 1: General Require- filed with the Food and Drug Adminis- ments for Safety,’’ tration on or before December 26, 1996 (3) American National Standards In- for any expandable cervical dilator stitute/American Association for Med- that was in commercial distribution ical Instrumentation’s HF–18, 1993, before May 28, 1976, or that has, on or ‘‘Electrosurgical Devices,’’ before December 26, 1996 been found to (4) Labeling: be substantially equivalent to an ex- (i) Indication: For female tubal steri- pandable cervical dilator that was in lization, and commercial distribution before May 28, (ii) Instructions for use: 1976. Any other expandable cervical di- (A) Destroy at least 2 centimeters of lator shall have an approved PMA or a the fallopian tubes, declared completed PDP in effect be- (B) Use a cut or undampened sinus- fore being placed in commercial dis- oidal waveform, tribution. (C) Use a minimum power of 25 watts, [45 FR 12684, Feb. 26, 1980, as amended at 52 and FR 17741, May 11, 1987; 61 FR 50708, Sept. 27, (D) For devices with ammeters: con- 1996] tinue electrode activation for 5 seconds after the visual endpoint (tissue § 884.4260 Hygroscopic Laminaria cer- blanching) is reached or current flow vical dilator. ceases indicating adequate tissue de- (a) Identification. A hygroscopic Lam- struction. inaria cervical dilator is a device de- [45 FR 12684, Feb. 26, 1980, as amended at 52 signed to dilate (stretch open) the cer- FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, vical os by cervical insertion of a con- 2000] ical and expansible material made from the root of a seaweed (Laminaria § 884.4160 Unipolar endoscopic coagu- digitata or Laminaria japonica). The de- lator-cutter and accessories. vice is used to induce abortion. (a) Identification. A unipolar (b) Classification. Class II (perform- endoscopic coagulator-cutter is a de- ance standards). vice designed to destroy tissue with high temperatures by directing a high § 884.4270 Vibratory cervical dilators. frequency electrical current through (a) Identification. A vibratory cervical the tissue between an energized probe dilator is a device designed to dilate and a grounding plate. It is used in fe- the cervical os by stretching it with a male sterilization and in other opera- power-driven vibrating probe head. The tive procedures under endoscopic obser- device is used to gain access to the vation. This generic type of device may uterus or to induce abortion, but is not include the following accessories: an to be used during labor when a viable electrical generator, probes and elec- fetus is desired or anticipated. trical cables, and a patient grounding (b) Classification. Class III (premarket plate. This generic type of device does approval). not include devices used to perform fe- (c) Date PMA or notice of completion of male sterilization under hysteroscopic a PDP is required. A PMA or a notice of observation. completion of a PDP is required to be

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filed with the Food and Drug Adminis- to perform simple obstetric and tration on or before December 26, 1996 gynecologic manipulative functions. for any vibratory cervical dilator that This generic type of device consists of was in commercial distribution before the following: May 28, 1976, or that has, on or before (1) An episiotomy scissors is a cut- December 26, 1996 been found to be sub- ting instrument, with two opposed stantially equivalent to a vibratory shearing blades, used for surgical inci- cervical dilator that was in commer- sion of the vulvar orifice for obstet- cial distribution before May 28, 1976. rical purposes. Any other vibratory cervical dilator (2) A fiberoptic metal vaginal spec- shall have an approved PMA or a de- ulum is a metal instrument, with clared completed PDP in effect before fiberoptic light, used to expose and il- being placed in commercial distribu- luminate the interior of the vagina. tion. (3) A metal vaginal speculum is a [45 FR 12684, Feb. 26, 1980, as amended at 52 metal instrument used to expose the FR 17741, May 11, 1987; 61 FR 50708, Sept. 27, interior of the vagina. 1996] (4) An umbilical scissors is a cutting instrument, with two opposed shearing § 884.4340 Fetal vacuum extractor. blades, used to cut the umbilical cord. (a) Identification. A fetal vacuum ex- (5) A uterine clamp is an instrument tractor is a device used to facilitate de- used to hold the uterus by compres- livery. The device enables traction to sion. be applied to the fetal head (in the (6) A uterine packer is an instrument birth canal) by means of a suction cup used to introduce dressing into the attached to the scalp and is powered by uterus or vagina. an external vacuum source. This ge- (7) A vaginal applicator is an instru- neric type of device may include the ment used to insert medication into cup, hosing, vacuum source, and vacu- the vagina. um control. (8) A vaginal retractor is an instru- (b) Classification. Class II (perform- ment used to maintain vaginal expo- ance standards). sure by separating the edges of the va- § 884.4400 Obstetric forceps. gina and holding back the tissue. (9) A gynecological fibroid hook is an (a) Identification. An obstetric forceps instrument used to exert traction upon is a device consisting of two blades, a fibroid. with handles, designed to grasp and (10) A pelvimeter (external) is an in- apply traction to the fetal head in the strument used to measure the external birth passage and facilitate delivery. diameters of the pelvis. (b) Classification. Class II (perform- (b) Classification. Class I (general con- ance standards). trols). The devices are exempt from the § 884.4500 Obstetric fetal destructive premarket notification procedures in instrument. subpart E of part 807 of this chapter, subject to the limitations in § 884.9. (a) Identification. An obstetric fetal destructive instrument is a device de- [45 FR 12684, Feb. 26, 1980, as amended at 54 signed to crush or pull the fetal body FR 25052, June 12, 1989; 66 FR 38809, July 25, to facilitate the delivery of a dead or 2001] anomalous (abnormal) fetus. This generic type of device includes the § 884.4530 Obstetric-gynecologic spe- cleidoclast, cranioclast, craniotribe, cialized manual instrument. and destructive hook. (a) Identification. An obstetric- (b) Classification. Class II (perform- gynecologic specialized manual instru- ance standards). ment is one of a group of devices used during obstetric-gynecologic proce- § 884.4520 Obstetric-gynecologic gen- dures to perform manipulative diag- eral manual instrument. nostic and surgical functions (e.g., di- (a) Identification. An obstetric- lating, grasping, measuring, and scrap- gynecologic general manual instru- ing), where structural integrity is the ment is one of a group of devices used chief criterion of device performance.

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This type of device consists of the fol- (17) A nonmetal vaginal speculum is lowing: a nonmetal instrument used to expose (1) An amniotome is an instrument the interior of the vagina. used to rupture the fetal membranes. (18) A fiberoptic nonmetal vaginal (2) A circumcision clamp is an instru- speculum is a nonmetal instrument, ment used to compress the foreskin of with fiberoptic light, used to expose the penis during circumcision of a male and illuminate the interior of the va- infant. gina. (3) An umbilical clamp is an instru- (b) Classification. (1) Class II (per- ment used to compress the umbilical formance standards). cord. (2) Class I for the amniotome, uterine (4) A uterine curette is an instrument curette, cervical dilator (fixed-size bou- used to scrape and remove material gies), cerclage needle, IUD remover, from the uterus. uterine sound, and gynecological bi- (5) A fixed-size cervical dilator is any opsy forceps. The devices subject to of a series of bougies of various sizes this paragraph (b)(2) are exempt from used to dilate the cervical os by the premarket notification procedures stretching the cervix. in subpart E of part 807 of this chapter, subject to the limitations in § 884.9. (6) A uterine elevator is an instrument inserted into the uterus used to [45 FR 12684, Feb. 26, 1980, as amended at 61 lift and manipulate the uterus. FR 1124, Jan. 16, 1996; 66 FR 38809, July 25, (7) A gynecological surgical forceps is 2001] an instrument with two blades and § 884.4550 Gynecologic surgical laser. handles used to pull, grasp, or compress during gynecological examina- (a) Identification. A gynecologic sur- tion. gical laser is a continuous wave carbon (8) A cervical cone knife is a cutting dioxide laser designed to destroy tissue instrument used to excise and remove thermally or to remove tissue by radi- tissue from the cervix. ant light energy. The device is used (9) A gynecological cerclage needle is only in conjunction with a colposcope a looplike instrument used to suture as part of a gynecological surgical sys- the cervix. tem. A colposcope is a magnifying lens system used to examine the vagina and (10) A hook-type contraceptive intra- cervix. uterine device (IUD) remover is an in- (b) Classification. Class II (perform- strument used to remove an IUD from ance standards). the uterus. (11) A gynecological fibroid screw is § 884.4900 Obstetric table and acces- an instrument used to hold onto a fi- sories. broid. (a) Identification. An obstetric table is (12) A uterine sound is an instrument a device with adjustable sections de- used to determine the depth of the signed to support a patient in the var- uterus by inserting it into the uterine ious positions required during obstetric cavity. and gynecologic procedures. This ge- (13) A cytological cervical spatula is neric type of device may include the a blunt instrument used to scrape and following accessories: patient equip- remove cytological material from the ment, support attachments, and cabi- surface of the cervix or vagina. nets for warming instruments and dis- (14) A gynecological biopsy forceps is posing of wastes. an instrument with two blades and (b) Classification. Class II (perform- handles used for gynecological biopsy ance standards). procedures. (15) A uterine tenaculum is a hook- § 884.4910 Specialized surgical instru- like instrument used to seize and hold mentation for use with the cervix or fundus. urogynecologic surgical mesh. (16) An internal pelvimeter is an in- (a) Identification. Specialized surgical strument used within the vagina to instrumentation for use with measure the diameter and capacity of urogynecologic surgical mesh is a pre- the pelvis. scription device specifically intended

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for use as an aid in the insertion, place- Subpart F—Obstetrical and Gyne- ment, fixation, or anchoring of surgical cological Therapeutic De- mesh during urogynecologic proce- vices dures. These procedures include transvaginal pelvic organ prolapse re- § 884.5050 Metreurynter-balloon abor- pair, sacrocolpopexy (transabdominal tion system. pelvic organ prolapse repair), and (a) Identification. A metreurynter-bal- treatment of female stress urinary in- loon abortion system is a device used continence. Examples of specialized to induce abortion. The device is in- surgical instrumentation include nee- serted into the uterine cavity, inflated, dle passers and trocars, needle guides, and slowly extracted. The extraction of fixation tools, and tissue anchors. This the balloon from the uterus causes di- device is not a manual gastro- lation of the cervical os. This generic enterology-urology surgical instru- type of device may include pressure ment and accessories (§ 876.4730) or a sources and pressure controls. manual surgical instrument for general (b) Classification. Class III (premarket use (§ 878.4800). approval). (b) Classification. Class II (special (c) Date PMA or notice of completion of controls). The special controls for spe- a PDP is required. A PMA or a notice of cialized surgical instrumentation for completion of a PDP is required to be use with urogynecologic surgical mesh filed with the Food and Drug Adminis- tration on or before December 26, 1996 are: for any metreurynter-balloon abortion (1) The device must be demonstrated system that was in commercial dis- to be biocompatible; tribution before May 28, 1976, or that (2) The device must be demonstrated has, on or before December 26, 1996 to be sterile and, if reusable, it must be been found to be substantially equiva- demonstrated that the device can be lent to a metreurynter-balloon abor- adequately reprocessed; tion system that was in commercial (3) Performance data must support distribution before May 28, 1976. Any the shelf life of the device by dem- other metreurynter-balloon abortion onstrating package integrity and de- system shall have an approved PMA or vice functionality over the requested a declared completed PDP in effect be- shelf life; fore being placed in commercial dis- (4) Non-clinical performance testing tribution. must demonstrate that the device [45 FR 12684, Feb. 26, 1980, as amended at 52 meets all design specifications and per- FR 17741, May 11, 1987; 61 FR 50709, Sept. 27, formance requirements, and that the 1996] device performs as intended under anticipated conditions of use; and § 884.5070 Vacuum abortion system. (5) Labeling must include: (a) Identification. A vacuum abortion (i) Information regarding the mesh system is a device designed to aspirate design that may be used with the de- transcervically the products of concep- vice; tion or menstruation from the uterus (ii) Detailed summary of the clinical by using a cannula connected to a suction source. This device is used for evaluations pertinent to use of the de- pregnancy termination or menstrual vice; regulation. This type of device may in- (iii) Expiration date; and clude aspiration cannula, vacuum (iv) Where components are intended source, and vacuum controller. to be sterilized by the user prior to ini- (b) Classification. Class II (perform- tial use and/or are reusable, validated ance standards). methods and instructions for sterilization and/or reprocessing of any reus- § 884.5100 Obstetric anesthesia set. able components. (a) Identification. An obstetric anes- [82 FR 1603, Jan. 6, 2017] thesia set is an assembly of antiseptic solution, needles, needle guides, syringes, and other accessories, intended

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for use with an anesthetic drug. This (4) Mechanical bench testing of mate- device is used to administer regional rial strength must demonstrate that blocks (e.g., paracervical, uterosacral, the device will withstand forces en- and pudendal) that may be used during countered during use. labor, delivery, or both. (5) Safety and effectiveness data (b) Classification. Class II (perform- must demonstrate that the device pre- ance standards). vents hemorrhoids in women undergoing spontaneous vaginal delivery, in § 884.5150 Nonpowered breast pump. addition to general controls. (a) Identification. A nonpowered [76 FR 21238, Apr. 15, 2011] breast pump is a manual suction device used to express milk from the breast. § 884.5225 Abdominal decompression (b) Classification. Class I. The device chamber. is exempt from the premarket notifica- (a) Identification. An abdominal de- tion procedures in subpart E of part 807 compression chamber is a hoodlike de- of this chapter, subject to the limita- vice used to reduce pressure on the tions in § 884.9, if the device is using ei- pregnant patient’s abdomen for the re- ther a bulb or telescoping mechanism lief of abdominal pain during preg- which does not develop more than 250 nancy or labor. mm Hg suction, and the device mate- (b) Classification. Class III (premarket rials that contact breast or breast milk approval). do not produce cytotoxicity, irritation, (c) Date PMA or notice of completion of or sensitization effects. a PDP is required. A PMA or a notice of [45 FR 12684, Feb. 26, 1980, as amended at 61 completion of a PDP is required to be FR 1124, Jan. 16, 1996; 66 FR 38809, July 25, filed with the Food and Drug Adminis- 2001] tration on or before December 26, 1996 for any abdominal decompression § 884.5160 Powered breast pump. chamber that was in commercial dis- (a) Identification. A powered breast tribution before May 28, 1976, or that pump in an electrically powered suc- has, on or before December 26, 1996 tion device used to express milk from been found to be substantially equiva- the breast. lent to an abdominal decompression (b) Classification. Class II (perform- chamber that was in commercial dis- ance standards). tribution before May 28, 1976. Any other abdominal decompression cham- § 884.5200 Hemorrhoid prevention ber shall have an approved PMA or a pressure wedge. declared completed PDP in effect be- (a) Identification. A hemorrhoid pre- fore being placed in commercial dis- vention pressure wedge provides me- tribution. chanical support to the perianal region [45 FR 12684, Feb. 26, 1980, as amended at 52 during the labor and delivery process. FR 17741, May 11, 1987; 61 FR 50709, Sept. 27, External mechanical support of the 1996] perianal region is intended to help prevent the occurrence of external hemor- § 884.5250 Cervical cap. rhoids associated with vaginal child- (a) Identification. A cervical cap is a birth. flexible cuplike receptacle that fits (b) Classification. Class II (special over the cervix to collect menstrual controls). The special controls for this flow or to aid artificial insemination. device are: This generic type of device is not for (1) The sale, distribution, and use of contraceptive use. this device are restricted to prescrip- (b) Classification. Class II (perform- tion use in accordance with § 801.109 of ance standards). this chapter. (2) The labeling must include specific § 884.5300 Condom. instructions regarding the proper (a) Identification. A condom is a placement and use of the device. sheath which completely covers the (3) The device must be demonstrated penis with a closely fitting membrane. to be biocompatible. The condom is used for contraceptive

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and for prophylactic purposes (pre- that has, on or before September 12, venting transmission of sexually trans- 2002, been found to be substantially mitted infections). The device may also equivalent to a glans sheath that was be used to collect semen to aid in the in commercial distribution before May diagnosis of infertility. 28, 1976. Any other glans sheath shall (b) Classification. (1) Class II (special have an approved PMA or declared controls) for condoms made of mate- completed PDP in effect before being rials other than natural rubber latex, placed in commercial distribution. including natural membrane (skin) or synthetic. [59 FR 67187, Dec. 29, 1994, as amended at 67 (2) Class II (special controls) for nat- FR 40849, June 14, 2002] ural rubber latex condoms. The guidance document entitled ‘‘Class II Spe- § 884.5330 Female condom. cial Controls Guidance Document: La- (a) Identification. A female condom is beling for Natural Rubber Latex a sheath-like device that lines the vag- Condoms Classified Under 21 CFR inal wall and is inserted into the va- 884.5300’’ will serve as the special con- gina prior to the initiation of coitus. It trol. See § 884.1(e) for the availability of is indicated for contraceptive and pro- this guidance document. phylactic (preventing the transmission [73 FR 66538, Nov. 10, 2008] of sexually transmitted diseases) purposes. § 884.5310 Condom with spermicidal (b) Classification. Class III (premarket lubricant. approval). (a) Identification. A condom with (c) Date PMA or notice of completion of spermicidal lubricant is a sheath which PDP is required. A PMA or notice of completely covers the penis with a completion of a PDP is required to be closely fitting membrane with a lubri- filed with the Food and Drug Adminis- cant that contains a spermicidal agent, tration on or before November 21, 2011, nonoxynol–9. This condom is used for for any female condom that was in contraceptive and prophylactic pur- commercial distribution before May 28, poses (preventing transmission of vene- 1976, or that has, on or before Novem- real disease). ber 21, 2011, been found to be substan- (b) Classification. Class II (perform- tially equivalent to any female condom ance standards). that was in commercial distribution [47 FR 49022, Oct. 29, 1982] before May 28, 1976. Any other female condom shall have an approved PMA or § 884.5320 Glans sheath. declared completed PDP in effect be- (a) Identification. A glans sheath de- fore being placed in commercial dis- vice is a sheath which covers only the tribution. glans penis or part thereof and may also cover the area in the immediate [65 FR 31455, May 18, 2000, as amended at 76 proximity thereof, the corona and FR 50667, Aug. 16, 2011] frenulum, but not the entire shaft of the penis. It is indicated only for the § 884.5350 Contraceptive diaphragm prevention of pregnancy and not for and accessories. the prevention of sexually-transmitted (a) Identification. A contraceptive dia- diseases. phragm is a closely fitting membrane (b) Classification. Class III (premarket placed between the posterior aspect of approval). the pubic bone and the posterior vag- (c) Date premarket approval application inal fornix. The device covers the cer- (PMA) or notice of completion of a prod- vix completely and is used with a uct development protocol (PDP) is re- spermicide to prevent pregnancy. This quired. A PMA or a notice of comple- generic type of device may include an tion of a PDP is required to be filed introducer. with the Food and Drug Administra- (b) Classification. Class II (perform- tion on or before September 12, 2002, for ance standards). any glans sheath that was in commercial distribution before May 28, 1976, or

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§ 884.5360 Contraceptive intrauterine tion on or before December 30, 1987, for device (IUD) and introducer. any TOD and introducer that was in (a) Identification. A contraceptive commercial distribution before May 28, intrauterine device (IUD) is a device 1976, or that has on or before December used to prevent pregnancy. The device 30, 1987, been found to be substantially is placed high in the uterine fundus equivalent to a TOD and introducer with a string extending from the device that was in commercial distribution through the cervical os into the va- before May 28, 1976. Any other TOD and gina. This generic type of device in- introducer shall have an approved PMA cludes the introducer, but does not in- or a declared completed PDP in effect clude contraceptive IUD’s that func- before being placed in commercial dis- tion by drug activity, which are sub- tribution. ject to the new drug provisions of the [45 FR 12684, Feb. 26, 1980, as amended at 52 Federal Food, Drug, and Cosmetic Act FR 36883, Oct. 1, 1987] (see § 310.502). (b) Classification. Class III (premarket § 884.5390 Perineal heater. approval). (a) Identification. A perineal heater is (c) Labeling. Labeling requirements a device designed to apply heat di- for contraceptive IUD’s are set forth in rectly by contact, or indirectly from a § 801.427. radiant source, to the surface of the (d) Date premarket approval application perineum (the area between the vulva (PMA) or notice of completion of a prod- and the anus) and is used to soothe or uct development protocol (PDP) is re- to help heal the perineum after an quired. A PMA or a notice of comple- episiotomy (incision of the vulvar ori- tion of a PDP is required to be filed fice for obstetrical purposes). with the Food and Drug Administra- (b) Classification. Class II (perform- tion on or before August 4, 1986, for any ance standards). IUD and introducer that was in commercial distribution before May 28, § 884.5400 Menstrual cup. 1976, or that has on or before August 4, (a) Identification. A menstrual cup is 1986, been found to be substantially a receptacle placed in the vagina to equivalent to an IUD and introducer collect menstrual flow. that was in commercial distribution (b) Classification. Class II (perform- before May 28, 1976. Any other IUD and ance standards). introducer shall have an approved PMA or a declared completed PDP in effect § 884.5425 Scented or scented deodor- before being placed in commercial dis- ized menstrual pad. tribution. (a) Identification. A scented or scent- [45 FR 12684, Feb. 26, 1980, as amended at 51 ed deodorized menstrual pad is a device FR 16649, May 5, 1986] that is a pad made of cellulosic or synthetic material which is used to absorb § 884.5380 Contraceptive tubal occlu- menstrual or other vaginal discharge. sion device (TOD) and introducer. It has scent (i.e., fragrance materials) (a) Identification. A contraceptive added for aesthetic purposes (scented tubal occlusion device (TOD) and intro- menstrual pad) or for deodorizing pur- ducer is a device designed to close a poses (scented deodorized menstrual fallopian tube with a mechanical struc- pad). This generic type of device in- ture, e.g., a band or clip on the outside cludes sterile scented menstrual pads of the fallopian tube or a plug or valve used for medically indicated condi- on the inside. The devices are used to tions, but does not include menstrual prevent pregnancy. pads treated with added antimicrobial (b) Classification. Class III (premarket agents or other drugs. approval). (b) Classification. (1) Class I (general (c) Date premarket approval application controls) for menstrual pads made of (PMA) or notice of completion of a prod- common cellulosic and synthetic mate- uct development protocol (PDP) is re- rial with an established safety profile. quired. A PMA or a notice of comple- The devices subject to this paragraph tion of a PDP is required to be filed (b)(1) are exempt from the premarket with the Food and Drug Administra- notification procedures in subpart E of

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part 807 of this chapter, subject to the (b) Classification. Class II (perform- limitations in § 884.9. This exemption ance standards). does not include the intralabial pads [45 FR 12684, Feb. 26, 1980, as amended at 45 and reusable menstrual pads. FR 51186, Aug. 1, 1980] (2) Class II (special controls) for scented or scented deodorized men- § 884.5470 Unscented menstrual tam- strual pads made of materials not de- pon. scribed in paragraph (b)(1). (a) Identification. An unscented men- [45 FR 12684, Feb. 26, 1980, as amended at 45 strual tampon is a device that is a plug FR 51185, Aug. 1, 1980; 61 FR 67714, Dec. 24, made of cellulosic or synthetic mate- 1996; 66 FR 38809, July 25, 2001] rial that is inserted into the vagina and used to absorb menstrual or other § 884.5435 Unscented menstrual pad. vaginal discharge. This generic type of (a) Identification. An unscented men- device does not include menstrual tam- strual pad is a device that is a pad pons treated with scent (i.e., fragrance made of cellulosic or synthetic mate- materials) or those with added anti- rial which is used to absorb menstrual microbial agents or other drugs. or other vaginal discharge. This ge- (b) Classification. Class II (perform- neric type of device includes sterile ance standards). unscented menstrual pads used for medically indicated conditions, but § 884.5900 Therapeutic vaginal douche does not include menstrual pads treat- apparatus. ed with scent (i.e., fragrance materials) (a) Identification. A therapeutic vag- or those with added antimicrobial inal douche apparatus is a device that agents or other drugs. is a bag or bottle with tubing and a (b) Classification. Class I (general con- nozzle. The apparatus does not include trols). The device is exempt from the douche solutions. The apparatus is in- premarket notification procedures in tended and labeled for use in the treat- subpart E of part 807 of this chapter ment of medical conditions except it is only when the device is made of com- not for contraceptive use. After filling mon cellulosic and synthetic material the therapeutic vaginal douche appa- with an established safety profile. This ratus with a solution, the patient uses exemption does not include the the device to direct a stream of solu- intralabial pads and reusable men- tion into the vaginal cavity. strual pads. (b) Classification. (1) Class II (performance standards). [45 FR 12684, Feb. 26, 1980, as amended at 61 FR 67714, Dec. 24, 1996; 65 FR 2320, Jan. 14, (2) Class I if the device is operated by 2000; 73 FR 34860, June 19, 2008] gravity feed. Devices subject to this paragraph (b)(2) are exempt from the § 884.5460 Scented or scented deodor- premarket notification procedures in ized menstrual tampon. subpart E of part 807 of this chapter, (a) Identification. A scented or scent- subject to the limitations in § 884.9. ed deodorized menstrual tampon is a [45 FR 12684, Feb. 26, 1980, as amended at 61 device that is a plug made of cellulosic FR 1124, Jan. 16, 1996; 66 FR 38809, July 25, or synthetic material that is inserted 2001] into the vagina and used to absorb menstrual or other vaginal discharge. § 884.5920 Vaginal insufflator. It has scent (i.e., fragrance materials) (a) Identification. A vaginal added for aesthetic purposes (scented insufflator is a device used to treat menstrual tampon) or for deodorizing vaginitis by introducing medicated purposes (scented deodorized menstrual powder from a hand-held bulb into the tampon). This generic type of device vagina through an open speculum. does not include menstrual tampons (b) Classification. Class I. The device treated with added antimicrobial is exempt from the premarket notifica- agents or other drugs. tion procedures in subpart E of part 807

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of this chapter, subject to the limita- § 884.5970 Clitoral engorgement de- tions in § 884.9. vice. [45 FR 12684, Feb. 26, 1980, as amended at 54 (a) Identification. A clitoral FR 25052, June 12, 1989; 66 FR 38809, July 25, engorgement device is designed to 2001] apply a vacuum to the clitoris. It is intended for use in the treatment of fe- § 884.5940 Powered vaginal muscle male sexual arousal disorder. stimulator for therapeutic use. (b) Classification. Class II (special (a) Identification. A powered vaginal controls). The special control is a guid- muscle stimulator is an electrically ance document entitled: ‘‘Guidance for powered device designed to stimulate Industry and FDA Reviewers: Class II directly the muscles of the vagina with Special Controls Guidance Document pulsating electrical current. This de- for Clitoral Engorgement Devices.’’ vice is intended and labeled for thera- [65 FR 47306, Aug. 2, 2000] peutic use in increasing muscular tone and strength in the treatment of sexual § 884.5980 Surgical mesh for dysfunction. This generic type of de- transvaginal pelvic organ prolapse vice does not include devices used to repair. treat urinary incontinence. (a) Identification. Surgical mesh for (b) Classification. Class III (premarket transvaginal pelvic organ prolapse re- approval). pair is a prescription device intended (c) Date PMA or notice of completion of to reinforce soft tissue in the pelvic a PDP is required. A PMA or a notice of floor. This device is a porous implant completion of a PDP for a device is re- that is made of synthetic material, quired to be filed with the Food and non-synthetic material, or a combina- Drug Administration on or before July tion of synthetic and non-synthetic 12, 2000, for any powered vaginal mus- materials. This device does not include cle stimulator for therapeutic use that surgical mesh for other intended uses was in commercial distribution before (§ 878.3300 of this chapter). May 28, 1976, or that has, on or before (b) Classification. Class III (premarket July 12, 2000, been found to be substan- approval). tially equivalent to a powered vaginal (c) Date premarket application approval muscle stimulator that was in commer- or notice of completion of a product devel- cial distribution before May 28, 1976. opment protocol is required. A premarket Any other powered vaginal muscle application approval or notice of com- stimulator for therapeutic use shall pletion of a product development pro- have an approved PMA or declared tocol for a device is required to be filed completed PDP in effect before being with the Food and Drug Administra- placed in commercial distribution. tion on or before July 5, 2018, for any [45 FR 12684, Feb. 26, 1980, as amended at 52 surgical mesh described in paragraph FR 17741, May 11, 1987; 65 FR 19834, Apr. 13, (a) of this section that was in commer- 2000] cial distribution before May 28, 1976, or that has, on or before July 5, 2018, been § 884.5960 Genital vibrator for thera- found substantially equivalent to a peutic use. surgical mesh described in paragraph (a) Identification. A genital vibrator (a) of this section that was in commer- for therapeutic use is an electrically cial distribution before May 28, 1976. operated device intended and labeled Any other surgical mesh for for therapeutic use in the treatment of transvaginal pelvic organ prolapse re- sexual dysfunction or as an adjunct to pair shall have an approved premarket Kegel’s exercise (tightening of the application or declared completed product development protocol in effect muscles of the pelvic floor to increase before being placed in commercial dis- muscle tone). tribution. (b) Classification. Class II (performance standards). [81 FR 361, Jan. 5, 2016, as amended at 81 FR 369, Jan. 5, 2016]

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Subpart G—Assisted Reproduction (1) Powered aspiration pumps used to Devices provide low flow, intermittent vacuum for the aspiration of eggs (ova). (2) Syringe pumps (powered or man- SOURCE: 63 FR 48436, Sept. 10, 1998, unless otherwise noted. ual) used to activate a syringe to infuse or aspirate small volumes of fluid § 884.6100 Assisted reproduction nee- during assisted reproduction proce- dles. dures. (a) Identification. Assisted reproduc- (3) Collection tube warmers, used to tion needles are devices used in in vitro maintain the temperature of egg (oo- fertilization (IVF), gamete cyte) collection tubes at or near body intrafallopian transfer (GIFT), or other temperature. A dish/plate/microscope assisted reproduction procedures to ob- stage warmer is a device used to maintain gametes from the body or intro- tain the temperature of the egg (oo- duce gametes, zygote(s), preembryo(s) cyte) during manipulation. and/or embryo(s) into the body. This (4) Embryo incubators, used to store generic type of device may include a and preserve gametes and/or embryos single or double lumen needle and com- at or near body temperature. ponent parts, including needle guides, (5) Cryopreservation instrumentation such as those used with ultrasound. and devices, used to contain, freeze, (b) Classification. Class II (special and maintain gametes and/or embryos controls) (mouse embryo assay infor- at an appropriate freezing temperature. mation, endotoxin testing, sterilization (b) Classification. Class II (special validation, design specifications, label- controls) (design specifications, labeling requirements, biocompatibility testing, and clinical testing). ing requirements, and clinical testing).

§ 884.6110 Assisted reproduction cath- § 884.6130 Assisted reproduction eters. microtools. (a) Identification. Assisted reproduc- (a) Identification. Assisted reproduction catheters are devices used in in tion microtools are pipettes or other vitro fertilization (IVF), gamete devices used in the laboratory to intrafallopian transfer (GIFT), or other denude, micromanipulate, hold, or assisted reproduction procedures to in- transfer human gametes or embryos for troduce or remove gametes, zygote(s), assisted hatching, intracytoplasmic preembryo(s), and/or embryo(s) into or sperm injection (ICSI), or other as- from the body. This generic type of de- sisted reproduction methods. vice may include catheters, cannulae, (b) Classification. Class II (special introducers, dilators, sheaths, stylets, controls) (mouse embryo assay infor- and component parts. mation, endotoxin testing, sterilization (b) Classification. Class II (special validation, design specifications, label- controls) (mouse embryo assay infor- ing requirements, and clinical testing). mation, endotoxin testing, sterilization validation, design specifications, label- § 884.6140 Assisted reproduction ing requirements, biocompatibility micropipette fabrication instru- testing, and clinical testing). ments. (a) Identification. Assisted reproduc- § 884.6120 Assisted reproduction accessories. tion micropipette fabrication devices are instruments intended to pull, bevel, (a) Identification. Assisted reproduc- or forge a micropipette or needle for tion accessories are a group of devices intracytoplasmic sperm injection used during assisted reproduction pro- (ICSI), in vitro fertilization (IVF) or cedures, in conjunction with assisted other similar assisted reproduction reproduction needles and/or assisted re- procedures. production catheters, to aspirate, incu- bate, infuse, and/or maintain tempera- (b) Classification. Class II (special ture. This generic type of device may controls) (design specifications, label- include: ing requirements, and clinical testing).

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§ 884.6150 Assisted reproduction rates, clinical pregnancy rates, live micromanipulators and birth rates, and any adverse events or microinjectors. outcomes. (a) Identification. Assisted reproduc- (2) Nonclinical performance testing tion micromanipulators are devices in- must demonstrate that the device per- tended to control the position of an as- forms as intended under anticipated sisted reproduction microtool. Assisted conditions of use. The following per- reproduction microinjectors are any formance characteristics must be dem- device intended to control aspiration onstrated: or expulsion of the contents of an as- (i) Mouse embryo assay testing to assisted reproduction microtool. sess embryotoxicity by evaluating the (b) Classification. Class II (special gamete and embryo-contacting device controls) (design specifications, label- components effect on the growth and ing requirements, and clinical testing). development of mouse embryos to the blastocyst stage; § 884.6160 Assisted reproduction (ii) Endotoxin testing on gamete and labware. embryo-contacting components of the (a) Identification. Assisted reproduc- device; tion labware consists of laboratory (iii) Cleaning and disinfection valida- equipment or supplies intended to pre- tion of reusable device components; pare, store, manipulate, or transfer (iv) Sterility maintenance of the cul- human gametes or embryos for in vitro ture media within the device through- fertilization (IVF), gamete out the vaginal incubation period and intrafallopian transfer (GIFT), or other subsequent embryo extraction; and assisted reproduction procedures. (v) Ability of the device to permit ox- These include syringes, IVF tissue cul- ygen and carbon dioxide exchange be- ture dishes, IVF tissue culture plates, tween the media contained within the pipette tips, dishes, plates, and other device and the external environment vessels that come into physical contact throughout the vaginal incubation pe- with gametes, embryos or tissue cul- riod. ture media. (3) The patient-contacting compo- (b) Classification. Class II (special nents of the device must be dem- controls) (mouse embryo assay infor- onstrated to be biocompatible. mation, endotoxin testing, sterilization (4) Performance data must dem- validation, design specifications, label- onstrate the sterility of the device ing requirements, and clinical testing). components intended to be provided § 884.6165 Intravaginal culture system. sterile. (5) Shelf life testing must dem- (a) Identification. An intravaginal cul- onstrate that the device maintains its ture system is a prescription device in- performance characteristics and the tended for preparing, holding, and packaging of device components la- transferring human gametes or em- beled as sterile maintain integrity and bryos during intravaginal in vitro fer- sterility for the duration of the shelf tilization or intravaginal culture pro- life. cedures. (b) Classification. Class II (special (6) Labeling for the device must in- controls). The special controls for this clude: device are: (i) A detailed summary of the clinical (1) Clinical performance testing must testing, including device effectiveness, demonstrate the following: device-related complications, and ad- (i) Comfort and retention of the verse events; intravaginal culture device; (ii) Validated methods and instruc- (ii) Adverse vaginal tissue reactions tions for reprocessing of reusable com- associated with intravaginal culture; ponents; (iii) Maximum number of gametes (iii) The maximum number of and/or embryos that can be placed in a gametes or embryos that can be loaded device; and into the device; (iv) Rates of embryo development to (iv) A warning that informs users the designated stage, implantation that the embryo development is first

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evaluated following intravaginal cul- come in direct physical contact with ture; and human gametes or embryos (including (v) A statement that instructs the water, acid solutions used to treat user to use legally marketed assisted gametes or embryos, rinsing solutions, reproductive technology media that sperm separation media, supplements, contain elements to mitigate the con- or oil used to cover the media) for the tamination risk (e.g., antibiotics) and purposes of preparation, maintenance, to support continued embryonic devel- transfer or storage. Supplements are opment over the intravaginal culture specific reagents added to media to en- period. hance specific properties of the media (7) Patient labeling must be provided (e.g., proteins, sera, antibiotics, etc.). and must include: (b) Classification. Class II (special (i) Relevant warnings, precautions, controls) (mouse embryo assay infor- and adverse effects and complications; mation, endotoxin testing, sterilization (ii) Information on how to use the de- validation, design specifications, label- vice; ing requirements, biocompatibility (iii) The risks and benefits associated testing, and clinical testing). with the use of the device; and (iv) A summary of the principal clin- § 884.6190 Assisted reproductive mi- ical device effectiveness results. croscopes and microscope accessories. [81 FR 379, Jan. 6, 2016] (a) Identification. Assisted reproduc- § 884.6170 Assisted reproduction water tion microscopes and microscope acces- and water purification systems. sories (excluding microscope stage (a) Identification. Assisted reproduc- warmers, which are classified under as- tion water purification systems are de- sisted reproduction accessories) are op- vices specifically intended to generate tical instruments used to enlarge im- high quality, sterile, pyrogen-free ages of gametes or embryos. Variations water for reconstitution of media used of microscopes and accessories used for for aspiration, incubation, transfer or these purposes would include phase storage of gametes or embryos for in contrast microscopes, dissecting mi- vitro fertilization (IVF) or other as- croscopes and inverted stage micro- sisted reproduction procedures. These scopes. devices may also be intended as the (b) Classification. Class I. The device final rinse for labware or other assisted is exempt from the premarket notifica- reproduction devices that will contact tion procedures in subpart E of part 807 the gametes or embryos. These devices of this chapter, subject to the limita- also include bottled water ready for re- tions in § 884.9. constitution available from a vendor [63 FR 48436, Sept. 10, 1998, as amended at 64 that is specifically intended for recon- FR 62977, Nov. 18, 1999; 66 FR 38809, July 25, stitution of media used for aspiration, 2001] incubation, transfer, or storage of gametes or embryos for IVF or other § 884.6195 Assisted Reproduction Em- assisted reproduction procedures. bryo Image Assessment System. (b) Classification. Class II (special (a) Identification. An Assisted Repro- controls) (mouse embryo assay infor- duction Embryo Image Assessment mation, endotoxin testing, sterilization System is a prescription device that is validation, water quality testing, de- designed to obtain and analyze light sign specifications, labeling require- microscopy images of developing em- ments, biocompatibility testing, and bryos. This device provides information clinical testing). to aid in the selection of embryo(s) for transfer when there are multiple em- § 884.6180 Reproductive media and bryos deemed suitable for transfer or supplements. freezing. (a) Identification. Reproductive media (b) Classification. Class II (special and supplement are products that are controls). The special control(s) for used for assisted reproduction proce- this device are: dures. Media include liquid and powder (1) Clinical performance testing must versions of various substances that demonstrate a reasonable assurance of

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safety and effectiveness of the device to ablate a small tangential hole in, or to predict embryo development. Classi- to thin, the zona pellucida of an em- fication performance (sensitivity and bryo for assisted hatching or other as- specificity) and predictive accuracy sisted reproduction procedures. (Positive Predictive Value and Nega- (b) Classification. Class II (special tive Predictive Value) must be assessed controls). The special control is FDA’s at the subject and embryo levels. guidance document entitled ‘‘Class II (2) Software validation, verification, Special Controls Guidance Document: and hazard analysis must be provided. Assisted Reproduction Laser Systems.’’ (3) Non-clinical performance testing See § 884.1(e) for the availability of this data must demonstrate the perform- guidance document. ance characteristics of the device. [69 FR 77624, Dec. 28, 2004] Testing must include the following: (i) Total light exposure and output testing; PART 886—OPHTHALMIC DEVICES (ii) A safety analysis must be performed based on maximum (worst-case) Subpart A—General Provisions light exposure to embryos, which also Sec. includes the safety of the light wave- 886.1 Scope. length(s) emitted by the device; 886.3 Effective dates of requirement for pre- (iii) Simulated-use testing; market approval. (iv) Mouse Embryo Assay testing to 886.9 Limitations of exemptions from sec- assess whether device operation im- tion 510(k) of the Federal Food, Drug, and Cosmetic Act (the act). pacts growth and development of mouse embryos to the blastocyst stage; Subpart B—Diagnostic Devices (v) Cleaning and disinfection validation of reusable components; 886.1040 Ocular esthesiometer. (vi) Package integrity and transit 886.1050 Adaptometer (biophotometer). testing; 886.1070 Anomaloscope. 886.1090 Haidinger brush. (vii) Hardware fail-safe validation; 886.1120 Ophthalmic camera. (viii) Electrical equipment safety and 886.1140 Ophthalmic chair. electromagnetic compatibility testing; 886.1150 Visual acuity chart. and 886.1160 Color vision plate illuminator. (ix) Prediction algorithm reproduc- 886.1170 Color vision tester. ibility. 886.1190 Distometer. (4) Labeling must include the fol- 886.1200 Optokinetic drum. 886.1220 Corneal electrode. lowing: 886.1250 Euthyscope. (i) A detailed summary of clinical 886.1270 Exophthalmometer. performance testing, including any ad- 886.1290 Fixation device. verse events; 886.1300 Afterimage flasher. (ii) Specific instructions, warnings, 886.1320 Fornixscope. precautions, and training needed for 886.1330 Amsler grid. safe use of the device 886.1340 Haploscope. 886.1342 Strabismus detection device. (iii) Appropriate electromagnetic 886.1350 Keratoscope. compatibility information; 886.1360 Visual field laser instrument. (iv) Validated methods and instruc- 886.1375 Bagolini lens. tions for cleaning and disinfection of 886.1380 Diagnostic condensing lens. reusable components; and 886.1385 Polymethylmethacrylate (PMMA) (v) Information identifying compat- diagnostic contact lens. ible cultureware and explain how they 886.1390 Flexible diagnostic Fresnel lens. are used with the device. 886.1395 Diagnostic Hruby fundus lens. 886.1400 Maddox lens. [80 FR 10332, Feb. 26, 2015] 886.1405 Ophthalmic trial lens set. 886.1410 Ophthalmic trial lens clip. § 884.6200 Assisted reproduction laser 886.1415 Ophthalmic trial lens frame. system. 886.1420 Ophthalmic lens gauge. 886.1425 Lens measuring instrument. (a) Identification. The assisted repro- 886.1430 Ophthalmic contact lens radius duction laser system is a device that measuring device. images, targets, and controls the power 886.1435 Maxwell spot. and pulse duration of a laser beam used 886.1450 Corneal radius measuring device.

