21 CFR Ch. I (4–1–20 Edition) § 884.4520

Food and Drug Administration, HHS Pt. 884

electroconvulsive therapy device with § 882.5970 Cranial orthosis. an intended use described in paragraph (a) Identification. A cranial orthosis is (b)(2) of this section, that was in com- a device that is intended for medical mercial distribution before May 28, purposes to apply pressure to promi- 1976, or that has, on or before March 26, nent regions of an infant’s cranium in 2019, been found to be substantially order to improve cranial symmetry equivalent to any electroconvulsive and/or shape in infants from 3 to 18 therapy device with an intended use de- months of age, with moderate to severe scribed in paragraph (b)(2) of this sec- nonsynostotic positional tion, that was in commercial distribu- plagiocephaly, including infants with tion before May 28, 1976. Any other plagiocephalic-, brachycephalic-, and electroconvulsive therapy device with scaphocephalic-shaped heads. an intended use described in paragraph (b) Classification. Class II (special (b)(2) of this section shall have an ap- controls) (prescription use in accord- proved PMA or declared completed ance with § 801.109 of this chapter, bio- PDP in effect before being placed in compatibility testing, and labeling commercial distribution. (contraindications, warnings, precautions, adverse events, instructions [83 FR 66123, Dec. 26, 2018] for physicians and parents)). § 882.5950 Neurovascular embolization [63 FR 40651, July 30, 1998] device. § 882.5975 Human dura mater. (a) Identification. A neurovascular embolization device is an intravascular (a) Identification. Human dura mater implant intended to permanently oc- is human pachymeninx tissue intended to repair defects in human dura mater. clude blood flow to cerebral aneurysms (b) Classification. Class II (special and cerebral ateriovenous malforma- controls). The special control for this tions. This does not include device is the FDA guidance document cyanoacrylates and other embolic entitled ‘‘Class II Special Controls agents, which act by polymerization or Guidance Document: Human Dura precipitation. Embolization devices Mater.’’ See § 882.1(e) for the avail- used in other vascular applications are ability of this guidance. also not included in this classification, (c) Scope. The classification set forth see § 870.3300. in this section is only applicable to (b) Classification. Class II (special human dura mater recovered prior to controls.) The special control for this May 25, 2005. device is the FDA guidance document [68 FR 70436, Dec. 18, 2003, as amended at 76 entitled ‘‘Class II Special Controls FR 36993, June 24, 2011] Guidance Document: Vascular and Neurovascular Embolization Devices.’’ PART 884—OBSTETRICAL AND For availability of this guidance document, see § 882.1(e). GYNECOLOGICAL DEVICES [69 FR 77900, Dec. 29, 2004] Subpart A—General Provisions

§ 882.5960 Skull tongs for traction. Sec. 884.1 Scope. (a) Identification. Skull tongs for 884.3 Effective dates of requirement for pre- traction is an instrument used to im- market approval. mobilize a patient with a cervical spine 884.9 Limitations of exemptions from sec- injury (e.g., fracture or dislocation). tion 510(k) of the Federal Food, Drug, The device is caliper shaped with tips and Cosmetic Act (the act). that penetrate the skin. It is anchored Subpart B—Obstetrical and Gynecological to the skull and has a heavy weight at- Diagnostic Devices tached to it that maintains, by traction, the patient’s position. 884.1040 Viscometer for cervical mucus. (b) Classification. Class II (perform- 884.1050 Endocervical aspirator. 884.1060 Endometrial aspirator. ance standards). 884.1100 Endometrial brush.

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884.1175 Endometrial suction curette and Subpart E—Obstetrical and Gynecological accessories. Surgical Devices 884.1185 Endometrial washer. 884.1300 Uterotubal carbon dioxide 884.4050 Gynecologic laparoscopic power insufflator and accessories. morcellation containment system. 884.1425 Perineometer. 884.4100 Endoscopic electrocautery and ac- 884.1550 Amniotic fluid sampler cessories. (amniocentesis tray). 884.4120 Gynecologic electrocautery and ac- 884.1560 Fetal blood sampler. cessories. 884.1600 Transabdominal amnioscope 884.4150 Bipolar endoscopic coagulator-cut- (fetoscope) and accessories. ter and accessories. 884.1630 Colposcope. 884.4160 Unipolar endoscopic coagulator- cutter and accessories. 884.1640 Culdoscope and accessories. 884.4250 Expandable cervical dilator. 884.1660 Transcervical endoscope 884.4260 Hygroscopic Laminaria cervical di- (amnioscope) and accessories. lator. 884.1690 Hysteroscope and accessories. 884.4270 Vibratory cervical dilators. 884.1700 Hysteroscopic insufflator. 884.4340 Fetal vacuum extractor. 884.1710 Closed loop hysteroscopic 884.4350 Fetal head elevator. insufflator with cutter-coagulator. 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. 884.2675 Fetal scalp circular (spiral) elec- 884.5070 Vacuum abortion system. trode and applicator. 884.5100 Obstetric anesthesia set. 884.2685 Fetal scalp clip electrode and appli- 884.5150 Nonpowered breast pump. cator. 884.5160 Powered breast pump. 884.2700 Intrauterine pressure monitor and 884.5200 Hemorrhoid prevention pressure accessories. wedge. 884.5210 Pressure wedge for the reduction of 884.2720 External uterine contraction mon- cesarean delivery. itor and accessories. 884.5225 Abdominal decompression chamber. 884.2730 Home uterine activity monitor. 884.5250 Cervical cap. 884.2740 Perinatal monitoring system and 884.5300 Condom. accessories. 884.5310 Condom with spermicidal lubricant. 884.2800 Computerized labor monitoring sys- 884.5320 Glans sheath. tem. 884.5330 Multiple-use female condom. 884.2900 Fetal stethoscope. 884.5340 Single-use internal condom. 884.2960 Obstetric ultrasonic transducer and 884.5350 Contraceptive diaphragm and acces- accessories. sories. 884.2980 Telethermographic system. 884.5360 Contraceptive intrauterine device 884.2982 Liquid crystal thermographic sys- (IUD) and introducer. tem. 884.5370 Software application for contracep- 884.2990 Breast lesion documentation sys- tion. tem. 884.5380 Contraceptive tubal occlusion device (TOD) and introducer. Subpart D—Obstetrical and Gynecological 884.5390 Perineal heater. Prosthetic Devices 884.5400 Menstrual cup. 884.5425 Scented or scented deodorized men- 884.3200 Cervical drain. strual pad. 884.3575 Vaginal pessary. 884.5435 Unscented menstrual pad. 884.3650 Fallopian tube prosthesis. 884.5460 Scented or scented deodorized men- 884.3900 Vaginal stent. strual tampon.

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884.5470 Unscented menstrual tampon. and as a therapeutic device) is listed 884.5900 Therapeutic vaginal douche appa- only in one subpart. ratus. (d) References in this part to regu- 884.5920 Vaginal insufflator. 884.5940 Powered vaginal muscle stimulator latory sections of the Code of Federal for therapeutic use. Regulations are to chapter I of title 21, 884.5960 Genital vibrator for therapeutic unless otherwise noted. use. (e) Guidance documents referenced in 884.5970 Clitoral engorgement device. this part are available on the Internet 884.5980 Surgical mesh for transvaginal pel- at http://www.fda.gov/MedicalDevices/ vic organ prolapse repair. DeviceRegulationandGuidance/ Subpart G—Assisted Reproduction Devices GuidanceDocuments/default.htm. [52 FR 17740, May 11, 1987, as amended at 68 884.6100 Assisted reproduction needles. FR 44415, Aug. 27, 2003; 78 FR 18233, Mar. 26, 884.6110 Assisted reproduction catheters. 2013] 884.6120 Assisted reproduction accessories. 884.6130 Assisted reproduction microtools. 884.6140 Assisted reproduction micropipette § 884.3 Effective dates of requirement fabrication instruments. for premarket approval. 884.6150 Assisted reproduction micro- A device included in this part that is manipulators and microinjectors. classified into class III (premarket ap- 884.6160 Assisted reproduction labware. proval) shall not be commercially dis- 884.6165 Intravaginal culture system. 884.6170 Assisted reproduction water and tributed after the date shown in the water purification systems. regulation classifying the device unless 884.6180 Reproductive media and supple- the manufacturer has an approval ments. under section 515 of the act (unless an 884.6190 Assisted reproductive microscopes exemption has been granted under sec- and microscope accessories. tion 520(g)(2) of the act). An approval 884.6195 Assisted reproduction embryo under section 515 of the act consists of image assessment system. 884.6200 Assisted reproduction laser system. FDA’s issuance of an order approving an application for premarket approval AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, (PMA) for the device or declaring com- 360j, 360l, 371. pleted a product development protocol SOURCE: 45 FR 12684, Feb. 26, 1980, unless (PDP) for the device. otherwise noted. (a) Before FDA requires that a device commercially distributed before the Subpart A—General Provisions enactment date of the amendments, or a device that has been found substan- § 884.1 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 obstetrical and gynecological FDA must promulgate a regulation devices intended for human use that under section 515(b) of the act requir- are 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, 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