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886.1460 Stereopsis measuring instrument. 886.4300 Intraocular lens guide. 886.1500 Headband mirror. 886.4335 Operating headlamp. 886.1510 Eye movement monitor. 886.4350 Manual ophthalmic surgical instru- 886.1570 Ophthalmoscope. ment. 886.1605 Perimeter. 886.4360 Ocular surgery irrigation device. 886.1630 AC-powered photostimulator. 886.4370 Keratome. 886.1640 Ophthalmic preamplifier. 886.4390 Ophthalmic laser. 886.1650 Ophthalmic bar prism. 886.4392 Nd:YAG laser for posterior 886.1655 Ophthalmic Fresnel prism. capsulotomy and peripheral iridotomy. 886.1660 Gonioscopic prism. 886.4400 Electronic metal locator. 886.1665 Ophthalmic rotary prism. 886.4440 AC-powered magnet. 886.1670 Ophthalmic isotope uptake probe. 886.4445 Permanent magnet. 886.1680 Ophthalmic projector. 886.4570 Ophthalmic surgical marker. 886.1690 Pupillograph. 886.4610 Ocular pressure applicator. 886.1700 Pupillometer. 886.4670 Phacofragmentation system. 886.1750 Skiascopic rack. 886.4690 Ophthalmic photocoagulator. 886.1760 Ophthalmic refractometer. 886.4750 Ophthalmic eye shield. 886.1770 Manual refractor. 886.4770 Ophthalmic operating spectacles 886.1780 Retinoscope. (loupes). 886.1790 Nearpoint ruler. 886.4790 Ophthalmic sponge. 886.1800 Schirmer strip. 886.4855 Ophthalmic instrument table. 886.1810 Tangent screen (campimeter). 886.1840 Simulatan (including crossed cylinder). Subpart F—Therapeutic Devices 886.1850 AC-powered slitlamp biomicro- 886.5100 Ophthalmic beta radiation source. scope. 886.5120 Low-power binocular loupe. 886.1860 Ophthalmic instrument stand. 886.5200 Eyelid thermal pulsation system. 886.1870 Stereoscope. 886.5420 Contact lens inserter/remover. 886.1880 Fusion and stereoscopic target. 886.5540 Low-vision magnifier. 886.1905 Nystagmus tape. 886.5600 Ptosis crutch. 886.1910 Spectacle dissociation test system. 886.5700 Eyelid weight. 886.1925 Diurnal pattern recorder system. 886.5800 Ophthalmic bar reader. 886.1930 Tonometer and accessories. 886.5810 Ophthalmic prism reader. 886.1940 Tonometer sterilizer. 886.5820 Closed-circuit television reading 886.1945 Transilluminator. system. Subpart C [Reserved] 886.5838 Nasolacrimal compression device. 886.5840 Magnifying spectacles. Subpart D—Prosthetic Devices 886.5842 Spectacle frame. 886.5844 Prescription spectacle lens. 886.3100 Ophthalmic tantalum clip. 886.5850 Sunglasses (nonprescription). 886.3130 Ophthalmic conformer. 886.5870 Low-vision telescope. 886.3200 Artificial eye. 886.5900 Electronic vision aid. 886.3300 Absorbable implant (scleral buck- 886.5905 Oral electronic vision aid. ling method). 886.5910 Image intensification vision aid. 886.3320 Eye sphere implant. 886.5915 Optical vision aid. 886.3340 Extraocular orbital implant. 886.5916 Rigid gas permeable contact lens. 886.3400 Keratoprosthesis. 886.5918 Rigid gas permeable contact lens 886.3600 Intraocular lens. care products. 886.3800 Scleral shell. 886.5925 Soft (hydrophilic) contact lens. 886.3920 Aqueous shunt. 886.5928 Soft (hydrophilic) contact lens care products. Subpart E—Surgical Devices 886.5933 [Reserved] 886.4070 Powered corneal burr. AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 886.4100 Radiofrequency electrosurgical cau- 360j, 371. tery apparatus. SOURCE: 52 FR 33355, Sept. 2, 1987, unless 886.4115 Thermal cautery unit. otherwise noted. 886.4150 Vitreous aspiration and cutting instrument. EDITORIAL NOTE: Nomenclature changes to 886.4155 Scleral plug. part 886 appear at 73 FR 35341, June 23, 2008. 886.4170 Cryophthalmic unit. 886.4230 Ophthalmic knife test drum. Subpart A—General Provisions 886.4250 Ophthalmic electrolysis unit. 886.4270 Intraocular gas. § 886.1 Scope. 886.4275 Intraocular fluid. 886.4280 Intraocular pressure measuring de- (a) This part sets forth the classifica- vice. tion of ophthalmic devices intended for

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human use that are in commercial dis- vided in paragraphs (b) and (c) of this tribution. section. Such a regulation under sec- (b) The identification of a device in a tion 515(b) of the act shall not be effec- regulation in this part is not a precise tive during the grace period ending on description of every device that is, or the 90th day after its promulgation or will be, subject to the regulation. A on the last day of the 30th full calendar manufacturer who submits a pre- month after the regulation that classi- market notification submission for a fies the device into class III is effec- device under part 807 cannot show tive, whichever is later. See section merely that the device is accurately 501(f)(2)(B) of the act. Accordingly, un- described by the section title and iden- less an effective date of the require- tification provision of a regulation in ment for premarket approval is shown this part but shall state why the device in the regulation for a device classified is substantially equivalent to other de- into class III in this part, the device vices, as required by § 807.87. may be commercially distributed with- (c) To avoid duplicative listings, an out FDA’s issuance of an order approv- ophthalmic device that has two or ing a PMA or declaring completed a more types of uses (e.g., used both as a PDP for the device. If FDA promul- diagnostic device and as a therapeutic gates a regulation under section 515(b) device) is listed in one subpart only. of the act requiring premarket ap- (d) References in this part to regu- proval for a device, section 501(f)(1)(A) latory sections of the Code of Federal of the act applies to the device. Regulations are to chapter I of title 21 (b) Any new, not substantially equiv- unless otherwise noted. alent, device introduced into commer- (e) Guidance documents referenced in cial distribution on or after May 28, this part are available on the Internet 1976, including a device formerly mar- at http://www.fda.gov/MedicalDevices/ keted that has been substantially al- DeviceRegulationandGuidance/ tered, is classified by statute (section GuidanceDocuments/default.htm.. 513(f) of the act) into class III without [52 FR 33355, Sept. 2, 1987, as amended at 73 any grace period and FDA must have FR 34860, June 19, 2008; 78 FR 18233, Mar. 26, issued an order approving a PMA or de- 2013] claring completed a PDP for the device before the device is commercially dis- § 886.3 Effective dates of requirement tributed unless it is reclassified. If for premarket approval. FDA knows that a device being com- A device included in this part that is mercially distributed may be a ‘‘new’’ classified into class III (premarket ap- device as defined in this section be- proval) shall not be commercially dis- cause of any new intended use or other tributed after the date shown in the reasons, FDA may codify the statutory regulation classifying the device unless classification of the device into class the manufacturer has an approval III for such new use. Accordingly, the under section 515 of the act (unless an regulation for such a class III device exemption has been granted under sec- states that as of the enactment date of tion 520(g)(2) of the act). An approval the amendments, May 28, 1976, the de- under section 515 of the act consists of vice must have an approval under sec- FDA’s issuance of an order approving tion 515 of the act before commercial an application for premarket approval distribution. (PMA) for the device or declaring com- (c) A device identified in a regulation pleted a product development protocol in this part that is classified into class (PDP) for the device. III and that is subject to the transi- (a) Before FDA requires that a device tional provisions of section 520(1) of the commercially distributed before the act is automatically classified by stat- enactment date of the amendments, or ute into class III and must have an ap- a device that has been found substan- proval under section 515 of the act be- tially equivalent to such a device, has fore being commercially distributed. an approval under section 515 of the Accordingly, the regulation for such a act, FDA must promulgate a regula- class III transitional device states that tion under section 515(b) of the act re- as of the enactment date of the amend- quiring such approval, except as pro- ments, May 28, 1976, the device must

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have an approval under section 515 of (3) For measuring an analyte that the act before commercial distribution. serves as a surrogate marker for screening, diagnosis, or monitoring § 886.9 Limitations of exemptions from life-threatening diseases such as ac- section 510(k) of the Federal Food, quired immune deficiency syndrome Drug, and Cosmetic Act (the act). (AIDS), chronic or active hepatitis, tu- The exemption from the requirement berculosis, or myocardial infarction or of premarket notification (section to monitor therapy; 510(k) of the act) for a generic type of (4) For assessing the risk of cardio- class I or II device is only to the extent vascular diseases; that the device has existing or reason- (5) For use in diabetes management; ably foreseeable characteristics of (6) For identifying or inferring the commercially distributed devices with- identity of a microorganism directly in that generic type or, in the case of in vitro diagnostic devices, only to the from clinical material; extent that misdiagnosis as a result of (7) For detection of antibodies to using the device would not be associ- microorganisms other than ated with high morbidity or mortality. immunoglobulin G (IgG) or IgG assays Accordingly, manufacturers of any when the results are not qualitative, or commercially distributed class I or II are used to determine immunity, or the device for which FDA has granted an assay is intended for use in matrices exemption from the requirement of other than serum or plasma; premarket notification must still sub- (8) For noninvasive testing as defined mit a premarket notification to FDA in § 812.3(k) of this chapter; and before introducing or delivering for in- (9) For near patient testing (point of troduction into interstate commerce care). for commercial distribution the device when: [65 FR 2320, Jan. 14, 2000] (a) The device is intended for a use different from the intended use of a le- Subpart B—Diagnostic Devices gally marketed device in that generic type of device; e.g., the device is in- § 886.1040 Ocular esthesiometer. tended for a different medical purpose, (a) Identification. An ocular or the device is intended for lay use esthesiometer is a device, such as a sin- where the former intended use was by gle-hair brush, intended to touch the health care professionals only; cornea to assess corneal sensitivity. (b) The modified device operates (b) Classification. Class I (general con- using a different fundamental sci- trols). The device is exempt from the entific technology than a legally mar- premarket notification procedures in keted device in that generic type of de- subpart E of part 807 of this chapter, vice; e.g., a surgical instrument cuts subject to the limitations in § 886.9. tissue with a laser beam rather than with a sharpened metal blade, or an in [52 FR 33355, Sept. 2, 1987, as amended at 53 vitro diagnostic device detects or iden- FR 35603, Sept. 14, 1988; 59 FR 63012, Dec. 7, tifies infectious agents by using 1994; 66 FR 38809, July 25, 2001] deoxyribonucleic acid (DNA) probe or nucleic acid hybridization technology § 886.1050 Adaptometer (biophotometer). rather than culture or immunoassay technology; or (a) Identification. An adaptometer (c) The device is an in vitro device (biophotometer) is an AC-powered de- that is intended: vice that provides a stimulating light (1) For use in the diagnosis, moni- source which has various controlled in- toring, or screening of neoplastic dis- tensities intended to measure the time eases with the exception of required for retinal adaptation (regen- immunohistochemical devices; eration of the visual purple) and the (2) For use in screening or diagnosis minimum light threshold. of familial or acquired genetic dis- (b) Classification. Class I (general con- orders, including inborn errors of me- trols). The device is exempt from the tabolism; premarket notification procedures in

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subpart E of part 807 of this chapter, 807 of this chapter, subject to the limi- subject to the limitations in § 886.9. tations in § 886.9. The manual device is also exempt from the current good [55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38809, July 25, manufacturing practice requirements 2001] of the quality system regulation in part 820 of this chapter, with the excep- § 886.1070 Anomaloscope. tion of § 820.180, with respect to general (a) Identification. An anomaloscope is requirements concerning records, and an AC-powered device intended to test § 820.198, with respect to complaint for anomalies of color vision by dis- files. playing mixed spectral lines to be [55 FR 48441, Nov. 20, 1990, as amended at 59 matched by the patient. FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, (b) Classification. Class I (general con- 2001] trols). The device is exempt from the premarket notification procedures in § 886.1150 Visual acuity chart. subpart E of part 807 of this chapter, (a) Identification. A visual acuity subject to the limitations in § 886.9. chart is a device that is a chart, such [55 FR 48441, Nov. 20, 1990, as amended at 59 as a Snellen chart with block letters or FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, other symbols in graduated sizes, in- 2001] tended to test visual acuity. (b) Classification. Class I (general con- § 886.1090 Haidinger brush. trols). The device is exempt from the (a) Identification. A Haidinger brush premarket notification procedures in is an AC-powered device that provides subpart E of part 807 of this chapter, two conical brushlike images with subject to the limitations in § 886.9. The apexes touching which are viewed by device is also exempt from the current the patient through a Nicol prism and good manufacturing practice require- intended to evaluate visual function. It ments of the quality system regulation may include a component for meas- in part 820 of this chapter, with the ex- uring macular integrity. ception of § 820.180, with respect to gen- (b) Classification. Class I (general con- eral requirements concerning records, trols). The device is exempt from the and § 820.198, with respect to complaint premarket notification procedures in files. subpart E of part 807 of this chapter, subject to the limitations in § 886.9. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988; 53 FR 40825, Oct. 18, [55 FR 48441, Nov. 20, 1990, as amended at 59 1988; 66 FR 38810, July 25, 2001] FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, 2001; 72 FR 17400, Apr. 9, 2007] § 886.1160 Color vision plate illuminator. § 886.1120 Ophthalmic camera. (a) Identification. A color vision plate (a) Identification. An ophthalmic cam- illuminator is an AC-powered device era is an AC-powered device intended that is a lamp intended to properly il- to take photographs of the eye and the luminate color vision testing plates. It surrounding area. may include a filter. (b) Classification. Class II. (b) Classification. Class I (general con- [55 FR 48441, Nov. 20, 1990] trols). The device is exempt from the premarket notification procedures in § 886.1140 Ophthalmic chair. subpart E of part 807 of this chapter, (a) Identification. An ophthalmic subject to the limitations in § 886.9. chair is an AC-powered or manual de- [55 FR 48441, Nov. 20, 1990, as amended at 59 vice with adjustable positioning in FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, which a patient is to sit or recline dur- 2001] ing ophthalmological examination or treatment. § 886.1170 Color vision tester. (b) Classification. Class I. The AC- (a) Identification. A color vision tester powered device and the manual device is a device that consists of various col- are exempt from the premarket notifi- ored materials, such as colored yarns cation procedures in subpart E of part or color vision plates (multicolored

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plates which patients with color vision device is also exempt from the current deficiency would perceive as being of good manufacturing practice require- one color), intended to evaluate color ments of the quality system regulation vision. in part 820 of this chapter, with the ex- (b) Classification. Class I (general con- ception of § 820.180, with respect to gen- trols). The device is exempt from the eral requirements concerning records, premarket notification procedures in and § 820.198, with respect to complaint subpart E of part 807 of this chapter, files. subject to the limitations in § 886.9. The device is also exempt from the current [52 FR 33355, Sept. 2, 1987, as amended at 53 good manufacturing practice require- FR 35604, Sept. 14, 1988; 66 FR 38810, July 25, ments of the quality system regulation 2001] in part 820 of this chapter, with the ex- § 886.1220 Corneal electrode. ception of § 820.180, with respect to general requirements concerning records, (a) Identification. A corneal electrode and § 820.198, with respect to complaint is an AC-powered device, usually part files. of a special contact lens, intended to be applied directly to the cornea to pro- [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35603, Sept. 14, 1988; 66 FR 38810, July 25, vide data showing the changes in elec- 2001] trical potential in the retina after electroretinography (stimulation by § 886.1190 Distometer. light). (a) Identification. A distometer is a (b) Classification. Class II. device intended to measure the distance between the cornea and a correc- § 886.1250 Euthyscope. tive lens during refraction to help (a) Identification. A euthyscope is a measure the change of the visual image device that is a modified AC-powered when a lens is in place. or battery-powered ophthalmoscope (a (b) Classification. Class I (general con- perforated mirror device intended to trols). The device is exempt from the inspect the interior of the eye) that premarket notification procedures in projects a bright light encompassing an subpart E of part 807 of this chapter, arc of about 30 degrees onto the fundus subject to the limitations in § 886.9. The of the eye. The center of the light bun- device is also exempt from the current dle is blocked by a black disk covering good manufacturing practice require- the fovea (the central depression of the ments of the quality system regulation macular retinae where only cones are in part 820 of this chapter, with the ex- present and blood vessels are lacking). ception of § 820.180, with respect to gen- The device is intended for use in the eral requirements concerning records, treatment of amblyopia (dimness of vi- and § 820.198, with respect to complaint sion without apparent disease of the files. eye). [52 FR 33355, Sept. 2, 1987, as amended at 53 (b) Classification. Class I for the bat- FR 35603, Sept. 14, 1988; 66 FR 38810, July 25, tery powered device. The battery pow- 2001] ered device is exempt from the pre- § 886.1200 Optokinetic drum. market notification procedures in subpart E of part 807 of this chapter, sub- (a) Identification. An optokinetic ject to the limitations in § 886.9. Class drum is a drum-like device covered II for the AC-powered device. with alternating white and dark stripes or pictures that can be rotated on its [55 FR 48441, Nov. 20, 1990, as amended at 59 handle. The device is intended to elicit FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, and evaluate nystagmus (involuntary 2001] rapid movement of the eyeball) in patients. § 886.1270 Exophthalmometer. (b) Classification. Class I (general con- (a) Identification. An trols). The device is exempt from the exophthalmometer is a device, such as premarket notification procedures in a ruler, gauge, or caliper, intended to subpart E of part 807 of this chapter, measure the degree of exophthalmos subject to the limitations in § 886.9. The (abnormal protrusion of the eyeball).

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(b) Classification. Class I (general con- and § 820.198, with respect to complaint trols). The device is exempt from the files. premarket notification procedures in subpart E of part 807 of this chapter, [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 66 FR 38810, July 25, subject to the limitations in § 886.9. 2001] [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 66 FR 38810, July 25, § 886.1330 Amsler grid. 2001] (a) Identification. An Amsler grid is a § 886.1290 Fixation device. device that is a series of charts with grids of different sizes that are held at (a) Identification. A fixation device is an AC-powered device intended for use 30 centimeters distance from the pa- as a fixation target for the patient dur- tient and intended to rapidly detect ing ophthalmological examination. The central and paracentral irregularities patient directs his or her gaze so that in the visual field. the visual image of the object falls on (b) Classification. Class I (general con- the fovea centralis (the center of the trols). The device is exempt from the macular retina of the eye.) premarket notification procedures in (b) Classification. Class I (general con- subpart E of part 807 of this chapter, trols). The device is exempt from the subject to the limitations in § 886.9. The premarket notification procedures in device is also exempt from the current subpart E of part 807 of this chapter, good manufacturing practice require- subject to the limitations in § 886.9. ments of the quality system regulation [55 FR 48441, Nov. 20, 1990, as amended at 59 in part 820 of this chapter, with the ex- FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, ception of § 820.180, with respect to gen- 2001] eral requirements concerning records, and § 820.198, with respect to complaint § 886.1300 Afterimage flasher. files. (a) Identification. An afterimage flasher is an AC-powered light that [52 FR 33355, Sept. 2, 1987, as amended at 53 automatically switches on and off to FR 35604, Sept. 14, 1988; 66 FR 38810, July 25, 2001] allow performance of an afterimage test in which the patient indicates the § 886.1340 Haploscope. positions of afterimages after the light is off. The device is intended to deter- (a) Identification. A haploscope is an mine harmonious/anomalous retinal AC-powered device that consists of two correspondence (the condition in which movable viewing tubes, each con- corresponding points on the retina taining a slide carrier, a low-intensity have the same directional value). light source for the illumination of the (b) Classification. Class II. slides, and a high-intensity light [55 FR 48441, Nov. 20, 1990] source for creating afterimages. The device is intended to measure stra- § 886.1320 Fornixscope. bismus (eye muscle imbalance), to as- (a) Identification. A fornixscope is a sess binocular vision (use of both eyes device intended to pull back and hold to see), and to treat suppression and open the eyelid to aid examination of amblyopia (dimness of vision without the conjunctiva. any apparent disease of the eye). (b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter, subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The subject to the limitations in § 886.9. device is also exempt from the current good manufacturing practice require- [55 FR 48441, Nov. 20, 1990, as amended at 59 ments of the quality system regulation FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, 2001] in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records,

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§ 886.1342 Strabismus detection de- (iv) Information related to electro- vice. magnetic compatibility and optical ra- (a) Identification. A strabismus detec- diation classification. tion device is a prescription device de- [81 FR 65280, Sept. 22, 2016] signed to simultaneously illuminate both eyes with polarized light for auto- § 886.1350 Keratoscope. mated detection of strabismus by ana- (a) Identification. A keratoscope is an lyzing foveal birefringence properties. AC-powered or battery-powered device (b) Classification. Class II (special intended to measure and evaluate the controls). The special controls for this corneal curvature of the eye. Lines and device are: circles within the keratoscope are used (1) Clinical performance testing must to observe the corneal reflex. This ge- demonstrate the device performs as in- neric type of device includes the tended under anticipated conditions of photokeratoscope which records cor- use. Testing must be conducted in a neal curvature by taking photographs representative patient population and of the cornea. clinical setting for the indicated use. (b) The device is exempt from the Demonstration of clinical performance premarket notification procedures in must include assessment of sensitivity subpart E of part 807 of this chapter and specificity compared to a clearly subject to § 886.9. The battery-powered defined reference standard (e.g., com- device is exempt from the current good prehensive ophthalmological examina- manufacturing practice requirements tion comprises age-appropriate visual of the quality system regulation in acuity testing, examination of the ex- part 820 of this chapter, with the excep- ternal ocular adnexae and orbit, ante- tion of § 820.180 of this chapter, with re- rior segment evaluation, extraocular spect to general requirements con- motility evaluation, assessment of cerning records, and § 820.198 of this stereopsis, cycloplegic refraction, and chapter, with respect to complaint files dilated fundus examination). [55 FR 48441, Nov. 20, 1990, as amended at 59 (2) Non-clinical performance testing FR 63012, Dec. 7, 1994; 65 FR 2320, Jan. 14, must demonstrate the device performs 2000] as intended under anticipated conditions of use. The following technical § 886.1360 Visual field laser instru- characteristics must be evaluated: ment. (i) Verification of lowest detectable (a) Identification. A visual field laser amount of deviation; and instrument is an AC-powered device in- (ii) Validation of the accuracy and tended to provide visible laser radi- precision at the lowest detectable ation that produces an interference amount of deviation. pattern on the retina to evaluate ret- (3) Software verification, validation, inal function. and hazard analysis must be performed. (b) Classification. Class II. (4) Optical radiation safety testing must demonstrate the device is safe per § 886.1375 Bagolini lens. the directions for use. (a) Identification. A Bagolini lens is a (5) Performance testing must dem- device that consists of a plane lens con- onstrate the electromagnetic compat- taining almost imperceptible striations ibility of the device. that do not obscure visualization of ob- (6) Performance testing must dem- jects. The device is placed in a trial onstrate the electrical safety of the de- frame and intended to determine har- vice. monious/anomalous retinal correspond- (7) Labeling must include the fol- ence (a condition in which cor- lowing: responding points on the retina have (i) Summaries of non-clinical and the same directional values). clinical performance testing; (b) Classification. Class I (general con- (ii) Instructions on how to correctly trols). The device is exempt from the use and maintain the device; premarket notification procedures in (iii) Instructions and explanation of subpart E of part 807 of this chapter, all user-interface components; and subject to the limitations in § 886.9. The

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device is also exempt from the current (b) Classification. Class I (general con- good manufacturing practice require- trols). The device is exempt from the ments of the quality system regulation premarket notification procedures in in part 820 of this chapter, with the ex- subpart E of part 807 of this chapter, ception of § 820.180, with respect to gen- subject to the limitations in § 886.9. The eral requirements concerning records, device is also exempt from the current and § 820.198, with respect to complaint good manufacturing practice require- files. ments of the quality system regulation [52 FR 33355, Sept. 2, 1987, as amended at 53 in part 820 of this chapter, with the ex- FR 35604, Sept. 14, 1988; 66 FR 38810, July 25, ception of § 820.180, with respect to gen- 2001] eral requirements concerning records, and § 820.198, with respect to complaint § 886.1380 Diagnostic condensing lens. files. (a) Identification. A diagnostic condensing lens is a device used in bin- [52 FR 33355, Sept. 2, 1987, as amended at 53 ocular indirect ophthalmoscopy (a pro- FR 35604, Sept. 14, 1988; 66 FR 38811, July 25, 2001] cedure that produces an inverted or reversed direct magnified image of the § 886.1395 Diagnostic Hruby fundus eye) intended to focus reflected light lens. from the fundus of the eye. (b) Classification. Class I (general con- (a) Identification. A diagnostic Hruby trols). The device is exempt from the fundus lens is a device that is a 55 diop- premarket notification procedures in ter lens intended for use in the exam- subpart E of part 807 of this chapter, ination of the vitreous body and the subject to the limitations in § 886.9. The fundus of the eye under slitlamp illu- device is also exempt from the current mination and magnification. good manufacturing practice require- (b) Classification. Class I (general con- ments of the quality system regulation trols). The device is exempt from the in part 820 of this chapter, with the ex- premarket notification procedures in ception of § 820.180, with respect to gen- subpart E of part 807 of this chapter, eral requirements concerning records, subject to the limitations in § 886.9. The and § 820.198, with respect to complaint device is also exempt from the current files. good manufacturing practice require- [52 FR 33355, Sept. 2, 1987, as amended at 53 ments of the quality system regulation FR 35604, Sept. 14, 1988; 66 FR 38810, July 25, in part 820 of this chapter, with the ex- 2001] ception of § 820.180, with respect to general requirements concerning records, § 886.1385 Polymethylmethacrylate and § 820.198, with respect to complaint (PMMA) diagnostic contact lens. files. (a) Identification. A polymethylmethacrylate (PMMA) diag- [52 FR 33355, Sept. 2, 1987, as amended at 53 nostic contact lens is a device that is a FR 35604, Sept. 14, 1988; 66 FR 38811, July 25, 2001] curved shell of PMMA intended to be applied for a short period of time di- § 886.1400 Maddox lens. rectly on the globe or cornea of the eye for diagnosis or therapy of intraocular (a) Identification. A Maddox lens is a abnormalities. device that is a series of red cylinders (b) Classification. Class II. that change the size, shape, and color of an image. The device is intended to § 886.1390 Flexible diagnostic Fresnel be handheld or placed in a trial frame lens. to evaluate eye muscle dysfunction. (a) Identification. A flexible diag- (b) Classification. Class I (general con- nostic Fresnel lens is a device that is a trols). The device is exempt from the very thin lens which has its surface a premarket notification procedures in concentric series of increasingly re- subpart E of part 807 of this chapter, fractive zones. The device is intended subject to the limitations in § 886.9. The to be applied to the back of the spec- device is also exempt from the current tacle lenses of patients with aphakia good manufacturing practice require- (absence of the lens of the eye). ments of the quality system regulation

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[52 FR 33355, Sept. 2, 1987, as amended at 53 § 886.1420 Ophthalmic lens gauge. FR 35604, Sept. 14, 1988; 66 FR 38811, July 25, 2001] (a) Identification. An ophthalmic lens gauge is a calibrated device intended to § 886.1405 Ophthalmic trial lens set. manually measure the curvature of a spectacle lens. (a) Identification. An ophthalmic trial (b) Classification. Class I (general con- lens set is a device that is a set of trols). The device is exempt from the lenses of various dioptric powers in- premarket notification procedures in tended to be handheld or inserted in a subpart E of part 807 of this chapter, trial frame for vision testing to deter- subject to the limitations in § 886.9. mine refraction. (b) Classification. Class I (general con- [52 FR 33355, Sept. 2, 1987, as amended at 53 trols). The device is exempt from the FR 35604, Sept. 14, 1988; 66 FR 38811, July 25, 2001] premarket notification procedures in subpart E of part 807 of this chapter, § 886.1425 Lens measuring instrument. subject to the limitations in § 886.9. (a) Identification. A lens measuring [52 FR 33355, Sept. 2, 1987, as amended at 61 instrument is an AC-powered device in- FR 1124, Jan. 16, 1996; 66 FR 38811, July 25, tended to measure the power of lenses, 2001] prisms, and their centers (e.g., lensometer). § 886.1410 Ophthalmic trial lens clip. (b) Classification. Class I (general con- (a) Identification. An ophthalmic trial trols). The device is exempt from the lens clip is a device intended to hold premarket notification procedures in prisms, spheres, cylinders, or occluders subpart E of part 807 of this chapter, on a trial frame or spectacles for vision subject to the limitations in § 886.9. testing. [55 FR 48442, Nov. 20, 1990, as amended at 59 (b) Classification. Class I (general con- FR 63013, Dec. 7, 1994; 66 FR 38811, July 25, trols). The device is exempt from the 2001] premarket notification procedures in subpart E of part 807 of this chapter, § 886.1430 Ophthalmic contact lens radius measuring device. subject to the limitations in § 886.9. (a) Identification. An ophthalmic con- [52 FR 33355, Sept. 2, 1987, as amended at 53 tact lens radius measuring device is an FR 35604, Sept. 14, 1988; 66 FR 38811, July 25, AC-powered device that is a microscope 2001] and dial gauge intended to measure the radius of a contact lens. § 886.1415 Ophthalmic trial lens frame. (b) Classification. Class I (general con- (a) Identification. An opthalmic trial trols). The device is exempt from the lens frame is a mechanical device in- premarket notification procedures in tended to hold trial lenses for vision subpart E of part 807 of this chapter, testing. subject to the limitations in § 886.9. (b) Classification. Class I (general con- [55 FR 48442, Nov. 20, 1990, as amended at 59 trols). The device is exempt from the FR 63013, Dec. 7, 1994; 66 FR 38811, July 25, premarket notification procedures in 2001] subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The § 886.1435 Maxwell spot. device is also exempt from the current (a) Identification. A Maxwell spot is good manufacturing practice require- an AC-powered device that is a light ments of the quality system regulation source with a red and blue filter in- in part 820 of this chapter, with the extended to test macular function. ception of § 820.180, with respect to gen- (b) Classification. Class I (general con- eral requirements concerning records, trols). The device is exempt from the

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premarket notification procedures in (b) Classification. Class I (general con- subpart E of part 807 of this chapter, trols). The device is exempt from the subject to the limitations in § 886.9. premarket notification procedures in subpart E of part 807 of this chapter, [55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38811, July 25, subject to the limitations in § 886.9. The 2001] device is also exempt from the current good manufacturing practice require- § 886.1450 Corneal radius measuring ments of the quality system regulation device. in part 820 of this chapter, with the ex- (a) Identification. A corneal radius ception of § 820.180, with respect to gen- measuring device is an AC-powered de- eral requirements concerning records, vice intended to measure corneal size and § 820.198, with respect to complaint by superimposing the image of the cor- files. nea on a scale at the focal length of the [52 FR 33355, Sept. 2, 1987, as amended at 53 lens of a small, hand held, single tube FR 35605, Sept. 14, 1988; 66 FR 38811, July 25, penscope or eye gauge magnifier. 2001] (b) Classification. Class I (general controls). The device is exempt from the § 886.1510 Eye movement monitor. premarket notification procedures in (a) Identification. An eye movement subpart E of part 807 of this chapter, monitor is an AC-powered device with subject to the limitations in § 886.9, an electrode intended to measure and only when the device does not include record ocular movements. computer software in the unit or (b) Classification. Class II. topographers. [55 FR 48442, Nov. 20, 1990, as amended at 59 § 886.1570 Ophthalmoscope. FR 63013, Dec. 7, 1994; 66 FR 38811, July 25, (a) Identification. An ophthalmoscope 2001] is an AC-powered or battery-powered § 886.1460 Stereopsis measuring in- device containing illumination and strument. viewing optics intended to examine the media (cornea, aqueous, lens, and vit- (a) Identification. A stereopsis meas- reous) and the retina of the eye. uring instrument is a device intended (b) Classification. Class II. to measure depth perception by illumination of objects placed on different § 886.1605 Perimeter. planes. (b) Classification. Class I (general con- (a) Identification. A perimeter is an trols). The device is exempt from the AC-powered or manual device intended premarket notification procedures in to determine the extent of the periph- subpart E of part 807 of this chapter, eral visual field of a patient. The de- subject to the limitations in § 886.9. The vice projects light on various points of device is also exempt from the current a curved surface, and the patient indi- good manufacturing practice require- cates whether he or she sees the light. ments of the quality system regulation (b) Classification. Class I (general con- in part 820 of this chapter, with the ex- trols). The device is exempt from the ception of § 820.180, with respect to gen- premarket notification procedures in eral requirements concerning records, subpart E of part 807 of this chapter, and § 820.198, with respect to complaint subject to the limitations in § 886.9. The files. device is also exempt from the current good manufacturing practice require- [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 66 FR 38811, July 25, ments of the quality system regulation 2001] in part 820 of this chapter, with the exception of § 820.180, with respect to gen- § 886.1500 Headband mirror. eral requirements concerning records, and § 820.198, with respect to complaint (a) Identification. A headband mirror files. is a device intended to be strapped to the head of the user to reflect light for [55 FR 48442, Nov. 20, 1990, as amended at 66 use in examination of the eye. FR 38811, July 25, 2001]

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§ 886.1630 AC-powered plied to spectacle lenses to give a pris- photostimulator. matic effect. (a) Identification. An AC-powered (b) Classification. Class I (general con- photostimulator is an AC-powered de- trols). The device is exempt from the vice intended to provide light stimulus premarket notification procedures in which allows measurement of retinal subpart E of part 807 of this chapter, or visual function by perceptual or subject to the limitations in § 886.9. The electrical methods (e.g., stroboscope). device is also exempt from the current (b) Classification. Class II. good manufacturing practice requirements of the quality system regulation § 886.1640 Ophthalmic preamplifier. in part 820 of this chapter, with the ex- (a) Identification. An ophthalmic pre- ception of § 820.180, with respect to gen- amplifier is an AC-powered or battery- eral requirements concerning records, powered device intended to amplify and § 820.198, with respect to complaint electrical signals from the eye in files. electroretinography (recording retinal [52 FR 33355, Sept. 2, 1987, as amended at 53 action currents from the surface of the FR 35605, Sept. 14, 1988; 66 FR 38812, July 25, eyeball after stimulation by light), 2001] electrooculography (testing for retinal dysfunction by comparing the standing § 886.1660 Gonioscopic prism. potential in the front and the back of (a) Identification. A gonioscopic prism the eyeball), and electromyography is a device that is a prism intended to (recording electrical currents gen- be placed on the eye to study the ante- erated in active muscle). rior chamber. The device may have an- (b) Classification. Class II. gled mirrors to facilitate visualization § 886.1650 Ophthalmic bar prism. of anatomical features. (b) Classification. Class I (general con- (a) Identification. An ophthalmic bar trols). The device is exempt from the prism is a device that is a bar com- premarket notification procedures in posed of fused prisms of gradually in- subpart E of part 807 of this chapter, creasing strengths intended to measure subject to the limitations in § 886.9. latent and manifest strabismus (eye muscle deviation) or the power of fu- [52 FR 33355, Sept. 2, 1987, as amended at 53 sion of a patient’s eyes. FR 35605, Sept. 14, 1988; 59 FR 63013, Dec. 7, (b) Classification. Class I (general con- 1994; 66 FR 38812, July 25, 2001] trols). The device is exempt from the premarket notification procedures in § 886.1665 Ophthalmic rotary prism. subpart E of part 807 of this chapter, (a) Identification. An ophthalmic ro- subject to the limitations in § 886.9. The tary prism is a device with various device is also exempt from the current prismatic powers intended to be good manufacturing practice require- handheld and used to measure ocular ments of the quality system regulation deviation in patients with latent or in part 820 of this chapter, with the ex- manifest strabismus (eye muscle devi- ception of § 820.180, with respect to gen- ation). eral requirements concerning records, (b) Classification. Class I (general con- and § 820.198, with respect to complaint trols). The device is exempt from the files. premarket notification procedures in [52 FR 33355, Sept. 2, 1987, as amended at 53 subpart E of part 807 of this chapter, FR 35605, Sept. 14, 1988; 66 FR 38812, July 25, subject to the limitations in § 886.9. The 2001] device is also exempt from the current good manufacturing practice require- § 886.1655 Ophthalmic Fresnel prism. ments of the quality system regulation (a) Identification. An ophthalmic in part 820 of this chapter, with the ex- Fresnel prism is a device that is a thin ception of § 820.180, with respect to gen- plastic sheet with embossed rulings eral requirements concerning records, which provides the optical effect of a prism. The device is intended to be ap-

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and § 820.198, with respect to complaint manual device is also exempt from the files. current good manufacturing practice requirements of the quality system [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 66 FR 38812, July 25, regulation in part 820 of this chapter, 2001] with the exception of § 820.180, with respect to general requirements con- § 886.1670 Ophthalmic isotope uptake cerning records, and § 820.198, with re- probe. spect to complaint files. (a) Identification. An ophthalmic iso- [55 FR 48442, Nov. 20, 1990, as amended at 59 tope uptake probe is an AC-powered de- FR 63013, Dec. 7, 1994; 66 FR 38812, July 25, vice intended to measure, by a probe 2001] which is placed in close proximity to the eye, the uptake of a radioisotope § 886.1750 Skiascopic rack. (phosphorus 32) by tumors to detect (a) Identification. A skiascopic rack is tumor masses on, around, or within the a device that is a rack and a set of at- eye. tached ophthalmic lenses of various (b) Classification. Class II. dioptric strengths intended as an aid in refraction. § 886.1680 Ophthalmic projector. (b) Classification. Class I (general con- (a) Identification. An ophthalmic pro- trols). The device is exempt from the jector is an AC-powered device in- premarket notification procedures in tended to project an image on a screen subpart E of part 807 of this chapter, for vision testing. subject to the limitations in § 886.9. (b) Classification. Class I (general con- [52 FR 33355, Sept. 2, 1987, as amended at 61 trols). The device is exempt from the FR 1124, Jan. 16, 1996; 66 FR 38812, July 25, premarket notification procedures in 2001] subpart E of part 807 of this chapter, subject to the limitations in § 886.9. § 886.1760 Ophthalmic refractometer. [55 FR 48442, Nov. 20, 1990, as amended at 59 (a) Identification. An ophthalmic re- FR 63013, Dec. 7, 1994; 66 FR 38812, July 25, fractometer is an automatic AC-pow- 2001] ered device that consists of a fixation system, a measurement and recording § 886.1690 Pupillograph. system, and an alignment system in- (a) Identification. A pupillograph is an tended to measure the refractive power AC-powered device intended to meas- of the eye by measuring light reflexes ure the pupil of the eye by reflected from the retina. light and record the responses of the (b) Classification. Class I (general con- pupil. trols). The device is exempt from the (b) Classification. Class I (general con- premarket notification procedures in trols). The device is exempt from the subpart E of part 807 of this chapter, premarket notification procedures in subject to the limitations in § 886.9. subpart E of part 807 of this chapter, [52 FR 33355, Sept. 2, 1987, as amended at 61 subject to the limitations in § 886.9. FR 1124, Jan. 16, 1996; 66 FR 38812, July 25, [55 FR 48442, Nov. 20, 1990, as amended at 59 2001] FR 63013, Dec. 7, 1994; 66 FR 38812, July 25, 2001] § 886.1770 Manual refractor. (a) Identification. A manual refractor § 886.1700 Pupillometer. is a device that is a set of lenses of (a) Identification. A pupillometer is an varous dioptric powers intended to AC-powered or manual device intended measure the refractive error of the eye. to measure by reflected light the width (b) Classification. Class I (general con- or diameter of the pupil of the eye. trols). The device is exempt from the (b) Classification. Class I (general con- premarket notification procedures in trols). The AC-powered device and the subpart E of part 807 of this chapter, manual device are exempt from the subject to the limitations in § 886.9. The premarket notification procedures in device is also exempt from the current subpart E of part 807 of this chapter, good manufacturing practice require- subject to the limitations in § 886.9. The ments of the quality system regulation

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in part 820 of this chapter, with the ex- and § 820.198, with respect to complaint ception of § 820.180, with respect to gen- files. eral requirements concerning records, [52 FR 33355, Sept. 2, 1987, as amended at 53 and § 820.198, with respect to complaint FR 35605, Sept. 14, 1988; 53 FR 40825, Oct. 18, files. 1988; 66 FR 38812, July 25, 2001] [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 66 FR 38812, July 25, § 886.1800 Schirmer strip. 2001] (a) Identification. A Schirmer strip is a device made of filter paper or similar § 886.1780 Retinoscope. material intended to be inserted under (a) Identification. A retinoscope is an a patient’s lower eyelid to stimulate AC-powered or battery-powered device and evaluate formation of tears. intended to measure the refraction of (b) Classification. Class I (general con- the eye by illuminating the retina and trols). If the device is made of the same noting the direction of movement of materials that were used in the device the light on the retinal surface and of before May 28, 1976, the device is ex- the refraction by the eye of the emer- empt from the premarket notification gent rays. procedures in subpart E of part 807 of (b) Classification. (1) Class II (special this chapter, subject to the limitations controls) for the AC-powered device. in § 886.9. (2) Class I (general controls) for the battery-powered device. The class I [52 FR 33355, Sept. 2, 1987, as amended at 53 battery-powered device is exempt from FR 35605, Sept. 14, 1988; 66 FR 38812, July 25, the premarket notification procedures 2001] in subpart E of part 807 of this chapter subject to § 886.9. The battery-powered § 886.1810 Tangent screen (campimeter). device is exempt from the current good manufacturing practice requirements (a) Identification. A tangent screen of the quality system regulation in (campimeter) is an AC-powered or bat- part 820 of this chapter, with the excep- tery-powered device that is a large tion of § 820.180 of this chapter, with re- square cloth chart with a central mark spect to general requirements con- of fixation intended to map on a flat cerning records, and § 820.198 of this surface the central 30 degrees of a pa- chapter, with respect to complaint tient’s visual field. This generic type of files. device includes projection tangent [55 FR 48442, Nov. 20, 1990; 55 FR 51799, Dec. screens, target tangent screens and 17, 1990, as amended at 65 FR 2320, Jan. 14, targets, felt tangent screens, and 2000] stereo campimeters. (b) Classification. Class I (general con- § 886.1790 Nearpoint ruler. trols). The AC-powered device and the (a) Identification. A nearpoint ruler is battery-powered device are exempt a device calibrated in centimeters in- from the premarket notification proce- tended to measure the nearpoint of dures in subpart E of part 807 of this convergence (the point to which the chapter, subject to the limitations in visual lines are directed when conver- § 886.9. The battery-powered device is gence is at its maximum). also exempt from the current good (b) Classification. Class I (general con- manufacturing practice requirements trols). The device is exempt from the of the quality system regulation in premarket notification procedures in part 820 of this chapter, with the excep- subpart E of part 807 of this chapter, tion of § 820.180, with respect to general subject to the limitations in § 886.9. The requirements concerning records, and device is also exempt from the current § 820.198, with respect to complaint good manufacturing practice require- files. ments of the quality system regulation in part 820 of this chapter, with the ex- [55 FR 48442, Nov. 20, 1990, as amended at 59 ception of § 820.180, with respect to gen- FR 63013, Dec. 7, 1994; 66 FR 38812, July 25, 2001] eral requirements concerning records,

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§ 886.1840 Simulatan (including of the quality system regulation in crossed cylinder). part 820 of this chapter, with the excep- (a) Identification. A simulatan (in- tion of § 820.180, with respect to general cluding crossed cylinder) is a device requirements concerning records, and that is a set of pairs of cylinder lenses § 820.198, with respect to complaint that provides various equal plus and files. minus refractive strengths. The lenses [55 FR 48442, Nov. 20, 1990, as amended at 59 are arranged so that the user can ex- FR 63013, Dec. 7, 1994; 66 FR 38812, July 25, change the positions of plus and minus 2001] cylinder lenses of equal strengths. The device is intended for subjective refrac- § 886.1870 Stereoscope. tion (refraction in which the patient judges whether a given object is clearly (a) Identification. A stereoscope is an in focus, as the examiner uses different AC-powered or battery-powered device lenses). that combines the images of two simi- (b) Classification. Class I (general con- lar objects to produce a three-dimen- trols). The device is exempt from the sional appearance of solidity and relief. premarket notification procedures in It is intended to measure the angle of subpart E of part 807 of this chapter, strabismus (eye muscle deviation), subject to the limitations in § 886.9. The evaluate binocular vision (usage of device is also exempt from the current both eyes to see), and guide a patient’s good manufacturing practice require- corrective exercises of eye muscles. ments of the quality system regulation (b) Classification. Class I (general con- in part 820 of this chapter, with the ex- trols). The AC-powered device and the ception of § 820.180, with respect to gen- battery-powered device are exempt eral requirements concerning records, from the premarket notification proce- and § 820.198, with respect to complaint dures in subpart E of part 807 of this files. chapter, subject to the limitations in [52 FR 33355, Sept. 2, 1987, as amended at 53 § 886.9. The battery-powered device is FR 35605, Sept. 14, 1988; 66 FR 38812, July 25, also exempt from the current good 2001] manufacturing practice requirements of the quality system regulation in § 886.1850 AC-powered slitlamp bio- part 820 of this chapter, with the excep- microscope. tion of § 820.180, with respect to general (a) Identification. An AC-powered requirements concerning records, and slitlamp biomicroscope is an AC-pow- § 820.198, with respect to complaint ered device that is a microscope in- files. tended for use in eye examination that projects into a patient’s eye through a [55 FR 48442, Nov. 20, 1990, as amended at 59 control diaphragm a thin, intense beam FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, 2001] of light. (b) Classification. Class II. § 886.1880 Fusion and stereoscopic target. § 886.1860 Ophthalmic instrument stand. (a) Identification. A fusion and stereo- (a) Identification. An ophthalmic in- scopic target is a device intended for strument stand is an AC-powered or use as a viewing object with a stereo- nonpowered device intended to store scope (§ 886.1870). ophthalmic instruments in a readily (b) Classification. Class I (general con- accessible position. trols). The device is exempt from the (b) Classification. Class I (general con- premarket notification procedures in trols). The AC-powered device and the subpart E of part 807 of this chapter, battery-powered device are exempt subject to the limitations in § 886.9. The from the premarket notification proce- device is also exempt from the current dures in subpart E of part 807 of this good manufacturing practice require- chapter, subject to the limitations in ments of the quality system regulation § 886.9. The battery-powered device is in part 820 of this chapter, with the ex- also exempt from the current good ception of § 820.180, with respect to gen- manufacturing practice requirements eral requirements concerning records,

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and § 820.198, with respect to complaint § 820.198, with respect to complaint files. files. [52 FR 33355, Sept. 2, 1987, as amended at 53 [55 FR 48442, Nov. 20, 1990; 55 FR 51799, Dec. FR 35606, Sept. 14, 1988; 66 FR 38813, July 25, 17, 1990, as amended at 59 FR 63013, Dec. 7, 2001] 1994; 66 FR 38813, July 25, 2001]

§ 886.1905 Nystagmus tape. § 886.1925 Diurnal pattern recorder system. (a) Identification. Nystagmus tape is a (a) Identification. A diurnal pattern device that is a long, narrow strip of recorder system is a nonimplantable, fabric or other flexible material on prescription device incorporating a tel- which a series of objects are printed. emetric sensor to detect changes in oc- The device is intended to be moved ular dimension for monitoring diurnal across a patient’s field of vision to elic- patterns of intraocular pressure (IOP) it optokinetic nystagmus (abnormal fluctuations. and irregular eye movements) and to (b) Classification. Class II (special test for blindness. controls). The special controls for this (b) Classification. Class I (general con- device are: trols). The device is exempt from the (1) Clinical performance data must premarket notification procedures in demonstrate that the device and all of subpart E of part 807 of this chapter, its components perform as intended subject to the limitations in § 886.9. The under anticipated conditions of use. device is also exempt from the current The following performance characteris- good manufacturing practice require- tics must be demonstrated: ments of the quality system regulation (i) Ability of the device to detect di- in part 820 of this chapter, with the ex- urnal changes. (ii) Tolerability of the system at the ception of § 820.180, with respect to gen- corneoscleral interface in the intended eral requirements concerning records, use population. and § 820.198, with respect to complaint (2) Nonclinical testing must validate files. measurements in an appropriate non- [52 FR 33355, Sept. 2, 1987, as amended at 53 clinical testing model to ensure ability FR 35606, Sept. 14, 1988; 66 FR 38813, July 25, to detect changes in intraocular pres- 2001] sure. (3) Patient-contacting components § 886.1910 Spectacle dissociation test must be demonstrated to be biocompat- system. ible. (a) Identification. A spectacle disso- (4) Any component that is intended ciation test system is an AC-powered to contact the eye must be dem- or battery-powered device, such as a onstrated to be sterile throughout its Lancaster test system, that consists of intended shelf life. a light source and various filters, usu- (5) Software verification, validation, ally red or green filters, intended to and hazard analysis must be performed. subjectively measure imbalance of ocu- (6) Performance testing must demonstrate the electromagnetic compat- lar muscles. ibility and electromagnetic inter- (b) Classification. Class I (general conference of the device. trols). The AC-powered device and the (7) Performance testing must dem- battery-powered device are exempt onstrate electrical safety of the device. from the premarket notification proce- (8) Labeling must include the fol- dures in subpart E of part 807 of this lowing: chapter, subject to the limitations in (i) Warning against activities and en- § 886.9. The battery-powered device is vironments that may put the user at also exempt from the current good greater risk. manufacturing practice requirements (ii) Specific instructions for the safe of the quality system regulation in use of the device, which includes: part 820 of this chapter, with the excep- (A) Description of all device compo- tion of § 820.180, with respect to general nents and instructions for assembling requirements concerning records, and the device;

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(B) Explanations of all available pro- subject to the limitations in § 886.9. grams and instructions for their use; Class II for the AC-powered device. (C) Instructions and explanation of [55 FR 48443, Nov. 20, 1990, as amended at 59 all user-interface components; FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, (D) Instructions on all safety fea- 2001] tures of the device; and (E) Instructions for properly maintaining the device. Subpart C [Reserved] (iii) A summary of nonclinical testing information to describe EMC safety Subpart D—Prosthetic Devices considerations. (iv) A summary of safety information § 886.3100 Ophthalmic tantalum clip. obtained from clinical testing. (a) Identification. An ophthalmic tan- (v) Patient labeling to convey infor- talum clip is a malleable metallic de- mation regarding appropriate use of device intended to be implanted perma- vice. nently or temporarily to bring together the edges of a wound to aid [81 FR 34270, May 31, 2016] healing or prevent bleeding from small § 886.1930 Tonometer and accessories. blood vessels in the eye. (b) Classification. Class II (special (a) Identification. A tonometer and ac- controls). The device is exempt from cessories is a manual device intended the premarket notification procedures to measure intraocular pressure by ap- in subpart E of part 807 of this chapter plying a known force on the globe of subject to § 886.9. the eye and measuring the amount of indentation produced (Schiotz type) or [52 FR 33355, Sept. 2, 1987, as amended at 63 to measure intraocular tension by FR 59230, Nov. 3, 1998] applanation (applying a small flat disk to the cornea). Accessories for the de- § 886.3130 Ophthalmic conformer. vice may include a tonometer cali- (a) Identification. An ophthalmic con- brator or a tonograph recording sys- former is a device usually made of tem. The device is intended for use in molded plastic intended to be inserted the diagnosis of glaucoma. temporarily between the eyeball and (b) Classification. Class II. eyelid to maintain space in the orbital cavity and prevent closure or adhesions § 886.1940 Tonometer sterilizer. during the healing process following (a) Identification. A tonometer steri- surgery. ] lizer is an AC-powered device intended (b) Classification. Class II (special to heat sterilize a tonometer (a device controls). The device is exempt from used to measure intraocular pressure). the premarket notification procedures (b) Classification. Class I (general con- in subpart E of part 807 of this chapter trols). The device is exempt from the subject to § 886.9. premarket notification procedures in [52 FR 33355, Sept. 2, 1987, as amended at 63 subpart E of part 807 of this chapter FR 59230, Nov. 3, 1998] subject to § 886.9. [55 FR 48443, Nov. 20, 1990, as amended at 65 § 886.3200 Artificial eye. FR 2321, Jan. 14, 2000] (a) Identification. An artificial eye is a device resembling the anterior por- § 886.1945 Transilluminator. tion of the eye, usually made of glass (a) Identification. A transilluminator or plastic, intended to be inserted in a is an AC-powered or battery-powered patient’s eye socket anterior to an or- device that is a light source intended bital implant, or the eviscerated eye- to transmit light through tissues to aid ball, for cosmetic purposes. The device examination of patients. is not intended to be implanted. (b) Classification. Class I for the bat- (b) Classification. Class I (general con- tery-powered device. The battery-pow- trols). The device is exempt from the ered device is also exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter, subpart E of part 807 of this chapter, subject to the limitations in § 886.9, if

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the device is made from the same ma- glass or plastic intended to be im- terials, has the same chemical com- planted to replace the natural lens of position, and uses the same manufac- an eye. turing processes as currently legally (b) Classification. Class III. marketed devices. (c) Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an [61 FR 1124, Jan. 16, 1996, as amended at 66 FR 38813, July 25, 2001] approval under section 515 of the act is required before this device may be § 886.3300 Absorbable implant (scleral commercially distributed. See § 886.3. buckling method). § 886.3800 Scleral shell. (a) Identification. An absorbable implant (scleral buckling method) is a de- (a) Identification. A scleral shell is a vice intended to be implanted on the device made of glass or plastic that is sclera to aid retinal reattachment. intended to be inserted for short time (b) Classification. Class II. periods over the cornea and proximal- cornea sclera for cosmetic or recon- § 886.3320 Eye sphere implant. structive purposes. An artificial eye is (a) Identification. An eye sphere im- usually painted on the device. The de- plant is a device intended to be im- vice is not intended to be implanted. planted in the eyeball to occupy space (b) Classification. Class II (special following the removal of the contents controls). The device is exempt from of the eyeball with the sclera left in- the premarket notification procedures tact. in subpart E of part 807 of this chapter (b) Classification. Class II. subject to § 886.9. [52 FR 33355, Sept. 2, 1987, as amended at 63 § 886.3340 Extraocular orbital implant. FR 59230, Nov. 3, 1998] (a) Identification. An extraocular orbital implant is a nonabsorbable device § 886.3920 Aqueous shunt. intended to be implanted during scleral (a) Identification. An aqueous shunt is surgery for buckling or building up the an implantable device intended to re- floor of the eye, usually in conjunction duce intraocular pressure in the ante- with retinal reattachment. Injectable rior chamber of the eye in patients substances are excluded. with neovascular glaucoma or with (b) Classification. Class II. glaucoma when medical and conventional surgical treatments have failed. § 886.3400 Keratoprosthesis. (b) Classification. Class II. The special (a) Identification. A keratoprosthesis controls for this device are FDA’s: is a device intended to provide a trans- (1) ‘‘Use of International Standard parent optical pathway through an ISO 10993 ‘Biological Evaluation of opacified cornea, either Medical Devices—Part I: Evaluation intraoperatively or permanently, in an and Testing,’ ’’ eye that is not a reasonable candidate (2) ‘‘510(k) Sterility Review Guidance for a corneal transplant. of 2/12/90 (K90–1),’’ and (b) Classification. Class II. The special (3) ‘‘Aqueous Shunts—510(k) Submis- controls for this device are FDA’s: sions.’’ (1) ‘‘Use of International Standard [65 FR 17147, Mar. 31, 2000, as amended at 66 ISO 10993 ‘Biological Evaluation of FR 18542, Apr. 10, 2001] Medical Devices—Part I: Evaluation and Testing,’ ’’ Subpart E—Surgical Devices (2) ‘‘510(k) Sterility Review Guidance of 2/12/90 (K90–1),’’ and § 886.4070 Powered corneal burr. (3) ‘‘Guidance on 510(k) Submissions (a) Identification. A powered corneal for Keratoprostheses.’’ burr is an AC-powered or battery-pow- [65 FR 17147, Mar. 31, 2000] ered device that is a motor and drilling tool intended to remove rust rings § 886.3600 Intraocular lens. from the cornea of the eye. (a) Identification. An intraocular lens (b) Classification. Class I (general con- is a device made of materials such as trols). When intended only for rust ring

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removal, the device is exempt from the less steel with or without a gold, silver, premarket notification procedures in or titanium coating. The special con- subpart E of part 807 of this chapter trols for the surgical grade stainless subject to § 886.9. steel scleral plug (with or without a [55 FR 48443, Nov. 20, 1990; 55 FR 51799, Dec. gold, silver, or titanium coating) are: 17, 1990, as amended at 65 FR 2321, Jan. 14, (i) The device must be demonstrated 2000] to be sterile during the labeled shelf life; § 886.4100 Radiofrequency (ii) The device must be demonstrated electrosurgical cautery apparatus. to be biocompatible; and (a) Identification. A radiofrequency (iii) Labeling must include all infor- electrosurgical cautery apparatus is an mation required for the safe and effec- AC-powered or battery-powered device tive use of the device, including spe- intended for use during ocular surgery cific instructions regarding the proper to coagulate tissue or arrest bleeding sizing, placement, and removal of the by a high frequency electric current. device. (b) Classification. Class II. (2) The device is not exempt from premarket notification procedures if it § 886.4115 Thermal cautery unit. is composed of a material other than (a) Identification. A thermal cautery surgical grade stainless steel (with or unit is an AC-powered or battery-pow- without a gold, silver, or titanium ered device intended for use during oc- coating). The special controls for ular surgery to coagulate tissue or ar- scleral plugs made of other materials rest bleeding by heat conducted are: through a wire tip. (i) The device must be demonstrated (b) Classification. Class II. to be sterile during the labeled shelf life; § 886.4150 Vitreous aspiration and cut- (ii) The device must be demonstrated ting instrument. to be biocompatible; (a) Identification. A vitreous aspira- (iii) Characterization of the device tion and cutting instrument is an elec- materials must be performed; trically powered device, which may use (iv) Performance data must dem- ultrasound, intended to remove vit- onstrate acceptable mechanical prop- reous matter from the vitreous cavity erties under simulated clinical use con- or remove a crystalline lens. ditions including insertion and removal (b) Classification. Class II. of the device; (v) Performance data must dem- § 886.4155 Scleral plug. onstrate adequately low levels of the (a) Identification. A scleral plug is a extractables or residues from manufac- prescription device intended to provide turing (or processing) of the device; temporary closure of a scleral incision and during an ophthalmic surgical proce- (vi) Labeling must include all infor- dure. These plugs prevent intraocular mation required for the safe and effec- fluid and pressure loss when instru- tive use of the device, including spe- ments are withdrawn from the eye. cific instructions regarding the proper Scleral plugs include a head portion re- sizing, placement, and removal of the maining above the sclera, which can be device. gripped for insertion and removal, and a shaft that fits inside the scleral inci- [78 FR 68715, Nov. 15, 2013] sion. Scleral plugs are removed before completing the surgery. § 886.4170 Cryophthalmic unit. (b) Classification. Class II (special (a) Identification. A cryophthalmic controls). The special controls for the unit is a device that is a probe with a scleral plug are as follows: small tip that becomes extremely cold (1) The device is exempt from the through the controlled use of a refrig- premarket notification procedures in erant or gas. The device may be AC- subpart E of part 807 of this chapter powered. The device is intended to re- subject to the limitations in § 886.9 if move cataracts by the formation of an the material is a surgical grade stain- adherent ice ball in the lens, to freeze

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the eye and adjunct parts for surgical § 886.4275 Intraocular fluid. removal of scars, and to freeze tumors. (a) Identification. An intraocular fluid (b) Classification. Class II. is a device consisting of a nongaseous fluid intended to be introduced into the § 886.4230 Ophthalmic knife test drum. eye to aid performance of surgery, such (a) Identification. An ophthalmic as to maintain anterior chamber depth, knife test drum is a device intended to preserve tissue integrity, protect tissue test the keenness of ophthalmic sur- from surgical trauma, or function as a gical knives to determine whether re- tamponade during retinal reattach- sharpening is needed. ment. (b) Classification. Class I (general con- (b) Classification. Class III. trols). The device is exempt from the (c) Date PMA or notice of completion of premarket notification procedures in a PDP is required. As of May 28, 1976, an subpart E of part 807 of this chapter, approval under section 515 of the act is subject to the limitations in § 886.9. The required before this device may be device is also exempt from the current commercially distributed. See § 886.3. good manufacturing practice require- § 886.4280 Intraocular pressure meas- ments of the quality system regulation uring device. in part 820 of this chapter, with the ex- (a) Identification. An intraocular pres- ception of § 820.180, with respect to gen- sure measuring device is a manual or eral requirements concerning records, AC-powered device intended to meas- and § 820.198, with respect to complaint ure intraocular pressure. Also included files. are any devices found by FDA to be [52 FR 33355, Sept. 2, 1987, as amended at 53 substantially equivalent to such de- FR 35606, Sept. 14, 1988; 66 FR 38813, July 25, vices. Accessories for the device may 2001] include calibrators or recorders. The device is intended for use in the diag- § 886.4250 Ophthalmic electrolysis nosis of glaucoma. unit. (b) Classification. Class III. (a) Identification. An ophthalmic elec- (c) Date PMA or notice of completion of trolysis unit is an AC-powered or bat- PDP is required. As of May 28, 1976, an tery-powered device intended to de- approval under section 515 of the act is stroy ocular hair follicles by applying a required before this device may be galvanic electrical current. commercially distributed. See § 886.3. (b) Classification. Class I for the bat- § 886.4300 Intraocular lens guide. tery-powered device. Class II for the AC-powered device. The battery-pow- (a) Identification. An intraocular lens ered device is exempt from the pre- guide is a device intended to be in- market notification procedures in sub- serted into the eye during surgery to direct the insertion of an intraocular part E of part 807 of this chapter, sub- lens and be removed after insertion is ject to the limitations in § 886.9. completed. [55 FR 48443, Nov. 20, 1990, as amended at 59 (b) Classification. Class I (general con- FR 63013, Dec. 7, 1994; 66 FR 38813, July 25, trols). Except when used as folders or 2001] injectors for soft or foldable intraocular lenses, the device is exempt § 886.4270 Intraocular gas. from the premarket notification proce- (a) Identification. An intraocular gas dures in subpart E of part 807 of this is a device consisting of a gaseous fluid chapter subject to § 886.9. intended to be introduced into the eye [52 FR 33355, Sept. 2, 1987, as amended at 65 to place pressure on a detached retina. FR 2321, 2000] (b) Classification. Class III. (c) Date PMA or notice of completion of § 886.4335 Operating headlamp. a PDP is required. As of May 28, 1976, an (a) Identification. An operating approval under section 515 of the act is headlamp is an AC-powered or battery- required before this device may be powered device intended to be worn on commercially distributed. See § 886.3. the user’s head to provide a light

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source to aid visualization during sur- subpart E of part 807 of this chapter, gical, diagnostic, or therapeutic proce- subject to the limitations in § 886.9. dures. (b) Classification. Class I for the bat- [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 59 FR 63013, Dec. 7, tery-powered device. Class II for the 1994; 66 FR 38813, July 25, 2001] AC-powered device. The battery-powered device is exempt from the pre- § 886.4370 Keratome. market notification procedures in subpart E of part 807 of this chapter, sub- (a) Identification. A keratome is an ject to the limitations in § 886.9. AC-powered or battery-powered device intended to shave tissue from sections [55 FR 48443, Nov. 20, 1990, as amended at 66 of the cornea for a lamellar (partial FR 38813, July 25, 2001] thickness) transplant. § 886.4350 Manual ophthalmic surgical (b) Classification. Class I. instrument. [55 FR 48443, Nov. 20, 1990] (a) Identification. A manual ophthalmic surgical instrument is a non- § 886.4390 Ophthalmic laser. powered, handheld device intended to (a) Identification. An ophthalmic laser aid or perform ophthalmic surgical is an AC-powered device intended to procedures. This generic type of device coagulate or cut tissue of the eye, includes the manual corneal burr, oph- orbit, or surrounding skin by a laser thalmic caliper, ophthalmic cannula, beam. eyelid clamp, ophthalmic muscle (b) Classification. Class II. clamp, iris retractor clip, orbital compressor, ophthalmic curette, § 886.4392 Nd:YAG laser for posterior cystotome, orbital depressor, lach- capsulotomy and peripheral rymal dilator, erisophake, expressor, iridotomy. ophthalmic forcep, ophthalmic hook, (a) Identification. The Nd:YAG laser sphere introducer, ophthalmic knife, for posterior capsulotomy and periph- ophthalmic suturing needle, lachrymal eral iridotomy consists of a mode- probe, trabeculotomy probe, cornea- locked or Q-switched solid state sclera punch, ophthalmic retractor, Nd:YAG laser intended for disruption ophthalmic ring (Flieringa), lachrymal of the posterior capsule or the iris via sac rongeur, ophthalmic scissors, optical breakdown. The Nd:YAG laser enucleating snare, ophthalmic spatula, generates short pulse, low energy, high ophthalmic specula, ophthalmic spoon, power, coherent optical radiation. ophthalmic spud, trabeculotome or When the laser output is combined ophthalmic manual trephine. with focusing optics, the high irradi- (b) Classification. Class I (general con- ance at the target causes tissue disrup- trols). The device is exempt from the tion via optical breakdown. A visible premarket notification procedures in aiming system is utilized to target the subpart E of part 807 of this chapter, invisible Nd:YAG laser radiation on or subject to the limitations in § 886.9. in close proximity to the target tissue. [52 FR 33355, Sept. 2, 1987, as amended at 53 (b) Classification. Class II (special FR 35606, Sept. 14, 1988; 59 FR 63013, Dec. 7, controls). Design Parameters: Device 1994; 60 FR 15872, Mar. 28, 1995; 66 FR 38813, must emit a laser beam with the fol- July 25, 2001] lowing parameters: wavelength = 1064 nanometers; spot size = 50 to 100 § 886.4360 Ocular surgery irrigation micros; pulse width = 3 to 30 nano- device. seconds; output energy per pulse = 0.5 (a) Identification. An ocular surgery to 15 millijoules (mJ); repetition rate = irrigation device is a device intended 1 to 10 pulses; and total energy = 20 to to be suspended over the ocular area 120 mJ. during ophthalmic surgery to deliver continuous, controlled irrigation to the [65 FR 6894, Feb. 11, 2000] surgical field. (b) Classification. Class I (general con- § 886.4400 Electronic metal locator. trols). The device is exempt from the (a) Identification. An electronic metal premarket notification procedures in locator is an AC-powered device with

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probes intended to locate metallic for- on the eye in preparation for oph- eign bodies in the eye or eye socket. thalmic surgery. (b) Classification. Class II. (b) Classification. Class II.

§ 886.4440 AC-powered magnet. § 886.4670 Phacofragmentation system. (a) Identification. An AC-powered (a) Identification. A magnet is an AC-powered device that phacofragmentation system is an AC- generates a magnetic field intended to powered device with a fragmenting find and remove metallic foreign bodies needle intended for use in cataract sur- from eye tissue. gery to disrupt a cataract with ultrasound and extract the cataract. (b) Classification. Class II. (b) Classification. Class II.

§ 886.4445 Permanent magnet. § 886.4690 Ophthalmic (a) Identification. A permanent mag- photocoagulator. net is a nonelectric device that gen- (a) Identification. An ophthalmic erates a magnetic field intended to find photocoagulator is an AC-powered de- and remove metallic foreign bodies vice intended to use the energy from an from eye tissue. extended noncoherent light source to (b) Classification. Class I (general con- occlude blood vessels of the retina, trols). The device is exempt from the choroid, or iris. premarket notification procedures in (b) Classification. Class II. subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The § 886.4750 Ophthalmic eye shield. device is also exempt from the current (a) Identification. An ophthalmic eye good manufacturing practice require- shield is a device that consists of a ments of the quality system regulation plastic or aluminum eye covering in- in part 820 of this chapter, with the extended to protect the eye or retain ception of § 820.180, with respect to gen- dressing materials in place. eral requirements concerning records, (b) Classification. Class I (general con- and § 820.198, with respect to complaint trols). When made only of plastic or files. aluminum, the device is exempt from the premarket notification procedures [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35606, Sept. 14, 1988; 66 FR 38813, July 25, in subpart E of part 807 of this chapter 2001] subject to § 886.9. When made only of plastic or aluminum, the devices are § 886.4570 Ophthalmic surgical mark- exempt from the current good manu- er. facturing practice requirements of the quality system regulation in part 820 of (a) Identification. An ophthalmic sur- this chapter, with the exception of gical marker is a device intended to § 820.180 of this chapter, with respect to mark by use of ink, dye, or indentation general requirements concerning the location of ocular or scleral sur- records, and § 820.198 of this chapter, gical manipulation. with respect to complaint files. (b) Classification. Class I (general controls). The device is exempt from the [52 FR 33355, Sept. 2, 1987, as amended at 59 premarket notification procedures in FR 63014, Dec. 7, 1994; 65 FR 2321, Jan. 14, subpart E of part 807 of this chapter, 2000] subject to the limitations in § 886.9. § 886.4770 Ophthalmic operating spec- [52 FR 33355, Sept. 2, 1987, as amended at 53 tacles (loupes). FR 35606, Sept. 14, 1988; 59 FR 63013, Dec. 7, (a) Identification. Ophthalmic oper- 1994; 66 FR 38813, July 25, 2001] ating spectacles (loupes) are devices that consist of convex lenses or lens § 886.4610 Ocular pressure applicator. systems intended to be worn by a sur- (a) Identification. An ocular pressure geon to magnify the surgical site dur- applicator is a manual device that con- ing ophthalmic surgery. sists of a sphygmomanometer-type (b) Classification. Class I (general con- squeeze bulb, a dial indicator, a band, trols). The device is exempt from the and bellows, intended to apply pressure premarket notification procedures in

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subpart E of part 807 of this chapter, § 886.5120 Low-power binocular loupe. subject to the limitations in § 886.9. The (a) Identification. A low-power bin- device is also exempt from the current ocular loupe is a device that consists of good manufacturing practice require- two eyepieces, each with a lens or lens ments of the quality system regulation system, intended for medical purposes in part 820 of this chapter, with the ex- to magnify the appearance of objects. ception of § 820.180, with respect to gen- (b) Classification. Class I (general con- eral requirements concerning records, trols). The device is exempt from the and § 820.198, with respect to complaint premarket notification procedures in files. subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The [52 FR 33355, Sept. 2, 1987, as amended at 53 device is also exempt from the current FR 35606, Sept. 14, 1988; 66 FR 38813, July 25, 2001] good manufacturing practice requirements of the quality system regulation § 886.4790 Ophthalmic sponge. in part 820 of this chapter, with the exception of § 820.180, with respect to gen- (a) Identification. An ophthalmic eral requirements concerning records, sponge is a device that is an absorbant and § 820.198, with respect to complaint sponge, pad, or spear made of folded files. gauze, cotton, cellulose, or other material intended to absorb fluids from the [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 66 FR 38814, July 25, operative field in ophthalmic surgery. 2001] (b) Classification. Class II. § 886.5200 Eyelid thermal pulsation § 886.4855 Ophthalmic instrument system. table. (a) Identification. An eyelid thermal (a) Identification. An ophthalmic in- pulsation system is an electrically- strument table is an AC-powered or powered device intended for use in the manual device on which ophthalmic in- application of localized heat and pres- struments are intended to be placed. sure therapy to the eyelids. The device (b) Classification. Class I (general con- is used in adult patients with chronic trols). The AC-powered device and the cystic conditions of the eyelids, includ- manual device are exempt from the ing meibomian gland dysfunction (MGD), also known as evaporative dry premarket notification procedures in eye or lipid deficiency dry eye. The sys- subpart E of part 807 of this chapter, tem consists of a component that is in- subject to the limitations in § 886.9. The serted around the eyelids and a compo- manual device is also exempt from the nent to control the application of heat current good manufacturing practice and pressure to the eyelids. requirements of the quality system (b) Classification. Class II (special regulation in part 820 of this chapter, controls). The special controls for this with the exception of § 820.180, with re- device are: spect to general requirements con- (1) Appropriate analysis/testing cerning records, and § 820.198, with re- should validate electromagnetic com- spect to complaint files. patibility (EMC) and safety of exposure to non-ionizing radiation; [55 FR 48443, Nov. 20, 1990, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, (2) Design, description, and perform- 2001] ance data should validate safeguards related to the temperature and pressure aspects of the device, including Subpart F—Therapeutic Devices during fault conditions; (3) Performance data should dem- § 886.5100 Ophthalmic beta radiation source. onstrate the sterility of patient-contacting components and the shelf-life (a) Identification. An ophthalmic beta of these components; radiation source is a device intended to (4) The device should be dem- apply superficial radiation to benign onstrated to be biocompatible; and and malignant ocular growths. (5) Performance data should dem- (b) Classification. Class II. onstrate that any technological

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changes do not adversely effect safety in part 820 of this chapter, with the ex- and effectiveness. ception of § 820.180, with respect to general requirements concerning records, [76 FR 51878, Aug. 19, 2011] and § 820.198, with respect to complaint § 886.5420 Contact lens inserter/re- files. mover. [52 FR 33355, Sept. 2, 1987, as amended at 53 (a) Identification. A contact lens FR 35607, Sept. 14, 1988; 66 FR 38814, July 25, inserter/remover is a handheld device 2001] intended to insert or remove contact lenses by surface adhesion or suction. § 886.5700 Eyelid weight. (b) Classification. Class I (general con- (a) Identification. An eyelid weight is trols). The device is exempt from the a prescription device made of gold, tan- premarket notification procedures in talum, platinum, iridium, or surgical subpart E of part 807 of this chapter, grade stainless steel that is rectan- subject to the limitations in § 886.9. gular in shape and contoured to the shape of the eye. The device is intended [52 FR 33355, Sept. 2, 1987, as amended at 53 for the gravity assisted treatment of FR 35607, Sept. 14, 1988; 66 FR 38814, July 25, 2001] lagophthalmos (incomplete eyelid closure). § 886.5540 Low-vision magnifier. (1) The external eyelid weight is ad- hered to the outer skin of the upper (a) Identification. A low-vision mag- eyelid. nifier is a device that consists of a (2) The implantable eyelid weight is magnifying lens intended for use by a implanted into the upper eyelid. patient who has impaired vision. The (b) Classification. (1) Class II (special device may be held in the hand or at- controls) for the external eyelid tached to spectacles. weight. The external eyelid weight is (b) Classification. Class I (general con- exempt from the premarket notifica- trols). The device is exempt from the tion procedures in subpart E of part 807 premarket notification procedures in of this chapter subject to the limita- subpart E of part 807 of this chapter, tions in § 886.9. The special controls for subject to the limitations in § 886.9. The the external eyelid weight are: device is also exempt from the current (i) Testing demonstrating the bio- good manufacturing practice require- compatibility of the device; and ments of the quality system regulation (ii) Labeling must include the fol- in part 820 of this chapter, with the ex- lowing information: ception of § 820.180, with respect to gen- (A) Specific instructions regarding eral requirements concerning records, the proper placement, sizing, and re- and § 820.198, with respect to complaint moval of the device; and files. (B) A warning stating that the pa- [52 FR 33355, Sept. 2, 1987, as amended at 53 tient should be instructed to remove FR 35607, Sept. 14, 1988; 66 FR 38814, July 25, the device prior to entering a magnetic 2001] resonance environment. (2) Class II (special controls) for the § 886.5600 Ptosis crutch. implantable eyelid weight. The special (a) Identification. A ptosis crutch is a controls for the implantable eyelid device intended to be mounted on the weight are: spectacles of a patient who has ptosis (i) Testing demonstrating the bio- (drooping of the upper eyelid as a re- compatibility of the device; sult of faulty development or paralysis) (ii) Testing demonstrating the ste- to hold the upper eyelid open. rility and shelf life of the device; (b) Classification. Class I (general con- (iii) Nonclinical testing evaluating trols). The device is exempt from the the compatibility of the device in a premarket notification procedures in magnetic resonance environment. subpart E of part 807 of this chapter, (iv) Patient labeling to convey infor- subject to the limitations in § 886.9. The mation regarding the safety and com- device is also exempt from the current patibility of the device in a magnetic good manufacturing practice require- resonance environment, the conditions ments of the quality system regulation under which a patient with the device

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can be safely scanned, and a mecha- consists of a lens, video camera, and nism for a healthcare provider to ob- video monitor that is intended for use tain detailed information about mag- by a patient who has subnormal vision netic resonance safety and compat- to magnify reading material. ibility if needed. (b) Classification. Class I (general con- [79 FR 22015, Apr. 21, 2014] trols). The device is exempt from the premarket notification procedures in § 886.5800 Ophthalmic bar reader. subpart E of part 807 of this chapter, subject to the limitations in § 886.9. (a) Identification. An ophthalmic bar reader is a device that consists of a [55 FR 48443, Nov. 20, 1990, as amended at 59 magnifying lens intended for use by a FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, patient who has impaired vision. The 2001] device is placed directly onto reading material to magnify print. § 886.5838 Nasolacrimal compression (b) Classification. Class I (general con- device. trols). The device is exempt from the (a) Identification. A nasolacrimal premarket notification procedures in compression device is a prescription subpart E of part 807 of this chapter, device that is fitted to apply mechan- subject to the limitations in § 886.9. The ical pressure to the nasal aspect of the device is also exempt from the current orbital rim to reduce outflow through good manufacturing practice require- the nasolacrimal ducts. ments of the quality system regulation (b) Classification. Class I (general con- in part 820 of this chapter, with the ex- trols). The device is exempt from the ception of § 820.180, with respect to gen- premarket notification procedures in eral requirements concerning records, subpart E of part 807 of this chapter, and § 820.198, with respect to complaint subject to the limitations in § 886.9. files. [81 FR 37500, June 10, 2016] [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 66 FR 38814, July 25, § 886.5840 Magnifying spectacles. 2001] (a) Identification. Magnifying spec- § 886.5810 Ophthalmic prism reader. tacles are devices that consist of spectacle frames with convex lenses in- (a) Identification. An ophthalmic tended to be worn by a patient who has prism reader is a device intended for impaired vision to enlarge images. use by a patient who is in a supine po- (b) Classification. Class I (general con- sition to change the angle of print to trols). The device is exempt from the aid reading. premarket notification procedures in (b) Classification. Class I (general con- subpart E of part 807 of this chapter, trols). The device is exempt from the subject to the limitations in § 866.9. premarket notification procedures in subpart E of part 807 of this chapter, [52 FR 33355, Sept. 2, 1987, as amended at 53 subject to the limitations in § 886.9. The FR 35607, Sept. 14, 1988; 59 FR 63014, Dec. 7, device is also exempt from the current 1994; 66 FR 38814, July 25, 2001] good manufacturing practice requirements of the quality system regulation § 886.5842 Spectacle frame. in part 820 of this chapter, with the ex- (a) Identification. A spectacle frame is ception of § 820.180, with respect to gen- a device made of metal or plastic in- eral requirements concerning records, tended to hold prescription spectacle and § 820.198, with respect to complaint lenses worn by a patient to correct re- files. fractive errors. (b) Classification. Class I (general con- [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 66 FR 38814, July 25, trols). The device is exempt from the 2001] premarket notification procedures in subpart E of part 807 of this chapter, § 886.5820 Closed-circuit television subject to the limitations in § 886.9. reading system. [52 FR 33355, Sept. 2, 1987, as amended at 59 (a) Identification. A closed-circuit tel- FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, evision reading system is a device that 2001]

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§ 886.5844 Prescription spectacle lens. ception of § 820.180, with respect to general requirements concerning records, (a) Identification. A prescription spec- and § 820.198, with respect to complaint tacle lens is a glass or plastic device files. that is a lens intended to be worn by a patient in a spectacle frame to provide [52 FR 33355, Sept. 2, 1987, as amended at 53 refractive corrections in accordance FR 35607, Sept. 14, 1988; 66 FR 38814, July 25, with a prescription for the patient. The 2001] device may be modified to protect the § 886.5900 Electronic vision aid. eyes from bright sunlight (i.e., prescription sunglasses). Prescription sun- (a) Identification. An electronic vision glass lenses may be reflective, tinted, aid is an AC-powered or battery-pow- polarizing, or photosensitized. ered device that consists of an elec- (b) Classification. Class I (general con- tronic sensor/transducer intended for trols). The device is exempt from the use by a patient who has impaired vi- premarket notification procedures in sion or blindness to translate visual subpart E of part 807 of this chapter, images of objects into tactile or audi- subject to the limitations in § 886.9. tory signals. (b) Classification. Class I (general con- [52 FR 33355, Sept. 2, 1987, as amended at 53 trols). The device is exempt from the FR 35607, Sept. 14, 1988; 59 FR 63014, Dec. 7, premarket notification procedures in 1994; 66 FR 38814, July 25, 2001] subpart E of part 807 of this chapter, § 886.5850 Sunglasses (nonprescrip- subject to the limitations in § 886.9. tion). [55 FR 48443, Nov. 20, 1990, as amended at 59 (a) Identification. Sunglasses (non- FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, prescription) are devices that consist of 2001] spectacle frames or clips with absorb- § 886.5905 Oral electronic vision aid. ing, reflective, tinted, polarizing, or photosensitized lenses intended to be (a) Identification. An oral electronic worn by a person to protect the eyes vision aid is a battery-powered pre- from bright sunlight but not to provide scription device that contains an elec- refractive corrections. This device is trode stimulation array to generate usually available over-the-counter. electrotactile stimulation patterns (b) Classification. Class I (general con- that are derived from digital object im- trols). The device is exempt from the ages captured by a camera. It is in- premarket notification procedures in tended to aid profoundly blind patients subpart E of part 807 of this chapter in orientation, mobility, and object subject to § 886.9. recognition as an adjunctive device to other assistive methods such as a white [52 FR 33355, Sept. 2, 1987, as amended at 65 cane or a guide dog. FR 2321, 2000] (b) Classification. Class II (special controls). The special controls for this § 886.5870 Low-vision telescope. device are: (a) Identification. A low-vision tele- (1) Clinical performance testing must scope is a device that consists of an ar- demonstrate an acceptable adverse rangement of lenses or mirrors in- event profile, including adverse events tended for use by a patient who has im- involving the mouth, tongue, and gums paired vision to increase the apparent and demonstrate the effect of the stim- size of objects. This generic type of de- ulation to provide clinically meaning- vice includes handheld or spectacle ful outcomes. The clinical performance telescopes. testing must also investigate the an- (b) Classification. Class I (general con- ticipated conditions of use, including trols). The device is exempt from the potential use error, intended environ- premarket notification procedures in ment of use, and duration of use. subpart E of part 807 of this chapter, (2) Non-clinical performance testing subject to the limitations in § 886.9. The must demonstrate that the device per- device is also exempt from the current forms as intended under anticipated good manufacturing practice require- conditions of use, including simulated ments of the quality system regulation moisture ingress, device durability, in part 820 of this chapter, with the ex- and battery reliability.

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(3) Software verification, validation, fying lens with an accompanying AC- and hazard analysis must be performed. powered or battery-powered light (4) Analysis/testing must validate source intended for use by a patient electromagnetic compatibility. who has impaired vision to increase the (5) Analysis/testing must validate apparent size of object detail. electrical safety. (b) Classification. Class I (general con- (6) Analysis/testing must assess and trols). The AC-powered device and the validate wireless coexistence concerns. battery-powered device are exempt (7) Any elements of the device that from the premarket notification proce- contact the patient must be dem- dures in subpart E of part 807 of this onstrated to be biocompatible. chapter, subject to the limitations in (8) Training must include elements to § 886.9. The battery-powered device is ensure that the healthcare provider also exempt from the current good and user can identify the safe environ- manufacturing practice requirements ments for device use, use all safety fea- of the quality system regulation in tures of the device, and operate the depart 820 of this chapter, with the excep- vice in the intended environment of tion of § 820.180, with respect to general use. requirements concerning records, and (9) Labeling for the trainer and user § 820.198, with respect to complaint must include a summary of the clinical files. testing including adverse events en- [55 FR 48443, Nov. 20, 1990, as amended at 59 countered under use conditions, sum- FR 63014, Dec. 7, 1994; 66 FR 38815, July 25, mary of study outcomes and endpoints, 2001] and information pertinent to use of the device including the conditions under § 886.5916 Rigid gas permeable contact which the device was studied (e.g., level lens. of supervision or assistance, and envi- (a) Identification. A rigid gas per- ronment of use). meable contact lens is a device in- [80 FR 57092, Sept. 22, 2015] tended to be worn directly against the cornea of the eye to correct vision con- § 886.5910 Image intensification vision ditions. The device is made of various aid. materials, such as cellulose acetate bu- (a) Identification. An image inten- tyrate, polyacrylate-silicone, or sili- sification vision aid is a battery-pow- cone elastomers, whose main polymer ered device intended for use by a pa- molecules generally do not absorb or tient who has limited dark adaptation attract water. or impaired vision to amplify ambient (b) Classification. (1) Class II if the de- light. vice is intended for daily wear only. (b) Classification. Class I (general con- (2) Class III if the device is intended trols). The device is exempt from the for extended wear. premarket notification procedures in (c) Date PMA or notice of completion of subpart E of part 807 of this chapter, a PDP is required. As of May 28, 1976, an subject to the limitations in § 886.9. The approval under section 515 of the act is device is also exempt from the current required before a device described in good manufacturing practice require- paragraph (b)(2) of this section may be ments of the quality system regulation commercially distributed. See § 886.3. in part 820 of this chapter, with the ex- [52 FR 33355, Sept. 2, 1987, as amended at 59 ception of § 820.180, with respect to gen- FR 10284, Mar. 4, 1994] eral requirements concerning records, and § 820.198, with respect to complaint § 886.5918 Rigid gas permeable contact files. lens care products. [52 FR 33355, Sept. 2, 1987, as amended at 53 (a) Identification. A rigid gas per- FR 35607, Sept. 14, 1988; 66 FR 38814, July 25, meable contact lens care product is a 2001] device intended for use in the cleaning, conditioning, rinsing, lubricating/re- § 886.5915 Optical vision aid. wetting, or storing of a rigid gas per- (a) Identification. An optical vision meable contact lens. This includes all aid is a device that consists of a magni- solutions and tablets used together

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with rigid gas permeable contact § 886.5933 [Reserved] lenses. (b) Classification. Class II (Special PART 888—ORTHOPEDIC DEVICES Controls) Guidance Document: ‘‘Guid- ance for Industry Premarket Notifica- Subpart A—General Provisions tion (510(k)) Guidance Document for Contact Lens Care Products.’’ Sec. 888.1 Scope. [62 FR 30987, June 6, 1997] 888.3 Effective dates of requirement for premarket approval. § 886.5925 Soft (hydrophilic) contact 888.5 Resurfacing technique. lens. 888.6 Degree of constraint. 888.9 Limitations of exemptions from sec- (a) Identification. A soft (hydrophilic) tion 510(k) of the Federal Food, Drug, contact lens is a device intended to be and Cosmetic Act (the act). worn directly against the cornea and adjacent limbal and scleral areas of the Subpart B—Diagnostic Devices eye to correct vision conditions or act 888.1100 Arthroscope. as a therapeutic bandage. The device is 888.1240 AC-powered dynamometer. made of various polymer materials the 888.1250 Nonpowered dynamometer. main polymer molecules of which ab- 888.1500 Goniometer. sorb or attract a certain volume (per- 888.1520 Nonpowered goniometer. centage) of water. Subpart C [Reserved] (b) Classification. (1) Class II if the device is intended for daily wear only. Subpart D—Prosthetic Devices (2) Class III if the device is intended 888.3000 Bone cap. for extended wear. 888.3010 Bone fixation cerclage. (c) Date PMA or notice of completion of 888.3015 Bone heterograft. a PDP is required. As of May 28, 1976, an 888.3020 Intramedullary fixation rod. approval under section 515 of the act is 888.3025 Passive tendon prosthesis. required before a device described in 888.3027 Polymethylmethacrylate (PMMA) bone cement. paragraph (b)(2) of this section may be 888.3030 Single/multiple component metallic commercially distributed. See § 886.3. bone fixation appliances and accessories. 888.3040 Smooth or threaded metallic bone [52 FR 33355, Sept. 2, 1987, as amended at 59 fixation fastener. FR 10284, Mar. 4, 1994] 888.3045 Resorbable calcium salt bone void filler device. § 886.5928 Soft (hydrophilic) contact 888.3050 Spinal interlaminal fixation ortho- lens care products. sis. (a) Identification. A soft (hydrophilic) 888.3060 Spinal intervertebral body fixation contact lens care product is a device orthosis. 888.3070 Thoracolumbosacral pedicle screw intended for use in the cleaning, rins- system. ing, disinfecting, lubricating/rewetting, 888.3080 Intervertebral body fusion device. or storing of a soft (hydrophilic) con- 888.3100 Ankle joint metal/composite semi- tact lens. This includes all solutions constrained cemented prosthesis. and tablets used together with soft (hy- 888.3110 Ankle joint metal/polymer semi- constrained cemented prosthesis. drophilic) contact lenses and heat dis- 888.3120 Ankle joint metal/polymer non-con- infecting units intended to disinfect a strained cemented prosthesis. soft (hydrophilic) contact lens by 888.3150 Elbow joint metal/polymer con- means of heat. strained cemented prosthesis. (b) Classification. Class II (Special 888.3160 Elbow joint metal/polymer semi- Controls) Guidance Document: ‘‘Guid- constrained cemented prosthesis. 888.3170 Elbow joint radial (hemi-elbow) ance for Industry Premarket Notifica- polymer prosthesis. tion (510(k)) Guidance Document for 888.3180 Elbow joint humeral (hemi-elbow) Contact Lens Care Products.’’ metallic uncemented prosthesis. 888.3200 Finger joint metal/metal con- [62 FR 30988, June 6, 1997] strained uncemented prosthesis. 888.3210 Finger joint metal/metal constrained cemented prosthesis.

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888.3220 Finger joint metal/polymer con- 888.3565 Knee joint patellofemorotibial strained cemented prosthesis. metal/polymer porous-coated 888.3230 Finger joint polymer constrained uncemented prosthesis. prosthesis. 888.3570 Knee joint femoral (hemi-knee) me- 888.3300 Hip joint metal constrained ce- tallic uncemented prosthesis. mented or uncemented prosthesis. 888.3580 Knee joint patellar (hemi-knee) me- 888.3310 Hip joint metal/polymer con- tallic resurfacing uncemented prosthesis. strained cemented or uncemented pros- 888.3590 Knee joint tibial (hemi-knee) me- thesis. tallic resurfacing uncemented prosthesis. 888.3320 Hip joint metal/metal semi-con- 888.3640 Shoulder joint metal/metal or strained, with a cemented acetabular metal/polymer constrained cemented component, prosthesis. prosthesis. 888.3330 Hip joint metal/metal semi-con- 888.3650 Shoulder joint metal/polymer non- strained, with an uncemented acetabular constrained cemented prosthesis. component, prosthesis. 888.3660 Shoulder joint metal/polymer semi- 888.3340 Hip joint metal/composite semi- constrained cemented prosthesis. constrained cemented prosthesis. 888.3670 Shoulder joint metal/polymer/metal 888.3350 Hip joint metal/polymer semi-con- nonconstrained or semi-constrained po- strained cemented prosthesis. rous-coated uncemented prosthesis. 888.3353 Hip joint metal/ceramic/polymer 888.3680 Shoulder joint glenoid (hemi-shoul- semi-constrained cemented or nonporous der) metallic cemented prosthesis. uncemented prosthesis. 888.3690 Shoulder joint humeral (hemi- 888.3358 Hip joint metal/polymer/metal shoulder) metallic uncemented pros- semi-constrained porous-coated thesis. uncemented prosthesis. 888.3720 Toe joint polymer constrained pros- 888.3360 Hip joint femoral (hemi-hip) metal- thesis. lic cemented or uncemented prosthesis. 888.3730 Toe joint phalangeal (hemi-toe) 888.3370 Hip joint (hemi-hip) acetabular polymer prosthesis. metal cemented prosthesis. 888.3750 Wrist joint carpal lunate polymer 888.3380 Hip joint femoral (hemi-hip) trun- prosthesis. nion-bearing metal/polyacetal cemented 888.3760 Wrist joint carpal scaphoid polymer prosthesis. prosthesis. 888.3390 Hip joint femoral (hemi-hip) metal/ 888.3770 Wrist joint carpal trapezium poly- polymer cemented or uncemented pros- mer prosthesis. thesis. 888.3780 Wrist joint polymer constrained 888.3400 Hip joint femoral (hemi-hip) metal- prosthesis. lic resurfacing prosthesis. 888.3790 Wrist joint metal constrained ce- 888.3410 Hip joint metal/polymer or ceramic/ mented prosthesis. polymer semiconstrained resurfacing 888.3800 Wrist joint metal/polymer semi- 888.3480 Knee joint femorotibial metallic constrained cemented prosthesis. constrained cemented prosthesis. 888.3810 Wrist joint ulnar (hemi-wrist) poly- 888.3490 Knee joint femorotibial metal/commer prosthesis. posite non-constrained cemented prosthesis. 888.3500 Knee joint femorotibial metal/com- Subpart E—Surgical Devices posite semi-constrained cemented pros- 888.4150 Calipers for clinical use. thesis. 888.4200 Cement dispenser. 888.3510 Knee joint femorotibial metal/poly- 888.4210 Cement mixer for clinical use. mer constrained cemented prosthesis. 888.4220 Cement monomer vapor evacuator. 888.3520 Knee joint femorotibial metal/poly- 888.4230 Cement ventilation tube. mer non-constrained cemented pros- 888.4300 Depth gauge for clinical use. thesis. 888.4540 Orthopedic manual surgical instru- 888.3530 Knee joint femorotibial metal/poly- ment. mer semi-constrained cemented pros- 888.4580 Sonic surgical instrument and ac- thesis. cessories/attachments. 888.3535 Knee joint femorotibial (uni-com- 888.4600 Protractor for clinical use. partmental) metal/polymer porous-coat- 888.4800 Template for clinical use. ed uncemented prosthesis. 888.5850 Nonpowered orthopedic traction ap- 888.3540 Knee joint patellofemoral polymer/ paratus and accessories. metal semi-constrained cemented pros- 888.5890 Noninvasive traction component. thesis. 888.5940 Cast component. 888.3550 Knee joint patellofemorotibial 888.5960 Cast removal instrument. polymer/metal/metal constrained ce- 888.5980 Manual cast application and re- mented prosthesis. moval instrument. 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, cemented prosthesis. 360j, 371.