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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- 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 (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 section 515 of the act before commercial of familial or acquired genetic dis- distribution. orders, including inborn errors of me- tabolism; [52 FR 17740, May 11, 1987] (3) For measuring an analyte that § 884.9 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 2319, Jan. 14, 2000] different from the intended use of a le-

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Subpart B—Obstetrical and Gyne- (ii) Contraindications: Pregnancy, cological Diagnostic Devices history of uterine perforation, or a re- cent cesarean section, and § 884.1040 Viscometer for cervical (3) The sampling component is cov- mucus. ered within vagina. (a) Identification. A viscometer for [45 FR 12684, Feb. 26, 1980, as amended at 52 cervical mucus is a device that is in- FR 17741, May 11, 1987; 65 FR 17146, Mar. 31, tended to measure the relative 2000] viscoelasticity of cervical mucus col- lected from a female patient. Measure- § 884.1100 Endometrial brush. ments of relative viscoelasticity are in- (a) Identification. An endometrial tended for use as an adjunct in the brush is a device designed to remove clinical evaluation of a female with samples of the endometrium (the chronic infertility, to determine the mucosal lining of the uterus) by brush- time of ovulation and the penetrability ing its surface. This device is used to of cervical mucus to motile sperm. study endometrial cytology (cells). (b) Classification. Class I (general con- (b) Classification. Class II. The special trols). The device is exempt from the controls for this device are: premarket notification procedures in (1) FDA’s: subpart E of part 807 of this chapter (i) ‘‘Use of International Standard subject to § 884.9. ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation [47 FR 14706, Apr. 6, 1982, as amended at 65 and Testing,’ ’’ and FR 2320, Jan. 14, 2000] (ii) ‘‘510(k) Sterility Review Guidance § 884.1050 Endocervical aspirator. of 2/12/90 (K90–1),’’ (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: (a) Identification. An endometrial (i) Indication: Only to evaluate the washer is a device used to remove ma- endometrium, and terials from the endometrium (the

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mucosal lining of the uterus) by wash- § 884.1550 Amniotic fluid sampler ing with water or saline solution and (amniocentesis tray). then aspirating with negative pressure. (a) Identification. The amniotic fluid This device is used to study sampler (amniocentesis tray) is a col- endometrial cytology (cells). lection of devices used to aspirate (b) Classification. Class II. The special amniotic fluid from the amniotic sac controls for this device are: via a transabdominal approach. Com- (1) FDA’s: ponents of the amniocentesis tray in- (i) ‘‘Use of International Organiza- clude a disposable 3 inch 20 gauge nee- tion for Standardization’s ISO 10993 dle with stylet and a 30 cc. syringe, as ‘Biological Evaluation of Medical De- well as the various sample collection vices—Part I: Evaluation and Test- accessories, such as vials, specimen ing,’ ’’ and containers, medium, drapes, etc. The (ii) ‘‘510(k) Sterility Review Guidance device is used at 16–18 weeks gestation of 2/12/90 (K90–1),’’ for antepartum diagnosis of certain (2) Labeling: congenital abnormalities or anytime (i) Indication: Only to evaluate the after 24 weeks gestation when used to endometrium, assess fetal maturity. (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: (i) The sampling component is cov- [61 FR 1123, Jan. 16, 1996, as amended at 66 ered within the vagina, and FR 33808, July 25, 2001] (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, 2000] blood transcervically through an endoscope by puncturing the fetal skin with § 884.1300 Uterotubal carbon dioxide a short blade and drawing blood into a insufflator and accessories. heparinized tube. The fetal blood pH is (a) Identification. A uterotubal carbon determined and used in the diagnosis of dioxide insufflator and accessories is a fetal distress and fetal hypoxia. device used to test the patency (lack of (b) Classification. Class II (perform- obstruction) of the fallopian tubes by ance standards). pressurizing the uterus and fallopian tubes and filling them with carbon di- § 884.1600 Transabdominal amnioscope oxide gas. (fetoscope) and accessories. (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 ab- (a) Identification. A perineometer is a dominal entry. The device is used to device consisting of a fluid-filled sack ascertain fetal abnormalities, to obtain for intravaginal use that is attached to fetal blood samples, or to obtain fetal 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).

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(c) Date premarket approval application clude trocar and cannula, instruments (PMA) or notice of completion of a prod- used through an operating channel, uct development protocol (PDP) is re- scope preheaters, light source and ca- quired. A PMA or a notice of comple- bles, and component parts. tion of a PDP is required to be filed (b) Classification. (1) Class II (per- with the Food and Drug Administra- formance standards). tion on or before January 29, 1987 for (2) Class I for culdoscope accessories any transabdominal amnioscope that are not part of a specialized in- (fetoscope) and accessories that was in strument or device delivery system; do commercial distribution before May 28, not have adapters, connectors, chan- 1976, or that has on or before January nels, or do not have portals for 29, 1987 been found to be substantially electrosurgical, laser, or other power equivalent to a transabdominal sources. Such culdoscope accessory in- amnioscope (fetoscope) and accessories struments include: lens cleaning brush, that was in commercial distribution biopsy brush, clip applier (without before May 28, 1976. Any other clips), applicator, cannula (without transabdominal amnioscope (fetoscope) trocar or valves), ligature carrier/nee- and accessories shall have an approved dle holder, clamp/hemostat/grasper, cu- PMA or a declared completed PDP in rette, instrument guide, ligature pass- effect before being placed in commer- ing and knotting instrument, suture cial distribution. needle (without suture), retractor, mechanical (noninflatable), snare, stylet, [45 FR 12684, Feb. 26, 1980, as amended at 51 forceps, dissector, mechanical (non- FR 39845, Oct. 31, 1986] inflatable) scissors, and suction/irriga- § 884.1630 Colposcope. tion probe. The devices subject to this paragraph (b)(2) are exempt from the (a) Identification. A colposcope is a premarket notification procedures in device designed to permit direct view- subpart E of part 807 of this chapter, ing of the tissues of the vagina and cer- subject to the limitations in § 884.9. vix by a telescopic system located outside the vagina. It is used to diagnose [45 FR 12684, Feb. 26, 1980, as amended at 61 abnormalities and select areas for bi- FR 1123, Jan. 16, 1996; 66 FR 38808, July 25, opsy. This generic type of device may 2001] include a light source, cables, and com- § 884.1660 Transcervical endoscope ponent parts. (amnioscope) and accessories. (b) Classification. Class II (special (a) Identification. A transcervical en- controls). The device, when it is a doscope is a device designed to permit standard colposcope (or direct viewing of the fetus and colpomicroscope) that uses only a amniotic sac by means of an open tube white light source, does not use filters introduced into the uterus through the other than a green filter, does not in- cervix. The device may be used to vis- clude image analysis software, and is ualize the fetus or amniotic fluid and not smartphone-based, is exempt from to sample fetal blood or amniotic fluid. the premarket notification procedures This generic type of device may in- in subpart E of part 807 of this chapter clude obturators, instruments used subject to the limitations in § 884.9. through an operating channel, light [45 FR 12684, Feb. 26, 1980, as amended at 84 sources and cables, and component FR 71816, Dec. 30, 2019] parts. (b) Classification. Class II (perform- § 884.1640 Culdoscope and accessories. ance standards). (a) Identification. A culdoscope is a device designed to permit direct view- § 884.1690 Hysteroscope and acces- ing of the organs within the peri- sories. toneum by a telescopic system intro- (a) Identification. A hysteroscope is a duced into the pelvic cavity through device used to permit direct viewing of the posterior vaginal fornix. It is used the cervical canal and the uterine cav- to perform diagnostic and surgical pro- ity by a telescopic system introduced cedures on the female genital organs. into the uterus through the cervix. It is This generic type of device may in- used to perform diagnostic and surgical

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procedures other than sterilization. perform diagnostic and surgical proce- This generic type of device may in- dures (i.e., resection and coagulation). clude obturators and sheaths, instru- This device type contains a closed-loop ments used through an operating chan- recirculating fluid management system nel, scope preheaters, light sources and for the controlled delivery of filtered cables, and component parts. distension fluid. This device type also (b) Classification. (1) Class II (per- contains a bipolar radiofrequency de- formance standards). vice used in conjunction with a (2) Class I for hysteroscope acces- hysteroscope for resection and coagula- sories that are not part of a specialized tion of intrauterine tissues. instrument or device delivery system; do not have adapters, connectors, chan- (b) Classification. Class II (special nels, or do not have portals for controls). The special control(s) for electrosurgical, laser, or other power this device are: sources. Such hysteroscope accessory (1) The patient-contacting compo- instruments include: lens cleaning nents of the device must be dem- brush, cannula (without trocar or onstrated to be biocompatible. valves), clamp/hemostat/grasper, cu- (2) Software validation, verification, rette, instrument guide, forceps, dis- and hazard analysis must be provided. sector, mechanical (noninflatable), and (3) Electrical equipment safety, in- scissors. The devices subject to this cluding appropriate thermal and me- paragraph (b)(2) are exempt from the chanical safety and electromagnetic premarket notification procedures in compatibility (EMC) testing must be subpart E of part 807 of this chapter, performed. subject to the limitations in § 884.9. (4) Device components that are la- [45 FR 12684, Feb. 26, 1980, as amended at 61 beled sterile must be validated to a ste- FR 1123, Jan. 16, 1996; 66 FR 38808, July 25, rility assurance level of 10¥6. 2001] (5) Shelf-life testing that dem- § 884.1700 Hysteroscopic insufflator. onstrates the device packaging maintains sterility and the functionality of (a) Identification. A hysteroscopic insufflator is a device designed to dis- the device is maintained following sim- tend the uterus by filling the uterine ulated shipping and handling must be cavity with a liquid or gas to facilitate provided to support the proposed shelf viewing with a hysteroscope. life. (b) Classification. (1) Class II (per- (6) Non-clinical testing data must formance standards). demonstrate the performance charac- (2) Class I for tubing and tubing/filter teristics of the device. Detailed proto- fits which only include accessory in- cols and the test reports must be pro- struments that are not used to effect vided for each test. intrauterine access, e.g., hysteroscopic (i) The following tests must be per- introducer sheaths, etc.; and single-use formed for the resection portion of the tubing kits used for only intrauterine device: insufflation. The devices subject to this (A) Mechanical testing to assess crit- paragraph (b)(2) are exempt from the ical joint strength. premarket notification procedures in (B) Device electrode temperature subpart E of part 807 of this chapter, subject to the limitations in § 884.9. testing. (C) Coagulation depth testing. [45 FR 12684, Feb. 26, 1980, as amended at 61 (D) Simulated use testing. FR 1124, Jan. 16, 1996; 66 FR 38808, July 25, 2001] (E) Device durability testing. (ii) The following tests must be per- § 884.1710 Closed loop hysteroscopic formed for the fluid management por- insufflator with cutter-coagulator. tion of the device: (a) Identification. A closed loop (A) Mechanical testing to assess ten- hysteroscopic insufflator with cutter- sile strength of connections. coagulator is a prescription device con- figured for hysteroscopic insufflation, resection, and coagulation. It is used to

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(B) Pressure testing that dem- brush, biopsy brush, clip applier (with- onstrates the following parameters, in- out clips), applicator, cannula (without cluding accuracy of the pressure dis- trocar or valves), ligature carrier/nee- played; appropriate detection and re- dle holder, clamp/hemostat/grasper, cu- sponse to overpressure conditions; acti- rette, instrument guide, ligature pass- vation of a secondary overpressure re- ing and knotting instrument, suture lief valve at the maximum safe level; needle (without suture), retractor, me- and all accessories within the fluid chanical (noninflatable), snare, stylet, path meet the pressure requirements. forceps, dissector, mechanical (non- (C) Fluid delivery volume testing inflatable), scissors, and suction/irriga- that demonstrates that the maximum tion probe. The devices subject to this fluid volume delivered is below a paragraph (b)(2) are exempt from the predefined level. premarket notification procedures in (D) Flow rate testing. subpart E of part 807 of this chapter, (E) Simulated use testing. subject to the limitations in § 884.9. (F) Filtration testing. (G) Blood filtration capacity testing. [45 FR 12684, Feb. 26, 1980, as amended at 61 (H) Tissue collection capacity test- FR 1124, Jan. 16, 1996; 66 FR 38808, July 25, 2001] ing. (I) Filtrate characterization and test- § 884.1730 Laparoscopic insufflator. ing that demonstrates that the continuous reintroduction of filtrate into the (a) Identification. A laparoscopic uterus does not pose a safety risk. insufflator is a device used to facilitate (7) Clinician labeling must include: the use of the laparoscope by filling the (i) Specific instructions and the clin- peritoneal cavity with gas to distend ical training needed for the safe use of it. the device. (b) Classification. (1) Class II (per- (ii) Appropriate warnings, pre- formance standards). cautions, and information related to (2) Class I for tubing and tubing/filter overpressurization. kits which include accessory instru- (iii) Appropriate EMC information. ments that are not used to effect intra- (iv) An expiration date/shelf life. abdominal insufflation (pneumoperitoneum). The devices sub- [82 FR 35073, July 28, 2017] 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.

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

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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 auto- matically 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 (b) Classification. Class II (perform- controls). The device, when it is a ance standards). breast examination recording sheet, is exempt from the premarket notifica- Subpart E—Obstetrical and tion procedures in subpart E of part 807 Gynecological Surgical Devices of this chapter subject to the limitations in § 884.9. The special control is § 884.4050 Gynecologic laparoscopic FDA’s guidance entitled ‘‘Class II Spe- power morcellation containment cial Controls Guidance Document: system. Breast Lesion Documentation Sys- (a) Identification. A gynecologic tem.’’ See § 884.1(e) for the availability laparoscopic power morcellation con- of this guidance document. tainment system is a prescription de- [68 FR 44415, Aug. 27, 2003, as amended at 84 vice consisting of an instrument port FR 71816, Dec. 30, 2019] and tissue containment method that creates a working space allowing for direct visualization during a power Subpart D—Obstetrical and morcellation procedure following a Gynecological Prosthetic Devices laparoscopic procedure for the excision of benign gynecologic tissue that is not § 884.3200 Cervical drain. suspected to contain malignancy. (a) Identification. A cervical drain is a (b) Classification. Class II (special device designed to provide an exit controls). The special controls for this channel for draining discharge from device are: the cervix after pelvic surgery. (1) The patient-contacting compo- (b) Classification. Class II (special nents of the device must be dem- controls). The device is exempt from onstrated to be biocompatible; the premarket notification procedures (2) Device components that are la- in subpart E of part 807 of this chapter beled sterile must be validated to a ste- subject to the limitations in § 884.9. rility assurance level of 10¥6; (3) Performance data must support [45 FR 12684, Feb. 26, 1980, as amended at 84 FR 71816, Dec. 30, 2019] shelf life by demonstrating continued sterility of the device or the sterile § 884.3575 Vaginal pessary. components, package integrity, and device functionality over the intended (a) Identification. A vaginal pessary is shelf life; a removable structure placed in the va- (4) Non-clinical performance data gina to support the pelvic organs and is must demonstrate that the device used to treat conditions such as uter- meets all design specifications and per- ine prolapse (falling down of uterus), formance requirements. The following uterine retroposition (backward dis- performance characteristics must be placement), or gynecologic hernia. tested: (b) Classification. Class II (perform- (i) Demonstration of the device im- ance standards). permeability to tissue, cells, and § 884.3650 Fallopian tube prosthesis. fluids; (ii) Demonstration that the device al- (a) Identification. A fallopian tube lows for the insertion and withdrawal prosthesis is a device designed to main- of laparoscopic instruments while tain the patency (openness) of the fal- maintaining pneumoperitoneum; lopian tube and is used after recon- (iii) Demonstration that the contain- structive surgery. ment system provides adequate space (b) Classification. Class II (perform- to perform morcellation and adequate ance standards). visualization of the laparoscopic instruments and tissue specimen relative § 884.3900 Vaginal stent. to the external viscera; (a) Identification. A vaginal stent is a (iv) Demonstration that intended device used to enlarge the vagina by laparoscopic instruments and stretching, or to support the vagina morcellators do not compromise the and to hold a skin graft after recon- integrity of the containment system; structive surgery. and

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(v) Demonstration that intended Medical Devices—Part I: Evaluation users can adequately deploy the device, and Testing,’ ’’ morcellate a specimen without com- (ii) ‘‘510(k) Sterility Review Guidance promising the integrity of the device, 2/12/90 (K–90),’’ and and remove the device without spillage (iii) ‘‘Guidance (‘Guidelines’) for of contents; Evaluation of Laproscopic Bipolar and (5) Training must be developed and Thermal Coagulators (and Acces- validated to ensure users can follow sories),’’ the instructions for use; and (2) International Electrotechnical (6) Labeling must include the fol- Commission’s IEC 60601–1–AM2 (1995– lowing: 03), Amendment 2, ‘‘Medical Electrical (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 and accessories. (v) An expiration date or shelf life. (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 by tissue contact with an electrically and accessories. 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

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under endoscopic observation. It de- and a grounding plate. It is used in fe- stroys tissue with high temperatures male sterilization and in other opera- by directing a high frequency electrical tive procedures under endoscopic obser- current through tissue between two vation. This generic type of device may electrical contacts of a probe. This ge- include the following accessories: an neric type of device may include the electrical generator, probes and elec- following accessories: an electrical trical cables, and a patient grounding generator, probes, and electrical ca- plate. This generic type of device does bles. not include devices used to perform fe- (b) Classification. Class II. The special male sterilization under hysteroscopic controls for this device are: observation. (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