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SOURCE: 52 FR 33702, Sept. 4, 1987, unless pleted a product development protocol otherwise noted. (PDP) for the device. EDITORIAL NOTE: Nomenclature changes to (a) Before FDA requires that a device part 888 appear at 73 FR 35341, June 23, 2008. commercially distributed before the enactment date of the amendments, or Subpart A—General Provisions a device that has been found substantially equivalent to such a device, has § 888.1 Scope. an approval under section 515 of the (a) This part sets forth the classifica- act, FDA must promulgate a regulation of orthopedic devices intended for tion under section 515(b) of the act re- human use that are in commercial dis- quiring such approval, except as pro- tribution. vided in paragraphs (b) and (c) of this (b) The identification of a device in a section. Such a regulation under sec- regulation in this part is not a precise tion 515(b) of the act shall not be effec- description of every device that is, or tive during the grace period ending on will be, subject to the regulation. A the 90th day after its promulgation or manufacturer who submits a pre- on the last day of the 30th full calendar market notification submission for a month after the regulation that classi- device under part 807 cannot show fies the device into class III is effec- merely that the device is accurately tive, whichever is later. See section described by the section title and iden- 501(f)(2)(B) of the act. Accordingly, un- tification provision of a regulation in less an effective date of the require- this part, but shall state why the de- ment for premarket approval is shown vice is substantially equivalent to in the regulation for a device classified other devices, as required by § 807.87. into class III in this part, the device (c) To avoid duplicative listings, an may be commercially distributed with- orthopedic device that has two or more out FDA’s issuance of an order approv- types of uses (e.g., used both as a diag- ing a PMA or declaring completed a nostic device and as a surgical device) PDP for the device. If FDA promul- is listed in one subpart only. gates a regulation under section 515(b) (d) References in this part to regu- of the act requiring premarket ap- latory sections of the Code of Federal proval for a device, section 501(f)(1)(A) Regulations are to chapter I of title 21 of the act applies to the device. unless otherwise noted. (b) Any new, not substantially equiv- (e) Guidance documents referenced in alent, device introduced into commer- this part are available on the Internet cial distribution on or after May 28, at http://www.fda.gov/MedicalDevices/ 1976, including a device formerly mar- DeviceRegulationandGuidance/ keted that has been substantially al- GuidanceDocuments/default.htm. tered, is classified by statute (section [52 FR 33702, Sept. 4, 1987, as amended at 68 513(f) of the act) into class III without FR 14137, Mar. 24, 2003; 78 FR 18233, Mar. 26, any grace period and FDA must have 2013] issued an order approving a PMA or declaring completed a PDP for the device § 888.3 Effective dates of requirement before the device is commercially dis- for premarket approval. tributed unless it is reclassified. If A device included in this part that is FDA knows that a device being com- classified into class III (premarket ap- mercially distributed may be a ‘‘new’’ proval) shall not be commercially dis- device as defined in this section be- tributed after the date shown in the cause of any new intended use or other regulation classifying the device unless reasons, FDA may codify the statutory the manufacturer has an approval classification of the device into class under section 515 of the act (unless an III for such new use. Accordingly, the exemption has been granted under sec- regulation for such a class III device tion 520(g)(2) of the act). An approval states that as of the enactment date of under section 515 of the act consists of the amendments, May 28, 1976, the de- FDA’s issuance of an order approving vice must have an approval under sec- an application for premarket approval tion 515 of the act before commercial (PMA) for the device or declaring com- distribution.

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(c) A device identified in a regulation § 888.9 Limitations of exemptions from in this part that is classified into class section 510(k) of the Federal Food, III and that is subject to the transi- Drug, and Cosmetic Act (the act). tional provisions of section 520(1) of the The exemption from the requirement act is automatically classified by stat- of premarket notification (section ute into class III and must have an ap- 510(k) of the act) for a generic type of proval under section 515 of the act be- class I or II device is only to the extent fore being commercially distributed. that the device has existing or reason- Accordingly, the regulation for such a ably foreseeable characteristics of class III transitional device states that commercially distributed devices with- as of the enactment date of the amend- in that generic type or, in the case of ments, May 28, 1976, the device must in vitro diagnostic devices, only to the have an approval under section 515 of extent that misdiagnosis as a result of using the device would not be associ- the act before commercial distribution. ated with high morbidity or mortality. § 888.5 Resurfacing technique. Accordingly, manufacturers of any commercially distributed class I or II Because of resurfacing techniques, device for which FDA has granted an certain joint prostheses require far less exemption from the requirement of bone resection than other devices in- premarket notification must still sub- tended to repair or replace the same mit a premarket notification to FDA joint. The amount of bone resection before introducing or delivering for in- may or may not affect the safety and troduction into interstate commerce effectiveness of the implantation of the for commercial distribution the device prosthesis. When a resurfacing tech- when: nique is used, the name of the pros- (a) The device is intended for a use thesis includes this information. different from the intended use of a legally marketed device in that generic § 888.6 Degree of constraint. type of device; e.g., the device is intended for a different medical purpose, Certain joint prostheses provide more or the device is intended for lay use constraint of joint movement than oth- where the former intended use was by ers. FDA believes that the degree of health care professionals only; constraint is an important factor af- (b) The modified device operates fecting the safety and effectiveness of using a different fundamental sci- orthopedic prostheses. FDA is defining entific technology than a legally mar- the following standard terms for cat- keted device in that generic type of de- egorizing the degree of constraint. vice; e.g., a surgical instrument cuts (a) A ‘‘constrained’’ joint prosthesis tissue with a laser beam rather than is used for joint replacement and pre- with a sharpened metal blade, or an in vents dislocation of the prosthesis in vitro diagnostic device detects or iden- more than one anatomic plane and con- tifies infectious agents by using sists of either a single, flexible, across- deoxyribonucleic acid (DNA) probe or the-joint component or more than one nucleic acid hybridization technology component linked together or affined. rather than culture or immunoassay (b) A ‘‘semi-constrained’’ joint pros- technology; or thesis is used for partial or total joint (c) The device is an in vitro device replacement and limits translation and that is intended: rotation of the prosthesis in one or (1) For use in the diagnosis, monitoring, or screening of neoplastic dis- more planes via the geometry of its ar- eases with the exception of ticulating surfaces. It has no across- immunohistochemical devices; the-joint linkage. (2) For use in screening or diagnosis (c) A ‘‘non-constrained’’ joint pros- of familial or acquired genetic dis- thesis is used for partial or total joint orders, including inborn errors of me- replacement and restricts minimally tabolism; prosthesis movement in one or more (3) For measuring an analyte that planes. Its components have no across- serves as a surrogate marker for the-joint linkage. screening, diagnosis, or monitoring

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life-threatening diseases such as ac- with a force transducer (a device that quired immune deficiency syndrome translates force into electrical im- (AIDS), chronic or active hepatitis, tu- pulses), the grip-strength of a patient’s berculosis, or myocardial infarction or hand. to monitor therapy; (b) Classification. Class II. (4) For assessing the risk of cardiovascular diseases; § 888.1250 Nonpowered dynamometer. (5) For use in diabetes management; (a) Identification. A nonpowered dyna- (6) For identifying or inferring the mometer is a mechanical device in- identity of a microorganism directly tended for medical purposes to measure from clinical material; the pinch and grip muscle strength of a (7) For detection of antibodies to patient’s hand. microorganisms other than (b) Classification. Class I. The device immunoglobulin G (IgG) or IgG assays is exempt from the premarket notifica- when the results are not qualitative, or tion procedures in subpart E of part are used to determine immunity, or the 807. assay is intended for use in matrices other than serum or plasma; § 888.1500 Goniometer. (8) For noninvasive testing as defined (a) Identification. A goniometer is an in § 812.3(k) of this chapter; and AC-powered or battery powered device (9) For near patient testing (point of intended to evaluate joint function by care). measuring and recording ranges of mo- [65 FR 2321, Jan. 14, 2000] tion, acceleration, or forces exerted by a joint. Subpart B—Diagnostic Devices (b) Classification. (1) Class I (general controls) for a goniometer that does § 888.1100 Arthroscope. not use electrode lead wires and patient cables. This device is exempt (a) Identification. An arthroscope is from the premarket notification proce- an electrically powered endoscope in- dures of subpart E of part 807 of this tended to make visible the interior of a chapter subject to § 888.9. joint. The arthroscope and accessories (2) Class II (special controls) for a go- also is intended to perform surgery niometer that uses electrode lead wires within a joint. and patient cables. The special controls (b) Classification. (1) Class II (per- consist of: formance standards). (i) The performance standard under (2) Class I for the following manual part 898 of this chapter, and arthroscopic instruments: cannulas, (ii) The guidance entitled ‘‘Guidance currettes, drill guides, forceps, gouges, on the Performance Standard for Elec- graspers, knives, obturators, trode Lead Wires and Patient Cables.’’ osteotomes, probes, punches, rasps, re- This device is exempt from the pre- tractors, rongeurs, suture passers, su- market notification procedures of sub- ture knotpushers, suture punches, part E of part 807 of this chapter sub- switching rods, and trocars. The de- ject to § 888.9. vices subject to this paragraph (b)(2) are exempt from the premarket notifi- [65 FR 19319, Apr. 11, 2000] cation procedures in subpart E of part 807 of this chapter, subject to the limi- § 888.1520 Nonpowered goniometer. tations in § 888.9. (a) Identification. A nonpowered goniometer is a mechanical device intended [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 1124, Jan. 16, 1996; 66 FR 38815, July 25, for medical purposes to measure the 2001] range of motion of joints. (b) Classification. Class I (general con- § 888.1240 AC-powered dynamometer. trols). The device is exempt from the (a) Identification. An AC-powered dy- premarket notification procedures in namometer is an AC-powered device in- subpart E of part 807 of this chapter, tended for medical purposes to assess subject to the limitations in § 888.9. neuromuscular function or degree of [52 FR 33702, Sept. 4, 1987, as amended at 66 neuromuscular blockage by measuring, FR 38815, July 25, 2001]

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Subpart C [Reserved] (b) Classification. Class II. § 888.3025 Passive tendon prosthesis. Subpart D—Prosthetic Devices (a) Identification. A passive tendon § 888.3000 Bone cap. prosthesis is a device intended to be implanted made of silicon elastomer or (a) Identification. A bone cap is a a polyester reinforced medical grade mushroom-shaped device intended to silicone elastomer intended for use in be implanted made of either silicone the surgical reconstruction of a flexor elastomer or ultra-high molecular tendon of the hand. The device is im- weight polyethylene. It is used to cover planted for a period of 2 to 6 months to the severed end of a long bone, such as aid growth of a new tendon sheath. The the humerus or tibia, to control bone device is not intended as a permanent overgrowth in juvenile amputees. implant nor to function as a replace- (b) Classification. Class I (general con- ment for the ligament or tendon nor to trols). The device is exempt from the function as a scaffold for soft tissue premarket notification procedures in ingrowth. subpart E of part 807 of this chapter, (b) Classification. Class II. subject to the limitations in § 888.9. [52 FR 33702, Sept. 4, 1987, as amended at 61 § 888.3027 Polymethylmethacrylate FR 1124, Jan. 16, 1996; 66 FR 38815, July 25, (PMMA) bone cement. 2001] (a) Identification. Polymethylmethacrylate (PMMA) bone § 888.3010 Bone fixation cerclage. cement is a device intended to be im- (a) Identification. A bone fixation planted that is made from cerclage is a device intended to be im- methylmethacrylate, planted that is made of alloys, such as polymethylmethacrylate, esters of cobalt-chromium-molybdenum, and methacrylic acid, or copolymers con- that consists of a metallic ribbon or taining polymethylmethacrylate and flat sheet or a wire. The device is polystyrene. The device is intended for wrapped around the shaft of a long use in arthroplastic procedures of the bone, anchored to the bone with wire hip, knee, and other joints for the fixa- or screws, and used in the fixation of tion of polymer or metallic prosthetic fractures. implants to living bone. (b) Classification. Class II. (b) Classification. Class II (special controls). The special control for this § 888.3015 Bone heterograft. device is the FDA guidance document (a) Identification. Bone heterograft is entitled ‘‘Class II Special Controls a device intended to be implanted that Guidance Document: is made from mature (adult) bovine Polymethylmethacrylate (PMMA) bones and used to replace human bone Bone Cement.’’ following surgery in the cervical region [67 FR 46855, July 17, 2002] of the spinal column. (b) Classification. Class III. § 888.3030 Single/multiple component (c) Date PMA or notice of completion of metallic bone fixation appliances a PDP is required. As of May 28, 1976, an and accessories. approval under section 515 of the act is (a) Identification. Single/multiple required before this device may be component metallic bone fixation ap- commercially distributed. See § 888.3. pliances and accessories are devices intended to be implanted consisting of § 888.3020 Intramedullary fixation rod. one or more metallic components and (a) Identification. An intramedullary their metallic fasteners. The devices fixation rod is a device intended to be contain a plate, a nail/plate combina- implanted that consists of a rod made tion, or a blade/plate combination that of alloys such as cobalt-chromium-mo- are made of alloys, such as cobalt-chro- lybdenum and stainless steel. It is in- mium-molybdenum, stainless steel, serted into the medullary (bone mar- and titanium, that are intended to be row) canal of long bones for the fixa- held in position with fasteners, such as tion of fractures. screws and nails, or bolts, nuts, and

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washers. These devices are used for fix- § 888.3050 Spinal interlaminal fixation ation of fractures of the proximal or orthosis. distal end of long bones, such as (a) Identification. A spinal interlam- intracapsular, intertrochanteric, inter- inal fixation orthosis is a device in- cervical, supracondylar, or condylar tended to be implanted made of an fractures of the femur; for fusion of a alloy, such as stainless steel, that con- joint; or for surgical procedures that sists of various hooks and a posteriorly involve cutting a bone. The devices placed compression or distraction rod. may be implanted or attached through The device is implanted, usually across the skin so that a pulling force (trac- three adjacent vertebrae, to straighten tion) may be applied to the skeletal and immobilize the spine to allow bone system. grafts to unite and fuse the vertebrae (b) Classification. Class II. together. The device is used primarily in the treatment of scoliosis (a lateral § 888.3040 Smooth or threaded metallic curvature of the spine), but it also may bone fixation fastener. be used in the treatment of fracture or (a) Identification. A smooth or thread- dislocation of the spine, grades 3 and 4 ed metallic bone fixation fastener is a of spondylolisthesis (a dislocation of device intended to be implanted that the spinal column), and lower back syndrome. consists of a stiff wire segment or rod made of alloys, such as cobalt-chro- (b) Classification. Class II. mium-molybdenum and stainless steel, § 888.3060 Spinal intervertebral body and that may be smooth on the out- fixation orthosis. side, fully or partially threaded, straight or U-shaped; and may be ei- (a) Identification. A spinal intervertebral body fixation orthosis is ther blunt pointed, sharp pointed, or a device intended to be implanted made have a formed, slotted head on the end. of titanium. It consists of various It may be used for fixation of bone vertebral plates that are punched into fractures, for bone reconstructions, as each of a series of vertebral bodies. An a guide pin for insertion of other im- eye-type screw is inserted in a hole in plants, or it may be implanted through the center of each of the plates. A the skin so that a pulling force (trac- braided cable is threaded through each tion) may be applied to the skeletal eye-type screw. The cable is tightened system. with a tension device and it is fastened (b) Classification. Class II. or crimped at each eye-type screw. The device is used to apply force to a series § 888.3045 Resorbable calcium salt of vertebrae to correct ‘‘sway back,’’ bone void filler device. scoliosis (lateral curvature of the (a) Identification. A resorbable cal- spine), or other conditions. cium salt bone void filler device is a (b) Classification. Class II. resorbable implant intended to fill bony voids or gaps of the extremities, § 888.3070 Thoracolumbosacral pedicle spine, and pelvis that are caused by screw system. trauma or surgery and are not intrinsic (a) Identification. (1) Rigid pedicle to the stability of the bony structure. screw systems are comprised of mul- (b) Classification. Class II (special tiple components, made from a variety controls). The special control for this of materials that allow the surgeon to device is the FDA guidance document build an implant system to fit the pa- entitled ‘‘Class II Special Controls tient’s anatomical and physiological Guidance: Resorbable Calcium Salt requirements. Such a spinal implant Bone Void Filler Device; Guidance for assembly consists of a combination of screws, longitudinal members (e.g., Industry and FDA.’’ See § 888.1(e) of plates, rods including dual diameter this chapter for the availability of this rods, plate/rod combinations), trans- guidance. verse or cross connectors, and inter- [68 FR 32636, June 2, 2003] connection mechanisms (e.g., rod-to- rod connectors, offset connectors).

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(2) Semi-rigid systems are defined as an adjunct to fusion in the treatment systems that contain one or more of of degenerative disc disease and the following features (including but spondylolisthesis other than either se- not limited to): Non-uniform longitu- vere spondylolisthesis (grades 3 and 4) dinal elements, or features that allow at L5–S1 or degenerative more motion or flexibility compared to spondylolisthesis with objective evi- rigid systems. dence of neurologic impairment. These (b) Classification. (1) Class II (special pedicle screw systems must comply controls), when intended to provide im- with the following special controls: mobilization and stabilization of spinal (i) The design characteristics of the segments in skeletally mature patients device, including engineering sche- as an adjunct to fusion in the treat- matics, must ensure that the geometry ment of the following acute and chron- and material composition are con- ic instabilities or deformities of the sistent with the intended use. thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) (ii) Non-clinical performance testing of the L5–S1 vertebra; degenerative must demonstrate the mechanical spondylolisthesis with objective evi- function and durability of the implant. dence of neurologic impairment; frac- (iii) Device components must be dem- ture; dislocation; scoliosis; kyphosis; onstrated to be biocompatible. spinal tumor; and failed previous fu- (iv) Validation testing must dem- sion (pseudarthrosis). These pedicle onstrate the cleanliness and sterility screw spinal systems must comply with of, or the ability to clean and sterilize, the following special controls: the device components and device-spe- (i) Compliance with material stand- cific instruments. ards; (v) Labeling must include the fol- (ii) Compliance with mechanical test- lowing: ing standards; (A) A clear description of the techno- (iii) Compliance with biocompat- logical features of the device including ibility standards; and identification of device materials and (iv) Labeling that contains these two the principles of device operation; statements in addition to other appro- (B) Intended use and indications for priate labeling information: use, including levels of fixation; ‘‘Warning: The safety and effectiveness of (C) Identification of magnetic reso- pedicle screw spinal systems have been es- nance (MR) compatibility status; tablished only for spinal conditions with significant mechanical instability or deformity (D) Cleaning and sterilization in- requiring fusion with instrumentation. structions for devices and instruments These conditions are significant mechanical that are provided non-sterile to the end instability or deformity of the thoracic, lum- user; and bar, and sacral spine secondary to severe (E) Detailed instructions of each sur- spondylolisthesis (grades 3 and 4) of the L5– gical step, including device removal. S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impair- (3) Class II (special controls), when a ment, fracture, dislocation, scoliosis, kypho- semi-rigid system is intended to pro- sis, spinal tumor, and failed previous fusion vide immobilization and stabilization (pseudarthrosis). The safety and effective- of spinal segments in the thoracic, ness of these devices for any other conditions lumbar, and sacral spine as an adjunct are unknown.’’ to fusion for any indication. In addi- ‘‘Precaution: The implantation of pedicle screw spinal systems should be performed tion to complying with the special con- only by experienced spinal surgeons with trols in paragraphs (b)(2)(i) through (v) specific training in the use of this pedicle of this section, these pedicle screw sys- screw spinal system because this is a tech- tems must comply with the following nically demanding procedure presenting a special controls: risk of serious injury to the patient.’’ (i) Demonstration that clinical per- (2) Class II (special controls), when a formance characteristics of the device rigid pedicle screw system is intended support the intended use of the prod- to provide immobilization and sta- uct, including assessment of fusion bilization of spinal segments in the compared to a clinically acceptable fu- thoracic, lumbar, and sacral spine as sion rate.

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(ii) Semi-rigid systems marketed It has no linkage across-the-joint. This prior to the effective date of this re- generic type of device includes pros- classification must submit an amend- theses that consist of a talar resur- ment to their previously cleared pre- facing component made of alloys, such market notification (510(k)) dem- as cobalt-chromium-molybdenum, and onstrating compliance with the special a tibial resurfacing component fab- controls in paragraphs (b)(2)(i) through ricated from ultra-high molecular (v) and paragraph (b)(3)(i) of this sec- weight polyethylene with carbon fibers tion. composite, and is limited to those pros- [66 FR 28053, May 22, 2001, as amended at 81 theses intended for use with bone ce- FR 96373, Dec. 30, 2016] ment (§ 888.3027). (b) Classification. Class II. § 888.3080 Intervertebral body fusion device. § 888.3110 Ankle joint metal/polymer (a) Identification. An intervertebral semi-constrained cemented pros- body fusion device is an implanted sin- thesis. gle or multiple component spinal de- (a) Identification. An ankle joint vice made from a variety of materials, metal/polymer semi-constrained ce- including titanium and polymers. The mented prosthesis is a device intended device is inserted into the to be implanted to replace an ankle intervertebral body space of the cer- joint. The device limits translation and vical or lumbosacral spine, and is in- rotation in one or more planes via the tended for intervertebral body fusion. geometry of its articulating surfaces (b) Classification. (1) Class II (special and has no linkage across-the-joint. controls) for intervertebral body fusion This generic type of device includes devices that contain bone grafting ma- prostheses that have a talar resur- terial. The special control is the FDA facing component made of alloys, such guidance document entitled ‘‘Class II as cobalt-chromium-molybdenum, and Special Controls Guidance Document: a tibial resurfacing component made of Intervertebral Body Fusion Device.’’ ultra-high molecular weight poly- See § 888.1(e) for the availability of this ethylene and is limited to those pros- guidance document. theses intended for use with bone ce- (2) Class III (premarket approval) for ment (§ 888.3027). intervertebral body fusion devices that include any therapeutic biologic (e.g., (b) Classification. Class II. bone morphogenic protein). Intervertebral body fusion devices that § 888.3120 Ankle joint metal/polymer non-constrained cemented pros- contain any therapeutic biologic re- thesis. quire premarket approval. (c) Date premarket approval application (a) Identification. An ankle joint (PMA) or notice of product development metal/polymer non-constrained ce- protocol (PDP) is required. Devices de- mented prosthesis is a device intended scribed in paragraph (b)(2) of this sec- to be implanted to replace an ankle tion shall have an approved PMA or a joint. The device limits minimally (less declared completed PDP in effect be- than normal anatomic constraints) fore being placed in commercial dis- translation in one or more planes. It tribution. has no linkage across-the-joint. This generic type of device includes pros- [72 FR 32172, June 12, 2007] theses that have a tibial component § 888.3100 Ankle joint metal/composite made of alloys, such as cobalt-chro- semi-constrained cemented pros- mium-molybdenum, and a talar compo- thesis. nent made of ultra-high molecular (a) Identification. An ankle joint weight polyethylene, and is limited to metal/composite semi-constrained ce- those prostheses intended for use with mented prosthesis is a device intended bone cement (§ 888.3027). to be implanted to replace an ankle (b) Classification. Class III. joint. The device limits translation and (c) Date PMA or notice of completion of rotation: in one or more planes via the a PDP is required. A PMA or a notice of geometry of its articulating surfaces. completion of a PDP is required to be

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filed with the Food and Drug Adminis- (i) ISO 5832–3:1996 ‘‘Implants for Sur- tration on or before December 26, 1996 gery—Metallic Materials—Part 3: for any ankle joint metal/polymer non- Wrought Titanium 6-Aluminum 4- constrained cemented prosthesis that Vandium Alloy,’’ was in commercial distribution before (ii) ISO 5832–4:1996 ‘‘Implants for Sur- May 28, 1976, or that has, on or before gery—Metallic Materials—Part 4: Co- December 26, 1996, been found to be balt-Chromium-Molybdenum Casting substantially equivalent to an ankle Alloy,’’ joint metal/polymer non-constrained (iii) ISO 5832–12:1996 ‘‘Implants for cemented prosthesis that was in com- Surgery—Metallic Materials—Part 12: mercial distribution before May 28, Wrought Cobalt-Chromium-Molyb- 1976. Any other ankle joint metal/poly- denum Alloy,’’ mer non-constrained cemented pros- (iv) ISO 5833:1992 ‘‘Implants for Sur- thesis shall have an approved PMA or a gery—Acrylic Resin Cements,’’ declared completed PDP in effect be- (v) ISO 5834–2:1998 ‘‘Implants for Sur- fore being placed in commercial dis- gery—Ultra High Molecular Weight tribution. Polyethylene—Part 2: Moulded [52 FR 33702, Sept. 4, 1987, as amended at 61 Forms,’’ FR 50709, Sept. 27, 1996] (vi) ISO 6018:1987 ‘‘Orthopaedic Im- plants—General Requirements for § 888.3150 Elbow joint metal/polymer constrained cemented prosthesis. Marking, Packaging, and Labeling,’’ (vii) ISO 9001:1994 ‘‘Quality Systems— (a) Identification. An elbow joint Model for Quality Assurance in Design/ metal/polymer constrained cemented Development, Production, Installation, prosthesis is a device intended to be and Servicing,’’ and implanted to replace an elbow joint. It (viii) ISO 14630:1997 ‘‘Non-active Sur- is made of alloys, such as cobalt-chro- gical Implants—General Require- mium-molybdenum, or of these alloys ments,’’ and of an ultra-high molecular weight polyethylene bushing. The device pre- (3) American Society for Testing and vents dislocation in more than one Materials’: anatomic plane and consists of two (i) F 75–92 ‘‘Specification for Cast Co- components that are linked together. balt-28 Chromium-6 Molybdenum Alloy This generic type of device is limited for Surgical Implant Material,’’ to those prostheses intended for use (ii) F 648–98 ‘‘Specification for Ultra- with bone cement (§ 888.3027). High-Molecular-Weight Polyethylene (b) Classification. Class II. The special Powder and Fabricated Form for Sur- controls for this device are: gical Implants,’’ (1) FDA’s: (iii) F 799–96 ‘‘Specification for Co- (i) ‘‘Use of International Standard balt-28 Chromium-6 Molybdenum Alloy ISO 10993 ‘Biological Evaluation of Forgings for Surgical Implants,’’ Medical Devices—Part I: Evaluation (iv) F 981–93 ‘‘Practice for Assess- and Testing,’ ’’ ment of Compatibility of Biomaterials (ii) ‘‘510(k) Sterility Review Guidance (Nonporous) for Surgical Implant with of 2/12/90 (K90–1),’’ Respect to Effect of Material on Mus- (iii) ‘‘Guidance Document for Testing cle and Bone,’’ Orthopedic Implants with Modified Me- (v) F 1044–95 ‘‘Test Method for Shear tallic Surfaces Apposing Bone or Bone Testing of Porous Metal Coatings,’’ Cement,’’ (vi) F 1108–97 ‘‘Specification for Tita- (iv) ‘‘Guidance Document for the nium-6 Aluminum-4 Vanadium Alloy Preparation of Premarket Notification Castings for Surgical Implants,’’ (510(k)) Application for Orthopedic De- (vii) F 1147–95 ‘‘Test Method for Ten- vices,’’ sion Testing of Porous Metal Coatings, (v) ‘‘Guidance Document for Testing ’’ and Non-articulating, ‘Mechanically (viii) F 1537–94 ‘‘Specification for Locked’ Modular Implant Compo- Wrought Cobalt-28 Chromium-6 Molyb- nents,’’ denum Alloy for Surgical Implants.’’ (2) International Organization for Standardization’s (ISO): [65 FR 17147, Mar. 31, 2000]

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§ 888.3160 Elbow joint metal/polymer uncemented prosthesis that was in semi-constrained cemented pros- commercial distribution before May 28, thesis. 1976. Any other elbow joint humeral (a) Identification. An elbow joint (hemi-elbow) metallic uncemented metal/polymer semi-constrained ce- prosthesis shall have an approved PMA mented prosthesis is a device intended or a declared completed PDP in effect to be implanted to replace an elbow before being placed in commercial dis- joint. The device limits translation and tribution. rotation in one or more planes via the [52 FR 33702, Sept. 4, 1987, as amended at 61 geometry of its articulating surfaces. FR 50709, Sept. 27, 1996] It has no linkage across-the-joint. This generic type of device includes pros- § 888.3200 Finger joint metal/metal theses that consist of a humeral resur- constrained uncemented prosthesis. facing component made of alloys, such (a) Identification. A finger joint as cobalt-chromium-molybdenum, and metal/metal constrained uncemented a radial resurfacing component made prosthesis is a device intended to be of ultra-high molecular weight poly- implanted to replace a ethylene. This generic type of device is metacarpophalangeal or proximal limited to those prostheses intended interphalangeal (finger) joint. The de- for use with bone cement (§ 888.3027). vice prevents dislocation in more than (b) Classification. Class II. one anatomic plane and consists of two components which are linked together. § 888.3170 Elbow joint radial (hemi- This generic type of device includes elbow) polymer prosthesis. prostheses made of alloys, such as co- (a) Identification. An elbow joint ra- balt-chromium-molybdenum, or dial (hemi-elbow) polymer prosthesis is protheses made from alloys and ultra- a device intended to be implanted made high molecular weight polyethylene. of medical grade silicone elastomer This generic type of device is limited used to replace the proximal end of the to prostheses intended for use without radius. bone cement (§ 888.3027). (b) Classification. Class II. (b) Classification. Class III. (c) Date PMA or notice of completion of § 888.3180 Elbow joint humeral (hemi- a PDP is required. A PMA or a notice of elbow) metallic uncemented pros- completion of a PDP is required to be thesis. filed with the Food and Drug Adminis- (a) Identification. An elbow joint hu- tration on or before December 26, 1996 meral (hemi-elbow) metallic for any finger joint metal/metal con- uncemented prosthesis is a device in- strained uncemented prosthesis that tended to be implanted made of alloys, was in commercial distribution before such as cobalt-chromium-molybdenum, May 28, 1976, or that has, on or before that is used to replace the distal end of December 26, 1996 been found to be sub- the humerus formed by the trochlea stantially equivalent to a finger joint humeri and the capitulum humeri. The metal/metal constrained uncemented generic type of device is limited to prosthesis that was in commercial dis- prostheses intended for use without tribution before May 28, 1976. Any bone cement (§ 888.3027). other finger joint metal/metal con- (b) Classification. Class III. strained uncemented prosthesis shall (c) Date PMA or notice of completion of have an approved PMA or a declared a PDP is required. A PMA or a notice of completed PDP in effect before being completion of a PDP is required to be placed in commercial distribution. filed with the Food and Drug Adminis- [52 FR 33702, Sept. 4, 1987, as amended at 61 tration on or before December 26, 1996 FR 50709, Sept. 27, 1996] for any elbow joint humeral (hemi- elbow) metallic uncemented prosthesis § 888.3210 Finger joint metal/metal that was in commercial distribution constrained cemented prosthesis. before May 28, 1976, or that has, on or (a) Identification. A finger joint before December 26, 1996 been found to metal/metal constrained cemented be substantially equivalent to an elbow prosthesis is a device intended to be joint humeral (hemi-elbow) metallic implanted to replace a

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metacarpophalangeal (finger) joint. in commercial distribution before May This device prevents dislocation in 28, 1976, or that has, on or before De- more than one anatomic plane and has cember 26, 1996 been found to be sub- components which are linked together. stantially equivalent to a finger joint This generic type of device includes metal/polymer constrained cemented prostheses that are made of alloys, prosthesis that was in commercial dis- such as cobalt-chromium-molybdenum, tribution before May 28, 1976. Any and is limited to those prostheses in- other finger joint metal/polymer con- tended for use with bone cement strained cemented prosthesis shall (§ 888.3027). have an approved PMA or a declared (b) Classification. Class III. completed PDP in effect before being (c) Date PMA or notice of completion of placed in commercial distribution. a PDP is required. A PMA or a notice of completion of a PDP is required to be [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996] filed with the Food and Drug Adminis- tration on or before December 26, 1996 § 888.3230 Finger joint polymer con- for any finger joint metal/metal constrained prosthesis. strained cemented prosthesis that was (a) Identification. A finger joint poly- in commercial distribution before May mer constrained prosthesis is a device 28, 1976, or that has, on or before De- intended to be implanted to replace a cember 26, 1996 been found to be sub- metacarpophalangeal or proximal stantially equivalent to a finger joint interphalangeal (finger) joint. This ge- metal/metal constrained cemented neric type of device includes prostheses prosthesis that was in commercial dis- that consist of a single flexible across- tribution before May 28, 1976. Any the-joint component made from either other finger joint metal/metal con- a silicone elastomer or a combination strained cemented prosthesis shall pf polypropylene and polyester mate- have an approved PMA or a declared rial. The flexible across-the-joint com- completed PDP in effect before being ponent may be covered with a silicone placed in commercial distribution. rubber sleeve. [52 FR 33702, Sept. 4, 1987, as amended at 61 (b) Classification. Class II. FR 50709, Sept. 27, 1996] § 888.3300 Hip joint metal constrained § 888.3220 Finger joint metal/polymer cemented or uncemented pros- constrained cemented prosthesis. thesis. (a) Identification. A finger joint (a) Identification. A hip joint metal metal/polymer constrained cemented constrained cemented or uncemented prosthesis is a device intended to be prosthesis is a device intended to be implanted to replace a implanted to replace a hip joint. The metacarpophalangeal or proximal device prevents dislocation in more interphalangeal (finger) joint. The de- than one anatomic plane and has com- vice prevents dislocation in more than ponents that are linked together. This one anatomic plane, and consists of generic type of device includes pros- two components which are linked to- theses that have components made of gether. This generic type of device in- alloys, such as cobalt-chromium-mo- cludes prostheses that are made of al- lybdenum, and is intended for use with loys, such as cobalt-chromium-molyb- or without bone cement (§ 888.3027). denum, and ultra-high molecular This device is not intended for biologi- weight polyethylene, and is limited to cal fixation. those prostheses intended for use with (b) Classification. Class III. bone cement (§ 888.3027). (c) Date PMA or notice of completion of (b) Classification. Class III. a PDP is required. A PMA or a notice of (c) Date PMA or notice of completion of completion of a PDP is required to be a PDP is required. A PMA or a notice of filed with the Food and Drug Adminis- completion of a PDP is required to be tration on or before December 26, 1996 filed with the Food and Drug Adminis- for any hip joint metal constrained ce- tration on or before December 26, 1996 mented or uncemented prosthesis that for any finger joint metal/polymer con- was in commercial distribution before strained cemented prosthesis that was May 28, 1976, or that has, on or before

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December 26, 1996 been found to be sub- component, both made of alloys, such stantially equivalent to a hip joint as cobalt-chromium-molybdenum. This metal constrained cemented or generic type of device is limited to uncemented prosthesis that was in those prostheses intended for use with commercial distribution before May 28, bone cement (§ 888.3027). 1976. Any other hip joint metal con- (b) Classification. Class III. strained cemented or uncemented pros- (c) Date PMA or notice of completion of thesis shall have an approved PMA or a PDP is required. A PMA or a notice of declared completed PDP in effect be- completion of a PDP is required to be fore being placed in commercial dis- filed with the Food and Drug Adminis- tribution. tration on or before May 18, 2016, for any hip joint metal/metal semi-con- [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50709, Sept. 27, 1996] strained prosthesis with a cemented acetabular component that was in com- § 888.3310 Hip joint metal/polymer con- mercial distribution before May 28, strained cemented or uncemented 1976, or that has, on or before May 18, prosthesis. 2016, been found to be substantially (a) Identification. A hip joint metal/ equivalent to a hip joint metal/metal polymer constrained cemented or semi-constrained prosthesis with a ce- uncemented prosthesis is a device in- mented acetabular component that was tended to be implanted to replace a hip in commercial distribution before May joint. The device prevents dislocation 28, 1976. Any other hip joint metal/ in more than one anatomic plane and metal semi-constrained prosthesis with has components that are linked to- a cemented acetabular component gether. This generic type of device in- shall have an approved PMA or a de- cludes prostheses that have a femoral clared completed PDP in effect before component made of alloys, such as co- being placed in commercial distribu- balt-chromium-molybdenum, and an tion. acetabular component made of ultra- [52 FR 33702, Sept. 4, 1987, as amended at 81 high-molecular-weight polyethylene FR 8149, Feb. 18, 2016] with or without a metal shell, made of alloys, such as cobalt-chromium-mo- § 888.3330 Hip joint metal/metal semi- lybdenum and titanium alloys. This ge- constrained, with an uncemented neric type of device is intended for use acetabular component, prosthesis. with or without bone cement (a) Identification. A hip joint metal/ (§ 888.3027). metal semi-constrained, with an (b) Classification. Class II (special uncemented acetabular component, controls). The special control for this prosthesis is a two-part device intended device is the FDA guidance document to be implanted to replace a hip joint. entitled ‘‘Class II Special Controls The device limits translation and rota- Guidance: Hip Joint Metal/Polymer tion in one or more planes via the ge- Constrained Cemented or Uncemented ometry of its articulating surfaces. It Prosthesis.’’ has no linkage across-the-joint. This [67 FR 21173, Apr. 30, 2002] generic type of device includes prostheses that consist of a femoral and an § 888.3320 Hip joint metal/metal semi- acetabular component, both made of constrained, with a cemented ace- alloys, such as cobalt-chromium-mo- tabular component, prosthesis. lybdenum. The femoral component is (a) Identification. A hip joint metal/ intended to be fixed with bone cement. metal semi-constrained, with a ce- The acetabular component is intended mented acetabular component, pros- for use without bone cement (§ 888.3027). thesis is a two-part device intended to (b) Classification. Class III. be implanted to replace a hip joint. The (c) Date PMA or notice of completion of device limits translation and rotation PDP is required. A PMA or a notice of in one or more planes via the geometry completion of a PDP is required to be of its articulating surfaces. It has no filed with the Food and Drug Adminis- linkage across-the-joint. This generic tration on or before May 18, 2016, for type of device includes prostheses that any hip joint metal/metal semi-con- consist of a femoral and an acetabular strained prosthesis with an

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uncemented acetabular component to those prostheses intended for use that was in commercial distribution with bone cement (§ 888.3027). before May 28, 1976, or that has, on or (b) Classification. Class II. before May 18, 2016, been found to be substantially equivalent to a hip joint § 888.3353 Hip joint metal/ceramic/ metal/metal semi-constrained pros- polymer semi-constrained cemented thesis with an uncemented acetabular or nonporous uncemented pros- component that was in commercial dis- thesis. tribution before May 28, 1976. Any (a) Identification. A hip joint metal/ other hip joint metal/metal semi-con- ceramic/polymer semi-constrained ce- strained prosthesis with an mented or nonporous uncemented pros- uncemented acetabular component thesis is a device intended to be im- shall have an approved PMA or a de- planted to replace a hip joint. This declared completed PDP in effect before vice limits translation and rotation in being placed in commercial distribu- one or more planes via the geometry of tion. its articulating surfaces. It has no linkage across-the-joint. The two-part [52 FR 33702, Sept. 4, 1987, as amended at 81 femoral component consists of a fem- FR 8149, Feb. 18, 2016] oral stem made of alloys to be fixed in § 888.3340 Hip joint metal/composite the intramedullary canal of the femur semi-constrained cemented pros- by impaction with or without use of thesis. bone cement. The proximal end of the femoral stem is tapered with a surface (a) Identification. A hip joint metal/ composite semi-constrained cemented that ensures positive locking with the prosthesis is a two-part device intended spherical ceramic (aluminium oxide, 0 ) head of the femoral component. to be implanted to replace a hip joint. A12 3 The acetabular component is made of The device limits translation and rota- ultra-high molecular weight poly- tion in one or more planes via the ge- ethylene or ultra-high molecular ometry of its articulating surfaces. It weight polyethylene reinforced with has no linkage across-the-joint. This nonporous metal alloys, and used with generic type of device includes pros- or without bone cement. theses that consist of a femoral component made of alloys, such as cobalt- (b) Classification. Class II. chromium-molybdenum, and an ace- [54 FR 48239, Nov. 22, 1989; 54 FR 51342, Dec. tabular component made of ultra-high 14, 1989] molecular weight polyethylene with carbon fibers composite. Both compo- § 888.3358 Hip joint metal/polymer/ nents are intended for use with bone metal semi-constrained porous-coat- cement (§ 888.3027). ed uncemented prosthesis. (b) Classification. Class II. (a) Identification. A hip joint metal/ polymer/metal semi-constrained po- § 888.3350 Hip joint metal/polymer rous-coated uncemented prosthesis is a semi-constrained cemented pros- device intended to be implanted to re- thesis. place a hip joint. The device limits (a) Identification. A hip joint metal/ translation and rotation in one or more polymer semi-constrained cemented planes via the geometry of its articu- prosthesis is a device intended to be lating surfaces. It has no linkage implanted to replace a hip joint. The across the joint. This generic type of device limits translation and rotation device has a femoral component made in one or more planes via the geometry of a cobalt-chromium-molybdenum of its articulating surfaces. It has no (Co-Cr-Mo) alloy or a titanium-alu- linkage across-the-joint. This generic minum-vanadium (Ti-6Al-4V) alloy and type of device includes prostheses that an acetabular component composed of have a femoral component made of al- an ultra-high molecular weight poly- loys, such as cobalt-chromium-molyb- ethylene articulating bearing surface denum, and an acetabular resurfacing fixed in a metal shell made of Co-Cr-Mo component made of ultra-high molec- or Ti-6Al-4V. The femoral stem and ular weight polyethylene and is limited acetabular shell have a porous coating

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made of, in the case of Co-Cr-Mo sub- metal cemented prosthesis that was in strates, beads of the same alloy, and in commercial distribution before May 28, the case of Ti-6Al-4V substrates, fibers 1976, or that has, on or before Decem- of commercially pure titanium or Ti- ber 26, 1996 been found to be substan- 6Al-4V alloy. The porous coating has a tially equivalent to a hip joint (hemi- volume porosity between 30 and 70 per- hip) acetabular metal cemented pros- cent, an average pore size between 100 thesis that was in commercial distribu- and 1,000 microns, interconnecting po- tion before May 28, 1976. Any other hip rosity, and a porous coating thickness joint metal (hemi-hip) acetabular between 500 and 1,500 microns. The ge- metal cemented prosthesis shall have neric type of device has a design to an approved PMA or a declared com- achieve biological fixation to bone pleted PDP in effect before being without the use of bone cement. placed in commercial distribution. (b) Classification. Class II. [52 FR 33702, Sept. 4, 1987, as amended at 61 [58 FR 3228, Jan. 8, 1993] FR 50710, Sept. 27, 1996]

§ 888.3360 Hip joint femoral (hemi-hip) § 888.3380 Hip joint femoral (hemi-hip) metallic cemented or uncemented trunnion-bearing metal/polyacetal prosthesis. cemented prosthesis. (a) Identification. A hip joint femoral (a) Identification. A hip joint femoral (hemi-hip) metallic cemented or (hemi-hip) trunnion-bearing metal/ uncemented prosthesis is a device in- polyacetal cemented prosthesis is a tended to be implanted to replace a two-part device intended to be im- portion of the hip joint. This generic planted to replace the head and neck of type of device includes prostheses that the femur. This generic type of device have a femoral component made of al- includes prostheses that consist of a loys, such as cobalt-chromium-molyb- metallic stem made of alloys, such as denum. This generic type of device in- cobalt-chromium-molybdenum, with cludes designs which are intended to be an integrated cylindrical trunnion fixed to the bone with bone cement bearing at the upper end of the stem (§ 888.3027) as well as designs which that fits into a recess in the head of have large window-like holes in the the device. The head of the device is stem of the device and which are in- made of polyacetal (polyoxymethylene) tended for use without bone cement. and it is covered by a metallic alloy, However, in these latter designs, fixa- such as cobalt-chromium-molybdenum. tion of the device is not achieved by The trunnion bearing allows the head means of bone ingrowth. of the device to rotate on its stem. The (b) Classification. Class II. prosthesis is intended for use with bone cement (§ 888.3027). § 888.3370 Hip joint (hemi-hip) ace- (b) Classification. Class III. tabular metal cemented prosthesis. (c) Date PMA or notice of completion of (a) Identification. A hip joint (hemi- a PDP is required. A PMA or a notice of hip) acetabular metal cemented pros- completion of a PDP is required to be thesis is a device intended to be im- filed with the Food and Drug Adminis- planted to replace a portion of the hip tration on or before December 26, 1996 joint. This generic type of device infor any hip joint femoral (hemi-hip) cludes prostheses that have an ace- trunnion-bearing metal/polyacetal ce- tabular component made of alloys, mented prosthesis that was in commer- such as cobalt-chromium-molybdenum. cial distribution before May 28, 1976, or This generic type of device is limited that has, on or before December 26, 1996 to those prostheses intended for use been found to be substantially equiva- with bone cement (§ 888.3027). lent to a hip joint femoral (hemi-hip) (b) Classification. Class III. trunnion-bearing metal/polyacetal ce- (c) Date PMA or notice of completion of mented prosthesis that was in commer- a PDP is required. A PMA or a notice of cial distribution before May 28, 1976. completion of a PDP is required to be Any other hip joint femoral (hemi-hip) filed with the Food and Drug Adminis- trunnion-bearing metal/polyacetal ce- tration on or before December 26, 1996 mented prosthesis shall have an ap- for any hip joint (hemi-hip) acetabular proved PMA or a declared completed

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PDP in effect before being placed in nent. Both components are intended commercial distribution. for use with bone cement (§ 888.3027). [52 FR 33702, Sept. 4, 1987, as amended at 61 (b) Classification. Class III. FR 50710, Sept. 27, 1996] (c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of § 888.3390 Hip joint femoral (hemi-hip) completion of a PDP is required to be metal/polymer cemented or filed with the Food and Drug Adminis- uncemented prosthesis. tration on or before January 3, 2005, for (a) Identification. A hip joint femoral any hip joint metal/polymer or ce- (hemi-hip) metal/polymer cemented or ramic/polymer semiconstrained resur- uncemented prosthesis is a two-part facing cemented prosthesis that was in device intended to be implanted to re- commercial distribution before May 28, place the head and neck of the femur. 1976, or that has, on or before January This generic type of device includes 3, 2005, been found to be substantially prostheses that have a femoral compo- equivalent to a hip joint metal/polymer nent made of alloys, such as cobalt- or ceramic/polymer semiconstrained chromium-molybdenum, and a snap-fit resurfacing cemented prosthesis that acetabular component made of an was in commercial distribution before alloy, such as cobalt-chromium-molyb- May 28, 1976. Any other hip joint metal/ denum, and ultra-high molecular polymer or ceramic/polymer weight polyethylene. This generic type semiconstrained resurfacing cemented of device may be fixed to the bone with prosthesis must have an approved PMA bone cement (§ 888.3027) or implanted by or a declared completed PDP in effect impaction. before being placed in commercial dis- (b) Classification. Class II. tribution. § 888.3400 Hip joint femoral (hemi-hip) [69 FR 59134, Oct. 4, 2004] metallic resurfacing prosthesis. § 888.3480 Knee joint femorotibial me- (a) Identification. A hip joint femoral tallic constrained cemented pros- (hemi-hip) metallic resurfacing prosthesis. thesis is a device intended to be implanted to replace a portion of the hip (a) Identification. A knee joint joint. This generic type of device in- femorotibial metallic constrained ce- cludes prostheses that have a femoral mented prosthesis is a device intended resurfacing component made of alloys, to be implanted to replace part of a such as cobalt-chromium-molybdenum. knee joint. The device prevents dis- (b) Classification. Class II. location in more than one anatomic plane and has components that are § 888.3410 Hip joint metal/polymer or linked together. The only knee joint ceramic/polymer semiconstrained movement allowed by the device is in resurfacing cemented prosthesis. the sagittal plane. This generic type of (a) Identification. A hip joint metal/ device includes prostheses that have an polymer or ceramic/polymer semi-con- intramedullary stem at both the proxi- strained resurfacing cemented pros- mal and distal locations. The upper and thesis is a two-part device intended to lower components may be joined either be implanted to replace the articu- by a solid bolt or pin, an internally lating surfaces of the hip while pre- threaded bolt with locking screw, or a serving the femoral head and neck. The bolt retained by circlip. The compo- device limits translation and rotation nents of the device are made of alloys, in one or more planes via the geometry such as cobalt-chromium-molybdenum. of its articulating surfaces. It has no The stems of the device may be per- linkage across the joint. This generic forated, but are intended for use with type of device includes prostheses that bone cement (§ 888.3027). consist of a femoral cap component (b) Classification. Class III. made of a metal alloy, such as cobalt- (c) Date PMA or notice of completion of chromium-molybdenum, or a ceramic a PDP is required. A PMA or a notice of material, that is placed over a sur- completion of a PDP is required to be gically prepared femoral head, and an filed with the Food and Drug Adminis- acetabular resurfacing polymer compo- tration on or before December 26, 1996

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for any knee joint femorotibial metal- polyethylene with carbon-fibers com- lic constrained cemented prosthesis posite and is limited to those pros- that was in commercial distribution theses intended for use with bone ce- before May 28, 1976, or that has, on or ment (§ 888.3027). before December 26, 1996 been found to (b) Classification. Class II. be substantially equivalent to a knee joint femorotibial metallic constrained § 888.3510 Knee joint femorotibial cemented prosthesis that was in com- metal/polymer constrained ce- mercial distribution before May 28, mented prosthesis. 1976. Any other knee joint femorotibial (a) Identification. A knee joint metallic constrained cemented pros- femorotibial metal/polymer con- thesis shall have an approved PMA or a strained cemented prosthesis is a de- declared completed PDP in effect be- vice intended to be implanted to re- fore being placed in commercial displace part of a knee joint. The device tribution. limits translation or rotation in one or more planes and has components that [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996] are linked together or affined. This generic type of device includes prostheses § 888.3490 Knee joint femorotibial composed of a ball-and-socket joint lo- metal/composite non-constrained cated between a stemmed femoral and cemented prosthesis. a stemmed tibial component and a run- (a) Identification. A knee joint ner and track joint between each pair femorotibial metal/composite non-con- of femoral and tibial condyles. The strained cemented prosthesis is a de- ball-and-socket joint is composed of a vice intended to be implanted to re- ball at the head of a column rising place part of a knee joint. The device from the stemmed tibial component. limits minimally (less than normal The ball, the column, the tibial pla- anatomic constraints) translation in teau, and the stem for fixation of the one or more planes. It has no linkage tibial component are made of an alloy, across-the-joint. This generic type of such as cobalt-chromium-molybdenum. device includes prostheses that have a The ball of the tibial component is held femoral condylar resurfacing compo- within the socket of the femoral com- nent or components made of alloys, ponent by the femoral component’s flat such as cobalt-chromium-molybdenum, outer surface. The flat outer surface of and a tibial condylar component or the tibial component abuts both a re- components made of ultra-high molec- ciprocal flat surface within the cavity ular weight polyethylene with carbon of the femoral component and flanges fibers composite and are intended for on the femoral component designed to use with bone cement (§ 888.3027). prevent distal displacement. The stem (b) Classification. Class II. of the femoral component is made of an alloy, such as cobalt-chromium-molyb- § 888.3500 Knee joint femorotibial denum, but the socket of the compo- metal/composite semi-constrained nent is made of ultra-high molecular cemented prosthesis. weight polyethylene. The femoral com- (a) Identification. A knee joint ponent has metallic runners which femorotibial metal/composite semi- align with the ultra-high molecular constrained cemented prosthesis is a weight polyethylene tracks that press- two-part device intended to be im- fit into the metallic tibial component. planted to replace part of a knee joint. The generic class also includes devices The device limits translation and rota- whose upper and lower components are tion in one or more planes via the ge- linked with a solid bolt passing ometry of its articulating surfaces. It through a journal bearing of greater has no linkage across-the-joint. This radius, permitting some rotation in the generic type of device includes pros- transverse plane, a minimal arc of ab- theses that have a femoral component duction/adduction. This generic type of made of alloys, such as cobalt-chro- device is limited to those prostheses mium-molybdenum, and a tibial com- intended for use with bone cement ponent with the articulating surfaces (§ 888.3027). made of ultra-high molecular weight (b) Classification. Class II.