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the cervical os by stretching it with a (3) Performance data must support power-driven vibrating probe head. The the shelf life of the device by dem- device is used to gain access to the onstrating continued sterility, package uterus or to induce abortion, but is not integrity, and device functionality to be used during labor when a viable over the identified shelf life. fetus is desired or anticipated. (4) Non-clinical performance data (b) Classification. Class III (premarket must demonstrate that the device per- approval). forms as intended under anticipated (c) Date PMA or notice of completion of conditions of use. The following per- a PDP is required. A PMA or a notice of formance characteristics must be test- completion of a PDP is required to be ed: filed with the Food and Drug Adminis- (i) Reliability testing of device de- tration on or before December 26, 1996 ployment and retrieval under relevant for any vibratory cervical dilator that use conditions must be conducted. was in commercial distribution before (ii) Testing of the maximum force ap- May 28, 1976, or that has, on or before plied to the fetal head in an anatomic December 26, 1996 been found to be sub- model must be conducted. stantially equivalent to a vibratory (iii) Testing of uniform application of cervical dilator that was in commer- the elevator mechanism on the fetal cial distribution before May 28, 1976. Any other vibratory cervical dilator head must be conducted. shall have an approved PMA or a de- (5) Labeling must include the fol- clared completed PDP in effect before lowing: being placed in commercial distribu- (i) Contraindication for use in the tion. presence of active genital infection; (ii) Specific instructions regarding [45 FR 12684, Feb. 26, 1980, as amended at 52 the proper placement and use of the de- FR 17741, May 11, 1987; 61 FR 50708, Sept. 27, 1996] vice; and (iii) A shelf life. § 884.4340 Fetal vacuum extractor. [82 FR 60114, Dec. 19, 2017] (a) Identification. A fetal vacuum extractor is a device used to facilitate de- § 884.4400 Obstetric forceps. livery. The device enables traction to (a) Identification. An obstetric forceps be applied to the fetal head (in the is a device consisting of two blades, birth canal) by means of a suction cup with handles, designed to grasp and attached to the scalp and is powered by apply traction to the fetal head in the an external vacuum source. This ge- birth passage and facilitate delivery. neric type of device may include the (b) Classification. Class II (special cup, hosing, vacuum source, and vacu- controls). The device is exempt from um control. the premarket notification procedures (b) Classification. Class II (perform- in subpart E of part 807 of this chapter ance standards). subject to the limitations in § 884.9. § 884.4350 Fetal head elevator. [45 FR 12684, Feb. 26, 1980, as amended at 84 (a) Identification. A fetal head eleva- FR 71816, Dec. 30, 2019] tor is a prescription device consisting of a mechanism that elevates the fetal § 884.4500 Obstetric fetal destructive head to facilitate delivery during a instrument. Caesarean section. (a) Identification. An obstetric fetal (b) Classification. Class II (special destructive instrument is a device de- controls). The special controls for this signed to crush or pull the fetal body device are: to facilitate the delivery of a dead or (1) The patient-contacting compo- anomalous (abnormal) fetus. This ge- nents of the device must be dem- neric type of device includes the onstrated to be biocompatible. cleidoclast, cranioclast, craniotribe, (2) Performance data must dem- and destructive hook. onstrate the sterility of patient-con- (b) Classification. Class II (perform- tacting components of the device. ance standards).

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§ 884.4520 Obstetric-gynecologic gen- nostic and surgical functions (e.g., di- eral manual instrument. lating, grasping, measuring, and scrap- (a) Identification. An obstetric- ing), where structural integrity is the gynecologic general manual instru- chief criterion of device performance. ment is one of a group of devices used This type of device consists of the fol- to perform simple obstetric and lowing: gynecologic manipulative functions. (1) An amniotome is an instrument This generic type of device consists of used to rupture the fetal membranes. the following: (2) A circumcision clamp is an instru- (1) An episiotomy scissors is a cut- ment used to compress the foreskin of ting instrument, with two opposed the penis during circumcision of a male shearing blades, used for surgical inci- infant. sion of the vulvar orifice for obstet- (3) An umbilical clamp is an instru- rical purposes. ment used to compress the umbilical (2) A fiberoptic metal vaginal spec- cord. ulum is a metal instrument, with (4) A uterine curette is an instrument fiberoptic light, used to expose and il- used to scrape and remove material luminate the interior of the vagina. from the uterus. (3) A metal vaginal speculum is a (5) A fixed-size cervical dilator is any metal instrument used to expose the of a series of bougies of various sizes interior of the vagina. used to dilate the cervical os by (4) An umbilical scissors is a cutting stretching the cervix. instrument, with two opposed shearing (6) A uterine elevator is an instru- blades, used to cut the umbilical cord. ment inserted into the uterus used to (5) A uterine clamp is an instrument lift and manipulate the uterus. used to hold the uterus by compres- (7) A gynecological surgical forceps is sion. an instrument with two blades and (6) A uterine packer is an instrument handles used to pull, grasp, or com- used to introduce dressing into the press during gynecological examina- uterus or vagina. tion. (7) A vaginal applicator is an instrument used to insert medication into (8) A cervical cone knife is a cutting the vagina. instrument used to excise and remove (8) A vaginal retractor is an instru- tissue from the cervix. ment used to maintain vaginal expo- (9) A gynecological cerclage needle is sure by separating the edges of the va- a looplike instrument used to suture gina and holding back the tissue. the cervix. (9) A gynecological fibroid hook is an (10) A hook-type contraceptive intra- instrument used to exert traction upon uterine device (IUD) remover is an in- a fibroid. strument used to remove an IUD from (10) A pelvimeter (external) is an in- the uterus. strument used to measure the external (11) A gynecological fibroid screw is diameters of the pelvis. an instrument used to hold onto a fi- (b) Classification. Class I (general con- broid. trols). The devices are exempt from the (12) A uterine sound is an instrument premarket notification procedures in used to determine the depth of the subpart E of part 807 of this chapter, uterus by inserting it into the uterine subject to the limitations in § 884.9. cavity. [45 FR 12684, Feb. 26, 1980, as amended at 54 (13) A cytological cervical spatula is FR 25052, June 12, 1989; 66 FR 38809, July 25, a blunt instrument used to scrape and 2001] remove cytological material from the surface of the cervix or vagina. § 884.4530 Obstetric-gynecologic spe- (14) A gynecological biopsy forceps is cialized manual instrument. an instrument with two blades and (a) Identification. An obstetric- handles used for gynecological biopsy gynecologic specialized manual instru- procedures. ment is one of a group of devices used (15) A uterine tenaculum is a hook- during obstetric-gynecologic proce- like instrument used to seize and hold dures to perform manipulative diag- the cervix or fundus.

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(16) An internal pelvimeter is an in- ment, support attachments, and cabi- strument used within the vagina to nets for warming instruments and dis- measure the diameter and capacity of posing of wastes. the pelvis. (b) Classification. Class II (special (17) A nonmetal vaginal speculum is controls). The device is exempt from a nonmetal instrument used to expose the premarket notification procedures the interior of the vagina. in subpart E of part 807 of this chapter (18) A fiberoptic nonmetal vaginal subject to the limitations in § 884.9. speculum is a nonmetal instrument, with fiberoptic light, used to expose [45 FR 12684, Feb. 26, 1980, as amended at 84 and illuminate the interior of the va- FR 71816, Dec. 30, 2019] gina. (b) Classification. (1) Class II (special § 884.4910 Specialized surgical instrumentation for use with controls). The device, when it is an um- urogynecologic surgical mesh. bilical clamp with or without a cutter, a uterine tenaculum which is sterile (a) Identification. Specialized surgical and does not use suction and is in- instrumentation for use with tended for single use, a nonmetal vag- urogynecologic surgical mesh is a pre- inal speculum, or a fiberoptic nonmetal scription device specifically intended vaginal speculum, is exempt from the for use as an aid in the insertion, place- premarket notification procedures in ment, fixation, or anchoring of surgical subpart E of part 807 of this chapter mesh during urogynecologic proce- subject to the limitations in § 884.9. dures. These procedures include (2) Class I for the amniotome, uterine transvaginal pelvic organ prolapse re- curette, cervical dilator (fixed-size bou- pair, sacrocolpopexy (transabdominal gies), cerclage needle, IUD remover, pelvic organ prolapse repair), and uterine sound, and gynecological bi- treatment of female stress urinary in- opsy forceps. The devices subject to continence. Examples of specialized this paragraph (b)(2) are exempt from surgical instrumentation include nee- the premarket notification procedures dle passers and trocars, needle guides, in subpart E of part 807 of this chapter, fixation tools, and tissue anchors. This subject to the limitations in § 884.9. device is not a manual gastro- enterology-urology surgical instru- [45 FR 12684, Feb. 26, 1980, as amended at 61 ment and accessories (§ 876.4730) or a FR 1124, Jan. 16, 1996; 66 FR 38809, July 25, manual surgical instrument for general 2001; 84 FR 71816, Dec. 30, 2019] use (§ 878.4800). § 884.4550 Gynecologic surgical laser. (b) Classification. Class II (special controls). The special controls for spe- (a) Identification. A gynecologic sur- cialized surgical instrumentation for gical laser is a continuous wave carbon use with urogynecologic surgical mesh dioxide laser designed to destroy tissue are: thermally or to remove tissue by radiant light energy. The device is used (1) The device must be demonstrated only in conjunction with a colposcope to be biocompatible; as part of a gynecological surgical sys- (2) The device must be demonstrated tem. A colposcope is a magnifying lens to be sterile and, if reusable, it must be system used to examine the vagina and demonstrated that the device can be cervix. adequately reprocessed; (b) Classification. Class II (perform- (3) Performance data must support ance standards). the shelf life of the device by demonstrating package integrity and de- § 884.4900 Obstetric table and acces- vice functionality over the requested sories. shelf life; (a) Identification. An obstetric table is (4) Non-clinical performance testing a device with adjustable sections de- must demonstrate that the device signed to support a patient in the var- meets all design specifications and per- ious positions required during obstetric formance requirements, and that the and gynecologic procedures. This ge- device performs as intended under an- neric type of device may include the ticipated conditions of use; and following accessories: patient equip- (5) Labeling must include:

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(i) Information regarding the mesh tion or menstruation from the uterus design that may be used with the de- by using a cannula connected to a suc- vice; tion source. This device is used for (ii) Detailed summary of the clinical pregnancy termination or menstrual evaluations pertinent to use of the de- regulation. This type of device may in- vice; clude aspiration cannula, vacuum (iii) Expiration date; and source, and vacuum controller. (iv) Where components are intended (b) Classification. Class II (perform- to be sterilized by the user prior to ini- ance standards). tial use and/or are reusable, validated methods and instructions for steriliza- § 884.5100 Obstetric anesthesia set. tion and/or reprocessing of any reus- (a) Identification. An obstetric anes- able components. thesia set is an assembly of antiseptic [82 FR 1603, Jan. 6, 2017] solution, needles, needle guides, syringes, and other accessories, intended Subpart F—Obstetrical and Gyne- for use with an anesthetic drug. This cological Therapeutic De- device is used to administer regional vices blocks (e.g., paracervical, uterosacral, and pudendal) that may be used during § 884.5050 Metreurynter-balloon abor- labor, delivery, or both. tion system. (b) Classification. Class II (perform- (a) Identification. A metreurynter-bal- ance standards). loon abortion system is a device used to induce abortion. The device is in- § 884.5150 Nonpowered breast pump. serted into the uterine cavity, inflated, (a) Identification. A nonpowered and slowly extracted. The extraction of breast pump is a manual suction device the balloon from the uterus causes di- used to express milk from the breast. lation of the cervical os. This generic (b) Classification. Class I. The device type of device may include pressure is exempt from the premarket notifica- sources and pressure controls. tion procedures in subpart E of part 807 (b) Classification. Class III (premarket of this chapter, subject to the limita- approval). tions in § 884.9, if the device is using ei- (c) Date PMA or notice of completion of ther a bulb or telescoping mechanism a PDP is required. A PMA or a notice of which does not develop more than 250 completion of a PDP is required to be mm Hg suction, and the device mate- filed with the Food and Drug Adminis- rials that contact breast or breast milk tration on or before December 26, 1996 do not produce cytotoxicity, irritation, for any metreurynter-balloon abortion or sensitization effects. system that was in commercial distribution before May 28, 1976, or that [45 FR 12684, Feb. 26, 1980, as amended at 61 has, on or before December 26, 1996 FR 1124, Jan. 16, 1996; 66 FR 38809, July 25, been found to be substantially equiva- 2001] lent to a metreurynter-balloon abortion system that was in commercial § 884.5160 Powered breast pump. distribution before May 28, 1976. Any (a) Identification. A powered breast other metreurynter-balloon abortion pump in an electrically powered suc- system shall have an approved PMA or tion device used to express milk from a declared completed PDP in effect be- the breast. fore being placed in commercial dis- (b) Classification. Class II (perform- tribution. ance standards). [45 FR 12684, Feb. 26, 1980, as amended at 52 FR 17741, May 11, 1987; 61 FR 50709, Sept. 27, § 884.5200 Hemorrhoid prevention 1996] pressure wedge. (a) Identification. A hemorrhoid pre- § 884.5070 Vacuum abortion system. vention pressure wedge provides me- (a) Identification. A vacuum abortion chanical support to the perianal region system is a device designed to aspirate during the labor and delivery process. transcervically the products of concep- External mechanical support of the

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perianal region is intended to help pre- (5) Clinical performance data must be vent the occurrence of external hemor- provided that characterizes the rate of rhoids associated with vaginal child- skin/tissue trauma. birth. (6) The labeling must include: (b) Classification. Class II (special (i) Specific instructions regarding controls). The device is exempt from the proper placement and use of the de- the premarket notification procedures vice. in subpart E of part 807 of this chapter (ii) A shelf life. subject to the limitations in § 884.9. The special controls for this device are: [82 FR 61448, Dec. 28, 2017] (1) The sale, distribution, and use of this device are restricted to prescrip- § 884.5225 Abdominal decompression chamber. tion use in accordance with § 801.109 of this chapter. (a) Identification. An abdominal de- (2) The labeling must include specific compression chamber is a hoodlike de- instructions regarding the proper vice used to reduce pressure on the placement and use of the device. pregnant patient’s abdomen for the re- (3) The device must be demonstrated lief of abdominal pain during preg- to be biocompatible. nancy or labor. (4) Mechanical bench testing of mate- (b) Classification. Class III (premarket rial strength must demonstrate that approval). the device will withstand forces en- (c) Date PMA or notice of completion of countered during use. a PDP is required. A PMA or a notice of (5) Safety and effectiveness data completion of a PDP is required to be must demonstrate that the device pre- filed with the Food and Drug Adminis- vents hemorrhoids in women under- tration on or before December 26, 1996 going spontaneous vaginal delivery, in for any abdominal decompression addition to general controls. chamber that was in commercial distribution before May 28, 1976, or that [76 FR 21238, Apr. 15, 2011, as amended at 84 has, on or before December 26, 1996 FR 71816, Dec. 30, 2019] been found to be substantially equivalent to an abdominal decompression § 884.5210 Pressure wedge for the reduction of cesarean delivery. chamber that was in commercial distribution before May 28, 1976. Any (a) Identification. A pressure wedge other abdominal decompression cham- for the reduction of cesarean delivery ber shall have an approved PMA or a is a prescription device that provides declared completed PDP in effect be- external mechanical support to the fore being placed in commercial dis- perianal region during the labor and tribution. vaginal delivery process. External mechanical support of the perianal region [45 FR 12684, Feb. 26, 1980, as amended at 52 is intended to help reduce the occur- FR 17741, May 11, 1987; 61 FR 50709, Sept. 27, rence of cesarean delivery. 1996] (b) Classification. Class II (special § 884.5250 Cervical cap. controls). The special controls for this device are: (a) Identification. A cervical cap is a (1) The patient contacting materials flexible cuplike receptacle that fits must be evaluated to be biocompatible. over the cervix to collect menstrual (2) Nonclinical performance data flow or to aid artificial insemination. must demonstrate that the device will This generic type of device is not for not break when subjected to the forces contraceptive use. it will be exposed to during labor. (b) Classification. Class II (perform- (3) Performance data must validate ance standards). the sterility of the device. (4) Performance data must support § 884.5300 Condom. the shelf life of the device by dem- (a) Identification. A condom is a onstrating continued sterility and sheath which completely covers the package integrity over the labeled penis with a closely fitting membrane. shelf life. 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 Multiple-use female condom. cial Controls Guidance Document: La- (a) Identification. A multiple-use fe- beling for Natural Rubber Latex male condom is a sheath-like device Condoms Classified Under 21 CFR that lines the vaginal wall and is in- 884.5300’’ will serve as the special con- serted into the vagina prior to the ini- trol. See § 884.1(e) for the availability of tiation of coitus. At the conclusion of this guidance document. coitus, the device can be reused. It is [73 FR 66538, Nov. 10, 2008] indicated for contraception and prophylactic (preventing the transmission § 884.5310 Condom with spermicidal of sexually transmitted infections) pur- lubricant. poses. (a) Identification. A condom with (b) Classification. Class III (premarket spermicidal lubricant is a sheath which approval). completely covers the penis with a (c) Date PMA or notice of completion of closely fitting membrane with a lubri- PDP is required. A PMA or notice of cant that contains a spermicidal agent, completion of a PDP is required to be nonoxynol–9. This condom is used for filed with the Food and Drug Adminis- contraceptive and prophylactic pur- tration on or before November 21, 2011, poses (preventing transmission of vene- for any female condom that was in real disease). commercial distribution before May 28, (b) Classification. Class II (perform- 1976, or that has, on or before Novem- ance standards). ber 21, 2011, been found to be substan- [47 FR 49022, Oct. 29, 1982] tially equivalent to any female condom that was in commercial distribution § 884.5320 Glans sheath. before May 28, 1976. Any other female (a) Identification. A glans sheath de- condom shall have an approved PMA or vice is a sheath which covers only the declared completed PDP in effect be- glans penis or part thereof and may fore being placed in commercial dis- also cover the area in the immediate tribution. proximity thereof, the corona and frenulum, but not the entire shaft of [65 FR 31455, May 18, 2000, as amended at 76 FR 50667, Aug. 16, 2011; 83 FR 48714, Sept. 27, the penis. It is indicated only for the 2018] prevention of pregnancy and not for the prevention of sexually-transmitted § 884.5340 Single-use internal condom. diseases. (b) Classification. Class III (premarket (a) Identification. A single-use inter- approval). nal condom is an over-the-counter (c) Date premarket approval application sheath-like device that lines the vag- (PMA) or notice of completion of a prod- inal or anal wall and is inserted into uct development protocol (PDP) is re- the vagina or anus prior to the initi- quired. A PMA or a notice of comple- ation of coitus. At the conclusion of co- tion of a PDP is required to be filed itus, it is removed and discarded. It is with the Food and Drug Administra- indicated for contraception and/or pro- tion on or before September 12, 2002, for phylactic (preventing the transmission any glans sheath that was in commer- of sexually transmitted infections) pur- cial distribution before May 28, 1976, or poses.