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§ 888.3520 Knee joint femorotibial ment. This identification includes metal/polymer non-constrained ce- fixed-bearing knee prostheses where mented prosthesis. the ultra-high molecular weight poly- (a) Identification. A knee joint ethylene tibial bearing is rigidly se- femorotibial metal/polymer non-con- cured to the metal tibial baseplate. strained cemented prosthesis is a de- (b) Classification. Class II (special vice intended to be implanted to re- controls). The special control is FDA’s place part of a knee joint. The device guidance: ‘‘Class II Special Controls limits minimally (less than normal Guidance Document: Knee Joint anatomic constraints) translation in Patellofemorotibial and Femorotibial one or more planes. It has no linkage Metal/Polymer Porous-Coated across-the-joint. This generic type of Uncemented Prostheses; Guidance for device includes prostheses that have a Industry and FDA.’’ See § 888.1 for the femoral condylar resurfacing compo- availability of this guidance. nent or components made of alloys, [68 FR 14137, Mar. 24, 2003] such as cobalt-chromium-molybdenum, and a tibial component or components § 888.3540 Knee joint patellofemoral made of ultra-high molecular weight polymer/metal semi-constrained ce- polyethylene and are intended for use mented prosthesis. with bone cement (§ 888.3027). (a) Identification. A knee joint (b) Classification. Class II. patellofemoral polymer/metal semi- constrained cemented prosthesis is a § 888.3530 Knee joint femorotibial two-part device intended to be im- metal/polymer semi-constrained ce- planted to replace part of a knee joint mented prosthesis. in the treatment of primary (a) Identification. A knee joint patellofemoral arthritis or femorotibial metal/polymer semi-con- chondromalacia. The device limits strained cemented prosthesis is a de- translation and rotation in one or more vice intended to be implanted to re- planes via the geometry of its articu- place part of a knee joint. The device lating surfaces. It has no linkage limits translation and rotation in one across-the-joint. This generic type of or more planes via the geometry of its device includes a component made of articulating surfaces. It has no linkage alloys, such as cobalt-chromium-mo- across-the-joint. This generic type of lybdenum or austenitic steel, for resur- device includes prostheses that consist facing the intercondylar groove (fem- of a femoral component made of alloys, oral sulcus) on the anterior aspect of such as cobalt-chromium-molybdenum, the distal femur, and a patellar compo- and a tibial component made of ultra- nent made of ultra-high molecular high molecular weight polyethylene weight polyethylene. This generic type and is limited to those prostheses in- of device is limited to those devices intended for use with bone cement tended for use with bone cement (§ 888.3027). (§ 888.3027). The patellar component is (b) Classification. Class II. designed to be implanted only with its femoral component. § 888.3535 Knee joint femorotibial (uni- (b) Classification. Class II. The special compartmental) metal/polymer po- controls for this device are: rous-coated uncemented prosthesis. (1) FDA’s: (a) Identification. A knee joint (i) ‘‘Use of International Standard femorotibial (uni-compartmental) ISO 10993 ‘Biological Evaluation of metal/polymer porous-coated Medical Devices—Part I: Evaluation uncemented prosthesis is a device in- and Testing,’ ’’ tended to be implanted to replace part (ii) ‘‘510(k) Sterility Review Guidance of a knee joint. The device limits of 2/12/90 (K90–1),’’ translation and rotation in one or more (iii) ‘‘Guidance Document for Testing planes via the geometry of its articu- Orthopedic Implants with Modified Me- lating surface. It has no linkage across- tallic Surfaces Apposing Bone or Bone the-joint. This generic type of device is Cement,’’ designed to achieve biological fixation (iv) ‘‘Guidance Document for the to bone without the use of bone ce- Preparation of Premarket Notification

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(510(k)) Applications for Orthopedic De- (vii) F 1537–94 ‘‘Specification for vices,’’ and Wrought Cobalt-28 Chromium-6 Molyb- (v) ‘‘Guidance Document for Testing denum Alloy for Surgical Implants,’’ Non-articulating, ‘Mechanically and Locked’ Modular Implant Compo- (viii) F 1672–95 ‘‘Specification for Re- nents,’’ and surfacing Patellar Prosthesis.’’ (2) International Organization for Standardization’s (ISO): [52 FR 33702, Sept. 4, 1987, as amended at 61 FR 50710, Sept. 27, 1996; 65 FR 17147, Mar. 31, (i) ISO 5832–3:1996 ‘‘Implants for Sur- 2000] gery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4- § 888.3550 Knee joint Vandium Alloy,’’ patellofemorotibial polymer/metal/ (ii) ISO 5832–4:1996 ‘‘Implants for Sur- metal constrained cemented pros- gery—Metallic Materials—Part 4: Co- thesis. balt-Chromium-Molybdenum Casting (a) Identification. A knee joint Alloy,’’ patellofemorotibial polymer/metal/ (iii) ISO 5832–12:1996 ‘‘Implants for metal constrained cemented prosthesis Surgery—Metallic Materials—Part 12: is a device intended to be implanted to Wrought Cobalt-Chromium-Molyb- replace a knee joint. The device pre- denum Alloy,’’ vents dislocation in more than one (iv) ISO 5833:1992 ‘‘Implants for Sur- anatomic plane and has components gery—Acrylic Resin Cements,’’ that are linked together. This generic (v) ISO 5834–2:1998 ‘‘Implants for Sur- type of device includes prostheses that gery—Ultra-high Molecular Weight have a femoral component, a tibial Polyethylene—Part 2: Moulded component, a cylindrical bolt and ac- Forms,’’ companying locking hardware that are (vi) ISO 6018:1987 ‘‘Orthopaedic Im- all made of alloys, such as cobalt-chro- plants—General Requirements for mium-molybdenum, and a Marking, Packaging, and Labeling,’’ retropatellar resurfacing component (vii) ISO 7207–2:1998 ‘‘Implants for made of ultra-high molecular weight Surgery—Components for Partial and polyethylene. The retropatellar sur- Total Knee Joint Prostheses—Part 2: facing component may be attached to Articulating Surfaces Made of Metal, the resected patella either with a me- Ceramic and Plastic Materials,’’ and tallic screw or bone cement. All (viii) ISO 9001:1994 ‘‘Quality Sys- stemmed metallic components within tems—Model for Quality Assurance in this generic type are intended for use Design/Development, Production, In- with bone cement (§ 888.3027). stallation, and Servicing,’’ and (b) Classification. Class III. (3) American Society for Testing and (c) Date PMA or notice of completion of Materials’: a PDP is required. A PMA or a notice of (i) F 75–92 ‘‘Specification for Cast Co- completion of a PDP is required to be balt-28 Chromium-6 Molybdenum Alloy filed with the Food and Drug Adminis- for Surgical Implant Material,’’ tration on or before December 26, 1996 (ii) F 648–98 ‘‘Specification for Ultra- for any knee joint patellofemorotibial High-Molecular-Weight Polyethylene polymer/metal/metal constrained ce- Powder and Fabricated Form for Sur- mented prosthesis that was in commer- gical Implants,’’ cial distribution before May 28, 1976, or (iii) F 799–96 ‘‘Specification for Co- that has, on or before December 26, 1996 balt-28 Chromium-6 Molybdenum Alloy been found to be substantially equiva- Forgings for Surgical Implants,’’ lent to a knee joint patellofemorotibial (iv) F 1044–95 ‘‘Test Method for Shear polymer/metal/metal constrained ce- Testing of Porous Metal Coatings,’’ mented prosthesis that was in commer- (v) F 1108–97 ‘‘Titanium-6 Aluminum- cial distribution before May 28, 1976. 4 Vanadium Alloy Castings for Surgical Any other knee joint Implants,’’ patellofemorotibial polymer/metal/ (vi) F 1147–95 ‘‘Test Method for Ten- metal constrained cemented prosthesis sion Testing of Porous Metal Coat- shall have an approved PMA or a de- ings,’’ clared completed PDP in effect before

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being placed in commercial distribu- Industry and FDA.’’ See § 888.1 for the tion. availability of this guidance. [52 FR 33702, Sept. 4, 1987, as amended at 61 [68 FR 14137, Mar. 24, 2003] FR 50710, Sept. 27, 1996] § 888.3570 Knee joint femoral (hemi- § 888.3560 Knee joint knee) metallic uncemented pros- patellofemorotibial polymer/metal/ thesis. polymer semi-constrained cemented (a) Identification. A knee joint fem- prosthesis. oral (hemi-knee) metallic uncemented (a) Identification. A knee joint prosthesis is a device made of alloys, patellofemorotibial polymer/metal/ such as cobalt-chromium-molybdenum, polymer semi-constrained cemented intended to be implanted to replace part of a knee joint. The device limits prosthesis is a device intended to be translation and rotation in one or more implanted to replace a knee joint. The planes via the geometry of its articu- device limits translation and rotation lating surfaces. It has no linkage in one or more planes via the geometry across-the-joint. This generic type of of its articulating surfaces. It has no device includes prostheses that consist linkage across-the-joint. This generic of a femoral component with or with- type of device includes prostheses that out protuberance(s) for the enhance- have a femoral component made of al- ment of fixation and is limited to those loys, such as cobalt-chromium-molyb- prostheses intended for use without denum, and a tibial component or com- bone cement (§ 888.3027). ponents and a retropatellar resurfacing (b) Classification. Class III. component made of ultra-high molec- (c) Date PMA or notice of completion of ular weight polyethylene. This generic a PDP is required. A PMA or a notice of type of device is limited to those pros- completion of a PDP is required to be theses intended for use with bone ce- filed with the Food and Drug Adminis- ment (§ 888.3027). tration on or before December 26, 1996 (b) Classification. Class II. for any knee joint femoral (hemi-knee) metallic uncemented prosthesis that § 888.3565 Knee joint was in commercial distribution before patellofemorotibial metal/polymer May 28, 1976, or that has, on or before porous-coated uncemented pros- December 26, 1996 been found to be sub- thesis. stantially equivalent to a knee joint (a) Identification. A knee joint femoral (hemi-knee) metallic patellofemorotibial metal/polymer po- uncemented prosthesis that was in commercial distribution before May 28, rous-coated uncemented prosthesis is a 1976. Any other knee joint femoral device intended to be implanted to re- (hemi-knee) metallic uncemented pros- place a knee joint. The device limits thesis shall have an approved PMA or a translation and rotation in one or more declared completed PDP in effect be- planes via the geometry of its articu- fore being placed in commercial dis- lating surfaces. It has no linkage tribution. across-the-joint. This generic type of device is designed to achieve biological [52 FR 33702, Sept. 4, 1987, as amended at 61 fixation to bone without the use of FR 50710, Sept. 27, 1996] bone cement. This identification in- § 888.3580 Knee joint patellar (hemi- cludes fixed-bearing knee prostheses knee) metallic resurfacing where the ultra high molecular weight uncemented prosthesis. polyethylene tibial bearing is rigidly (a) Identification. A knee joint secured to the metal tibial base plate. patellar (hemi-knee) metallic resur- (b) Classification. Class II (special facing uncemented prosthesis is a de- controls). The special control is FDA’s vice made of alloys, such as cobalt- guidance: ‘‘Class II Special Controls chromium-molybdenum, intended to be Guidance Document: Knee Joint implanted to replace the retropatellar Patellofemorotibial and Femorotibial articular surface of the patellofemoral Metal/Polymer Porous-Coated joint. The device limits minimally (less Uncemented Prostheses; Guidance for than normal anatomic constraints)

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translation in one or more planes. It § 888.3640 Shoulder joint metal/metal has no linkage across-the-joint. This or metal/polymer constrained ce- generic type of device includes pros- mented prosthesis. theses that have a retropatellar resur- (a) Identification. A shoulder joint facing component and an orthopedic metal/metal or metal/polymer con- screw to transfix the patellar remnant. strained cemented prosthesis is a de- This generic type of device is limited vice intended to be implanted to re- to those prostheses intended for use place a shoulder joint. The device pre- without bone cement (§ 888.3027). vents dislocation in more than one (b) Classification. (1) Class II when in- anatomic plane and has components tended for treatment of degenerative that are linked together. This generic and posttraumatic patellar arthritis. type of device includes prostheses that (2) Class III when intended for uses have a humeral component made of al- other than treatment of degenerative loys, such as cobalt-chromium-molyb- and posttraumatic patellar arthritis. denum, and a glenoid component made (c) Date PMA or notice of completion of of this alloy or a combination of this a PDP is required. A PMA or a notice of alloy and ultra-high molecular weight completion of a PDP is required to be polyethylene. This generic type of de- filed with the Food and Drug Adminis- vice is limited to those prostheses in- tration on or before December 26, 1996 tended for use with bone cement for any knee joint patellar (hemi-knee) (§ 888.3027). (b) Classification. Class III. metallic resurfacing uncemented pros- (c) Date PMA or notice of completion of thesis described in paragraph (b)(2) of a PDP is required. A PMA or a notice of this section that was in commercial completion of a PDP is required to be distribution before May 28, 1976, or that filed with the Food and Drug Adminis- has, on or before December 26, 1996 tration on or before December 26, 1996 been found to be substantially equiva- for any shoulder joint metal/metal or lent to a knee joint patellar (hemi- metal/polymer constrained cemented knee) metallic resurfacing uncemented prosthesis that was in commercial dis- prosthesis that was in commercial distribution before May 28, 1976, or that tribution before May 28, 1976. Any has, on or before December 26, 1996 other knee joint patellar (hemi-knee) been found to be substantially equiva- metallic resurfacing uncemented pros- lent to a shoulder joint metal/metal or thesis shall have an approved PMA or a metal/polymer constrained cemented declared completed PDP in effect be- prosthesis that was in commercial dis- fore being placed in commercial distribution before May 28, 1976. Any tribution. other shoulder joint metal/metal or [52 FR 33702, Sept. 4, 1987, as amended at 61 metal/polymer constrained cemented FR 50711, Sept. 27, 1996] prosthesis shall have an approved PMA or a declared completed PDP in effect § 888.3590 Knee joint tibial (hemi- before being placed in commercial dis- knee) metallic resurfacing tribution. uncemented prosthesis. [52 FR 33702, Sept. 4, 1987, as amended at 61 (a) Identification. A knee joint tibial FR 50711, Sept. 27, 1996] (hemi-knee) metallic resurfacing uncemented prosthesis is a device in- § 888.3650 Shoulder joint metal/poly- tended to be implanted to replace part mer non-constrained cemented of a knee joint. The device limits mini- prosthesis. mally (less than normal anatomic con- (a) Identification. A shoulder joint straints) translation in one or more metal/polymer non-constrained ce- planes. It has no linkage across-the- mented prosthesis is a device intended joint. This prosthesis is made of alloys, to be implanted to replace a shoulder such as cobalt-chromium-molybdenum, joint. The device limits minimally (less and is intended to resurface one tibial than normal anatomic constraints) condyle. The generic type of device is translation in one or more planes. It limited to those prostheses intended has no linkage across-the-joint. This for use without bone cement (§ 888.3027). generic type of device includes pros- (b) Classification. Class II. theses that have a humeral component

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made of alloys, such as cobalt-chro- (i) F 75–92 ‘‘Specification for Cast Co- mium-molybdenum, and a glenoid re- balt-28 Chromium-6 Molybdenum Alloy surfacing component made of ultra- for Surgical Implant Material,’’ high molecular weight polyethylene, (ii) F 648–98 ‘‘Specification for Ultra- and is limited to those prostheses in- High-Molecular-Weight Polyethylene tended for use with bone cement Powder and Fabricated Form for Sur- (§ 888.3027). gical Implants,’’ (b) Classification. Class II. The special (iii) F 799–96 ‘‘Specification for Co- controls for this device are: balt-28 Chromium-6 Molybdenum Alloy (1) FDA’s: Forgings for Surgical Implants,’’ (i) ‘‘Use of International Standard (iv) F 1044–95 ‘‘Test Method for Shear ISO 10993 ‘Biological Evaluation of Testing of Porous Metal Coatings,’’ Medical Devices—Part I: Evaluation (v) F 1108–97 ‘‘Titanium-6 Aluminum- and Testing,’ ’’ 4 Vanadium Alloy Castings for Surgical (ii) ‘‘510(k) Sterility Review Guidance Implants,’’ of 2/12/90 (K90–1),’’ (vi) F 1147–95 ‘‘Test Method for Ten- (iii) ‘‘Guidance Document for Testing sion Testing of Porous Metal Coat- Orthopedic Implants with Modified Me- ings,’’ (vii) F 1378–97 ‘‘Specification for tallic Surfaces Apposing Bone or Bone Shoulder Prosthesis,’’ and Cement,’’ (viii) F 1537–94 ‘‘Specification for (iv) ‘‘Guidance Document for the Wrought Cobalt-28 Chromium-6 Molyb- Preparation of Premarket Notification denum Alloy for Surgical Implants.’’ (510(k)) Application for Orthopedic De- vices,’’ and [52 FR 33702, Sept. 4, 1987, as amended at 65 (v) ‘‘Guidance Document for Testing FR 17148, Mar. 31, 2000] Non-articulating, ‘Mechanically § 888.3660 Shoulder joint metal/poly- Locked’ Modular Implant Compo- mer semi-constrained cemented nents,’’ prosthesis. (2) International Organization for (a) Identification. A shoulder joint Standardization’s (ISO): metal/polymer semi-constrained ce- (i) ISO 5832–3:1996 ‘‘Implants for Sur- mented prosthesis is a device intended gery—Metallic Materials—Part 3: to be implanted to replace a shoulder Wrought Titanium 6-Aluminum 4- joint. The device limits translation and Vandium Alloy,’’ rotation in one or more planes via the (ii) ISO 5832–4:1996 ‘‘Implants for Sur- geometry of its articulating surfaces. gery—Metallic Materials—Part 4: Co- It has no linkage across-the-joint. This balt-Chromium-Molybdenum Casting generic type of device includes pros- Alloy,’’ theses that have a humeral resurfacing (iii) ISO 5832–12:1996 ‘‘Implants for component made of alloys, such as co- Surgery—Metallic Materials—Part 12: balt-chromium-molybdenum, and a Wrought Cobalt-Chromium-Molyb- glenoid resurfacing component made of denum Alloy,’’ ultra-high molecular weight poly- (iv) ISO 5833:1992 ‘‘Implants for Sur- ethylene, and is limited to those pros- gery—Acrylic Resin Cements,’’ theses intended for use with bone ce- (v) ISO 5834–2:1998 ‘‘Implants for Sur- ment (§ 888.3027). gery—Ultra-high Molecular Weight (b) Classification. Class II. The special Polyethylene—Part 2: Moulded controls for this device are: Forms,’’ (1) FDA’s: (vi) ISO 6018:1987 ‘‘Orthopaedic Im- (i) ‘‘Use of International Standard plants—General Requirements for ISO 10993 ‘Biological Evaluation of Marking, Packaging, and Labeling,’’ Medical Devices—Part I: Evaluation and and Testing,’ ’’ (vii) ISO 9001:1994 ‘‘Quality Systems— (ii) ‘‘510(k) Sterility Review Guidance Model for Quality Assurance in Design/ of 2/12/90 (K90–1),’’ Development, Production, Installation, (iii) ‘‘Guidance Document for Testing and Servicing,’’ and Orthopedic Implants with Modified Me- (3) American Society for Testing and tallic Surfaces Apposing Bone or Bone Materials’: Cement,’’

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(iv) ‘‘Guidance Document for the (viii) F 1537–94 ‘‘Specification for Preparation of Premarket Notification Wrought Cobalt-28 Chromium-6 Molyb- (510(k)) Application for Orthopedic De- denum Alloy for Surgical Implants.’’ vices,’’ and [52 FR 33702, Sept. 4, 1987, as amended at 65 (v) ‘‘Guidance Document for Testing FR 17148, Mar. 31, 2000] Non-articulating, ‘Mechanically Locked’ Modular Implant Compo- § 888.3670 Shoulder joint metal/poly- nents,’’ mer/metal nonconstrained or semi- (2) International Organization for constrained porous-coated Standardization’s (ISO): uncemented prosthesis. (i) ISO 5832–3:1996 ‘‘Implants for Sur- (a) Identification. A shoulder joint gery—Metallic Materials—Part 3: metal/polymer/metal nonconstrained Wrought Titanium 6-aluminum 4- or semi-constrained porous-coated vandium Alloy,’’ uncemented prosthesis is a device in- (ii) ISO 5832–4:1996 ‘‘Implants for Sur- tended to be implanted to replace a gery—Metallic Materials—Part 4: Co- shoulder joint. The device limits move- balt-chromium-molybdenum casting ment in one or more planes. It has no alloy,’’ linkage across-the-joint. This generic (iii) ISO 5832–12:1996 ‘‘Implants for type of device includes prostheses that Surgery—Metallic Materials—Part 12: have a humeral component made of al- Wrought Cobalt-chromium-molyb- loys such as cobalt-chromium-molybdenum alloy,’’ denum (Co-Cr-Mo) and titanium-alu- (iv) ISO 5833:1992 ‘‘Implants for Sur- minum-vanadium (Ti-6Al-4V) alloys, gery—Acrylic Resin Cements,’’ and a glenoid resurfacing component (v) ISO 5834–2:1998 ‘‘Implants for Sur- made of ultra-high molecular weight gery—Ultra-high Molecular Weight polyethylene, or a combination of an Polyethylene—Part 2: Moulded articulating ultra-high molecular Forms,’’ weight bearing surface fixed in a metal (vi) ISO 6018:1987 ‘‘Orthopaedic Im- shell made of alloys such as Co-Cr-Mo plants—General Requirements for and Ti-6Al-4V. The humeral component Marking, Packaging, and Labeling,’’ and glenoid backing have a porous and coating made of, in the case of Co-Cr- (vii) ISO 9001:1994 ‘‘Quality Systems— Mo components, beads of the same Model for Quality Assurance in Design/ alloy or commercially pure titanium Development, Production, Installation, and Servicing,’’ and powder, and in the case of Ti-6Al-4V components, beads or fibers of commer- (3) American Society for Testing and cially pure titanium or Ti-6Al-4V alloy, Materials’: or commercially pure titanium powder. (i) F 75–92 ‘‘Specification for Cast Co- The porous coating has a volume poros- balt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,’’ ity between 30 and 70 percent, an average pore size between 100 and 1,000 mi- (ii) F 648–98 ‘‘Specification for Ultra- High-Molecular-Weight Polyethylene crons, interconnecting porosity, and a Powder and Fabricated Form for Sur- porous coating thickness between 500 gical Implants,’’ and 1,500 microns. This generic type of (iii) F 799–96 ‘‘Specification for Co- device is designed to achieve biological balt-28 Chromium-6 Molybdenum Alloy fixation to bone without the use of Forgings for Surgical Implants,’’ bone cement. (iv) F 1044–95 ‘‘Test Method for Shear (b) Classification. Class II (special Testing of Porous Metal Coatings,’’ controls). The special control for this (v) F 1108–97 ‘‘Specification for Tita- device is FDA’s ‘‘Class II Special Con- nium-6 Aluminum-4 Vanadium Alloy trols Guidance: Shoulder Joint Metal/ Castings for Surgical Implants,’’ Polymer/Metal Nonconstrained or (vi) F 1147–95 ‘‘Test Method for Ten- Semi-Constrained Porous-Coated sion Testing of Porous Metal,’’ Uncemented Prosthesis.’’ (vii) F 1378–97 ‘‘Standard Specifica- [66 FR 12737, Feb. 28, 2001] tion for Shoulder Prosthesis,’’ and

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§ 888.3680 Shoulder joint glenoid of silicone elastomer or polyester rein- (hemi-shoulder) metallic cemented forced silicone elastomer intended to prosthesis. be implanted to replace the first (a) Identification. A shoulder joint metatarsophalangeal (big toe) joint. glenoid (hemi-shoulder) metallic ce- This generic type of device consists of mented prosthesis is a device that has a single flexible across-the-joint com- a glenoid (socket) component made of ponent that prevents dislocation in alloys, such as cobalt-chromium-mo- more than one anatomic plane. lybdenum, or alloys with ultra-high (b) Classification. Class II. molecular weight polyethylene and intended to be implanted to replace part § 888.3730 Toe joint phalangeal (hemi- of a shoulder joint. This generic type of toe) polymer prosthesis. device is limited to those prostheses (a) Identification. A toe joint phalan- intended for use with bone cement geal (hemi-toe) polymer prosthesis is a (§ 888.3027). device made of silicone elastomer in- (b) Classification. Class III. tended to be implanted to replace the (c) Date PMA or notice of completion of base of the proximal phalanx of the a PDP is required. A PMA or a notice of completion of a PDP is required to be toe. filed with the Food and Drug Adminis- (b) Classification. Class II. tration on or before December 26, 1996 for any shoulder joint glenoid (hemi- § 888.3750 Wrist joint carpal lunate polymer prosthesis. shoulder) metallic cemented prosthesis that was in commercial distribution (a) Identification. A wrist joint carpal before May 28, 1976, or that has, on or lunate prosthesis is a one-piece device before December 26, 1996 been found to made of silicone elastomer intended to be substantially equivalent to a shoul- be implanted to replace the carpal der joint glenoid (hemi-shoulder) me- lunate bone of the wrist. tallic cemented prosthesis that was in (b) Classification. Class II. commercial distribution before May 28, 1976. Any other shoulder joint glenoid § 888.3760 Wrist joint carpal scaphoid (hemi-shoulder) metallic cemented polymer prosthesis. prosthesis shall have an approved PMA (a) Identification. A wrist joint carpal or a declared completed PDP in effect scaphoid polymer prosthesis is a one- before being placed in commercial dis- piece device made of silicone elastomer tribution. intended to be implanted to replace the [52 FR 33702, Sept. 4, 1987, as amended at 61 carpal scaphoid bone of the wrist. FR 50711, Sept. 27, 1996] (b) Classification. Class II.

§ 888.3690 Shoulder joint humeral § 888.3770 Wrist joint carpal trapezium (hemi-shoulder) metallic polymer prosthesis. uncemented prosthesis. (a) Identification. A wrist joint carpal (a) Identification. A shoulder joint hu- trapezium polymer prosthesis is a one- meral (hemi-shoulder) metallic piece device made of silicone elastomer uncemented prosthesis is a device made of alloys, such as cobalt-chro- or silicone elastomer/polyester mate- mium-molybdenum. It has an rial intended to be implanted to re- intramedullary stem and is intended to place the carpal trapezium bone of the be implanted to replace the articular wrist. surface of the proximal end of the hu- (b) Classification. Class II. merus and to be fixed without bone cement (§ 888.3027). This device is not in- § 888.3780 Wrist joint polymer constrained prosthesis. tended for biological fixation. (b) Classification. Class II. (a) Identification. A wrist joint polymer constrained prosthesis is a device § 888.3720 Toe joint polymer con- made of polyester-reinforced silicone strained prosthesis. elastomer intended to be implanted to (a) Identification. A toe joint polymer replace a wrist joint. This generic type constrained prosthesis is a device made of device consists of a single flexible

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across-the-joint component that pre- bearing surface, or a two-part radial vents dislocation in more than one component made of alloys and an anatomic plane. ultra-high molecular weight poly- (b) Classification. Class II. ethylene ball that is mounted on the radial component with a trunnion bear- § 888.3790 Wrist joint metal con- ing. The metallic portion of the two- strained cemented prosthesis. part radial component is inserted into (a) Identification. A wrist joint metal the radius. These devices have a meta- constrained cemented prosthesis is a carpal component(s) made of alloys, device intended to be implanted to re- such as cobalt-chromium-molybdenum. place a wrist joint. The device prevents This generic type of device is limited dislocation in more than one anatomic to those prostheses intended for use plane and consists of either a single with bone cement (§ 888.3027). flexible across-the-joint component or (b) Classification. Class II. two components linked together. This generic type of device is limited to a § 888.3810 Wrist joint ulnar (hemi- device which is made of alloys, such as wrist) polymer prosthesis. cobalt-chromium-molybdenum, and is (a) Identification. A wrist joint ulnar limited to those prostheses intended (hemi-wrist) polymer prosthesis is a for use with bone cement (§ 888.3027). mushroom-shaped device made of a (b) Classification. Class III. medical grade silicone elastomer or (c) Date PMA or notice of completion of ultra-high molecular weight poly- a PDP is required. A PMA or a notice of ethylene intended to be implanted into completion of a PDP is required to be the intramedullary canal of the bone filed with the Food and Drug Adminis- and held in place by a suture. Its pur- tration on or before December 26, 1996 pose is to cover the resected end of the for any wrist joint metal constrained distal ulna to control bone overgrowth cemented prosthesis that was in com- and to provide an articular surface for mercial distribution before May 28, the radius and carpus. 1976, or that has, on or before Decem- (b) Classification. Class II. ber 26, 1996 been found to be substantially equivalent to a wrist joint metal constrained cemented prosthesis that Subpart E—Surgical Devices was in commercial distribution before § 888.4150 Calipers for clinical use. May 28, 1976. Any other wrist joint metal constrained cemented prosthesis (a) Identification. A caliper for clin- shall have an approved PMA or a de- ical use is a compass-like device in- clared completed PDP in effect before tended for use in measuring the thick- being placed in commercial distribu- ness or diameter of a part of the body tion. or the distance between two body surfaces, such as for measuring an excised [52 FR 33702, Sept. 4, 1987, as amended at 61 skeletal specimen to determine the FR 50711, Sept. 27, 1996] proper replacement size of a prosthesis. (b) Classification. Class I (general con- § 888.3800 Wrist joint metal/polymer semi-constrained cemented pros- trols). The device is exempt from the thesis. premarket notification procedures in subpart E of part 807 of this chapter, (a) Identification. A wrist joint metal/ subject to the limitations in § 888.9. polymer semi-constrained cemented prosthesis is a device intended to be [52 FR 33702, Sept. 4, 1987, as amended at 66 implanted to replace a wrist joint. The FR 38815, July 25, 2001] device limits translation and rotation in one or more planes via the geometry § 888.4200 Cement dispenser. of its articulating surfaces. It has no (a) Identification. A cement dispenser linkage across-the-joint. This generic is a nonpowered syringe-like device in- type of device includes prostheses that tended for use in placing bone cement have either a one-part radial compo- (§ 888.3027) into surgical sites. nent made of alloys, such as cobalt- (b) Classification. Class I (general con- chromium-molybdenum, with an ultra- trols). The device is exempt from the high molecular weight polyethylene premarket notification procedures in

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subpart E of part 807 of this chapter, tended for various medical purposes, subject to the limitations in § 888.9. such as to determine the proper length of screws for fastening the ends of a [52 FR 33702, Sept. 4, 1987, as amended at 53 FR 52953, Dec. 29, 1988; 59 FR 63014, Dec. 7, fractured bone. 1994; 66 FR 38815, July 25, 2001] (b) Classification. Class I (general controls). The device is exempt from the § 888.4210 Cement mixer for clinical premarket notification procedures in use. subpart E of part 807 of this chapter, (a) Identification. A cement mixer for subject to the limitations in § 888.9. clinical use is a device consisting of a [52 FR 33702, Sept. 4, 1987, as amended at 66 container intended for use in mixing FR 38815, July 25, 2001] bone cement (§ 888.3027). (b) Classification. Class I (general con- § 888.4540 Orthopedic manual surgical trols). The device is exempt from the instrument. premarket notification procedures in (a) Identification. An orthopedic man- subpart E of part 807 of this chapter, ual surgical instrument is a nonpow- subject to the limitations in § 888.9. ered hand-held device intended for [52 FR 33702, Sept. 4, 1987, as amended at 53 medical purposes to manipulate tissue, FR 52953, Dec. 29, 1988; 59 FR 63014, Dec. 7, or for use with other devices in ortho- 1994; 66 FR 38815, July 25, 2001] pedic surgery. This generic type of device includes the cerclage applier, awl, § 888.4220 Cement monomer vapor bender, drill brace, broach, burr, cork- evacuator. screw, countersink, pin crimper, wire (a) Identification. A cement monomer cutter, prosthesis driver, extractor, vapor evacuator is a device intended file, fork, needle holder, impactor, for use during surgery to contain or re- bending or contouring instrument, move undesirable fumes, such as mon- compression instrument, passer, socket omer vapor from bone cement positioner, probe, femoral neck punch, (§ 888.3027). socket pusher, reamer, rongeur, scis- (b) Classification. Class I (general con- sors, screwdriver, bone skid, staple trols). The device is exempt from the driver, bone screw starter, surgical premarket notification procedures in stripper, tamp, bone tap, trephine, wire subpart E of part 807 of this chapter, twister, and wrench. subject to the limitations in § 888.9. (b) Classification. Class I (general con- [52 FR 33702, Sept. 4, 1987, as amended at 53 trols). The device is exempt from the FR 52954, Dec. 29, 1988; 66 FR 38815, July 25, premarket notification procedures in 2001] subpart E of part 807 of this chapter, subject to the limitations in § 888.9. § 888.4230 Cement ventilation tube. [52 FR 33702, Sept. 4, 1987, as amended at 59 (a) Identification. A cement ventila- FR 63014, Dec. 7, 1994; 66 FR 38815, July 25, tion tube is a tube-like device usually 2001] made of plastic intended to be inserted into a surgical cavity to allow the re- § 888.4580 Sonic surgical instrument lease of air or fluid from the cavity as and accessories/attachments. it is being filled with bone cement (a) Identification. A sonic surgical in- (§ 888.3027). strument is a hand-held device with (b) Classification. Class I (general con- various accessories or attachments, trols). The device is exempt from the such as a cutting tip that vibrates at premarket notification procedures in high frequencies, and is intended for subpart E of part 807 of this chapter, medical purposes to cut bone or other subject to the limitations in § 888.9. materials, such as acrylic. [52 FR 33702, Sept. 4, 1987, as amended at 53 (b) Classification. Class II. FR 52954, Dec. 29, 1988; 59 FR 63014, Dec. 7, 1994; 66 FR 38815, July 25, 2001] § 888.4600 Protractor for clinical use. (a) Identification. A protractor for § 888.4300 Depth gauge for clinical use. clinical use is a device intended for use (a) Identification. A depth gauge for in measuring the angles of bones, such clinical use is a measuring device in- as on x-rays or in surgery.

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(b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter, subpart E of part 807 of this chapter, subject to the limitations in § 888.9. subject to the limitations in § 888.9. The [52 FR 33702, Sept. 4, 1987, as amended at 66 device is also exempt from the current FR 38815, July 25, 2001] good manufacturing practice requirements of the quality system regulation § 888.4800 Template for clinical use. in part 820 of this chapter, with the ex- (a) Identification. A template for clin- ception of § 820.180, regarding general ical use is a device that consists of a requirements concerning records, and pattern or guide intended for medical § 820.198, regarding complaint files. purposes, such as selecting or posi- [52 FR 33702, Sept. 4, 1987, as amended at 53 tioning orthopedic implants or guiding FR 52954, Dec. 29, 1988; 66 FR 38815, July 25, the marking of tissue before cutting. 2001] (b) Classification. Class I (general controls). The device is exempt from the § 888.5940 Cast component. premarket notification procedures in (a) Identification. A cast component is subpart E of part 807 of this chapter, a device intended for medical purposes subject to the limitations in § 888.9. to protect or support a cast. This ge- [52 FR 33702, Sept. 4, 1987, as amended at 66 neric type of device includes the cast FR 38815, July 25, 2001] heel, toe cap, cast support, and walking iron. § 888.5850 Nonpowered orthopedic (b) Classification. Class I (general contraction apparatus and accessories. trols). The device is exempt from the (a) Identification. A nonpowered or- premarket notification procedures in thopedic traction apparatus is a device subpart E of part 807 of this chapter, that consists of a rigid frame with non- subject to the limitations in § 888.9. The powered traction accessories, such as device is also exempt from the current cords, pulleys, or weights, and that is good manufacturing practice require- intended to apply a therapeutic pulling ments of the quality system regulation force to the skeletal system. in part 820 of this chapter, with the ex- (b) Classification. Class I (general con- ception of § 820.180, regarding general trols). The device is exempt from the requirements concerning records, and premarket notification procedures in § 820.198, regarding complaint files. subpart E of part 807 of this chapter, subject to the limitations in § 888.9. The [52 FR 33702, Sept. 4, 1987, as amended at 53 device is also exempt from the current FR 52954, Dec. 29, 1988; 59 FR 63014, Dec. 7, good manufacturing practice require- 1994; 66 FR 38815, July 25, 2001] ments of the quality system regulation in part 820 of this chapter, with the ex- § 888.5960 Cast removal instrument. ception of § 820.180, regarding general (a) Identification. A cast removal in- requirements concerning records, and strument is an AC-powered, hand-held § 820.198, regarding complaint files. device intended to remove a cast from [52 FR 33702, Sept. 4, 1987, as amended at 66 a patient. This generic type of device FR 38815, July 25, 2001] includes the electric cast cutter and cast vacuum. § 888.5890 Noninvasive traction com- (b) Classification. Class I (general con- ponent. trols). The device is exempt from the (a) Identification. A noninvasive trac- premarket notification procedures in tion component is a device, such as a subpart E of part 807 of this chapter, head halter, pelvic belt, or a traction subject to the limitations in § 888.9. splint, that does not penetrate the skin and is intended to assist in connecting [55 FR 48443, Nov. 20, 1990, as amended at 61 a patient to a traction apparatus so FR 1125, Jan. 16, 1996; 66 FR 38816, July 25, that a therapeutic pulling force may be 2001] applied to the patient’s body.

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§ 888.5980 Manual cast application and 890.3100 Mechanical chair. removal instrument. 890.3110 Electric positioning chair. 890.3150 Crutch. (a) Identification. A manual cast ap- 890.3175 Flotation cushion. plication and removal instrument is a 890.3410 External limb orthotic component. nonpowered hand-held device intended 890.3420 External limb prosthetic compo- to be used in applying or removing a nent. cast. This generic type of device in- 890.3450 Upper extremity prosthesis includ- cludes the cast knife, cast spreader, ing a simultaneously powered elbow and/ plaster saw, plaster dispenser, and or shoulder with greater than two simultaneous powered degrees of freedom and casting stand. controlled by non-implanted electrical (b) Classification. Class I (general con- components. trols). The device is exempt from the 890.3475 Limb orthosis. premarket notification procedures in 890.3480 Powered lower extremity subpart E of part 807 of this chapter, exoskeleton. subject to the limitations in § 888.9. The 890.3490 Truncal orthosis. device is also exempt from the current 890.3500 External assembled lower limb good manufacturing practice require- prosthesis. ments of the quality system regulation 890.3520 Plinth. 890.3610 Rigid pneumatic structure orthosis. in part 820 of this chapter, with the ex- 890.3640 Arm sling. ception of § 820.180, regarding general 890.3665 Congenital hip dislocation abduc- requirements concerning records, and tion splint. § 820.198, regarding complaint files. 890.3675 Denis Brown splint. 890.3690 Powered wheeled stretcher. [52 FR 33702, Sept. 4, 1987, as amended at 53 890.3700 Nonpowered communication sys- FR 52954, Dec. 29, 1988; 66 FR 38816, July 25, tem. 2001] 890.3710 Powered communication system. 890.3725 Powered environmental control sys- PART 890—PHYSICAL MEDICINE tem. DEVICES 890.3750 Mechanical table. 890.3760 Powered table. 890.3790 Cane, crutch, and walker tips and Subpart A—General Provisions pads. Sec. 890.3800 Motorized three-wheeled vehicle. 890.1 Scope. 890.3825 Mechanical walker. 890.3 Effective dates of requirement for pre- 890.3850 Mechanical wheelchair. market approval. 890.3860 Powered wheelchair. 890.9 Limitations of exemptions from sec- 890.3880 Special grade wheelchair. tion 510(k) of the Federal Food, Drug, 890.3890 Stair-climbing wheelchair. and Cosmetic Act (the act). 890.3900 Standup wheelchair. 890.3910 Wheelchair accessory. Subpart B—Physical Medicine Diagnostic 890.3920 Wheelchair component. 890.3930 Wheelchair elevator. Devices 890.3940 Wheelchair platform scale. 890.1175 Electrode cable. 890.1225 Chronaximeter. Subpart E [Reserved] 890.1375 Diagnostic electromyograph. 890.1385 Diagnostic electromyograph needle Subpart F—Physical Medicine Therapeutic electrode. Devices 890.1450 Powered reflex hammer. 890.1575 Force-measuring platform. 890.5050 Daily activity assist device. 890.1600 Intermittent pressure measurement 890.5100 Immersion hydrobath. system. 890.5110 Paraffin bath. 890.1615 Miniature pressure transducer. 890.5125 Nonpowered sitz bath. 890.1850 Diagnostic muscle stimulator. 890.5150 Powered patient transport. 890.1925 Isokinetic testing and evaluation 890.5160 Air-fluidized bed. system. 890.5170 Powered flotation therapy bed. 890.5180 Manual patient rotation bed. Subpart C [Reserved] 890.5225 Powered patient rotation bed. 890.5250 Moist steam cabinet. Subpart D—Physical Medicine Prosthetic 890.5275 Microwave diathermy. Devices 890.5290 Shortwave diathermy. 890.5300 Ultrasonic diathermy. 890.3025 Prosthetic and orthotic accessory. 890.5350 Exercise component. 890.3075 Cane. 890.5360 Measuring exercise equipment.