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(b) Classification. Class II (special (iv) Statement regarding compat- controls). The special controls for this ibility with additional types of per- device are: sonal lubricants. (1) Clinical performance testing must evaluate the following: [83 FR 48714, Sept. 27, 2018] (i) Rate of clinical failure of the de- § 884.5350 Contraceptive diaphragm vice and rate of individual failure and accessories. modes of the device based on an acute failure modes study evaluating the in- (a) Identification. A contraceptive dia- tended use (vaginal and/or anal inter- phragm is a closely fitting membrane course); and placed between the posterior aspect of (ii) Cumulative pregnancy rate when the pubic bone and the posterior vag- using the device based on a contracep- inal fornix. The device covers the cer- tive effectiveness study (when the de- vix completely and is used with a vice is indicated for vaginal inter- spermicide to prevent pregnancy. This course). generic type of device may include an (2) Viral penetration testing must introducer. demonstrate the device is an effective (b) Classification. Class II (perform- barrier to sexually transmitted infec- ance standards). tions. (3) Nonclinical performance testing § 884.5360 Contraceptive intrauterine must demonstrate that the device per- device (IUD) and introducer. forms as intended under anticipated (a) Identification. A contraceptive conditions of use. The following per- intrauterine device (IUD) is a device formance characteristics must be eval- used to prevent pregnancy. The device uated: is placed high in the uterine fundus (i) Mechanical testing must dem- with a string extending from the device onstrate the device can withstand through the cervical os into the va- forces under anticipated use condi- gina. This generic type of device in- tions, include evaluation of tensile, cludes the introducer, but does not in- tear, and burst properties of the device; clude contraceptive IUD’s that func- and tion by drug activity, which are sub- (ii) Compatibility testing with per- ject to the new drug provisions of the sonal lubricants must determine Federal Food, Drug, and Cosmetic Act whether the physical properties of the (see § 310.502). device are adversely affected by use of additional lubricants. (b) Classification. Class III (premarket (4) The device must be demonstrated approval). to be biocompatible. (c) Labeling. Labeling requirements (5) Shelf-life testing must dem- for contraceptive IUD’s are set forth in onstrate that the device maintains its § 801.427. performance characteristics and the (d) Date premarket approval application packaging of the device must maintain (PMA) or notice of completion of a prod- integrity for the duration of the shelf- uct development protocol (PDP) is re- life. quired. A PMA or a notice of comple- (6) Labeling of the device must in- tion of a PDP is required to be filed clude: with the Food and Drug Administra- (i) Contraceptive effectiveness table tion on or before August 4, 1986, for any comparing typical use and perfect use IUD and introducer that was in com- pregnancy rates with the device to mercial distribution before May 28, other available methods of birth con- 1976, or that has on or before August 4, trol; 1986, been found to be substantially (ii) Statement regarding the adverse equivalent to an IUD and introducer events associated with the device, in- that was in commercial distribution cluding potential transmission of infec- before May 28, 1976. Any other IUD and tion, adverse tissue reaction, and ulcer- introducer shall have an approved PMA ation or other physical trauma; or a declared completed PDP in effect (iii) Expiration date; and

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before being placed in commercial dis- (D) A warning that the application tribution. cannot protect against sexually transmitted infections. [45 FR 12684, Feb. 26, 1980, as amended at 51 (ii) Hardware platform and operating FR 16649, May 5, 1986] system requirements. § 884.5370 Software application for (iii) Instructions identifying and ex- contraception. plaining how to use the software application, including required user inputs (a) Identification. A software applica- and how to interpret the application tion for contraception is a device that outputs. provides user-specific fertility informa- (iv) A summary of the clinical validation for preventing a pregnancy. This tion study and results, including effec- device includes an algorithm that per- tiveness of the application as a stand- forms analysis of patient-specific data alone contraceptive and how this effec- (e.g., temperature, menstrual cycle tiveness compares to other forms of le- dates) to distinguish between fertile gally marketed contraceptives. and non-fertile days, then provides patient-specific recommendations related [84 FR 7995, Mar. 6, 2019] to contraception. § 884.5380 Contraceptive tubal occlu- (b) Classification. Class II (special sion device (TOD) and introducer. controls). The special controls for this device are: (a) Identification. A contraceptive (1) Clinical performance testing must tubal occlusion device (TOD) and introducer is a device designed to close a demonstrate the contraceptive effec- fallopian tube with a mechanical struc- tiveness of the software in the intended ture, e.g., a band or clip on the outside use population. of the fallopian tube or a plug or valve (2) Human factors performance eval- on the inside. The devices are used to uation must be provided to dem- prevent pregnancy. onstrate that the intended users can (b) Classification. Class III (premarket self-identify that they are in the in- approval). tended use population and can cor- (c) Date premarket approval application rectly use the application, based solely (PMA) or notice of completion of a prod- on reading the directions for use for uct development protocol (PDP) is re- contraception. quired. A PMA or a notice of comple- (3) Software verification, validation, tion of a PDP is required to be filed and hazard analysis must be performed. with the Food and Drug Administra- Documentation must include the fol- tion on or before December 30, 1987, for lowing: any TOD and introducer that was in (i) A cybersecurity vulnerability and commercial distribution before May 28, management process to assure software 1976, or that has on or before December functionality; and 30, 1987, been found to be substantially (ii) A description of the technical pa- equivalent to a TOD and introducer rameters of the software, including the that was in commercial distribution algorithm used to determine fertility before May 28, 1976. Any other TOD and status and alerts for user inputs out- introducer shall have an approved PMA side of expected ranges. or a declared completed PDP in effect (4) Labeling must include: before being placed in commercial dis- (i) The following warnings and pre- tribution. cautions: [45 FR 12684, Feb. 26, 1980, as amended at 52 (A) A statement that no contracep- FR 36883, Oct. 1, 1987] tive method is 100% effective. (B) A statement that another form of § 884.5390 Perineal heater. contraception (or abstinence) must be (a) Identification. A perineal heater is used on days specified by the applica- a device designed to apply heat di- tion. rectly by contact, or indirectly from a (C) Statements of any factors that radiant source, to the surface of the may affect the accuracy of the contra- perineum (the area between the vulva ceptive information. and the anus) and is used to soothe or

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to help heal the perineum after an of this chapter subject to the limita- episiotomy (incision of the vulvar ori- tions in § 884.9. fice for obstetrical purposes). [45 FR 12684, Feb. 26, 1980, as amended at 45 (b) Classification. Class II (special FR 51185, Aug. 1, 1980; 61 FR 67714, Dec. 24, controls). The device is exempt from 1996; 66 FR 38809, July 25, 2001; 84 FR 71816, the premarket notification procedures Dec. 30, 2019] in subpart E of part 807 of this chapter subject to the limitations in § 884.9. § 884.5435 Unscented menstrual pad. [45 FR 12684, Feb. 26, 1980, as amended at 84 (a) Identification. An unscented men- FR 71816, Dec. 30, 2019] strual pad is a device that is a pad made of cellulosic or synthetic mate- § 884.5400 Menstrual cup. rial which is used to absorb menstrual or other vaginal discharge. This ge- (a) Identification. A menstrual cup is neric type of device includes sterile a receptacle placed in the vagina to unscented menstrual pads used for collect menstrual flow. medically indicated conditions, but (b) Classification. Class II (special does not include menstrual pads treat- controls). The device is exempt from ed with scent (i.e., fragrance materials) the premarket notification procedures or those with added antimicrobial in subpart E of part 807 of this chapter agents or other drugs. subject to the limitations in § 884.9. (b) Classification. Class I (general con- [45 FR 12684, Feb. 26, 1980, as amended at 84 trols). The device is exempt from the FR 71816, Dec. 30, 2019] premarket notification procedures in subpart E of part 807 of this chapter § 884.5425 Scented or scented deodor- subject to the limitations in § 884.9 only ized menstrual pad. when the device is made of common (a) Identification. A scented or scent- cellulosic and synthetic material with ed deodorized menstrual pad is a device an established safety profile. that is a pad made of cellulosic or syn- [45 FR 12684, Feb. 26, 1980, as amended at 61 thetic material which is used to absorb FR 67714, Dec. 24, 1996; 65 FR 2320, Jan. 14, menstrual or other vaginal discharge. 2000; 73 FR 34860, June 19, 2008; 84 FR 71816, It has scent (i.e., fragrance materials) Dec. 30, 2019] added for aesthetic purposes (scented menstrual pad) or for deodorizing pur- § 884.5460 Scented or scented deodorized menstrual tampon. poses (scented deodorized menstrual pad). This generic type of device in- (a) Identification. A scented or scent- cludes sterile scented menstrual pads ed deodorized menstrual tampon is a used for medically indicated condi- device that is a plug made of cellulosic tions, but does not include menstrual or synthetic material that is inserted pads treated with added antimicrobial into the vagina and used to absorb agents or other drugs. menstrual or other vaginal discharge. (b) Classification. (1) Class I (general It has scent (i.e., fragrance materials) controls) for menstrual pads made of added for aesthetic purposes (scented common cellulosic and synthetic mate- menstrual tampon) or for deodorizing rial with an established safety profile. purposes (scented deodorized menstrual The devices subject to this paragraph tampon). This generic type of device (b)(1) are exempt from the premarket does not include menstrual tampons notification procedures in subpart E of treated with added antimicrobial part 807 of this chapter, subject to the agents or other drugs. limitations in § 884.9. This exemption (b) Classification. Class II (perform- does not include the intralabial pads ance standards). and reusable menstrual pads. [45 FR 12684, Feb. 26, 1980, as amended at 45 (2) Class II (special controls) for FR 51186, Aug. 1, 1980] scented or scented deodorized menstrual pads made of materials not de- § 884.5470 Unscented menstrual tam- scribed in paragraph (b)(1). The device pon. is exempt from the premarket notifica- (a) Identification. An unscented men- tion procedures in subpart E of part 807 strual tampon is a device that is a plug