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890.5370 Nonmeasuring exercise equipment. Regulations are to chapter I of title 21, 890.5380 Powered exercise equipment. unless otherwise noted. 890.5410 Powered finger exerciser. (e) Guidance documents referenced in 890.5500 Infrared lamp. this part are available on the Internet 890.5525 Iontophoresis device. 890.5575 Powered external limb overload at http://www.fda.gov/MedicalDevices/ warning device. DeviceRegulationandGuidance/ 890.5650 Powered inflatable tube massager. GuidanceDocuments/default.htm.. 890.5660 Therapeutic massager. [52 FR 17741, May 11, 1987, as amended at 73 890.5700 Cold pack. FR 34860, June 19, 2008; 78 FR 18233, Mar. 26, 890.5710 Hot or cold disposable pack. 2013] 890.5720 Water circulating hot or cold pack. 890.5730 Moist heat pack. § 890.3 Effective dates of requirement 890.5740 Powered heating pad. for premarket approval. 890.5760 Nonpowered lower extremity pressure wrap. A device included in this part that is 890.5765 Pressure-applying device. classified into class III (premarket ap- 890.5850 Powered muscle stimulator. proval) shall not be commercially dis- 890.5860 Ultrasound and muscle stimulator. tributed after the date shown in the 890.5880 Multi-function physical therapy regulation classifying the device unless table. the manufacturer has an approval 890.5900 Powered traction equipment. 890.5925 Traction accessory. under section 515 of the act (unless an 890.5940 Chilling unit. exemption has been granted under sec- 890.5950 Powered heating unit. tion 520(g)(2) of the act). An approval 890.5975 Therapeutic vibrator. under section 515 of the act consists of AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, FDA’s issuance of an order approving 360j, 360l, 371. an application of premarket approval (PMA) for the device or declaring com- SOURCE: 48 FR 53047, Nov. 23, 1983, unless pleted a product development protocol otherwise noted. (PDP) for the device. EDITORIAL NOTE: Nomenclature changes to (a) Before FDA requires that a device part 890 appear at 73 FR 35341, June 23, 2008. commercially distributed before the enactment date of the amendments, or Subpart A—General Provisions a device that has been found substantially equivalent to such a device, has § 890.1 Scope. an approval under section 515 of the act (a) This part sets forth the classifica- FDA must promulgate a regulation tion of physical medicine devices in- under section 515(b) of the act requir- tended for human use that are in com- ing such approval, except as provided mercial distribution. in paragraph (b) of this section. Such a (b) The identification of a device in a regulation under section 515(b) of the regulation in this part is not a precise act shall not be effective during the description of every device that is, or grace period ending on the 90th day will be, subject to the regulation. A after its promulgation or on the last manufacturer who submits a pre- day of the 30th full calendar month market notification submission for a after the regulation that classifies the device under part 807 may not show device into class III is effective, which- merely that the device is accurately ever is later. See section 501(f)(2)(B) of described by the section title and iden- the act. Accordingly, unless an effec- tification provisions of a regulation in tive date of the requirement for pre- this part, but shall state why the de- market approval is shown in the regu- vice is substantially equivalent to lation for a device classified into class other devices, as required by § 807.87. III in this part, the device may be com- (c) To avoid duplicative listings, a mercially distributed without FDA’s physical medicine device that has two issuance of an order approving a PMA or more types of uses (e.g., used both as or declaring completed a PDP for the a diagnostic device and as a thera- device. If FDA promulgates a regula- peutic device) is listed only in one sub- tion under section 515(b) of the act re- part. quiring premarket approval for a de- (d) References in this part to regu- vice, section 501(f)(1)(A) of the act ap- latory sections of the Code of Federal plies to the device.

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(b) Any new, not substantially equiv- where the former intended use was by alent, device introduced into commer- health care professionals only; cial distribution on or after May 28, (b) The modified device operates 1976, includiing a device formerly mar- using a different fundamental sci- keted that has been substantially al- entific technology than a legally mar- tered, is classified by statute (section keted device in that generic type of de- 513(f) of the act) into class III without vice; e.g., a surgical instrument cuts any grace period and FDA must have tissue with a laser beam rather than issued an order approving a PMA or de- with a sharpened metal blade, or an in claring completed a PDP for the device vitro diagnostic device detects or iden- before the device is commercially dis- tifies infectious agents by using tributed unless it is reclassified. If deoxyribonucleic acid (DNA) probe or FDA knows that a device being com- nucleic acid hybridization technology mercially distributed may be a ‘‘new’’ rather than culture or immunoassay device as defined in this section be- technology; or cause of any new intended use or other reasons, FDA may codify the statutory (c) The device is an in vitro device classification of the device into class that is intended: III for such new use. Accordingly, the (1) For use in the diagnosis, moni- regulation for such a class III device toring, or screening of neoplastic dis- states that as of the enactment date of eases with the exception of the amendments, May 28, 1976, the de- immunohistochemical devices; vice must have an approval under sec- (2) For use in screening or diagnosis tion 515 of the act before commercial of familial or acquired genetic dis- distribution. orders, including inborn errors of metabolism; [52 FR 17741, May 11, 1987] (3) For measuring an analyte that § 890.9 Limitations of exemptions from serves as a surrogate marker for section 510(k) of the Federal Food, screening, diagnosis, or monitoring Drug, and Cosmetic Act (the act). life-threatening diseases such as ac- The exemption from the requirement quired immune deficiency syndrome of premarket notification (section (AIDS), chronic or active hepatitis, tu- 510(k) of the act) for a generic type of berculosis, or myocardial infarction or class I or II device is only to the extent to monitor therapy; that the device has existing or reason- (4) For assessing the risk of cardio- ably foreseeable characteristics of vascular diseases; commercially distributed devices with- (5) For use in diabetes management; in that generic type or, in the case of (6) For identifying or inferring the in vitro diagnostic devices, only to the identity of a microorganism directly extent that misdiagnosis as a result of from clinical material; using the device would not be associ- (7) For detection of antibodies to ated with high morbidity or mortality. microorganisms other than Accordingly, manufacturers of any immunoglobulin G (IgG) or IgG assays commercially distributed class I or II when the results are not qualitative, or device for which FDA has granted an are used to determine immunity, or the exemption from the requirement of assay is intended for use in matrices premarket notification must still sub- other than serum or plasma; mit a premarket notification to FDA before introducing or delivering for in- (8) For noninvasive testing as defined troduction into interstate commerce in § 812.3(k) of this chapter; and for commercial distribution the device (9) For near patient testing (point of when: care). (a) The device is intended for a use [65 FR 2321, Jan. 14, 2000] different from the intended use of a legally marketed device in that generic type of device; e.g., the device is intended for a different medical purpose, or the device is intended for lay use

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Subpart B—Physical Medicine device is intended for medical purposes Diagnostic Devices for use in connection with electromyography (recording the in- § 890.1175 Electrode cable. trinsic electrical properties of skeletal muscle). (a) Identification. An electrode cable (b) Classification. Class II (perform- is a device composed of strands of insu- ance standards). lated electrical conductors laid together around a central core and in- § 890.1450 Powered reflex hammer. tended for medical purposes to connect an electrode from a patient to a diag- (a) Identification. A powered reflex nostic machine. hammer is a motorized device intended (b) Classification. Class II (special for medical purposes to elicit and de- controls). The special controls consist termine controlled deep tendon re- of: flexes. (1) The performance standard under (b) Classification. Class II (perform- part 898 of this chapter, and ance standards). (2) The guidance document entitled § 890.1575 Force-measuring platform. ‘‘Guidance on the Performance Stand- ard for Electrode Lead Wires and Pa- (a) Identification. A force-measuring tient Cables.’’ This device is exempt platform is a device intended for med- from the premarket notification proce- ical purposes that converts pressure dures of subpart E of part 807 of this applied upon a planar surface into ana- chapter subject to § 890.9. log mechanical or electrical signals. This device is used to determine [48 FR 53047, Nov. 23, 1983, as amended at 59 ground reaction force, centers of per- FR 63014, Dec. 7, 1994; 65 FR 19319, Apr. 11, cussion, centers of torque, and their 2000] variations in both magnitude and di- § 890.1225 Chronaximeter. rection with time. (b) Classification. Class I (general con- (a) Identification. A chronaximeter is trols). The device is exempt from the a device intended for medical purposes premarket notification procedures in to measure neuromuscular excitability subpart E of part 807 of this chapter, by means of a strength-duration curve subject to the limitations in § 890.9. that provides a basis for diagnosis and prognosis of neurological dysfunction. [48 FR 53047, Nov. 23, 1983, as amended at 61 (b) Classification. Class II (perform- FR 1125, Jan. 16, 1996; 66 FR 38816, July 25, ance standards). 2001]

§ 890.1375 Diagnostic § 890.1600 Intermittent pressure meas- electromyograph. urement system. (a) Identification. A diagnostic (a) Identification. An intermittent electromyograph is a device intended pressure measurement system is an for medical purposes, such as to mon- evaluative device intended for medical itor and display the bioelectric signals purposes, such as to measure the ac- produced by muscles, to stimulate pe- tual pressure between the body surface ripheral nerves, and to monitor and and the supporting media. display the electrical activity produced (b) Classification. Class I (general con- by nerves, for the diagnosis and prog- trols). The device is exempt from the nosis of neuromuscular disease. premarket notification procedures in (b) Classification. Class II (perform- subpart E of part 807 of this chapter, ance standards). subject to the limitations in § 890.9. [48 FR 53047, Nov. 23, 1983, as amended at 61 § 890.1385 Diagnostic electromyograph FR 1125, Jan. 16, 1996; 66 FR 38816, July 25, needle electrode. 2001] (a) Identification. A diagnostic electromyograph needle electrode is a § 890.1615 Miniature pressure trans- monopolar or bipolar needle intended ducer. to be inserted into muscle or nerve tis- (a) Identification. A miniature pres- sue to sense bioelectrical signals. The sure transducer is a device intended for

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medical purposes to measure the pres- ment device, a postsurgical pylon, a sure between a device and soft tissue transverse rotator, and a temporary by converting mechanical inputs to training splint. analog electrical signals. (b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter, subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The subject to the limitations in § 890.9. device is also exempt from the current [48 FR 53047, Nov. 23, 1983, as amended at 61 good manufacturing practice require- FR 1125, Jan. 16, 1996; 66 FR 38816, July 25, ments of the quality system regulation 2001] in part 820 of this chapter, with the exception of § 820.180, regarding general § 890.1850 Diagnostic muscle stimu- requirements concerning records and lator. § 820.198, regarding complaint files. (a) Identification. A diagnostic muscle [48 FR 53047, Nov. 23, 1983, as amended at 66 stimulator is a device used mainly with FR 38816, July 25, 2001] an electromyograph machine to initiate muscle activity. It is intended for § 890.3075 Cane. medical purposes, such as to diagnose (a) Identification. A cane is a device motor nerve or sensory neuromuscular intended for medical purposes that is disorders and neuromuscular function. used to provide minimal weight sup- (b) Classification. Class II (perform- port while walking. Examples of canes ance standards). include the following: A standard cane, a forearm cane, and a cane with a tri- § 890.1925 Isokinetic testing and evaluation system. pod, quad, or retractable stud on the ground end. (a) Identification. An isokinetic test- (b) Classification. Class I (general con- ing and evaluation system is a rehabili- trols). The device is exempt from the tative exercise device intended for premarket notification procedures in medical purposes, such as to measure, subpart E of part 807 of this chapter, evaluate, and increase the strength of subject to the limitations in § 890.9. The muscles and the range of motion of device is also exempt from the current joints. good manufacturing practice require- (b) Classification. Class II (special ments of the quality system regulation controls). The device is exempt from in part 820 of this chapter, with the ex- the premarket notification procedures ception of § 820.180, regarding general in subpart E of part 807 of this chapter requirements concerning records and subject to § 890.9. § 820.198, regarding complaint files. [48 FR 53047, Nov. 23, 1983, as amended at 63 [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 59230, Nov. 3, 1998] FR 38816, July 25, 2001]

Subpart C [Reserved] § 890.3100 Mechanical chair. (a) Identification. A mechanical chair Subpart D—Physical Medicine is a manually operated device intended Prosthetic Devices for medical purposes that is used to assist a disabled person in performing an § 890.3025 Prosthetic and orthotic ac- activity that the person would other- cessory. wise find difficult to do or be unable to (a) Identification. A prosthetic and do. Examples of mechanical chairs in- orthotic accessory is a device intended clude the following: A chair with an for medical purposes to support, pro- elevating seat used to raise a person tect, or aid in the use of a cast, ortho- from a sitting position to a standing sis (brace), or prosthesis. Examples of position and a chair with casters used prosthetic and orthotic accessories in- by a person to move from one place to clude the following: A pelvic support another while sitting. band and belt, a cast shoe, a cast ban- (b) Classification. Class I (general con- dage, a limb cover, a prosthesis align- trols). The device is exempt from the

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premarket notification procedures in electromagnetic compatibility and subpart E of part 807 of this chapter, electrical safety; subject to the limitations in § 890.9. (6) Appropriate analysis and non-clinical testing (such as that outlined in [48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38816, July 25, the currently FDA-recognized editions 2001] of ANSI/AAMI/ISO 10993–1, ‘‘Biological Evaluation of Medical Devices—Part 1: § 890.3110 Electric positioning chair. Evaluation and Testing Within a Risk Management Process,’’ ANSI/AAMI/ISO (a) Identification. An electric posi- 10993–5, ‘‘Biological Evaluation of Med- tioning chair is a device with a motor- ical Devices—Part 5: Tests for In Vitro ized positioning control that is in- Cytotoxicity,’’ and ANSI/AAMI/ISO tended for medical purposes and that 10993–10, ‘‘Biological Evaluation of can be adjusted to various positions. Medical Devices—Part 10: Tests for Ir- The device is used to provide stability ritation and Skin Sensitization’’) must for patients with athetosis (involun- validate that the skin-contacting com- tary spasms) and to alter postural posi- ponents of the device are biocompat- tions. ible; (b) Classification. Class II. The elec- (7) Appropriate analysis and non-clin- tric positioning chair is exempt from ical testing (such as that outlined in premarket notification procedures in the currently FDA-recognized editions subpart E of part 807 of this chapter, of IEC 62304, ‘‘Medical Device Soft- subject to § 890.9 and the following con- ware—Software Life Cycle Processes’’) ditions for exemption: must validate the software life cycle (1) Appropriate analysis and non-clin- and that all processes, activities, and ical testing must demonstrate that the tasks are implemented and docu- safety controls are adequate to ensure mented; safe use of the device and prevent user (8) Appropriate analysis and non-clin- falls from the device in the event of a ical testing must validate that the de- device failure; vice components are found to be non- (2) Appropriate analysis and non-clin- flammable; ical testing must demonstrate the abil- (9) Appropriate analysis and non-clin- ity of the device to withstand the rated ical testing must validate that the bat- user weight load with an appropriate tery in the device (if applicable) per- factor of safety; forms as intended over the anticipated (3) Appropriate analysis and non-clin- service life of the device; and ical testing must demonstrate the lon- (10) Adequate patient labeling is pro- gevity of the device to withstand exter- vided to the user to document proper nal forces applied to the device and use and maintenance of the device to provide the user with an expected serv- ensure safe use of the device by the pa- ice life of the device; tient in the intended use environment. (4) Appropriate analysis and non-clinical testing must demonstrate proper [48 FR 53047, Nov. 23, 1983, as amended at 80 environments of use and storage of the FR 72950, Nov. 20, 2015] device to maximize the longevity of the device; § 890.3150 Crutch. (5) Appropriate analysis and non-clin- (a) Identification. A crutch is a device ical testing (such as that outlined in intended for medical purposes for use the currently FDA-recognized editions by disabled persons to provide minimal of ANSI/AAMI/ES60601–1, ‘‘Medical to moderate weight support while Electrical Equipment—Part 1: General walking. Requirements for Basic Safety and Es- (b) Classification. Class I (general con- sential Performance,’’ and ANSI/AAMI/ trols). The device is exempt from the IEC 60601–1–2, ‘‘Medical Electrical premarket notification procedures in Equipment—Part 1–2: General Require- subpart E of part 807 of this chapter, ments for Basic Safety and Essential subject to the limitations in § 890.9. The Performance—Collateral Standard: device is also exempt from the current Electromagnetic Disturbances—Re- good manufacturing practice require- quirements and Tests’’) must validate ments of the quality system regulation

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in part 820 of this chapter, with the ex- components, constitutes a total pros- ception of § 820.180, regarding general thesis. Examples of external limb pros- requirements concerning records and thetic components include the fol- § 820.198, regarding complaint files. lowing: Ankle, foot, hip, knee, and [48 FR 53047, Nov. 23, 1983, as amended at 66 socket components; mechanical or FR 38816, July 25, 2001] powered hand, hook, wrist unit, elbow joint, and shoulder joint components; § 890.3175 Flotation cushion. and cable and prosthesis suction (a) Identification. A flotation cushion valves. is a device intended for medical pur- (b) Classification. Class I (general con- poses that is made of plastic, rubber, or trols). The device is exempt from the other type of covering, that is filled premarket notification procedures in with water, air, gel, mud, or any other subpart E of part 807 of this chapter, substance allowing a flotation media, subject to the limitations in § 890.9. The used on a seat to lessen the likelihood device is also exempt from the current of skin ulcers. good manufacturing practice require- (b) Classification. Class I (general con- ments of the quality system regulation trols). The device is exempt from the in part 820 of this chapter, with the ex- premarket notification procedures in ception of § 820.180, regarding general subpart E of part 807 of this chapter, requirements concerning records and subject to the limitations in § 890.9. § 820.198, regarding complaint files. [48 FR 53047, Nov. 23, 1983, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38816, July 25, [48 FR 53047, Nov. 23, 1983, as amended at 66 2001] FR 38816, July 25, 2001]

§ 890.3410 External limb orthotic com- § 890.3450 Upper extremity prosthesis ponent. including a simultaneously powered elbow and/or shoulder with (a) Identification. An external limb greater than two simultaneous pow- orthotic component is a device in- ered degrees of freedom and con- tended for medical purposes for use in trolled by non-implanted electrical conjunction with an orthosis (brace) to components. increase the function of the orthosis for a patient’s particular needs. Exam- (a) Identification. A upper extremity ples of external limb orthotic compo- prosthesis including a simultaneously nents include the following: A brace- powered elbow and/or shoulder with setting twister and an external brace greater than two simultaneous powered stirrup. degrees of freedom and controlled by (b) Classification. Class I (general con- non-implanted electrical components, trols). The device is exempt from the is a prescription device intended for premarket notification procedures in medical purposes, and is intended to re- subpart E of part 807 of this chapter, place a partially or fully amputated or subject to the limitations in § 890.9. The congenitally absent upper extremity. It device is also exempt from the current uses electronic inputs (other than sim- good manufacturing practice require- ple, manually controlled electrical ments of the quality system regulation components such as switches) to pro- in part 820 of this chapter, with the ex- vide greater than two independent and ception of § 820.180, regarding general simultaneously powered degrees of requirements concerning records and freedom and includes a simultaneously § 820.198, regarding complaint files. powered elbow and/or shoulder. Pros- [48 FR 53047, Nov. 23, 1983, as amended at 66 thetic arm components that are in- FR 38816, July 25, 2001] tended to be used as a system with other arm components must include all § 890.3420 External limb prosthetic degrees of freedom of the total upper component. extremity prosthesis system. (a) Identification. An external limb (b) Classification. Class II (special prosthetic component is a device in- controls). The special controls for this tended for medical purposes that, when device are: put together with other appropriate

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(1) Appropriate analysis/testing must (A) Instructions on assembling the validate electronic compatibility, elec- device in all available configurations, trical safety, thermal safety, mechan- (B) Instructions on fitting the pa- ical safety, battery performance and tient, safety, and wireless performance, if ap- (C) Instructions and explanations of plicable. all available programs and how to pro- (2) Appropriate software verification, gram the device, validation, and hazard analysis must (D) Instructions and explanation of be performed. all controls, input, and outputs, (3) Non-clinical performance data (E) Instructions on all available must demonstrate that the device per- modes or states of the device, forms as intended under anticipated (F) Instructions on all safety features conditions of use. Performance testing of the device, and must include: (G) Instructions for maintaining the (i) Mechanical bench data, including device. durability testing, to demonstrate that (iii) Information on the patient popu- the device will withstand forces, condi- lation for which the device has been tions, and environments encountered demonstrated to be effective. during use. (iv) A detailed summary of the non- (ii) Simulated use testing to dem- clinical and clinical testing pertinent onstrate performance of arm com- to use of the device. mands and available safeguard(s) under [81 FR 71612, Oct. 18, 2016] worst case conditions and after durability testing. § 890.3475 Limb orthosis. (iii) Verification and validation of (a) Identification. A limb orthosis force sensors and hand release button, (brace) is a device intended for medical if applicable, are necessary. purposes that is worn on the upper or (iv) Device functionality in terms of lower extremities to support, to cor- flame retardant materials, liquid/par- rect, or to prevent deformities or to ticle ingress prevention, sensor and ac- align body structures for functional tuator performance, and motor and improvement. Examples of limb brake performance. orthoses include the following: A whole (v) The accuracy of the device fea- limb and joint brace, a hand splint, an tures and safeguards. elastic stocking, a knee cage, and a (4) Non-clinical and clinical perform- corrective shoe. ance testing must demonstrate the ac- (b) Classification. Class I (general con- curacy of device features and safe- trols). The device is exempt from the guards. premarket notification procedures in (5) Elements of the device that may subpart E of part 807 of this chapter, contact the patient must be dem- subject to the limitations in § 890.9. The onstrated to be biocompatible. device is also exempt from the current (6) Documented clinical experience good manufacturing practice require- and human factors testing must dem- ments of the quality system regulation onstrate safe and effective use, capture in part 820 of this chapter, with the ex- any adverse events observed during ception of § 820.180, regarding general clinical use and demonstrate the accu- requirements concerning records and racy of device features and safeguards. § 820.198, regarding complaint files. (7) Labeling for the Prosthetist and [48 FR 53047, Nov. 23, 1983, as amended at 66 User Guide must include: FR 38816, July 25, 2001] (i) Appropriate instructions, warning, cautions, limitations, and information § 890.3480 Powered lower extremity related to the necessary safeguards of exoskeleton. the device, including warning against (a) Identification. A powered lower ex- activities that may put the user at tremity exoskeleton is a prescription greater risk (e.g., driving). device that is composed of an external, (ii) Specific instructions and the clin- powered, motorized orthosis that is ical training needed for the safe use of placed over a person’s paralyzed or the device, which includes: weakened limbs for medical purposes.

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(b) Classification. Class II (special ments so that upon completion of controls). The special controls for this training program, the clinician, user, device are: and companion can: (1) Elements of the device materials (i) Identify the safe environments for that may contact the patient must be device use, demonstrated to be biocompatible. (ii) Use all safety features of device, (2) Appropriate analysis/testing must and validate electromagnetic compat- (iii) Operate the device in simulated ibility/interference (EMC/EMI), elec- or actual use environments representa- trical safety, thermal safety, mechan- tive of indicated environments and use. ical safety, battery performance and (8) Labeling for the Physician and safety, and wireless performance, if ap- User must include the following: plicable. (i) Appropriate instructions, warning, (3) Appropriate software verification, cautions, limitations, and information validation, and hazard analysis must related to the necessary safeguards of be performed. the device, including warning against (4) Design characteristics must en- activities and environments that may sure geometry and materials composi- put the user at greater risk. tion are consistent with intended use. (ii) Specific instructions and the clin- (5) Non-clinical performance testing ical training needed for the safe use of must demonstrate that the device per- the device, which includes: forms as intended under anticipated (A) Instructions on assembling the conditions of use. Performance testing device in all available configurations; must include: (i) Mechanical bench testing (includ- (B) Instructions on fitting the pa- ing durability testing) to demonstrate tient; that the device will withstand forces, (C) Instructions and explanations of conditions, and environments encoun- all available programs and how to pro- tered during use; gram the device; (ii) Simulated use testing (i.e., cyclic (D) Instructions and explanation of loading testing) to demonstrate per- all controls, input, and outputs; formance of device commands and safe- (E) Instructions on all available guard under worst case conditions and modes or states of the device; after durability testing; (F) Instructions on all safety features (iii) Verification and validation of of the device; and manual override controls are nec- (G) Instructions for properly main- essary, if present; taining the device. (iv) The accuracy of device features (iii) Information on the patient popu- and safeguards; and lation for which the device has been (v) Device functionality in terms of demonstrated to have a reasonable as- flame retardant materials, liquid/par- surance of safety and effectiveness. ticle ingress prevention, sensor and ac- (iv) Pertinent non-clinical testing in- tuator performance, and motor per- formation (e.g., EMC, battery lon- formance. gevity). (6) Clinical testing must demonstrate (v) A detailed summary of the clin- a reasonable assurance of safe and ef- ical testing including: fective use and capture any adverse (A) Adverse events encountered events observed during clinical use under use conditions, when used under the proposed condi- (B) Summary of study outcomes and tions of use, which must include con- endpoints, and siderations for: (C) Information pertinent to use of (i) Level of supervision necessary, the device including the conditions and under which the device was studied (ii) Environment of use (e.g., indoors (e.g., level of supervision or assistance, and/or outdoors) including obstacles and environment of use (e.g., indoors and terrain representative of the in- and/or outdoors) including obstacles tended use environment. and terrain). (7) A training program must be included with sufficient educational ele- [80 FR 25529, May 4, 2015]

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§ 890.3490 Truncal orthosis. ments of the quality system regulation (a) Identification. A truncal orthosis in part 820 of this chapter, with the ex- is a device intended for medical pur- ception of § 820.180, regarding general poses to support or to immobilize frac- requirements concerning records and tures, strains, or sprains of the neck or § 820.198, regarding complaint files. trunk of the body. Examples of truncal [48 FR 53047, Nov. 23, 1983, as amended at 66 orthoses are the following: Abdominal, FR 38817, July 25, 2001] cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, § 890.3610 Rigid pneumatic structure and thoracic orthoses and clavicle orthosis. splints. (a) Identification. A rigid pneumatic (b) Classification. Class I (general con- structure orthosis is a device intended trols). The device is exempt from the for medical purposes to provide whole premarket notification procedures in body support by means of a pressurized subpart E of part 807 of this chapter, suit to help thoracic paraplegics walk. subject to the limitations in § 890.9. The (b) Classification. Class III (premarket device is also exempt from the current approval). good manufacturing practice require- (c) Date PMA or notice of completion of ments of the quality system regulation a PDP is required. A PMA or a notice of in part 820 of this chapter, with the ex- completion of a PDP is required to be ception of § 820.180, regarding general filed with the Food and Drug Adminis- requirements concerning records and tration on or before December 26, 1996 § 820.198, regarding complaint files. for any rigid pneumatic structure orthosis that was in commercial distribu- [48 FR 53047, Nov. 23, 1983, as amended at 66 FR 38816, July 25, 2001] tion before May 28, 1976, or that has, on or before December 26, 1996 been found § 890.3500 External assembled lower to be substantially equivalent to a limb prosthesis. rigid pneumatic structure orthosis that (a) Identification. An external assem- was in commercial distribution before bled lower limb prosthesis is a device May 28, 1976. Any other rigid pneu- that is intended for medical purposes matic structure orthosis shall have an and is a preassembled external artifi- approved PMA or a declared completed cial limb for the lower extremity. Ex- PDP in effect before being placed in amples of external assembled lower commercial distribution. limb prostheses are the following: [48 FR 53047, Nov. 23, 1983, as amended at 52 Knee/shank/ankle/foot assembly and FR 17742, May 11, 1987; 61 FR 50711, Sept. 27, thigh/knee/shank/ankle/foot assembly. 1996] (b) Classification. Class II (special controls). The device is exempt from § 890.3640 Arm sling. the premarket notification procedures (a) Identification. An arm sling is a in subpart E of part 807 of this chapter device intended for medical purposes to subject to § 890.9. immobilize the arm, by means of a fab- [48 FR 53047, Nov. 23, 1983, as amended at 63 ric band suspended from around the FR 59231, Nov. 3, 1998] neck. (b) Classification. Class I (general con- § 890.3520 Plinth. trols). The device is exempt from the (a) Identification. A plinth is a flat, premarket notification procedures in padded board with legs that is intended subpart E of part 807 of this chapter, for medical purposes. A patient is subject to the limitations in § 890.9. The placed on the device for treatment or device is also exempt from the current examination. good manufacturing practice require- (b) Classification. Class I (general con- ments of the quality system regulation trols). The device is exempt from the in part 820 of this chapter, with the ex- premarket notification procedures in ception of § 820.180, regarding general subpart E of part 807 of this chapter, requirements concerning records and subject to the limitations in § 890.9. The § 820.198, regarding complaint files. device is also exempt from the current [48 FR 53047, Nov. 23, 1983, as amended at 66 good manufacturing practice require- FR 38817, July 25, 2001]

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§ 890.3665 Congenital hip dislocation § 890.3700 Nonpowered communica- abduction splint. tion system. (a) Identification. A congenital hip (a) Identification. A nonpowered com- dislocation abduction splint is a device munication system is a mechanical de- intended for medical purposes to sta- vice intended for medical purposes that bilize the hips of a young child with is used to assist a patient in commu- dislocated hips in an abducted position nicating when physical impairment (away from the midline). prevents writing, telephone use, read- (b) Classification. Class I (general con- ing, or talking. Examples of nonpow- trols). The device is exempt from the ered communications systems include premarket notification procedures in an alphabet board and a page turner. subpart E of part 807 of this chapter, (b) Classification. Class I (general con- subject to the limitations in § 890.9. The trols). The device is exempt from the device is also exempt from the current premarket notification procedures in good manufacturing practice require- subpart E of part 807 of this chapter, ments of the quality system regulation subject to the limitations in § 890.9. The in part 820 of this chapter, with the ex- device is also exempt from the current ception of § 820.180, regarding general good manufacturing practice require- requirements concerning records and ments of the quality system regulation § 820.198, regarding complaint files. in part 820 of this chapter, with the exception of § 820.180, regarding general [48 FR 53047, Nov. 23, 1983, as amended at 66 requirements concerning records and FR 38817, July 25, 2001] § 820.198, regarding complaint files. § 890.3675 Denis Brown splint. [48 FR 53047, Nov. 23, 1983, as amended at 54 (a) Identification. A Denis Brown FR 25052, June 12, 1989; 66 FR 38817, July 25, 2001] splint is a device intended for medical purposes to immobilize the foot. It is § 890.3710 Powered communication used on young children with tibial tor- system. sion (excessive rotation of the lower (a) Identification. A powered commu- leg) or club foot. nication system is an AC- or battery- (b) Classification. Class I (general con- powered device intended for medical trols). The device is exempt from the purposes that is used to transmit or re- premarket notification procedures in ceive information. It is used by persons subpart E of part 807 of this chapter, unable to use normal communication subject to the limitations in § 890.9. The methods because of physical impair- device is also exempt from the current ment. Examples of powered commu- good manufacturing practice require- nication systems include the following: ments of the quality system regulation a specialized typewriter, a reading main part 820 of this chapter, with the ex- chine, and a video picture and word ception of § 820.180, regarding general screen. requirements concerning records and (b) Classification. Class II (special § 820.198, regarding complaint files. controls). The device is exempt from [48 FR 53047, Nov. 23, 1983, as amended at 66 the premarket notification procedures FR 38817, July 25, 2001] in subpart E of part 807 of this chapter subject to § 890.9. § 890.3690 Powered wheeled stretcher. [48 FR 53047, Nov. 23, 1983, as amended at 63 (a) Identification. A powered wheeled FR 59231, Nov. 3, 1998] stretcher is a battery-powered table with wheels that is intended for med- § 890.3725 Powered environmental ical purposes for use by patients who control system. are unable to propel themselves inde- (a) Identification. A powered environ- pendently and who must maintain a mental control system is an AC- or prone or supine position for prolonged battery-powered device intended for periods because of skin ulcers or con- medical purposes that is used by a pa- tractures (muscle contractions). tient to operate an environmental con- (b) Classification. Class II (perform- trol function. Examples of environ- ance standards). mental control functions include the

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following: to control room tempera- device for comfort or as an aid in using ture, to answer a doorbell or telephone, an ambulatory assist device. or to sound an alarm for assistance. (b) Classification. Class I (general con- (b) Classification. Class II (special trols). The device is exempt from the controls). The device is exempt from premarket notification procedures in the premarket notification procedures subpart E of part 807 of this chapter, in subpart E of part 807 of this chapter subject to the limitations in § 890.9. The subject to § 890.9. device is also exempt from the current good manufacturing practice require- [48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998] ments of the quality system regulation in part 820 of this chapter, with the ex- § 890.3750 Mechanical table. ception of § 820.180, regarding general (a) Identification. A mechanical table requirements concerning records and is a device intended for medical pur- § 820.198, regarding complaint files. poses that has a flat surface that can [48 FR 53047, Nov. 23, 1983, as amended at 66 be inclined or adjusted to various posi- FR 38817, July 25, 2001] tions. It is used by patients with circulatory, neurological, or musculo- § 890.3800 Motorized three-wheeled ve- skeletal conditions to increase toler- hicle. ance to an upright or standing posi- (a) Identification. A motorized three- tion. wheeled vehicle is a gasoline-fueled or (b) Classification. Class I (general con- battery-powered device intended for trols). The device is exempt from the medical purposes that is used for out- premarket notification procedures in side transportation by disabled per- subpart E of part 807 of this chapter, sons. subject to the limitations in § 890.9. (b) Classification. Class II (performance standards). [48 FR 53047, Nov. 23, 1983, as amended at 59 FR 63014, Dec. 7, 1994; 66 FR 38817, July 25, § 890.3825 Mechanical walker. 2001] (a) Identification. A mechanical walk- § 890.3760 Powered table. er is a four-legged device with a metal (a) Identification. A powered table is a frame intended for medical purposes to device intended for medical purposes provide moderate weight support while that is an electrically operated flat walking. It is used by disabled persons surface table that can be adjusted to who lack strength, good balance, or en- various positions. It is used by patients durance. with circulatory, neurological, or mus- (b) Classification. Class I (general con- culoskeletal conditions to increase tol- trols). The device is exempt from the erance to an upright or standing posi- premarket notification procedures in tion. subpart E of part 807 of this chapter, (b) Classification. Class I (general con- subject to the limitations in § 890.9. The trols). The device is exempt from the device is also exempt from the current premarket notification procedures in good manufacturing practice require- subpart E of part 807 of this chapter, ments of the quality system regulation subject to the limitations in § 890.9. in part 820 of this chapter, with the exception of § 820.180, regarding general [48 FR 53047, Nov. 23, 1983, as amended at 61 requirements concerning records and FR 1125, Jan. 16, 1996; 66 FR 38817, July 25, § 820.198, regarding complaint files. 2001] [48 FR 53047, Nov. 23, 1983, as amended at 66 § 890.3790 Cane, crutch, and walker FR 38817, July 25, 2001] tips and pads. (a) Identification. Cane, crutch, and § 890.3850 Mechanical wheelchair. walker tips and pads are rubber (or (a) Identification. A mechanical rubber substitute) device accessories wheelchair is a manually operated de- intended for medical purposes that are vice with wheels that is intended for applied to the ground end of mobility medical purposes to provide mobility aids to prevent skidding or that are ap- to persons restricted to a sitting posi- plied to the body contact area of the tion.

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(b) Classification. Class I (general con- adverse temperatures and humidity trols). conditions. (3) The skin-contacting components § 890.3860 Powered wheelchair. of the device must be demonstrated to (a) Identification. A powered wheel- be biocompatible. chair is a battery-operated device with (4) Software design, verification, and wheels that is intended for medical validation must demonstrate that the purposes to provide mobility to persons device controls, alarms, and user inter- restricted to a sitting position. faces function as intended. (b) Classification. Class II (perform- (5) Appropriate analysis and performance standards). ance testing must be conducted to verify electrical safety and electro- § 890.3880 Special grade wheelchair. magnetic compatibility of the device. (6) Performance testing must dem- (a) Identification. A special grade onstrate battery safety and evaluate wheelchair is a device with wheels that longevity. is intended for medical purposes to pro- (7) Performance testing must evalu- vide mobility to persons restricted to a ate the flammability of device compo- sitting position. It is intended to be nents. used in all environments for long-term (8) Patient labeling must bear all in- use, e.g., for paraplegics, quadraplegics, formation required for the safe and ef- and amputees. fective use of the device, specifically (b) Classification. Class II (perform- including the following: ance standards). (i) A clear description of the technological features of the device and the § 890.3890 Stair-climbing wheelchair. principles of how the device works; (a) Identification. A stair-climbing (ii) A clear description of the appro- wheelchair is a device with wheels that priate use environments/conditions, in- is intended for medical purposes to pro- cluding prohibited environments; vide mobility to persons restricted to a (iii) Preventive maintenance rec- sitting position. The device is intended ommendations; to climb stairs. (iv) Operating specifications for prop- (b) Classification. Class II (special er use of the device such as patient controls). The special controls for this weight limitations, device width, and device are: clearance for maneuverability; and (1) The design characteristics of the (v) A detailed summary of the device- device must ensure that the geometry related adverse events and how to re- and material composition are con- port any complications. sistent with the intended use. (9) Clinician labeling must include all (2) Performance testing must dem- the information in the Patient labeling onstrate adequate mechanical perform- noted in paragraph (b)(8) of this section ance under simulated use conditions but must also include the following: and environments. Performance testing (i) Identification of patients who can must include the following: effectively operate the device; and (i) Fatigue testing; (ii) Instructions on how to fit, mod- (ii) Resistance to dynamic loads (im- ify, or calibrate the device. pact testing); (10) Usability studies of the device (iii) Effective use of the braking must demonstrate that the device can mechanism and how the device stops in be used by the patient in the intended case of an electrical brake failure; use environment with the instructions (iv) Demonstration of adequate sta- for use and user training. bility of the device on inclined planes [79 FR 20782, Apr. 14, 2014] (forward, backward, and lateral); (v) Demonstration of the ability of § 890.3900 Standup wheelchair. the device to safely ascend and descend (a) Identification. A standup wheel- obstacles (i.e., stairs, curb); and chair is a device with wheels that is in- (vi) Demonstration of ability to ef- tended for medical purposes to provide fectively use the device during adverse mobility to persons restricted to a sit- temperatures and following storage in ting position. The device incorporates

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an external manually controlled me- subpart E of part 807 of this chapter, chanical system that is intended to subject to the limitations in § 890.9. raise a paraplegic to an upright posi- [48 FR 53047, Nov. 23, 1983, as amended at 59 tion by means of an elevating seat. FR 63014, Dec. 7, 1994; 66 FR 38817, July 25, (b) Classification. Class II (perform- 2001] ance standards). § 890.3930 Wheelchair elevator. § 890.3910 Wheelchair accessory. (a) Permanently mounted wheelchair (a) Identification. A wheelchair acces- platform lift—(1) Identification. A perma- sory is a device intended for medical nently mounted wheelchair platform purposes that is sold separately from a lift is a motorized vertical or inclined wheelchair and is intended to meet the platform lift device permanently in- specific needs of a patient who uses a stalled in one location that is intended wheelchair. Examples of wheelchair ac- for use in mitigating mobility impair- cessories include but are not limited to ment caused by injury or other disease the following: armboard, lapboard, by providing a guided platform to move pusher cuff, crutch and cane holder, a person from one level to another, overhead suspension sling, head and with or without a wheelchair. trunk support, and blanket and leg rest (2) Classification. Class II. The perma- strap. nently mounted wheelchair platform lift is exempt from premarket notifica- (b) Classification. Class I (general con- tion procedures in subpart E of part 807 trols). If the device is not intended for of this chapter, subject to § 890.9 and use as a protective restraint as defined the following conditions for exemption: in § 880.6760 of this chapter, it is exempt (i) Appropriate analysis and nonclin- from the premarket notification proce- ical testing (such as that outlined in dures in subpart E of part 807 of this the currently FDA-recognized edition chapter, subject to the limitations in of ASME A18.1 ‘‘Safety Standard for § 890.9. The device is also exempt from Platform Lifts and Stairway Chair the current good manufacturing prac- Lifts’’) must demonstrate that the tice requirements of the quality sys- safety controls are adequate to prevent tem regulation in part 820 of this chap- a free fall of the platform in the event ter, with the exception of § 820.180, re- of a device failure; garding general requirements con- (ii) Appropriate analysis and nonclin- cerning records, and § 820.198, regarding ical testing (such as that outlined in complaint files. the currently FDA-recognized edition of ASME A18.1 ‘‘Safety Standard for [61 FR 8439, Mar. 4, 1996, as amended at 66 FR 38817, July 25, 2001] Platform Lifts and Stairway Chair Lifts’’) must demonstrate the ability of § 890.3920 Wheelchair component. the device to withstand the rated load with an appropriate factor of safety; (a) Identification. A wheelchair com- (iii) Appropriate analysis and non- ponent is a device intended for medical clinical testing (such as that outlined purposes that is generally sold as an in the currently FDA-recognized edi- integral part of a wheelchair, but may tion of ASME A18.1 ‘‘Safety Standard also be sold separately as a replace- for Platform Lifts and Stairway Chair ment part. Examples of wheelchair Lifts’’) must demonstrate the ability of components are the following: Arm- the enclosures to prevent the user from rest, narrowing attachment, belt, ex- falling from the device; and tension brake, curb climber, cushion, (iv) Appropriate analysis and non- antitip device, footrest, handrim, hill clinical testing (such as that outlined holder, leg rest, heel loops, and toe in the currently FDA-recognized edi- loops. tions of AAMI/ANSI/IEC 60601–1–2, (b) Classification. Class I (general con- ‘‘Medical Electrical Equipment—Part trols). The device is exempt from the 1–2: General Requirements for Safety— premarket notification procedures in Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,’’ and ASME A18.1 ‘‘Safety

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Standard for Platform Lifts and Stair- subpart E of part 807 of this chapter, way Chair Lifts’’) must validate elec- subject to the limitations in § 890.9. If tromagnetic compatibility and elec- the device is not labeled or otherwise trical safety. represented as sterile, the device is (b) Portable wheelchair elevators—(1) also exempt from the current good Identification. A portable wheelchair el- manufacturing practice requirements evator is a motorized lift device that is of the quality system regulation in not permanently mounted in one loca- part 820 of this chapter, with the exception and that is intended for use in tion of § 820.180, regarding general re- mitigating mobility impairment quirements concerning records and caused by injury or other disease by § 820.198, regarding complaint files. providing a means to move a person, [48 FR 53047, Nov. 23, 1983, as amended at 66 with or without a wheelchair, from one FR 38817, July 25, 2001] level to another (e.g., portable platform lifts, attendant-operated stair § 890.5100 Immersion hydrobath. climbing devices for wheelchairs). (a) Identification. An immersion (2) Classification. Class II. hydrobath is a device intended for med- [78 FR 14015, Mar. 4, 2013] ical purposes that consists of water agitators and that may include a tub § 890.3940 Wheelchair platform scale. to be filled with water. The water tem- (a) Identification. A wheelchair plat- perature may be measured by a gauge. form scale is a device with a base de- It is used in hydrotherapy to relieve signed to accommodate a wheelchair. pain and itching and as an aid in the It is intended for medical purposes to healing process of inflamed and trau- weigh a person who is confined to a matized tissue, and it serves as a set- wheelchair. ting for removal of contaminated tis- (b) Classification. Class I (general con- sue. trols). The device is exempt from the (b) Classification. Class II (perform- premarket notification procedures in ance standards). subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The § 890.5110 Paraffin bath. device is also exempt from the current (a) Identification. A paraffin bath is a good manufacturing practice require- device intended for medical purposes ments of the quality system regulation that consists of a tub to be filled with in part 820 of this chapter, with the ex- liquid paraffin (wax) and maintained at ception of § 820.180, regarding general an elevated temperature in which the requirements concerning records and patient’s appendages (e.g., hands or fin- § 820.198, regarding complaint files. gers) are placed to relieve pain and stiffness. [48 FR 53047, Nov. 23, 1983, as amended at 59 (b) Classification. Class II (perform- FR 63015, Dec. 7, 1994; 66 FR 38817, July 25, 2001] ance standards). § 890.5125 Nonpowered sitz bath. Subpart E [Reserved] (a) Identification. A nonpowered sitz bath is a device intended for medical Subpart F—Physical Medicine purposes that consists of a tub to be Therapeutic Devices filled with water for use in external hydrotherapy to relieve pain or § 890.5050 Daily activity assist device. pruritis and to accelerate the healing (a) Identification. A daily activity as- of inflamed or traumatized tissues of sist device is a modified adaptor or the perianal and perineal areas. utensil (e.g., a dressing, grooming, rec- (b) Classification. Class I (general con- reational activity, transfer, eating, or trols). The device is exempt from the homemaking aid) that is intended for premarket notification procedures in medical purposes to assist a patient to subpart E of part 807 of this chapter, perform a specific function. subject to the limitations in § 890.9. The (b) Classification. Class I (general con- device is also exempt from the current trols). The device is exempt from the good manufacturing practice require- premarket notification procedures in ments of the quality system regulation