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made of cellulosic or synthetic mate- vice is intended and labeled for thera- rial that is inserted into the vagina peutic use in increasing muscular tone and used to absorb menstrual or other and strength in the treatment of sexual vaginal discharge. This generic type of dysfunction. This generic type of de- device does not include menstrual tam- vice does not include devices used to pons treated with scent (i.e., fragrance treat urinary incontinence. materials) or those with added anti- (b) Classification. Class III (premarket microbial agents or other drugs. approval). (b) Classification. Class II (perform- (c) Date PMA or notice of completion of ance standards). a PDP is required. A PMA or a notice of completion of a PDP for a device is re- § 884.5900 Therapeutic vaginal douche quired to be filed with the Food and apparatus. Drug Administration on or before July (a) Identification. A therapeutic vag- 12, 2000, for any powered vaginal mus- inal douche apparatus is a device that cle stimulator for therapeutic use that is a bag or bottle with tubing and a was in commercial distribution before nozzle. The apparatus does not include May 28, 1976, or that has, on or before douche solutions. The apparatus is in- July 12, 2000, been found to be substan- tended and labeled for use in the treat- tially equivalent to a powered vaginal ment of medical conditions except it is muscle stimulator that was in commer- not for contraceptive use. After filling cial distribution before May 28, 1976. the therapeutic vaginal douche appa- Any other powered vaginal muscle ratus with a solution, the patient uses stimulator for therapeutic use shall the device to direct a stream of solu- have an approved PMA or declared tion into the vaginal cavity. completed PDP in effect before being (b) Classification. (1) Class II (per- placed in commercial distribution. formance standards). [45 FR 12684, Feb. 26, 1980, as amended at 52 (2) Class I if the device is operated by FR 17741, May 11, 1987; 65 FR 19834, Apr. 13, gravity feed. Devices subject to this 2000] paragraph (b)(2) are exempt from the premarket notification procedures in § 884.5960 Genital vibrator for thera- subpart E of part 807 of this chapter, peutic use. subject to the limitations in § 884.9. (a) Identification. A genital vibrator [45 FR 12684, Feb. 26, 1980, as amended at 61 for therapeutic use is an electrically FR 1124, Jan. 16, 1996; 66 FR 38809, July 25, operated device intended and labeled 2001] for therapeutic use in the treatment of sexual dysfunction or as an adjunct to § 884.5920 Vaginal insufflator. Kegel’s exercise (tightening of the (a) Identification. A vaginal muscles of the pelvic floor to increase insufflator is a device used to treat muscle tone). vaginitis by introducing medicated (b) Classification. Class II (perform- powder from a hand-held bulb into the ance standards). The device is exempt vagina through an open speculum. from the premarket notification proce- (b) Classification. Class I. The device dures in part 807, subpart E, of this is exempt from the premarket notifica- chapter subject to the limitations in tion procedures in subpart E of part 807 § 884.9. of this chapter, subject to the limita- [45 FR 12684, Feb. 26, 1980, as amended at 83 tions in § 884.9. FR 29215, June 5, 2018] [45 FR 12684, Feb. 26, 1980, as amended at 54 FR 25052, June 12, 1989; 66 FR 38809, July 25, § 884.5970 Clitoral engorgement de- 2001] vice. (a) Identification. A clitoral § 884.5940 Powered vaginal muscle engorgement device is designed to stimulator for therapeutic use. apply a vacuum to the clitoris. It is in- (a) Identification. A powered vaginal tended for use in the treatment of fe- muscle stimulator is an electrically male sexual arousal disorder. powered device designed to stimulate (b) Classification. Class II (special directly the muscles of the vagina with controls). The special control is a guid- pulsating electrical current. This de- ance document entitled: ‘‘Guidance for

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Industry and FDA Reviewers: Class II intrafallopian transfer (GIFT), or other Special Controls Guidance Document assisted reproduction procedures to ob- for Clitoral Engorgement Devices.’’ tain gametes from the body or introduce gametes, zygote(s), preembryo(s) [65 FR 47306, Aug. 2, 2000] and/or embryo(s) into the body. This § 884.5980 Surgical mesh for generic type of device may include a transvaginal pelvic organ prolapse single or double lumen needle and com- repair. ponent parts, including needle guides, (a) Identification. Surgical mesh for such as those used with ultrasound. transvaginal pelvic organ prolapse re- (b) Classification. Class II (special pair is a prescription device intended controls) (mouse embryo assay infor- to reinforce soft tissue in the pelvic mation, endotoxin testing, sterilization floor. This device is a porous implant validation, design specifications, label- that is made of synthetic material, ing requirements, biocompatibility non-synthetic material, or a combina- testing, and clinical testing). tion of synthetic and non-synthetic § 884.6110 Assisted reproduction cath- materials. This device does not include eters. surgical mesh for other intended uses (§ 878.3300 of this chapter). (a) Identification. Assisted reproduc- (b) Classification. Class III (premarket tion catheters are devices used in in approval). vitro fertilization (IVF), gamete (c) Date premarket application approval intrafallopian transfer (GIFT), or other or notice of completion of a product devel- assisted reproduction procedures to in- opment protocol is required. A premarket troduce or remove gametes, zygote(s), application approval or notice of com- preembryo(s), and/or embryo(s) into or pletion of a product development pro- from the body. This generic type of de- tocol for a device is required to be filed vice may include catheters, cannulae, with the Food and Drug Administra- introducers, dilators, sheaths, stylets, tion on or before July 5, 2018, for any and component parts. surgical mesh described in paragraph (b) Classification. Class II (special (a) of this section that was in commer- controls) (mouse embryo assay infor- cial distribution before May 28, 1976, or mation, endotoxin testing, sterilization that has, on or before July 5, 2018, been validation, design specifications, label- found substantially equivalent to a ing requirements, biocompatibility surgical mesh described in paragraph testing, and clinical testing). (a) of this section that was in commer- § 884.6120 Assisted reproduction acces- cial distribution before May 28, 1976. sories. Any other surgical mesh for transvaginal pelvic organ prolapse re- (a) Identification. Assisted reproduc- pair shall have an approved premarket tion accessories are a group of devices application or declared completed used during assisted reproduction pro- product development protocol in effect cedures, in conjunction with assisted before being placed in commercial dis- reproduction needles and/or assisted re- tribution. production catheters, to aspirate, incu- bate, infuse, and/or maintain tempera- [81 FR 361, Jan. 5, 2016, as amended at 81 FR ture. This generic type of device may 369, Jan. 5, 2016] include: (1) Powered aspiration pumps used to Subpart G—Assisted Reproduction provide low flow, intermittent vacuum Devices for the aspiration of eggs (ova). (2) Syringe pumps (powered or man- SOURCE: 63 FR 48436, Sept. 10, 1998, unless ual) used to activate a syringe to in- otherwise noted. fuse or aspirate small volumes of fluid during assisted reproduction proce- § 884.6100 Assisted reproduction nee- dures. dles. (3) Collection tube warmers, used to (a) Identification. Assisted reproduc- maintain the temperature of egg (oo- tion needles are devices used in in vitro cyte) collection tubes at or near body fertilization (IVF), gamete temperature. A dish/plate/microscope