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in part 820 of this chapter, with the ex- (v) Appropriate analysis and nonclin- ception of § 820.180, regarding general ical testing must demonstrate the re- requirements concerning records and sistance of the device upholstery to ig- § 820.198, regarding complaint files. nition. [48 FR 53047, Nov. 23, 1983, as amended at 54 (b) All other powered patient trans- FR 25052, June 12, 1989; 66 FR 38818, July 25, port—(1) Identification. A powered pa- 2001] tient transport is a motorized device intended for use in mitigating mobility § 890.5150 Powered patient transport. impairment caused by injury or other (a) Powered patient stairway chair disease by moving a person from one lifts—(1) Identification. A powered pa- location or level to another, such as up tient stairway chair lift is a motorized and down flights of stairs (e.g., attend- lift equipped with a seat and perma- ant-operated portable stair-climbing nently mounted in one location that is chairs). This generic type of device intended for use in mitigating mobility does not include motorized three- impairment caused by injury or other disease by moving a person up and wheeled vehicles or wheelchairs. down a stairway. (2) Classification. Class II. (2) Classification. Class II. The stair- [78 FR 14017, Mar. 4, 2013] way chair lift is exempt from premarket notification procedures in sub- § 890.5160 Air-fluidized bed. part E of part 807 of this chapter, sub- (a) Identification. An air-fluidized bed ject to § 890.9 and the following conditions for exemption: is a device employing the circulation of (i) Appropriate analysis and nonclin- filtered air through ceramic spherules ical testing (such as that outlined in (small, round ceramic objects) that is the currently FDA-recognized edition intended for medical purposes to treat of American Society of Mechanical En- or prevent bedsores, to treat severe or gineers (ASME) A18.1 ‘‘Safety Standard extensive burns, or to aid circulation. for Platform Lifts and Stairway Chair (b) Classification. Class II (special Lifts’’) must demonstrate that the controls). The device is exempt from safety controls are adequate to prevent the premarket notification procedures a free fall of the chair in the event of in subpart E of part 807 of this chapter a device failure; subject to § 890.9. (ii) Appropriate analysis and nonclinical testing must demonstrate the abil- [48 FR 53047, Nov. 23, 1983, as amended at 63 ity of the device, including armrests, FR 59231, Nov. 3, 1998] to withstand the rated load with an ap- § 890.5170 Powered flotation therapy propriate factor of safety; bed. (iii) Appropriate restraints must be provided to prevent the user from fall- (a) Identification. A powered flotation ing from the device (such as that out- therapy bed is a device that is equipped lined in the currently FDA-recognized with a mattress that contains a large edition of ASME A18.1 ‘‘Safety Stand- volume of constantly moving water, ard for Platform Lifts and Stairway air, mud, or sand. It is intended for Chair Lifts’’); medical purposes to treat or prevent a (iv) Appropriate analysis and non- patient’s bedsores, to treat severe or clinical testing (such as that outlined extensive burns, or to aid circulation. in the currently FDA-recognized edi- The mattress may be electrically heat- tions of AAMI/ANSI/IEC 60601–1–2, ed. ‘‘Medical Electrical Equipment—Part (b) Classification. Class II (special 1–2: General Requirements for Safety— controls). The device is exempt from Collateral Standard: Electromagnetic the premarket notification procedures Compatibility—Requirements and in subpart E of part 807 of this chapter Tests,’’ and ASME A18.1 ‘‘Safety subject to § 890.9. Standard for Platform Lifts and Stair- way Chair Lifts’’) must validate elec- [48 FR 53047, Nov. 23, 1983, as amended at 63 tromagnetic compatibility and elec- FR 59231, Nov. 3, 1998] trical safety; and

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§ 890.5180 Manual patient rotation for the treatment of selected medical bed. conditions such as relief of pain, mus- (a) Identification. A manual patient cle spasms, and joint contractures, but rotation bed is a device that turns a not for the treatment of malignancies. patient who is restricted to a reclining (2) Classification. Class II (perform- position. It is intended for medical pur- ance standards). poses to treat or prevent bedsores, to (b) Microwave diathermy for all other treat severe and extensive burns, or to uses—(1) Identification. A microwave di- aid circulation. athermy for all other uses except for (b) Classification. Class I (general con- the treatment of malignancies is a de- trols). The device is exempt from the vice that applies to the body electro- premarket notification procedures in magnetic energy in the microwave frequency bands of 915 megahertz to 2,450 subpart E of part 807 of this chapter megahertz and that is intended for the subject to § 890.9. treatment of medical conditions by [48 FR 53047, Nov. 23, 1963, as amended at 65 means other than the generation of FR 2322, Jan. 14, 2000] deep heat within body tissues as described in paragraph (a) of this section. § 890.5225 Powered patient rotation (2) Classification. Class III (premarket bed. approval). (a) Identification. A powered patient (c) Date PMA or notice of completion of rotation bed is a device that turns a PDP is required. A PMA or a notice of patient who is restricted to a reclining completion of a PDP for a device deposition. It is intended for medical pur- scribed in paragraph (b) of this section poses to treat or prevent bedsores, to is required to be filed with the Food treat severe and extensive burns, uri- and Drug Administration on or before nary tract blockage, and to aid circula- July 13, 1999, for any microwave diation. thermy described in paragraph (b) of (b) Classification. Class II (special this section that was in commercial controls). The device is exempt from distribution before May 28, 1976, or that the premarket notification procedures has, on or before July 13, 1999, been in subpart E of part 807 of this chapter found to be substantially equivalent to subject to § 890.9. a microwave diathermy described in [48 FR 53047, Nov. 23, 1983, as amended at 63 paragraph (b) of this section that was FR 59231, Nov. 3, 1998] in commercial distribution before May 28, 1976. Any other microwave dia- § 890.5250 Moist steam cabinet. thermy described in paragraph (b) of (a) Identification. A moist steam cabi- this section shall have an approved net is a device intended for medical PMA or declared completed PDP in ef- purposes that delivers a flow of heated, fect before being placed in commercial moisturized air to a patient in an en- distribution. closed unit. It is used to treat arthritis [48 FR 53047, Nov. 23, 1983, as amended at 52 and fibrosis (a formation of fibrosis tis- FR 17742, May 11, 1987; 64 FR 18331, Apr. 14, sue) and to increase local blood flow. 1999] (b) Classification. Class II (performance standards). § 890.5290 Shortwave diathermy. (a) Shortwave diathermy for use in ap- § 890.5275 Microwave diathermy. plying therapeutic deep heat for selected (a) Microwave diathermy for use in ap- medical conditions—(1) Identification. A plying therapeutic deep heat for selected shortwave diathermy for use in apply- medical conditions—(1) Identification. A ing therapeutic deep heat for selected microwave diathermy for use in apply- medical conditions is a device that ap- ing therapeutic deep heat for selected plies to specific areas of the body elec- medical conditions is a device that ap- tromagnetic energy in the radio- plies to specific areas of the body elec- frequency (RF) bands of 13.56 mega- tromagnetic energy in the microwave hertz (MHz) or 27.12 MHz and that is in- frequency bands of 915 megahertz to tended to generate deep heat within 2,450 megahertz and that is intended to body tissues for the treatment of se- generate deep heat within body tissues lected medical conditions such as relief

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of pain, muscle spasms, and joint con- (I) Characterization of the deposited tractures, but not for the treatment of energy density in saline gel test load or malignancies. other appropriate model. (2) Classification. Class II (perform- (iv) A detailed summary of the clin- ance standards). ical testing pertinent to use of the de- (b) Nonthermal shortwave therapy—(1) vice to demonstrate the effectiveness Identification. A nonthermal shortwave of the device in its intended use. therapy is a prescription device that (v) Labeling must include the fol- applies to the body pulsed electro- lowing: magnetic energy in the RF bands of (A) Output characteristics of the de- 13.56 MHz or 27.12 MHz and that is in- vice; tended for adjunctive use in the pallia- (B) Recommended treatment re- tive treatment of postoperative pain gimes, including duration of use; and and edema of soft tissue by means (C) A detailed summary of the clin- other than the generation of deep heat ical testing pertinent to the use of the within body tissues as described in device and a summary of the adverse paragraph (a) of this section. events and complications. (2) Classification: Class II (special con- (vi) Nonthermal shortwave therapy trols). The device is classified as class devices marketed prior to the effective II. The special controls for this device date of this reclassification must sub- are: mit an amendment to their previously (i) Components of the device that cleared premarket notification (510(k)) come into human contact must be dem- demonstrating compliance with these onstrated to be biocompatible. special controls. (ii) Appropriate analysis/testing must [48 FR 53047, Nov. 23, 1983, as amended at 52 demonstrate that the device is elec- FR 17742, May 11, 1987; 80 FR 61302, Oct. 13, trically safe and electromagnetically 2015] compatible in its intended use environ- § 890.5300 Ultrasonic diathermy. ment. (iii) Non-clinical performance testing (a) Ultrasonic diathermy for use in ap- must demonstrate that the device per- plying therapeutic deep heat for selected forms as intended under anticipated medical conditions—(1) Identification. An conditions of use. Non-clinical per- ultrasonic diathermy for use in apply- formance testing must characterize the ing therapeutic deep heat for selected output waveform of the device and medical conditions is a device that ap- demonstrate that the device meets applies to specific areas of the body ultra- propriate output performance speci- sonic energy at a frequency beyond 20 fications. The output characteristics kilohertz and that is intended to gen- and the methods used to determine erate deep heat within body tissues for these characteristics, including the fol- the treatment of selected medical con- lowing, must be determined: ditions such as relief of pain, muscle spasms, and joint contractures, but not (A) Peak output power; for the treatment of malignancies. (B) Pulse width; (2) Classification. Class II (perform- (C) Pulse frequency; ance standards). (D) Duty cycle; (b) Ultrasonic diathermy for all other (E) Characteristics of other types of uses—(1) Identification. An ultrasonic modulation that may be used; diathermy for all other uses except for (F) Average measured output pow- the treatment of malignancies is a de- ered into the RF antenna/applicator; vice that applies to the body ultrasonic (G) Specific absorption rates in sa- energy at a frequency beyond 20 kilo- line gel test load or other appropriate hertz and that is intended for the model; treatment of medical conditions by (H) Characterization of the electrical means other than the generation of and magnetic fields in saline gel test deep heat within body tissues as de- load or other appropriate model for scribed in paragraph (a) of this section. each RF antenna and prescribed RF an- (2) Classification. Class III (premarket tenna orientation/position; and approval).

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(c) Date PMA or notice of completion of pulse rate monitor, that provide infor- PDP is required. A PMA or notice of mation used for physical evaluation completion of a PDP for a device de- and physical planning purposes., Exam- scribed in paragraph (b) of this section ples include a therapeutic exercise bi- is required to be filed with the Food cycle with measuring instrumentation, and Drug Administration on or before a manually propelled treadmill with July 13, 1999, for any ultrasonic dia- measuring instrumentation, and a row- thermy described in paragraph (b) of ing machine with measuring instru- this section that was in commercial mentation. distribution before May 28, 1976, or that (b) Classification. Class II (perform- has, on or before July 13, 1999, been ance standards). found to be substantially equivalent to an ultrasonic diathermy described in § 890.5370 Nonmeasuring exercise paragraph (b) of this section that was equipment. in commercial distribution before May 28, 1976. Any other ultrasonic dia- (a) Identification. Nonmeasuring exer- thermy described in paragraph (b) of cise equipment consist of devices in- this section shall have an approved tended for medical purposes, such as to PMA or declared completed PDP in ef- redevelop muscles or restore motion to fect before being placed in commercial joints or for use as an adjunct treat- distribution. ment for obesity. Examples include a prone scooter board, parallel bars, a [48 FR 53047, Nov. 23, 1983, as amended at 52 mechanical treadmill, an exercise FR 17742, May 11, 1987; 64 FR 18331, Apr. 14, 1999] table, and a manually propelled exercise bicycle. § 890.5350 Exercise component. (b) Classification. Class I (general con- (a) Identification. An exercise compo- trols). The device is exempt from the nent is a device that is used in conjunc- premarket notification procedures in tion with other forms of exercise and subpart E of part 807 of this chapter, that is intended for medical purposes, subject to the limitations in § 890.9. The such as to redevelope muscles or re- device is also exempt from the current store motion to joints or for use as an good manufacturing practice require- adjunct treatment for obesity. Exam- ments of the quality system regulation ples include weights, dumbbells, straps, in part 820 of this chapter, with the ex- and adaptive hand mitts. ception of § 820.180, regarding general (b) Classification. Class I (general con- requirements concerning records and trols). The device is exempt from the § 820.198, regarding complaint files. premarket notification procedures in [48 FR 53047, Nov. 23, 1983, as amended at 66 subpart E of part 807 of this chapter, FR 38818, July 25, 2001] subject to the limitations in § 890.9. The device is also exempt from the current § 890.5380 Powered exercise equip- good manufacturing practice requirement. ments of the quality system regulation in part 820 of this chapter, with the ex- (a) Identification. Powered exercise ception of § 820.180, regarding general equipment consist of powered devices requirements concerning records and intended for medical purposes, such as § 820.198, regarding complaint files. to redevelop muscles or restore motion to joints or for use as an adjunct treat- [48 FR 53047, Nov. 23, 1983, as amended at 66 ment for obesity. Examples include a FR 38818, July 25, 2001] powered treadmill, a powered bicycle, § 890.5360 Measuring exercise equip- and powered parallel bars. ment. (b) Classification. Class I (general con- (a) Identification. Measuring exercise trols). The device is exempt from the equipment consist of manual devices premarket notification procedures in intended for medical purposes, such as subpart E of part 807 of this chapter, to redevelop muscles or restore motion subject to the limitations in § 890.9. to joints or for use as an adjunct treat- [48 FR 53047, Nov. 23, 1983, as amended at 61 ment for obesity. These devices also in- FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, clude instrumentation, such as the 2001]

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§ 890.5410 Powered finger exerciser. (2) Classification. Class II (special controls). The device is classified as class (a) Identification. A powered finger ex- II. The special controls for this device erciser is a device intended for medical are: purposes to increase flexion and the ex- (i) The following performance testing tension range of motion of the joints of must be conducted: the second to the fifth fingers of the hand. (A) Testing using a drug approved for iontophoretic delivery, or a solution, if (b) Classification. Class I (general con- identified in the labeling, to dem- trols). The device is exempt from the onstrate safe use of the device as in- premarket notification procedures in tended; subpart E of part 807 of this chapter, subject to the limitations in § 890.9. (B) Testing of the ability of the device to maintain a safe pH level; and [48 FR 53047, Nov. 23, 1983, as amended at 61 (C) If used in the ear, testing of the FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, device to demonstrate mechanical safe- 2001] ty. (ii) Labeling must include adequate § 890.5500 Infrared lamp. instructions for use, including suffi- (a) Identification. An infrared lamp is cient information for the health care a device intended for medical purposes provider to determine the device char- that emits energy at infrared fre- acteristics that affect delivery of the quencies (approximately 700 nano- drug or solution and to select appro- meters to 50,000 nanometers) to provide priate drug or solution dosing informa- topical heating. tion for administration by ionto- (b) Classification. Class II (perform- phoresis. This includes the following: ance standards). (A) A description and/or graphical representation of the electrical output; § 890.5525 Iontophoresis device. (B) A description of the electrode ma- (a) Iontophoresis device intended for terials and pH buffer; certain specified uses—(1) Identification. (C) When intended for general drug An iontophoresis device is a device delivery, language referring the user to that is intended to use a direct current drug labeling approved for to introduce ions of soluble salts or iontophoretic delivery to determine if other drugs into the body and induce the drug they intend to deliver is spe- sweating for use in the diagnosis of cifically approved for use with that cystic fibrosis or for other uses if the type of device and to obtain relevant labeling of the drug intended for use dosing information; and with the device bears adequate direc- (D) A detailed summary of the de- tions for the device’s use with that vice-related and procedure-related drug. When used in the diagnosis of complications pertinent to use of the cystic fibrosis, the sweat is collected device, and appropriate warnings and and its composition and weight are de- contraindications, including the fol- termined. lowing warning: (2) Classification. Class II (perform- Warning: Potential systemic adverse ance standards). effects may result from use of this de- (b) Iontophoresis device intended for vice. Drugs or solutions delivered with any other purposes—(1) Identification. An this device have the potential to reach iontophoresis device intended for any the blood stream and cause systemic other purposes is a prescription device effects. Carefully read all labeling of that is intended to use a current to in- the drug or solution used with this de- troduce ions of drugs or non-drug solu- vice to understand all potential ad- tions into the body for medical pur- verse effects and to ensure appropriate poses other than those specified in dosing information. If systemic mani- paragraph (a) of this section, meaning festations occur, refer to the drug or that the device is not intended for use solution labeling for appropriate ac- in diagnosis of cystic fibrosis, or a spe- tion. cific drug is not specified in the label- (iii) Appropriate analysis/testing ing of the iontophoresis device. must demonstrate electromagnetic

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compatibility, electrical safety, ther- subpart E of part 807 of this chapter, mal safety, and mechanical safety. subject to the limitations in § 890.9. (iv) Appropriate software [48 FR 53047, Nov. 23, 1983, as amended at 61 verification, validation, and hazard FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, analysis must be performed. 2001] (v) The elements of the device that may contact the patient must be dem- § 890.5700 Cold pack. onstrated to be biocompatible. (a) Identification. A cold pack is a de- (vi) The elements of the device that vice intended for medical purposes that may contact the patient must be as- consists of a compact fabric envelope sessed for sterility, for devices labeled containing a specially hydrated pliable as sterile. silicate gel capable of forming to the (vii) Performance data must support contour of the body and that provides the shelf life of the elements of the de- cold therapy for body surfaces. vice that may be affected by aging by (b) Classification. Class I (general con- demonstrating continued package in- trols). The device is exempt from the tegrity and device functionality over premarket notification procedures in the stated shelf life. subpart E of part 807. The device also is exempt from the current good manu- [48 FR 53047, Nov. 23, 1983, as amended at 52 facturing practice requirements of the FR 17742, May 11, 1987; 81 FR 48706, July 26, quality system regulation in part 820, 2016] with the exception of § 820.180, with respect to general requirements con- § 890.5575 Powered external limb over- cerning records, and § 820.198, with re- load warning device. spect to complaint files. (a) Identification. A powered external limb overload warning device is a de- § 890.5710 Hot or cold disposable pack. vice intended for medical purposes to (a) Identification. A hot or cold dis- warn a patient of an overload or an posable pack is a device intended for underload in the amount of pressure medical purposes that consists of a placed on a leg. sealed plastic bag incorporating chemi- (b) Classification. Class II (perform- cals that, upon activation, provides hot ance standards). or cold therapy for body surfaces. (b) Classification. Class I (general con- § 890.5650 Powered inflatable tube trols). Except when intended for use on massager. infants, the device is exempt from the (a) Identification. A powered inflat- premarket notification procedures in able tube massager is a powered device subpart E of part 807 of this chapter intended for medical purposes, such as subject to § 890.9. to relieve minor muscle aches and [48 FR 53047, Nov. 23, 1963, as amended at 65 pains and to increase circulation. It FR 2322, Jan. 14, 2000] simulates kneading and stroking of tissues with the hands by use of an inflat- § 890.5720 Water circulating hot or able pressure cuff. cold pack. (b) Classification. Class II (perform- (a) Identification. A water circulating ance standards). hot or cold pack is a device intended for medical purposes that operates by § 890.5660 Therapeutic massager. pumping heated or chilled water (a) Identification. A therapeutic mas- through a plastic bag and that provides sager is an electrically powered device hot or cold therapy for body surfaces. intended for medical purposes, such as (b) Classification. Class II (special to relieve minor muscle aches and controls). The device is exempt from pains. the premarket notification procedures in subpart E of part 807 of this chapter (b) Classification. Class I (general con- subject to § 890.9. trols). The device is exempt from the premarket notification procedures in [48 FR 53047, Nov. 23, 1983, as amended at 63 FR 59231, Nov. 3, 1998]

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§ 890.5730 Moist heat pack. to the paravertebral tissues for muscular relaxation and neuro-inhibition. (a) Identification. A moist heat pack It consists of a table with an adjustable is a device intended for medical pur- overhead weight that, in place of the poses that consists of silica gel in a therapist’s hands, presses on the back fabric container used to retain an ele- of a prone patient. vated temperature and that provides moist heat therapy for body surfaces. (b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter, subpart E of part 807 of this chapter, subject to the limitations in § 890.9. subject to the limitations in § 890.9. The [48 FR 53047, Nov. 23, 1983, as amended at 59 device is also exempt from the current FR 63015, Dec. 7, 1994; 66 FR 38818, July 25, good manufacturing practice require- 2001] ments of the quality system regulation in part 820 of this chapter, with the ex- § 890.5850 Powered muscle stimulator. ception of § 820.180, regarding general (a) Identification. A powered muscle requirements concerning records and stimulator is an electrically powered § 820.198, regarding complaint files. device intended for medical purposes [48 FR 53047, Nov. 23, 1983, as amended at 66 that repeatedly contracts muscles by FR 38818, July 25, 2001] passing electrical currents through electrodes contacting the affected body § 890.5740 Powered heating pad. area. (a) Identification. A powered heating (b) Classification. Class II (perform- pad is an electrical device intended for ance standards). medical purposes that provides dry heat therapy for body surfaces. It is ca- § 890.5860 Ultrasound and muscle stimulator. pable of maintaining an elevated temperature during use. (a) Ultrasound and muscle stimulator (b) Classification. Class II (special for use in applying therapeutic deep heat controls). The device is exempt from for selected medical conditions—(1) Identi- the premarket notification procedures fication. An ultrasound and muscle in subpart E part 807 of this chapter stimulator for use in applying thera- subject to § 890.9. peutic deep heat for selected medical conditions is a device that applies to [48 FR 53047, Nov. 23, 1983, as amended at 63 specific areas of the body ultrasonic FR 59231, Nov. 3, 1998] energy at a frequency beyond 20 kilo- § 890.5760 Nonpowered lower extrem- hertz and that is intended to generate ity pressure wrap. deep heat within body tissues for the treatment of selected medical condi- (a) Identification. A nonpowered lower tions such as relief of pain, muscle extremity pressure wrap is a prescrip- spasms, and joint contractures, but not tion device that applies mechanical for the treatment of malignancies. The pressure by wrapping around the lower device also passes electrical currents extremity, such as the leg or foot, and through the body area to stimulate or is intended for primary Restless Leg relax muscles. Syndrome. (2) Classification. Class II (perform- (b) Classification. Class I (general con- ance standards). trols). The device is exempt from the premarket notification procedures in (b) Ultrasound and muscle stimulator subpart E of part 807 of this chapter, for all other uses—(1) Identification. An subject to the limitations in § 890.9. ultrasound and muscle stimulator for all other uses except for the treatment [79 FR 37950, July 3, 2014] of malignancies is a device that applies to the body ultrasonic energy at a fre- § 890.5765 Pressure-applying device. quency beyond 20 kilohertz and applies (a) Identification. A pressure-applying to the body electrical currents and device is a device intended for medical that is intended for the treatment of purposes to apply continuous pressure medical conditions by means other

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than the generation of deep heat with- to aid in exerting therapeutic pulling in body tissues and the stimulation or forces on the patient’s body. This ge- relaxation of muscles as described in neric type of device includes the pul- paragraph (a) of this section. ley, strap, head halter, and pelvic belt. (2) Classification. Class III (premarket (b) Classification. Class I (general con- approval). trols). The device is exempt from the (c) Date PMA or notice of completion of premarket notification procedures in PDP is required. A PMA or notice of subpart E of part 807 of this chapter, completion of a PDP for a device de- subject to the limitations in § 890.9. The scribed in paragraph (b) of this section device is also exempt from the current is required to be filed with the Food good manufacturing practice require- and Drug Administration on or before ments of the quality system regulation July 13, 1999 for any ultrasound and in part 820 of this chapter, with the ex- muscle stimulator described in para- ception of § 820.180, regarding general graph (b) of this section that was in requirements concerning records and commercial distribution before May 28, § 820.198, regarding complaint files. 1976, or that has, on or before July 13, 1999, been found to be substantially [48 FR 53047, Nov. 23, 1983, as amended at 61 equivalent to an ultrasound and muscle FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, stimulator described in paragraph (b) 2001] of this section that was in commercial distribution before May 28, 1976. Any § 890.5940 Chilling unit. other ultrasound and muscle stimu- (a) Identification. A chilling unit is a lator described in paragraph (b) of this refrigerative device intended for med- section shall have an approved PMA or ical purposes to chill and maintain declared completed PDP in effect be- cold packs at a reduced temperature. fore being placed in commercial dis- (b) Classification. Class I (general con- tribution. trols). The device is exempt from the [48 FR 53047, Nov. 23, 1983, as amended at 52 premarket notification procedures in FR 17742, May 11, 1987; 64 FR 18331, Apr. 14, subpart E of part 807 of this chapter, 1999] subject to the limitations in § 890.9

§ 890.5880 Multi-function physical [48 FR 53047, Nov. 23, 1983, as amended at 61 therapy table. FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 2001] (a) Identification. A multi-function physical therapy table is a device in- § 890.5950 Powered heating unit. tended for medical purposes that con- (a) Identification. A powered heating sists of a motorized table equipped to unit is a device intended for medical provide patients with heat, traction, purposes that consists of an encased and muscle relaxation therapy. cabinet containing hot water and that (b) Classification. Class II (perform- is intended to heat and maintain hot ance standards). packs at an elevated temperature. § 890.5900 Power traction equipment. (b) Classification. Class I (general controls). The device is exempt from the (a) Identification. Powered traction premarket notification procedures in equipment consists of powered devices subpart E of part 807 of this chapter, intended for medical purposes for use subject to the limitations in § 890.9. in conjunction with traction accessories, such as belts and harnesses, to [48 FR 53047, Nov. 23, 1983, as amended at 61 exert therapeutic pulling forces on the FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, patient’s body. 2001] (b) Classification. Class II (performance standards). § 890.5975 Therapeutic vibrator. (a) Identification. A therapeutic vibra- § 890.5925 Traction accessory. tor is an electrically powered device in- (a) Identification. A traction acces- tended for medical purposes that incor- sory is a nonpowered accessory device porates various kinds of pads and that intended for medical purposes to be is held in the hand or attached to the used with powered traction equipment hand or to a table. It is intended for

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various uses, such as relaxing muscles 892.1670 Spot-film device. and relieving minor aches and pains. 892.1680 Stationary x-ray system. (b) Classification. Class I (general con- 892.1700 Diagnostic x-ray high voltage gen- trols). The device is exempt from the erator. 892.1710 Mammographic x-ray system. premarket notification procedures in 892.1715 Full-field digital mammography subpart E of part 807 of this chapter, system. subject to the limitations in § 890.9. 892.1720 Mobile x-ray system. 892.1730 Photofluorographic x-ray system. [48 FR 53047, Nov. 23, 1983, as amended at 61 892.1740 Tomographic x-ray system. FR 1125, Jan. 16, 1996; 66 FR 38818, July 25, 892.1750 Computed tomography x-ray sys- 2001] tem. 892.1760 Diagnostic x-ray tube housing as- PART 892—RADIOLOGY DEVICES sembly. 892.1770 Diagnostic x-ray tube mount. Subpart A—General Provisions 892.1820 Pneumoencephalographic chair. 892.1830 Radiologic patient cradle. Sec. 892.1840 Radiographic film. 892.1 Scope. 892.1850 Radiographic film cassette. 892.3 Effective dates of requirement for pre- 892.1860 Radiographic film/cassette changer. market approval. 892.1870 Radiographic film/cassette changer 892.9 Limitations of exemptions from sec- programmer. tion 510(k) of the Federal Food, Drug, 892.1880 Wall-mounted radiographic cassette and Cosmetic Act (the act). holder. 892.1890 Radiographic film illuminator. Subpart B—Diagnostic Devices 892.1900 Automatic radiographic film processor. 892.1000 Magnetic resonance diagnostic de- 892.1910 Radiographic grid. vice. 892.1920 Radiographic head holder. 892.1100 Scintillation (gamma) camera. 892.1940 Radiologic quality assurance in- 892.1110 Positron camera. strument. 892.1130 Nuclear whole body counter. 892.1950 Radiographic anthropomorphic 892.1170 Bone densitometer. phantom. 892.1180 Bone sonometer. 892.1960 Radiographic intensifying screen. 892.1200 Emission computed tomography 892.1970 Radiographic ECG/respirator syn- system. chronizer. 892.1220 Fluorescent scanner. 892.1980 Radiologic table. 892.1300 Nuclear rectilinear scanner. 892.1990 Transilluminator for breast evalua- 892.1310 Nuclear tomography system. tion. 892.1320 Nuclear uptake probe. 892.2010 Medical image storage device. 892.1330 Nuclear whole body scanner. 892.2020 Medical image communications de- 892.1350 Nuclear scanning bed. vice. 892.1360 Radionuclide dose calibrator. 892.2030 Medical image digitizer. 892.1370 Nuclear anthropomorphic phantom. 892.2040 Medical image hardcopy device. 892.1380 Nuclear flood source phantom. 892.2050 Picture archiving and communica- 892.1390 Radionuclide rebreathing system. tions system. 892.1400 Nuclear sealed calibration source. 892.1410 Nuclear electrocardiograph syn- Subparts C–E [Reserved] chronizer. 892.1420 Radionuclide test pattern phantom. Subpart F—Therapeutic Devices 892.1540 Nonfetal ultrasonic monitor. 892.1550 Ultrasonic pulsed doppler imaging 892.5050 Medical charged-particle radiation system. therapy system. 892.1560 Ultrasonic pulsed echo imaging sys- 892.5300 Medical neutron radiation therapy tem. system. 892.1570 Diagnostic ultrasonic transducer. 892.5650 Manual radionuclide applicator sys- 892.1600 Angiographic x-ray system. tem. 892.1610 Diagnostic x-ray beam-limiting de- 892.5700 Remote controlled radionuclide ap- vice. plicator system. 892.1620 Cine or spot fluorographic x-ray 892.5710 Radiation therapy beam-shaping camera. block. 892.1630 Electrostatic x-ray imaging system. 892.5730 Radionuclide brachytherapy source. 892.1640 Radiographic film marking system. 892.5740 Radionuclide teletherapy source. 892.1650 Image-intensified fluoroscopic x- 892.5750 Radionuclide radiation therapy sys- ray system. tem. 892.1660 Non-image-intensified fluoroscopic 892.5770 Powered radiation therapy patient x-ray system. support assembly.

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892.5780 Light beam patient position indi- proval) shall not be commercially dis- cator. tributed after the date shown in the 892.5840 Radiation therapy simulation sys- regulation classifying the device unless tem. 892.5900 X-ray radiation therapy system. the manufacturer has an approval 892.5930 Therapeutic x-ray tube housing as- under section 515 of the act (unless an sembly. exemption has been granted under section 520(g)(2) of the act). An approval Subpart G—Miscellaneous Devices under section 515 of the act consists of 892.6500 Personnel protective shield. FDA’s issuance of an order approving an application for premarket approval AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371. (PMA) for the device or declaring completed a product development protocol SOURCE: 53 FR 1567, Jan. 20, 1988, unless (PDP) for the device. otherwise noted. (a) Before FDA requires that a device EDITORIAL NOTE: Nomenclature changes to commercially distributed before the part 892 appear at 73 FR 35341, June 23, 2008. enactment date of the amendments, or a device that has been found substan- Subpart A—General Provisions tially equivalent to such a device, has an approval under section 515 of the § 892.1 Scope. act, FDA must promulgate a regula- (a) This part sets forth the classification under section 515(b) of the act re- tion of radiology devices intended for quiring such approval, except as pro- human use that are in commercial dis- vided in paragraph (b) of this section. tribution. Such a regulation under section 515(b) (b) The identification of a device in a of the act shall not be effective during regulation in this part is not a precise the grace period ending on the 90th day description of every device that is, or after its promulgation or on the last will be, subject to the regulation. A day of the 30th full calendar month manufacturer who submits a pre- after the regulation that classifies the market notification submission for a device into class III is effective, which- device under part 807 cannot show ever is later. See section 501(f)(2)(B) of merely that the device is accurately the act. Accordingly, unless an effec- described by the section title and identification provision of a regulation in tive date of the requirement for pre- this part but shall state why the device market approval is shown in the regu- is substantially equivalent to other de- lation for a device classified into class vices, as required by § 807.87. III in this part, the device may be com- (c) To avoid duplicative listings, a ra- mercially distributed without FDA’s diology device that has two or more issuance of an order approving a PMA types of uses (e.g., use both as a diag- or declaring completed a PDP for the nostic device and a therapeutic device) device. If FDA promulgates a regula- is listed in one subpart only. tion under section 515(b) of the act re- (d) References in this part to regu- quiring premarket approval for a de- latory sections of the Code of Federal vice, section 501(f)(1)(A) of the act ap- Regulations are to chapter I of this plies to the device. title 21, unless otherwise noted. (b) Any new, not substantially equiv- (e) Guidance documents referenced in alent, device introduced into commer- this part are available on the Internet cial distribution on or after May 28, at http://www.fda.gov/MedicalDevices/ 1976, including a device formerly mar- DeviceRegulationandGuidance/ keted that has been substantially al- GuidanceDocuments/default.htm.. tered, is classified by statute (section [53 FR 1567, Jan. 20, 1988, as amended at 73 513(f) of the act) into class III without FR 40969, July 17, 2008; 78 FR 18233, Mar. 26, any grace period and FDA must have 2013] issued an order approving a PMA or declaring completed a PDP for the device § 892.3 Effective dates of requirement before the device is commercially dis- for premarket approval. tributed unless it is reclassified. If A device included in this part that is FDA knows that a device being com- classified into class III (premarket ap- mercially distributed may be a ‘‘new’’

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device as defined in this section be- (c) The device is an in vitro device cause of any new intended use or other that is intended: reasons, FDA may codify the statutory (1) For use in the diagnosis, moni- classification of the device into class toring, or screening of neoplastic dis- III for such new use. Accordingly, the eases with the exception of regulation for such a class III device immunohistochemical devices; states that as of the enactment date of (2) For use in screening or diagnosis the amendments, May 28, 1976, the de- of familial or acquired genetic dis- vice must have an approval under sec- orders, including inborn errors of me- tion 515 of the act before commercial tabolism; distribution. (3) For measuring an analyte that serves as a surrogate marker for § 892.9 Limitations of exemptions from screening, diagnosis, or monitoring section 510(k) of the Federal Food, life-threatening diseases such as ac- Drug, and Cosmetic Act (the act). quired immune deficiency syndrome The exemption from the requirement (AIDS), chronic or active hepatitis, tu- of premarket notification (section berculosis, or myocardial infarction or 510(k) of the act) for a generic type of to monitor therapy; class I or II device is only to the extent (4) For assessing the risk of cardio- that the device has existing or reason- vascular diseases; ably foreseeable characteristics of (5) For use in diabetes management; commercially distributed devices with- (6) For identifying or inferring the in that generic type or, in the case of identity of a microorganism directly in vitro diagnostic devices, only to the from clinical material; extent that misdiagnosis as a result of (7) For detection of antibodies to using the device would not be associ- microorganisms other than ated with high morbidity or mortality. immunoglobulin G (IgG) or IgG assays Accordingly, manufacturers of any when the results are not qualitative, or commercially distributed class I or II are used to determine immunity, or the device for which FDA has granted an assay is intended for use in matrices exemption from the requirement of other than serum or plasma; premarket notification must still sub- (8) For noninvasive testing as defined mit a premarket notification to FDA in § 812.3(k) of this chapter; and before introducing or delivering for in- (9) For near patient testing (point of troduction into interstate commerce care). for commercial distribution the device when: [65 FR 2322, Jan. 14, 2000] (a) The device is intended for a use different from the intended use of a le- Subpart B—Diagnostic Devices gally marketed device in that generic type of device; e.g., the device is in- § 892.1000 Magnetic resonance diag- tended for a different medical purpose, nostic device. or the device is intended for lay use (a) Identification. A magnetic reso- where the former intended use was by nance diagnostic device is intended for health care professionals only; general diagnostic use to present im- (b) The modified device operates ages which reflect the spatial distribu- using a different fundamental sci- tion and/or magnetic resonance spectra entific technology than a legally mar- which reflect frequency and distribu- keted device in that generic type of de- tion of nuclei exhibiting nuclear mag- vice; e.g., a surgical instrument cuts netic resonance. Other physical param- tissue with a laser beam rather than eters derived from the images and/or with a sharpened metal blade, or an in spectra may also be produced. The de- vitro diagnostic device detects or iden- vice includes hydrogen-1 (proton) imag- tifies infectious agents by using ing, sodium-23 imaging, hydrogen-1 deoxyribonucleic acid (DNA) probe or spectroscopy, phosphorus-31 spectros- nucleic acid hybridization technology copy, and chemical shift imaging (pre- rather than culture or immunoassay serving simultaneous frequency and technology; or spatial information).

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(b) Classification. Class II. § 892.1170 Bone densitometer. [53 FR 5078, Feb. 1, 1989] (a) Identification. A bone densitometer is a device intended for medical § 892.1100 Scintillation (gamma) cam- purposes to measure bone density and era. mineral content by x-ray or gamma (a) Identification. A scintillation ray transmission measurements (gamma) camera is a device intended through the bone and adjacent tissues. to image the distribution of radio- This generic type of device may in- nuclides in the body by means of a pho- clude signal analysis and display equip- ton radiation detector. This generic ment, patient and equipment supports, type of device may include signal anal- component parts, and accessories. ysis and display equipment, patient (b) Classification. Class II. and equipment supports, radionuclide anatomical markers, component parts, § 892.1180 Bone sonometer. and accessories. (a) Identification. A bone sonometer is (b) Classification. Class I (general con- a device that transmits ultrasound en- trols). ergy into the human body to measure acoustic properties of bone that indi- [55 FR 48443, Nov. 20, 1990, as amended at 66 cate overall bone health and fracture FR 46953, Sept. 10, 2001] risk. The primary components of the § 892.1110 Positron camera. device are a voltage generator, a transmitting transducer, a receiving trans- (a) Identification. A positron camera ducer, and hardware and software for is a device intended to image the dis- reception and processing of the re- tribution of positron-emitting radio- ceived ultrasonic signal. nuclides in the body. This generic type (b) Classification. Class II (special of device may include signal analysis controls). The special control for this and display equipment, patient and device is FDA’s ‘‘Guidance for Industry equipment supports, radionuclide ana- and FDA Staff; Class II Special Con- tomical markers, component parts, and trols Guidance Document: Bone accessories. Sonometers.’’ See § 892.1(e) for the (b) Classification. Class I (general con- availability of this guidance document. trols). [73 FR 40969, July 17, 2008] [55 FR 48444, Nov. 20, 1990, as amended at 66 FR 46953, Sept. 10, 2001] § 892.1200 Emission computed tomography system. § 892.1130 Nuclear whole body (a) Identification. An emission com- counter. puted tomography system is a device (a) Identification. A nuclear whole intended to detect the location and dis- body counter is a device intended to tribution of gamma ray- and positron- measure the amount of radionuclides emitting radionuclides in the body and in the entire body. This generic type of produce cross-sectional images through device may include signal analysis and computer reconstruction of the data. display equipment, patient and equip- This generic type of device may in- ment supports, component parts, and clude signal analysis and display equip- accessories. ment, patient and equipment supports, (b) Classification. Class I (general con- radionuclide anatomical markers, com- trols). The device is exempt from the ponent parts, and accessories. premarket notification procedures in (b) Classification. Class II. subpart E of part 807 of this chapter, subject to the limitations in § 892.9. § 892.1220 Fluorescent scanner. (a) Identification. A fluorescent scan- [53 FR 1567, Jan. 20, 1988, as amended at 59 FR 63015, Dec. 7, 1994; 66 FR 38818, July 25, ner is a device intended to measure the 2001] induced fluorescent radiation in the body by exposing the body to certain x- [55 FR 48444, Nov. 20, 1990] rays or low-energy gamma rays. This

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generic type of device may include sig- subpart E of part 807 of this chapter nal analysis and display equipment, pa- subject to § 892.9. tient and equipment supports, compo- [55 FR 48444, Nov. 20, 1990, as amended at 65 nent parts and accessories. FR 2322, Jan. 14, 2000] (b) Classification. Class II. § 892.1330 Nuclear whole body scan- § 892.1300 Nuclear rectilinear scanner. ner. (a) Identification. A nuclear recti- (a) Identification. A nuclear whole linear scanner is a device intended to body scanner is a device intended to image the distribution of radionuclides measure and image the distribution of in the body by means of a detector (or radionuclides in the body by means of detectors) whose position moves in two a wide-aperture detector whose posi- directions with respect to the patient. tion moves in one direction with re- This generic type of device may inspect to the patient. This generic type of device may include signal analysis clude signal analysis and display equip- and display equipment, patient and ment, patient and equipment supports, equipment supports, radionuclide ana- radionuclide anatomical markers, com- tomical markers, component parts, and ponent parts, and accessories. accessories. (b) Classification. Class I (general con- (b) Classification. Class I (general controls). The device is exempt from the trols). The device is exempt from the premarket notification procedures in premarket notification procedures in subpart E of part 807 of this chapter, subpart E of part 807 of this chapter subject to the limitations in § 892.9. subject to § 892.9. [55 FR 48444, Nov. 20, 1990, as amended at 65 [55 FR 48444, Nov. 20, 1990, as amended at 65 FR 2322, Jan. 14, 2000; 66 FR 38818, July 25, FR 2322, Jan. 14, 2000] 2001] § 892.1350 Nuclear scanning bed. § 892.1310 Nuclear tomography system. (a) Identification. A nuclear scanning (a) Identification. A nuclear tomog- bed is an adjustable bed intended to raphy system is a device intended to support a patient during a nuclear detect nuclear radiation in the body medicine procedure. and produce images of a specific cross- (b) Classification. Class I (general con- sectional plane of the body by blurring trols). The device is exempt from the or eliminating detail from other premarket notification procedures in planes. This generic type of devices subpart E of part 807 of this chapter may include signal analysis and dis- subject to § 892.9. play equipment, patient and equipment [55 FR 48444, Nov. 20, 1990, as amended at 59 supports, radionuclide anatomical FR 63015, Dec. 7, 1994; 65 FR 2322, Jan. 14, markers, component parts, and acces- 2000] sories. (b) Classification. Class II. § 892.1360 Radionuclide dose calibrator. § 892.1320 Nuclear uptake probe. (a) Identification. A radionuclide dose calibrator is a radiation detection de- (a) Identification. A nuclear uptake vice intended to assay radionuclides probe is a device intended to measure before their administration to patients. the amount of radionuclide taken up (b) Classification. Class II. by a particular organ or body region. This generic type of device may in- § 892.1370 Nuclear anthropomorphic clude a single or multiple detector phantom. probe, signal analysis and display (a) Identification. A nuclear equipment, patient and equipment sup- anthropomorphic phantom is a human ports, component parts, and acces- tissue facsimile that contains a radio- sories. active source or a cavity in which a ra- (b) Classification. Class I (general con- dioactive sample can be inserted. It is trols). The device is exempt from the intended to calibrate nuclear uptake premarket notification procedures in probes or other medical instruments.

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(b) Classification. Class I (general con- subpart E of part 807 of this chapter, trols). The device is exempt from the subject to the limitations in § 892.9. premarket notification procedures in [53 FR 1567, Jan. 20, 1988, as amended at 54 subpart E of part 807 of this chapter, FR 13832, Apr. 5, 1989; 66 FR 38819, July 25, subject to the limitations in § 892.9. 2001] [53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989; 66 FR 38818, July 25, § 892.1410 Nuclear electrocardiograph 2001] synchronizer. (a) Identification. A nuclear electro- § 892.1380 Nuclear flood source phan- cardiograph synchronizer is a device tom. intended for use in nuclear radiology to (a) Identification. A nuclear flood relate the time of image formation to source phantom is a device that con- the cardiac cycle during the production sists of a radiolucent container filled of dynamic cardiac images. with a uniformly distributed solution (b) Classification. Class I (general con- of a desired radionuclide. It is intended trols). The device is exempt from the to calibrate a medical gamma camera- premarket notification procedures in collimator system for uniformity of re- subpart E of part 807 of this chapter sponse. subject to § 892.9. (b) Classification. Class I (general con- [55 FR 48444, Nov. 20, 1990, as amended at 65 trols). The device is exempt from the FR 2322, Jan. 14, 2000] premarket notification procedures in subpart E of part 807 of this chapter, § 892.1420 Radionuclide test pattern subject to the limitations in § 892.9. phantom. [53 FR 1567, Jan. 20, 1988, as amended at 54 (a) Identification. A radionuclide test FR 13832, Apr. 5, 1989; 66 FR 38819, July 25, pattern phantom is a device that con- 2001] sists of an arrangement of radiopaque or radioactive material sealed in a § 892.1390 Radionuclide rebreathing solid pattern intended to serve as a system. test for a performance characteristic of (a) Identification. A radionuclide re- a nuclear medicine imaging device. breathing system is a device intended (b) Classification. Class I (general con- to be used to contain a gaseous or vola- trols). The device is exempt from the tile radionuclide or a radionuclide-la- premarket notification procedures in beled aerosol and permit it to be re- subpart E of part 807 of this chapter, spired by the patient during nuclear subject to the limitations in § 892.9. medicine ventilatory tests (testing process of exchange between the lungs [53 FR 1567, Jan. 20, 1988, as amended at 54 FR 13832, Apr. 5, 1989; 66 FR 38819, July 25, and the atmosphere). This generic type 2001] of device may include signal analysis and display equipment, patient and § 892.1540 Nonfetal ultrasonic monitor. equipment supports, component parts, (a) Identification. A nonfetal ultra- and accessories. sonic monitor is a device that projects (b) Classification. Class II. a continuous high-frequency sound § 892.1400 Nuclear sealed calibration wave into body tissue other than a source. fetus to determine frequency changes (doppler shift) in the reflected wave (a) Identification. A nuclear sealed and is intended for use in the investiga- calibration source is a device that con- tion of nonfetal blood flow and other sists of an encapsulated reference nonfetal body tissues in motion. This radionuclide intended for calibration of generic type of device may include sig- medical nuclear radiation detectors. nal analysis and display equipment, pa- (b) Class I (general con- Classification. tient and equipment supports, compo- trols). The device is exempt from the nent parts, and accessories. premarket notification procedures in (b) Classification. Class II.

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§ 892.1550 Ultrasonic pulsed doppler equipment, patient and equipment sup- imaging system. ports, component parts, and acces- (a) Identification. An ultrasonic sories. pulsed doppler imaging system is a de- (b) Classification. Class II. vice that combines the features of continuous wave doppler-effect technology § 892.1610 Diagnostic x-ray beam-lim- with pulsed-echo effect technology and iting device. is intended to determine stationary (a) Identification. A diagnostic x-ray body tissue characteristics, such as beam-limiting device is a device such depth or location of tissue interfaces or as a collimator, a cone, or an aperture dynamic tissue characteristics such as intended to restrict the dimensions of a velocity of blood or tissue motion. This diagnostic x-ray field by limiting the generic type of device may include sig- size of the primary x-ray beam. nal analysis and display equipment, pa- (b) Classification. Class II. tient and equipment supports, component parts, and accessories. § 892.1620 Cine or spot fluorographic (b) Classification. Class II. x-ray camera. § 892.1560 Ultrasonic pulsed echo im- (a) Identification. A cine or spot fluo- aging system. rographic x-ray camera is a device in- (a) Identification. An ultrasonic tended to photograph diagnostic im- pulsed echo imaging system is a device ages produced by x-rays with an image intended to project a pulsed sound intensifier. beam into body tissue to determine the (b) Classification. Class II. depth or location of the tissue interfaces and to measure the duration of an § 892.1630 Electrostatic x-ray imaging acoustic pulse from the transmitter to system. the tissue interface and back to the re- (a) Identification. An electrostatic x- ceiver. This generic type of device may ray imaging system is a device in- include signal analysis and display tended for medical purposes that uses equipment, patient and equipment sup- an electrostatic field across a ports, component parts, and acces- semiconductive plate, a gas-filled sories. chamber, or other similar device to (b) Classification. Class II. convert a pattern of x-radiation into an electrostatic image and, subsequently, § 892.1570 Diagnostic ultrasonic trans- into a visible image. This generic type ducer. of device may include signal analysis (a) Identification. A diagnostic ultra- and display equipment, patient and sonic transducer is a device made of a equipment supports, component parts, piezoelectric material that converts and accessories. electrical signals into acoustic signals (b) Classification. Class II. and acoustic signals into electrical signals and intended for use in diagnostic § 892.1640 Radiographic film marking ultrasonic medical devices. Accessories system. of this generic type of device may in- (a) Identification. A radiographic film clude transmission media for acous- marking system is a device intended tically coupling the transducer to the for medical purposes to add identifica- body surface, such as acoustic gel, paste, or a flexible fluid container. tion and other information onto radio- (b) Classification. Class II. graphic film by means of exposure to visible light. § 892.1600 Angiographic x-ray system. (b) Classification. Class I (general con- (a) Identification. An angiographic x- trols). The device is exempt from the ray system is a device intended for premarket notification procedures in radiologic visualization of the heart, subpart E of part 807 of this chapter, blood vessels, or lymphatic system dur- subject to the limitations in § 892.9. ing or after injection of a contrast me- [55 FR 48444, Nov. 20, 1990, as amended at 59 dium. This generic type of device may FR 63015, Dec. 7, 1994; 66 FR 38819, July 25, include signal analysis and display 2001]

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§ 892.1650 Image-intensified § 892.1700 Diagnostic x-ray high volt- fluoroscopic x-ray system. age generator. (a) Identification. An image-intensi- (a) Identification. A diagnostic x-ray fied fluoroscopic x-ray system is a de- high voltage generator is a device that vice intended to visualize anatomical is intended to supply and control the structures by converting a pattern of electrical energy applied to a diag- x-radiation into a visible image nostic x-ray tube for medical purposes. through electronic amplification. This This generic type of device may in- generic type of device may include sig- clude a converter that changes alter- nal analysis and display equipment, pa- nating current to direct current, fila- tient and equipment supports, compo- ment transformers for the x-ray tube, nent parts, and accessories. high voltage switches, electrical pro- (b) Classification. Class II. When in- tective devices, or other appropriate tended as an accessory to the device elements. described in paragraph (a) of this sec- (b) Classification. Class I (general con- tion, the fluoroscopic compression de- trols). The device is exempt from the vice is exempt from the premarket no- premarket notification procedures in tification procedures in subpart E of subpart E of part 807 of this chapter, part 807 of this chapter subject to subject to the limitations in § 892.9. § 892.9. [53 FR 1567, Jan. 20, 1988, as amended at 61 [53 FR 1567, Jan. 20, 1988, as amended at 66 FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, FR 57369, Nov. 15, 2001] 2001]

§ 892.1660 Non-image-intensified § 892.1710 Mammographic x-ray sys- fluoroscopic x-ray system. tem. (a) Identification. A non-image-inten- (a) Identification. A mammographic x- sified fluoroscopic x-ray system is a de- ray system is a device intended to be vice intended to be used to visualize used to produce radiographs of the anatomical structures by using a fluo- breast. This generic type of device may rescent screen to convert a pattern of include signal analysis and display x-radiation into a visible image. This equipment, patient and equipment sup- generic type of device may include sig- ports, component parts, and acces- nal analysis and display equipment, pa- sories. tient and equipment supports, compo- (b) Classification. Class II. nent parts, and accessories. (b) Classification. Class II. § 892.1715 Full-field digital mammography system. § 892.1670 Spot-film device. (a) Identification. A full-field digital (a) Identification. A spot-film device mammography system is a device in- is an electromechanical component of tended to produce planar digital x-ray a fluoroscopic x-ray system that is in- images of the entire breast. This ge- tended to be used for medical purposes neric type of device may include dig- to position a radiographic film cassette ital mammography acquisition soft- to obtain radiographs during fluoros- ware, full-field digital image receptor, copy. acquisition workstation, automatic ex- (b) Classification. Class II. posure control, image processing and reconstruction programs, patient and § 892.1680 Stationary x-ray system. equipment supports, component parts, and accessories. (a) Identification. A stationary x-ray (b) Class II (special system is a permanently installed diag- Classification. controls). The special control for the nostic system intended to generate and device is FDA’s guidance document en- control x-rays for examination of var- titled ‘‘Class II Special Controls Guid- ious anatomical regions. This generic ance Document: Full-Field Digital type of device may include signal anal- Mammography System.’’ § 892.1(e) ysis and display equipment, patient See for the availability of this guidance and equipment supports, component document. parts, and accessories. (b) Classification. Class II. [75 FR 68203, Nov. 5, 2010]

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§ 892.1720 Mobile x-ray system. diagnostic purposes. This generic type (a) Identification. A mobile x-ray sys- of device may include high voltage and tem is a transportable device system filament transformers or other appro- intended to be used to generate and priate components. control x-ray for diagnostic procedures. (b) Classification. Class I (general con- This generic type of device may in- trols). The device is exempt from the clude signal analysis and display equip- premarket notification procedures in ment, patient and equipment supports, subpart E of part 807 of this chapter, component parts, and accessories. subject to the limitations in § 892.9. (b) Classification. Class II. [53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, § 892.1730 Photofluorographic x-ray 2001] system. (a) Identification. A § 892.1770 Diagnostic x-ray tube photofluorographic x-ray system is a mount. device that includes a fluoroscopic x- (a) Identification. A diagnostic x-ray ray unit and a camera intended to be tube mount is a device intended to sup- used to produce, then photograph, a port and to position the diagnostic x- fluoroscopic image of the body. This ray tube housing assembly for a med- generic type of device may include sig- ical radiographic procedure. nal analysis and display equipment, pa- (b) Classification. Class I (general con- tient and equipment supports, compo- trols). The device is exempt from the nent parts, and accessories. premarket notification procedures in (b) Classification. Class II. subpart E of part 807 of this chapter, subject to the limitations in § 892.9. § 892.1740 Tomographic x-ray system. (a) Identification. A tomographic x- [53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, ray system is an x-ray device intended 2001] to be used to produce radiologic images of a specific cross-sectional plane of § 892.1820 Pneumoencephalographic the body by blurring or eliminating de- chair. tail from other planes. This generic (a) Identification. A type of device may include signal anal- pneumoencephalographic chair is a ysis and display equipment, patient chair intended to support and position and equipment supports, component a patient during parts, and accessories. pneumoencephalography (x-ray imag- (b) Classification. Class II. ing of the brain). § 892.1750 Computed tomography x-ray (b) Classification. Class II. system. § 892.1830 Radiologic patient cradle. (a) Identification. A computed tomography x-ray system is a diagnostic x- (a) Identification. A radiologic patient ray system intended to produce cross- cradle is a support device intended to sectional images of the body by com- be used for rotational positioning puter reconstruction of x-ray trans- about the longitudinal axis of a patient mission data from the same axial plane during radiologic procedures. taken at different angles. This generic (b) Classification. Class I (general con- type of device may include signal anal- trols). The device is exempt from the ysis and display equipment, patient premarket notification procedures in and equipment supports, component subpart E of part 807 of this chapter, parts, and accessories. subject to the limitations in § 892.9. (b) Classification. Class II. [53 FR 1567, Jan. 20, 1988, as amended at 61 FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, § 892.1760 Diagnostic x-ray tube hous- 2001] ing assembly. (a) Identification. A diagnostic x-ray § 892.1840 Radiographic film. tube housing assembly is an x-ray gen- (a) Identification. Radiographic film is erating tube encased in a radiation- a device that consists of a thin sheet of shielded housing that is intended for radiotransparent material coated on

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one or both sides with a photographic § 892.1890 Radiographic film illu- emulsion intended to record images minator. during diagnostic radiologic proce- (a) Identification. A radiographic film dures. illuminator is a device containing a (b) Classification. Class I (general con- visible light source covered with a trols). The device is exempt from the translucent front that is intended to be premarket notification procedures in used to view medical radiographs. subpart E of part 807 of this chapter, (b) Classification. Class I (general con- subject to the limitations in § 892.9. trols). The device is exempt from the premarket notification procedures in [53 FR 1567, Jan. 20, 1988, as amended at 66 FR 38819, July 25, 2001] subpart E of part 807 of this chapter subject to § 892.9. § 892.1850 Radiographic film cassette. [55 FR 48444, Nov. 20, 1990, as amended at 65 (a) Identification. A radiographic film FR 2323, Jan. 14, 2000] cassette is a device intended for use § 892.1900 Automatic radiographic film during diagnostic x-ray procedures to processor. hold a radiographic film in close contact with an x-ray intensifying screen (a) Identification. An automatic radio- and to provide a light-proof enclosure graphic film processor is a device infor direct exposure of radiographic tended to be used to develop, fix, wash, film. and dry automatically and continuously film exposed for medical pur- (b) Classification. Class II. poses. (b) Classification. Class II. § 892.1860 Radiographic film/cassette changer. [55 FR 48444, Nov. 20, 1990] (a) Identification. A radiographic film/ § 892.1910 Radiographic grid. cassette changer is a device intended to be used during a radiologic procedure (a) Identification. A radiographic grid to move a radiographic film or cassette is a device that consists of alternating between x-ray exposures and to posi- radiolucent and radiopaque strips in- tion it during the exposure. tended to be placed between the pa- (b) Classification. Class II. tient and the image receptor to reduce the amount of scattered radiation § 892.1870 Radiographic film/cassette reaching the image receptor. changer programmer. (b) Classification. Class I (general controls). The device is exempt from the (a) Identification. A radiographic film/ premarket notification procedures in cassette changer programmer is a de- subpart E of part 807 of this chapter vice intended to be used to control the subject to § 892.9. operations of a film or cassette changer during serial medical radiography. [53 FR 1567, Jan. 20, 1988, as amended at 65 (b) Classification. Class II. FR 2323, Jan. 14, 2000] § 892.1920 Radiographic head holder. § 892.1880 Wall-mounted radiographic cassette holder. (a) Identification. A radiographic head holder is a device intended to position (a) Identification. A wall-mounted ra- the patient’s head during a radio- diographic cassette holder is a device graphic procedure. that is a support intended to hold and (b) Classification. Class I (general con- position radiographic cassettes for a trols). The device is exempt from the radiographic exposure for medical use. premarket notification procedures in (b) Classification. Class I (general con- subpart E of part 807 of this chapter, trols). The device is exempt from the subject to the limitations in § 892.9. The premarket notification procedures in device is also exempt from the current subpart E of part 807 of this chapter, good manufacturing practice require- subject to the limitations in § 892.9. ments of the quality system regulation [53 FR 1567, Jan. 20, 1988, as amended at 61 in part 820 of this chapter, with the ex- FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, ception of § 820.180, with respect to gen- 2001] eral requirements concerning records,

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and § 820.198, with respect to complaint light and intended for medical purposes files. to expose radiographic film. [53 FR 1567, Jan. 20, 1988, as amended at 66 (b) Classification. Class I (general con- FR 38819, July 25, 2001] trols). The device is exempt from the premarket notification procedures in § 892.1940 Radiologic quality assur- subpart E of part 807 of this chapter ance instrument. subject to § 892.9. (a) Identification. A radiologic quality [53 FR 1567, Jan. 20, 1988, as amended at 65 assurance instrument is a device in- FR 2323, Jan. 14, 2000] tended for medical purposes to measure a physical characteristic associated § 892.1970 Radiographic ECG/res- with another radiologic device. pirator synchronizer. (b) Classification. Class I (general con- (a) Identification. A radiographic ECG/ trols). The device is exempt from the respirator synchronizer is a device in- premarket notification procedures in tended to be used to coordinate an x- subpart E of part 807 of this chapter, subject to the limitations in § 892.9. The ray film exposure with the signal from device is also exempt from the current an electrocardiograph (ECG) or res- good manufacturing practice require- pirator at a predetermined phase of the ments of the quality system regulation cardiac or respiratory cycle. in part 820 of this chapter, with the ex- (b) Classification. Class I (general con- ception of § 820.180, with respect to gen- trols). The device is exempt from the eral requirements concerning records, premarket notification procedures in and § 820.198, with respect to complaint subpart E of part 807 of this chapter files. subject to § 892.9. [53 FR 1567, Jan. 20, 1988, as amended at 66 [55 FR 48444, Nov. 20, 1990, as amended at 65 FR 38819, July 25, 2001] FR 2323, Jan. 14, 2000]

§ 892.1950 Radiographic § 892.1980 Radiologic table. anthropomorphic phantom. (a) Identification. A radiologic table is (a) Identification. A radiographic a device intended for medical purposes anthropomorphic phantom is a device to support a patient during radiologic intended for medical purposes to simu- procedures. The table may be fixed or late a human body for positioning radi- tilting and may be electrically pow- ographic equipment. ered. (b) Classification. Class I (general con- (b) Classification. Class II (special trols). The device is exempt from the controls). The device is exempt from premarket notification procedures in the premarket notification procedures subpart E of part 807 of this chapter, in subpart E of part 807 of this chapter subject to the limitations in § 892.9. The subject to § 892.9. device is also exempt from the current good manufacturing practice require- [53 FR 1567, Jan. 20, 1988, as amended at 63 ments of the quality system regulation FR 59231, Nov. 3, 1998] in part 820 of this chapter, with the exception of § 820.180, with respect to gen- § 892.1990 Transilluminator for breast eral requirements concerning records, evaluation. and § 820.198, with respect to complaint (a) Identification. A transilluminator, files. also known as a diaphanoscope or [53 FR 1567, Jan. 20, 1988, as amended at 66 lightscanner, is an electrically powered FR 38819, July 25, 2001] device that uses low intensity emis- sions of visible light and near-infrared § 892.1960 Radiographic intensifying radiation (approximately 700–1050 nano- screen. meters (nm)), transmitted through the (a) Identification. A radiographic in- breast, to visualize translucent tissue tensifying screen is a device that is a for the diagnosis of cancer, other con- thin radiolucent sheet coated with a ditions, diseases, or abnormalities. luminescent material that transforms (b) Classification. Class III (premarket incident x-ray photons into visible approval).

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(c) Date premarket approval (PMA) or § 892.2030 Medical image digitizer. notice of completion of product develop- (a) Identification. A medical image ment protocol (PDP) is required. A PMA digitizer is a device intended to con- or notice of completion of a PDP is revert an analog medical image into a quired to be filed with FDA by April 17, digital format. Examples include 2014, for any transilluminator for Iystems employing video frame grab- breast evaluation that was in commer- bers, and scanners which use lasers or cial distribution before May 28, 1976, or charge-coupled devices. that has, by April 17, 2014, been found to be substantially equivalent to any (b) Classification. Class II (special transilluminator for breast evaluation controls; voluntary standards—Digital that was in commercial distribution Imaging and Communications in Medi- before May 28, 1976. Any other cine (DICOM) Std., Joint Photographic transilluminator for breast evaluation Experts Group (JPEG) Std.). shall have an approved PMA or de- [63 FR 23387, Apr. 29, 1998] clared completed PDP in effect before being placed in commercial distribu- § 892.2040 Medical image hardcopy de- tion. vice. [60 FR 36639, July 18, 1995, as amended at 79 (a) Identification. A medical image FR 3094, Jan. 17, 2014] hardcopy device is a device that produces a visible printed record of a med- § 892.2010 Medical image storage de- ical image and associated identifica- vice. tion information. Examples include (a) Identification. A medical image multiformat cameras and laser print- storage device is a device that provides ers. electronic storage and retrieval func- (b) Classification. Class II (special tions for medical images. Examples in- controls; voluntary standards—Digital clude devices employing magnetic and Imaging and Communications in Medi- optical discs, magnetic tape, and dig- cine (DICOM) Std., Joint Photographic ital memory. Experts Group (JPEG) Std., Society of (b) Classification. Class I (general con- Motion Picture and Television Engi- trols). The device is exempt from the neers (SMPTE) Test Pattern). premarket notification procedures in [63 FR 23387, Apr. 29, 1998] subpart E of part 807 of this chapter subject to § 892.9. § 892.2050 Picture archiving and com- [63 FR 23387, Apr. 29, 1998; 63 FR 44998, Aug. munications system. 24, 1998, as amended at 65 FR 2323, Jan. 14, (a) Identification. A picture archiving 2000] and communications system is a device that provides one or more capabilities § 892.2020 Medical image communica- relating to the acceptance, transfer, tions device. display, storage, and digital processing (a) Identification. A medical image of medical images. Its hardware com- communications device provides elec- ponents may include workstations, tronic transfer of medical image data digitizers, communications devices, between medical devices. It may in- computers, video monitors, magnetic, clude a physical communications me- optical disk, or other digital data stor- dium, modems, interfaces, and a com- age devices, and hardcopy devices. The munications protocol. software components may provide (b) Classification. Class I (general con- functions for performing operations re- trols). The device is exempt from the lated to image manipulation, enhance- premarket notification procedures in ment, compression or quantification. subpart E of part 807 of this chapter (b) Classification. Class II (special subject to § 892.9. controls; voluntary standards—Digital [63 FR 23387, Apr. 29, 1998; 63 FR 44998, Aug. Imaging and Communications in Medi- 24, 1998, as amended at 65 FR 2323, Jan. 14, cine (DICOM) Std., Joint Photographic 2000] Experts Group (JPEG) Std., Society of

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Motion Picture and Television Engi- planning computer programs, and ac- neers (SMPTE) Test Pattern). cessories. (b) Classification. Class I (general con- [63 FR 23387, Apr. 29, 1998] trols). The device is exempt from the premarket notification procedures in Subparts C–E [Reserved] subpart E of part 807 of this chapter subject to § 892.9. Subpart F—Therapeutic Devices [53 FR 1567, Jan. 20, 1988, as amended at 65 FR 2323, Jan. 14, 2000] § 892.5050 Medical charged-particle radiation therapy system. § 892.5700 Remote controlled radio- (a) Identification. A medical charged- nuclide applicator system. particle radiation therapy system is a (a) Identification. A remote controlled device that produces by acceleration radionuclide applicator system is an high energy charged particles (e.g., electromechanical or pneumatic device electrons and protons) intended for use intended to enable an operator to in radiation therapy. This generic type apply, by remote control, a radio- of device may include signal analysis nuclide source into the body or to the and display equipment, patient and surface of the body for radiation ther- equipment supports, treatment plan- apy. This generic type of device may ning computer programs, component include patient and equipment sup- parts, and accessories. ports, component parts, treatment (b) Classification. Class II. When in- planning computer programs, and ac- tended for use as a quality control sys- cessories. tem, the film dosimetry system (film (b) Classification. Class II. scanning system) included as an accessory to the device described in para- § 892.5710 Radiation therapy beam- graph (a) of this section, is exempt shaping block. from the premarket notification proce- (a) Identification. A radiation therapy dures in subpart E of part 807 of this beam-shaping block is a device made of chapter subject to the limitations in a highly attenuating material (such as § 892.9. lead) intended for medical purposes to [53 FR 1567, Jan. 20, 1988, as amended at 64 modify the shape of a beam from a ra- FR 1125, Jan. 8, 1999] diation therapy source. (b) Classification. Class II. § 892.5300 Medical neutron radiation therapy system. § 892.5730 Radionuclide brachytherapy (a) Identification. A medical neutron source. radiation therapy system is a device (a) Identification. A radionuclide intended to generate high-energy neu- brachytherapy source is a device that trons for radiation therapy. This ge- consists of a radionuclide which may neric type of device may include signal be enclosed in a sealed container made analysis and display equipment, pa- of gold, titanium, stainless steel, or tient and equipment support, treat- platinum and intended for medical pur- ment planning computer programs, poses to be placed onto a body surface component parts, and accessories. or into a body cavity or tissue as a (b) Classification. Class II. source of nuclear radiation for therapy. (b) Classification. Class II. § 892.5650 Manual radionuclide applicator system. § 892.5740 Radionuclide teletherapy (a) Identification. A manual radio- source. nuclide applicator system is a manu- (a) Identification. A radionuclide tele- ally operated device intended to apply therapy source is a device consisting of a radionuclide source into the body or a radionuclide enclosed in a sealed con- to the surface of the body for radiation tainer. The device is intended for radi- therapy. This generic type of device ation therapy, with the radiation may include patient and equipment source located at a distance from the supports, component parts, treatment patient’s body.

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(b) Classification. Class I (general con- § 892.5840 Radiation therapy simula- trols). The device is exempt from the tion system. premarket notification procedures in (a) Identification. A radiation therapy subpart E of part 807 of this chapter, simulation system is a fluoroscopic or subject to the limitations in § 892.9. radiographic x-ray system intended for [53 FR 1567, Jan. 20, 1988, as amended at 59 use in localizing the volume to be ex- FR 63015, Dec. 7, 1994; 66 FR 38819, July 25, posed during radiation therapy and 2001] confirming the position and size of the therapeutic irradiation field produced. § 892.5750 Radionuclide radiation ther- This generic type of device may in- apy system. clude signal analysis and display equip- (a) Identification. A radionuclide radi- ment, patient and equipment supports, ation therapy system is a device in- treatment planning computer pro- tended to permit an operator to admin- grams, component parts, and acces- ister gamma radiation therapy, with sories. the radiation source located at a dis- (b) Classification. Class II. tance from the patient’s body. This ge- § 892.5900 X-ray radiation therapy sys- neric type of device may include signal tem. analysis and display equipment, patient and equipment supports, treat- (a) Identification. An x-ray radiation ment planning computer programs, therapy system is a device intended to component parts (including beam-lim- produce and control x-rays used for ra- iting devices), and accessories. diation therapy. This generic type of device may include signal analysis and (b) Classification. Class II. display equipment, patient and equip- § 892.5770 Powered radiation therapy ment supports, treatment planning patient support assembly. computer programs, component parts, and accessories. (a) Identification. A powered radiation (b) Classification. Class II. therapy patient support assembly is an electrically powered adjustable couch § 892.5930 Therapeutic x-ray tube intended to support a patient during housing assembly. radiation therapy. (a) Identification. A therapeutic x-ray (b) Classification. Class II. tube housing assembly is an x-ray generating tube encased in a radiation- § 892.5780 Light beam patient position shielded housing intended for use in ra- indicator. diation therapy. This generic type of (a) Identification. A light beam pa- device may include high-voltage and tient position indicator is a device that filament transformers or other appro- projects a beam of light (incoherent priate components when contained in light or laser) to determine the align- radiation-shielded housing. ment of the patient with a radiation (b) Classification. Class II. beam. The beam of light is intended to be used during radiologic procedures to Subpart G—Miscellaneous ensure proper positioning of the pa- Devices tient and to monitor alignment of the radiation beam with the patient’s anat- § 892.6500 Personnel protective shield. omy. (a) Identification. A personnel protec- (b) Classification. Class I (general con- tive shield is a device intended for trols). The device is exempt from the medical purposes to protect the pa- premarket notification procedures in tient, the operator, or other persons subpart E of part 807 of this chapter, from unnecessary exposure to radiation subject to the limitations in § 892.9. during radiologic procedures by pro- [53 FR 1567, Jan. 20, 1988, as amended at 61 viding an attenuating barrier to radi- FR 1125, Jan. 16, 1996; 66 FR 38819, July 25, ation. This generic type of device may 2001] include articles of clothing, furniture, and movable or stationary structures.

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(b) Classification. Class I (general con- cannot avoid the ban by relabeling the trols). The device is exempt from the device for veterinary use. A device that premarket notification procedures in has been banned from human use but subpart E of part 807 of this chapter that also has a valid veterinary use subject to § 892.9. may be marketed for use as a veteri- [53 FR 1567, Jan. 20, 1988, as amended at 61 nary device only under the following FR 1125, Jan. 16, 1996; 65 FR 2323, Jan. 14, conditions: The device shall comply 2000] with all requirements applicable to veterinary devices under the Federal PART 895—BANNED DEVICES Food, Drug, and Cosmetic Act and this chapter, and the label for the device Subpart A—General Provisions shall bear the following statement: ‘‘For Veterinary Use Only. Caution: Sec. Federal law prohibits the distribution 895.1 Scope. 895.20 General. of this device for human use.’’ A device 895.21 Procedures for banning a device. so labeled, however, that is determined 895.22 Submission of data and information by the Food and Drug Administration by the manufacturer, distributor, or im- to be intended for human use, will be porter. considered to be a banned device. In de- 895.25 Labeling. 895.30 Special effective date. termining whether such a device is intended for human use, the Food and Subpart B—Listing of Banned Devices Drug Administration will consider, among other things, the ultimate des- 895.101 Prosthetic hair fibers. tination of the device. 895.102 Powdered surgeon’s glove. 895.103 Powdered patient examination glove. § 895.20 General. 895.104 Absorbable powder for lubricating a The Commissioner may initiate a surgeon’s glove. proceeding to make a device a banned AUTHORITY: 21 U.S.C. 352, 360f, 360h, 360i, device whenever the Commissioner 371. finds, on the basis of all available data SOURCE: 44 FR 29221, May 18, 1979, unless and information, that the device pre- otherwise noted. sents substantial deception or an unreasonable and substantial risk of ill- Subpart A—General Provisions ness or injury that the Commissioner determines cannot be, or has not been, § 895.1 Scope. corrected or eliminated by labeling or (a) This part describes the procedures by a change in labeling, or by a change by which the Commissioner may insti- in advertising if the device is a re- tute proceedings to make a device in- stricted device. tended for human use that presents substantial deception or an unreason- [44 FR 29221, May 18, 1979, as amended at 57 FR 58405, Dec. 10, 1992] able and substantial risk of illness or injury a banned device. § 895.21 Procedures for banning a de- (b) This part applies to any ‘‘device’’, vice. as defined in section 201(h) of the Fed- eral Food, Drug, and Cosmetic Act (a) Before initiating a proceeding to (act) that is intended for human use. make a device a banned device, the (c) A device that is made a banned Commissioner shall find that the con- device in accordance with this part is tinued marketing of the device pre- adulterated under section 501(g) of the sents a substantial deception or an un- act. A restricted device that is banned reasonable and substantial risk of ill- may also be misbranded under section ness or injury. 502(q) of the act. (1) In determining whether the decep- (d) Although this part does not cover tion or risk of illness or injury is sub- devices intended for animal use, the stantial, the Commissioner will con- manufacturer, distributor, importer, or sider whether the deception or risk any other person(s) responsible for the posed by continued marketing of the labeling of the device that is banned device, or continued marketing of the

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device as presently labeled, is impor- cordance with § 895.25. If such required tant, material, or significant in rela- relabeling or change in advertising is tion to the benefit to the public health not accomplished in accordance with from its continued marketing. § 895.25, the Commissioner may initiate (2) In determining whether a device is a proceeding to ban the device in ac- deceptive, the Commissioner will con- cordance with § 895.21(d) and, when ap- sider whether users of the device may propriate, may establish a special ef- be deceived or otherwise harmed by the fective date in accordance with § 895.30. device. The Commissioner is not re- (d) If the Commissioner decides to quired to determine that there was an initiate a proceeding to make a device intent on the part of the manufacturer, a banned device, a notice of proposed distributor, importer, or any other re- rulemaking will be published in the sponsible person(s) to mislead or other- FEDERAL REGISTER to this effect. The wise harm users of the device or that notice will briefly summarize— there exists any actual proof of decep- (1) The Commissioner’s finding under tion of, or injury to, an individual. paragraph (a) of this section that the (3) In determining whether a device device presents substantial deception presents deception or risk of illness or or an unreasonable and substantial injury, the Commissioner will consider risk of illness or injury, and, when ap- all available data and information, in- propriate, the Commissioner’s deter- cluding data and information that the mination under § 895.30 that the decep- Commissioner may obtain under other tion or risk of illness or injury presents provisions of the act, data and informa- an unreasonable, direct, and substan- tion that may be supplied by the manu- tial danger to the health of individuals; facturer, distributor, or importer of the (2) The reasons why the Commis- device under § 895.22, and data and in- sioner initiated the proceeding; formation voluntarily submitted by (3) The evaluation of data and infor- any other interested persons. mation obtained under other provisions (b) Before initiating a proceeding to of the act, submitted by the manufac- make a device a banned device, the turer, distributer, or importer of the Commissioner of Food and Drugs (the device, or voluntarily submitted by Commissioner) may consult with the any other interested persons under panel established under section 513 of paragraph (a)(3) of this section, if any; the act that has expertise with respect (4) The consultation with the panel, to the type of device under consider- if any, under paragraph (b) of this sec- ation. The consultation with the panel tion; may occur at a regular or specially (5) The determination as to whether scheduled panel meeting or may be ac- the deception or risk of illness or in- complished by correspondence or tele- jury or the danger to the health of in- phone conversation with panel mem- dividuals could be corrected by label- bers. The Commissioner may request ing or change in labeling, or change in that the panel submit in writing any advertising if the device is a restricted advice on the device under consider- device; ation. The Commissioner will record in (6) The determination of whether the written memoranda any oral commu- required labeling or change of labeling, nications with a panel or its members. or change in advertising if the device is (c) If the Commissioner determines a restricted device, if any, has been that any substantial deception or un- made in accordance with paragraph (c) reasonable and substantial risk of ill- of this section; ness or injury or any unreasonable, di- (7) The determination as to whether, rect, and substantial danger to the and the reasons why, the banning health of individuals presented by a de- should apply to devices already in com- vice can be corrected or eliminated by mercial distribution or those already labeling or change in labeling, or sold to the ultimate user, or both; and change in advertising if the device is a (8) Any other data and information restricted device, the Commissioner that the Commissioner believes are will notify the responsible person of pertinent to the proceeding. The notice the required labeling or change in la- will afford all interested persons an op- beling or change in advertising in ac- portunity to submit written comments

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within 30 days after the date of publi- dures in this section will be employed cation of the proposed regulation. All in such proceedings. nonconfidential information upon [44 FR 29221, May 18, 1979, as amended at 53 which the proposed finding is based, in- FR 11254, Apr. 6, 1988; 57 FR 58405, Dec. 10, cluding the recommendations of the 1992; 65 FR 43690, July 14, 2000] panel, will be available for public review in the Division of Dockets Man- § 895.22 Submission of data and infor- agement, Food and Drug Administra- mation by the manufacturer, dis- tion. tributor, or importer. (e)(1) If, after reviewing the adminis- (a) A manufacturer, distributor, or trative record of the regulatory hear- importer of a device may be required to ing before the Food and Drug Adminis- submit to the Food and Drug Adminis- tration, if any, the written comments tration all relevant and available data received on the proposed regulation, and information to enable the Commis- and any additional available data and sioner to determine whether the device information, the Commissioner deter- presents substantial deception, unrea- mines to ban a device, a final regula- sonable and substantial risk of illness tion to this effect will be published in or injury, or unreasonable, direct, and the FEDERAL REGISTER. The final regu- substantial danger to the health of in- lation will amend subpart B by adding dividuals. The data and information re- the name or description of the device, quired by the Commissioner may in- or both, to the list of banned devices. clude scientific or test data, reports, records, or other information, includ- (2) If the Commissioner determines ing data and information on whether not to ban the device, a notice of with- the device is safe and effective for its drawal and termination of rulemaking intended use or when used as directed, proceedings and reasons therefor will whether the device performs according be published in the FEDERAL REGISTER. to the claims made for the device, and (f) The effective date of a final regu- information on adulteration or mis- lation to make a device a banned de- branding. Any relevant information vice, promulgated under paragraph (e) that is voluntarily submitted will also of this section, will be the date of pub- be reviewed. lication of the final regulation in the (b) A manufacturer, distributor, or FEDERAL REGISTER unless the Commis- importer of a device required to submit sioner, for reasons stated, determines data and information as provided in that the effective date should be later paragraph (a) of this section will be no- than the date of the publication and tified in writing by the Food and Drug specifies that date in the notice. Each Administration that such data and in- such regulation will specify whether formation shall be submitted. The devices already in commercial distribu- written notification will advise the tion or sold to the ultimate user or manufacturer, distributor, or importer both are banned. of the device that the purpose for the (g) A regulation promulgated under request is to enable the Commissioner paragraph (e) of this section is final to determine whether any of the condi- agency action, subject to judicial re- tions listed in paragraph (a) of this sec- view under section 517 of the act. tion or § 895.30(a)(1) exists with respect (h) Upon petition of any interested to the device such that a proceeding person submitted in accordance with should be initiated to make the device § 10.30 of this chapter, or as a matter of a banned device. When the required discretion, the Commissioner may in- data and information can be identified by the Food and Drug Administration stitute proceedings to amend or revoke at the time of the notification, the a regulation that made a device a agency will provide such identification banned device if the Commissioner to the manufacturer, distributor, or finds that the conditions that con- importer of the device. stituted the basis for the regulation (c) The required data and informa- banning the device are no longer appli- tion shall be submitted to the Food and cable. When appropriate, the proce- Drug Administration no more than 30

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days after the date of receipt of the re- (1) The deception or risk of illness or quest, unless the Commissioner deter- injury or the danger to the health of mines that the data and information individuals, shall be submitted by some other date (2) The labeling or change in label- and so informs the manufacturer, dis- ing, or change in advertising if the de- tributor, or importer, in which case the vice is a restricted device, necessary to data and information shall be sub- correct the deception or eliminate or mitted on the date specified by the reduce such risk or danger, and Commissioner. (3) The period of time within which (d) If the data or information sub- the labeling, change in labeling, or mitted to the Food and Drug Adminis- change in advertising must be accom- tration is sufficient to persuade the plished. Commissioner that the deception or (b) In specifying the labeling or risk of illness or injury or the danger change in labeling or change in adver- to the health of individuals presented tising to correct the deception or to by a device could be corrected or elimi- eliminate or reduce the risk of illness nated by labeling or change in labeling, or injury or the danger to the health of or change in advertising if the device is individuals, the Commissioner may re- a restricted device, the Commissioner quire the manufacturer, distributor, will proceed in accordance with § 895.25. importer, or any other person(s) re- (e) If the data or information sub- sponsible for the labeling or adver- mitted to the Food and Drug Adminis- tising of the device to include in label- tration is insufficient to show that the ing for the device, and in advertising if device does not present a substantial the device is a restricted device, a deception or an unreasonable and sub- statement, notice, or warning. Such stantial risk of illness or injury, or an statement, notice, or warning shall be unreasonable, direct, and substantial in the manner and form prescribed by danger to the health of individuals, or the Commissioner and shall identify if the manufacturer, distributor, or im- the deception or risk of illness or in- porter fails to submit the required injury or the unreasonable, direct, and formation, the Commissioner may rely substantial danger to the health of in- upon this insufficiency or failure to dividuals associated with the device as submit the required information in previously labeled. Such statement, no- considering whether to initiate a pro- tice, or warning shall be used in the la- ceeding to make the device a banned beling and advertising of the device for device under § 895.21(d) and, when ap- a time period specified by the Commis- propriate, to establish a special effec- sioner on the basis of the degree of de- tive date in accordance with § 895.30. ception, risk of illness or injury, or The Commissioner may also initiate danger to health; the frequency of sale other regulatory action as provided in of the device; the length of time the de- the act or this chapter. vice has been on the market; the intended uses of the device; the method § 895.25 Labeling. of its use; and any other factors that (a) If the Commissioner determines the Commissioner considers pertinent. that the substantial deception or un- (c) The Commissioner will allow a reasonable and substantial risk of ill- manufacturer, distributor, importer, or ness or injury or the unreasonable, di- any other person(s) responsible for the rect, and substantial danger to the labeling or advertising of the device a health of individuals presented by a de- reasonable time, considering the decep- vice can be corrected or eliminated by tion or risk of illness or injury or the labeling or a change in labeling, or danger to the health of individuals pre- change in advertising if the device is a sented by the device, within which to restricted device, the Commissioner accomplish the required labeling, will provide written notice to the man- change in labeling, and, if the device is ufacturer, distributor, importer, or any a restricted device, any change in ad- other person(s) responsible for the la- vertising. The Commissioner may, beling or advertising of the device however, request that no additional de- specifying: vices be introduced into commerce

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until the labeling or change in label- not find that the danger is immediate, ing, or change in advertising is accom- and it shall be sufficient for the Com- plished by the manufacturer, dis- missioner to determine that the danger tributor, importer, or other person(s) may involve a serious long-term risk. responsible for the labeling or adver- (c) If the Commissioner makes a pro- tising of the device. posed regulation effective in accord- (d) If such voluntary action is not ance with this section, the Commis- taken, the Commissioner may take ac- sioner will, as expeditiously as pos- tion under other sections of the act to sible, give interested persons prompt prevent the introduction of the devices notice of this action in the FEDERAL into commerce. The Commissioner REGISTER and will provide an oppor- may consider the failure of a manufac- tunity for an informal hearing in ac- turer, distributor, importer, or any cordance with part 16 of this chapter. other person(s) responsible for the labeling or advertising of the device to (d) After the hearing, if any, and accomplish the required labeling or after considering any written com- change in labeling, or change in adver- ments submitted on the proposal and tising in accordance with this section any additional available information as a basis for initiating a proceeding to and data, the Commissioner will as ex- make a device a banned device in ac- peditiously as possible either affirm, cordance with § 895.21(d) and when ap- modify, or revoke the proposed regula- propriate to establish a special effec- tion making the device a banned de- tive date in accordance with § 895.30. vice. If the Commissioner decides to affirm or modify the proposed regulation § 895.30 Special effective date. to make a device a banned device, the (a) The Commissioner may declare a Commissioner will amend subpart B by proposed regulation under § 895.21(d) to adding the name or description of the be effective upon its publication in the device, or both, to the list of banned FEDERAL REGISTER and until the effec- devices. If the Commissioner decides to tive date of any final action taken re- revoke a proposed regulation making a specting the regulation if: device a banned device, a notice of ter- (1) The Commissioner determines, on mination of rulemaking proceedings the basis of all available data and in- and reasons therefor will be published formation, that the deception or risk of in the FEDERAL REGISTER. illness or injury associated with use of (e) The Commissioner may declare the device that is subject to the regula- the special effective date provided by tion presents an unreasonable, direct, this section to be in effect after the and substantial danger to the health of publication of a proposed regulation individuals, and under § 895.21(d), if, based on new infor- (2) Before the date of the publication mation, or upon reconsideration of pre- of such regulation, the Commissioner viously available information, the notifies the domestic manufacturer and Commissioner makes the determina- importer, if any, of the device that the tion and provides the appropriate no- regulation is to be made so effective. If tices and an opportunity for a hearing necessary, the Commissioner may also in accordance with paragraphs (a) and notify the distributor or any other re- (c) of this section. sponsible person(s). In addition, the (f) Those devices that have been Commissioner will attempt to notify named banned devices under § 895.30 any foreign manufacturer when the and that have already been sold to the name and address of the foreign manu- public may be subject to relabeling by facturer are readily available. the manufacturer, distributor, im- (b) This procedure may be used when the Commissioner determines that the porter, or any other person(s) respon- potential or actual injury involved is a sible for the labeling of the device or serious one that the Commissioner be- may be subject to the provisions of sec- lieves will endanger the health of indi- tion 518(a) or (b) of the act. viduals who have been, or will be, ex- [44 FR 29221, May 18, 1979, as amended at 57 posed to the device. In assessing the de- FR 58405, Dec. 10, 1992; 80 FR 31300, June 2, gree of danger, the Commissioner need 2015]

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Subpart B—Listing of Banned ting on a surgeon’s glove. The device is Devices absorbable through biological degradation. § 895.101 Prosthetic hair fibers. [81 FR 91731, Dec. 19, 2016] Prosthetic hair fibers are devices intended for implantation into the PART 898—PERFORMANCE STAND- human scalp to simulate natural hair ARD FOR ELECTRODE LEAD WIRES or conceal baldness. Prosthetic hair fibers may consist of various materials; AND PATIENT CABLES for example, synthetic fibers, such as modacrylic, polyacrylic, and polyester; Sec. 898.11 Applicability. and natural fibers, such as processed 898.12 Performance standard. human hair. Excluded from the banned 898.13 Compliance dates. device are natural hair transplants, in 898.14 Exemptions and variances. which a person’s hair and its sur- AUTHORITY: 21 U.S.C. 351, 352, 360c, 360d, rounding tissue are surgically removed 360gg–360ss, 371, 374; 42 U.S.C. 262, 264. from one location on the person’s scalp and then grafted onto another area of SOURCE: 62 FR 25497, May 9, 1997, unless the person’s scalp. otherwise noted. [48 FR 25136, June 3, 1983] § 898.11 Applicability. Electrode lead wires and patient ca- § 895.102 Powdered surgeon’s glove. bles intended for use with a medical de- (a) Identification. A powdered sur- vice shall be subject to the perform- geon’s glove is a device intended to be ance standard set forth in § 898.12. worn on the hands of operating room personnel to protect a surgical wound § 898.12 Performance standard. from contamination. A powdered sur- (a) Any connector in a cable or elec- geon’s glove incorporates powder for trode lead wire having a conductive purposes other than manufacturing. connection to a patient shall be con- (b) [Reserved] structed in such a manner as to comply [81 FR 91731, Dec. 19, 2016] with subclause 56.3(c) of the following standard: § 895.103 Powdered patient examination glove. International Electrotechnical Commis- sion (IEC) (a) Identification. A powdered patient 601–1: Medical Electrical Equipment examination glove is a disposable de- 601–1 (1988) Part 1: General requirements vice intended for medical purposes that for safety is worn on the examiner’s hand or fin- Amendment No. 1 (1991) ger to prevent contamination between Amendment No. 2 (1995). patient and examiner. A powdered pa- (b) Compliance with the standard tient examination glove incorporates shall be determined by inspection and powder for purposes other than manu- by applying the test requirements and facturing. test methods of subclause 56.3(c) of the (b) [Reserved] standard set forth in paragraph (a) of [81 FR 91731, Dec. 19, 2016] this section.

§ 895.104 Absorbable powder for lubri- § 898.13 Compliance dates. cating a surgeon’s glove. The dates for compliance with the Absorbable powder for lubricating a standard set forth in § 898.12(a) shall be surgeon’s glove is a powder made from as follows: cornstarch that meets the specifica- (a) For electrode lead wires and pa- tions for absorbable powder in the tient cables used with, or intended for United States Pharmacopeia (U.S.P.) use with, the following devices, the and that is intended to be used to lu- date for which compliance is required bricate the surgeon’s hand before put- is May 11, 1998:

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LISTING OF DEVICES FOR WHICH COMPLIANCE IS REQUIRED EFFECTIVE May 11, 1998

21 CFR sec- Phase Product code tion Class Device name

1 ...... 73 BZQ 868 .2375 II Monitor, Breathing Frequency. 1 ...... 73 FLS 868.2375 II Monitor (Apnea Detector), Ventilatory Effort. 1 ...... 74 DPS 870 .2340 II Electrocardiograph. 1 ...... 74 DRG 870.2910 II Transmitters and Receivers, Physiological Signal, Radio Frequency. 1 ...... 74 DRT 870.2300 II Monitor, Cardiac (including Cardiotachometer and Rate Alarm). 1 ...... 74 DRX 870.2360 II Electrode, Electrocardiograph. 1 ...... 74 DSA 870 .2900 II Cable, Transducer and Electrode, Patient (including Connector). 1 ...... 74 DSH 870.2800 II Recorder, Magnetic Tape, Medical. 1 ...... 74 DSI 870 .1025 III Detector and Alarm, Arrhythmia. 1 ...... 74 DXH 870.2920 II Transmitters and Receivers, Electrocardiograph, Tele- phone.

(b) For electrode lead wires and pa- (3) A complete description of alter- tient cables used with, or intended for native steps that are available, or that use with, any other device, the date for the petitioner has already taken, to en- which compliance is required is May 9, sure that a patient will not be inad- 2000. vertently connected to hazardous voltages via an unprotected patient § 898.14 Exemptions and variances. cable or electrode lead wire for in- (a) A request for an exemption or tended use with the device; and variance shall be submitted in the form (4) Other information justifying the of a petition under § 10.30 of this chap- exemption or variance. ter and shall comply with the requirements set out therein. The petition (b) An exemption or variance is not shall also contain the following: effective until the agency approves the (1) The name of the device, the class request under § 10.30(e)(2)(i) of this in which the device has been classified, chapter. and representative labeling showing EFFECTIVE DATE NOTE: At 62 FR 25477, May the intended uses(s) of the device; 9, 1997, § 898.14 was stayed pending Office of (2) The reasons why compliance with Management and Budget approval of infor- the performance standard is unneces- mation collection and recordkeeping require- sary or unfeasible; ments.

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