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stage warmer is a device used to main- other similar assisted reproduction tain the temperature of the egg (oo- procedures. cyte) during manipulation. (b) Classification. Class II (special (4) Embryo incubators, used to store controls) (design specifications, label- and preserve gametes and/or embryos ing requirements, and clinical testing). at or near body temperature. (5) Cryopreservation instrumentation § 884.6150 Assisted reproduction and devices, used to contain, freeze, micromanipulators and and maintain gametes and/or embryos microinjectors. at an appropriate freezing temperature. (a) Identification. Assisted reproduc- (b) Classification. Class II (special tion micromanipulators are devices in- controls) (design specifications, label- tended to control the position of an as- ing requirements, and clinical testing). sisted reproduction microtool. Assisted The device, when it is a simple embryo reproduction microinjectors are any incubator with only temperature, gas, and humidity control; a syringe pump; device intended to control aspiration a collection tube warmer; a dish/plate/ or expulsion of the contents of an as- microscope stage warmer; or a con- sisted reproduction microtool. trolled-rate cryopreservation freezer, is (b) Classification. Class II (special exempt from the premarket notifica- controls) (design specifications, label- tion procedures in subpart E of part 807 ing requirements, and clinical testing). of this chapter subject to the limita- The device is exempt from the pre- tions in § 884.9. market notification procedures in subpart E of part 807 of this chapter sub- [45 FR 12684, Feb. 26, 1980, as amended at 84 ject to the limitations in § 884.9. FR 71816, Dec. 30, 2019] [45 FR 12684, Feb. 26, 1980, as amended at 84 § 884.6130 Assisted reproduction FR 71816, Dec. 30, 2019] microtools. (a) Identification. Assisted reproduc- § 884.6160 Assisted reproduction tion microtools are pipettes or other labware. devices used in the laboratory to (a) Identification. Assisted reproduc- denude, micromanipulate, hold, or tion labware consists of laboratory transfer human gametes or embryos for equipment or supplies intended to pre- assisted hatching, intracytoplasmic pare, store, manipulate, or transfer sperm injection (ICSI), or other as- human gametes or embryos for in vitro sisted reproduction methods. fertilization (IVF), gamete (b) Classification. Class II (special intrafallopian transfer (GIFT), or other controls) (mouse embryo assay infor- assisted reproduction procedures. mation, endotoxin testing, sterilization These include syringes, IVF tissue cul- validation, design specifications, label- ture dishes, IVF tissue culture plates, ing requirements, and clinical testing). pipette tips, dishes, plates, and other The device, when the assisted reproduc- vessels that come into physical contact tion microtools (pipettes) are manufac- with gametes, embryos or tissue cul- tured from glass, is exempt from the ture media. premarket notification procedures in subpart E of part 807 of this chapter (b) Classification. Class II (special subject to the limitations in § 884.9. controls) (mouse embryo assay information, endotoxin testing, sterilization [45 FR 12684, Feb. 26, 1980, as amended at 84 validation, design specifications, label- FR 71816, Dec. 30, 2019] ing requirements, and clinical testing). The device, when it is a dish or plate § 884.6140 Assisted reproduction micropipette fabrication instru- intended for general assisted reproduc- ments. tion technology procedures, is exempt from the premarket notification proce- (a) Identification. Assisted reproduc- dures in subpart E of part 807 of this tion micropipette fabrication devices chapter subject to the limitations in are instruments intended to pull, bevel, or forge a micropipette or needle for § 884.9. intracytoplasmic sperm injection [45 FR 12684, Feb. 26, 1980, as amended at 84 (ICSI), in vitro fertilization (IVF) or FR 71816, Dec. 30, 2019]

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§ 884.6165 Intravaginal culture system. (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. (6) Labeling for the device must in- (b) Classification. Class II (special clude: controls). The special controls for this (i) A detailed summary of the clinical device are: testing, including device effectiveness, (1) Clinical performance testing must device-related complications, and ad- demonstrate the following: verse events; (i) Comfort and retention of the (ii) Validated methods and instruc- intravaginal culture device; tions for reprocessing of reusable com- (ii) Adverse vaginal tissue reactions ponents; associated with intravaginal culture; (iii) The maximum number of (iii) Maximum number of gametes gametes or embryos that can be loaded and/or embryos that can be placed in a into the device; device; and (iv) A warning that informs users (iv) Rates of embryo development to that the embryo development is first the designated stage, implantation evaluated following intravaginal cul- rates, clinical pregnancy rates, live ture; and birth rates, and any adverse events or (v) A statement that instructs the outcomes. user to use legally marketed assisted (2) Nonclinical performance testing reproductive technology media that must demonstrate that the device per- contain elements to mitigate the con- forms as intended under anticipated tamination risk (e.g., antibiotics) and conditions of use. The following per- to support continued embryonic devel- formance characteristics must be dem- opment over the intravaginal culture onstrated: period. (i) Mouse embryo assay testing to as- (7) Patient labeling must be provided sess embryotoxicity by evaluating the and must include: gamete and embryo-contacting device (i) Relevant warnings, precautions, components effect on the growth and and adverse effects and complications; development of mouse embryos to the (ii) Information on how to use the de- blastocyst stage; vice; (ii) Endotoxin testing on gamete and (iii) The risks and benefits associated embryo-contacting components of the with the use of the device; and device; (iv) A summary of the principal clin- (iii) Cleaning and disinfection valida- ical device effectiveness results. tion of reusable device components; (iv) Sterility maintenance of the cul- [81 FR 379, Jan. 6, 2016] ture media within the device throughout the vaginal incubation period and § 884.6170 Assisted reproduction water subsequent embryo extraction; and and water purification systems. (v) Ability of the device to permit ox- (a) Identification. Assisted reproduc- ygen and carbon dioxide exchange be- tion water purification systems are de- tween the media contained within the vices specifically intended to generate device and the external environment high quality, sterile, pyrogen-free throughout the vaginal incubation pe- water for reconstitution of media used riod. for aspiration, incubation, transfer or (3) The patient-contacting compo- storage of gametes or embryos for in nents of the device must be dem- vitro fertilization (IVF) or other as- onstrated to be biocompatible. sisted reproduction procedures. These (4) Performance data must dem- devices may also be intended as the onstrate the sterility of the device final rinse for labware or other assisted components intended to be provided reproduction devices that will contact sterile. the gametes or embryos. These devices

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also include bottled water ready for re- of this chapter, subject to the limita- constitution available from a vendor tions in § 884.9. that is specifically intended for recon- [63 FR 48436, Sept. 10, 1998, as amended at 64 stitution of media used for aspiration, FR 62977, Nov. 18, 1999; 66 FR 38809, July 25, incubation, transfer, or storage of 2001] gametes or embryos for IVF or other assisted reproduction procedures. § 884.6195 Assisted Reproduction Em- (b) Classification. Class II (special bryo Image Assessment System. controls) (mouse embryo assay infor- (a) Identification. An Assisted Repro- mation, endotoxin testing, sterilization duction Embryo Image Assessment validation, water quality testing, de- System is a prescription device that is sign specifications, labeling require- designed to obtain and analyze light ments, biocompatibility testing, and microscopy images of developing em- clinical testing). bryos. This device provides information to aid in the selection of embryo(s) for § 884.6180 Reproductive media and transfer when there are multiple em- supplements. bryos deemed suitable for transfer or (a) Identification. Reproductive media freezing. and supplement are products that are (b) Classification. Class II (special used for assisted reproduction proce- controls). The special control(s) for dures. Media include liquid and powder this device are: versions of various substances that (1) Clinical performance testing must come in direct physical contact with demonstrate a reasonable assurance of human gametes or embryos (including safety and effectiveness of the device water, acid solutions used to treat to predict embryo development. Classi- gametes or embryos, rinsing solutions, fication performance (sensitivity and sperm separation media, supplements, specificity) and predictive accuracy or oil used to cover the media) for the (Positive Predictive Value and Nega- purposes of preparation, maintenance, tive Predictive Value) must be assessed transfer or storage. Supplements are at the subject and embryo levels. specific reagents added to media to en- (2) Software validation, verification, hance specific properties of the media and hazard analysis must be provided. (e.g., proteins, sera, antibiotics, etc.). (3) Non-clinical performance testing (b) Classification. Class II (special data must demonstrate the perform- controls) (mouse embryo assay infor- ance characteristics of the device. mation, endotoxin testing, sterilization Testing must include the following: validation, design specifications, label- (i) Total light exposure and output ing requirements, biocompatibility testing; testing, and clinical testing). (ii) A safety analysis must be performed based on maximum (worst-case) § 884.6190 Assisted reproductive mi- light exposure to embryos, which also croscopes and microscope acces- includes the safety of the light wave- sories. length(s) emitted by the device; (a) Identification. Assisted reproduc- (iii) Simulated-use testing; tion microscopes and microscope acces- (iv) Mouse Embryo Assay testing to sories (excluding microscope stage assess whether device operation im- warmers, which are classified under as- pacts growth and development of sisted reproduction accessories) are op- mouse embryos to the blastocyst stage; tical instruments used to enlarge im- (v) Cleaning and disinfection valida- ages of gametes or embryos. Variations tion of reusable components; of microscopes and accessories used for (vi) Package integrity and transit these purposes would include phase testing; contrast microscopes, dissecting mi- (vii) Hardware fail-safe validation; croscopes and inverted stage micro- (viii) Electrical equipment safety and scopes. electromagnetic compatibility testing; (b) Classification. Class I. The device and is exempt from the premarket notifica- (ix) Prediction algorithm reproduction procedures in subpart E of part 807 ibility.

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(4) Labeling must include the fol- 886.1200 Optokinetic drum. lowing: 886.1220 Corneal electrode. (i) A detailed summary of clinical 886.1250 Euthyscope. performance testing, including any ad- 886.1270 Exophthalmometer. verse events; 886.1290 Fixation device. 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. (iii) Appropriate electromagnetic 886.1342 Strabismus detection device. compatibility information; 886.1350 Keratoscope. (iv) Validated methods and instruc- 886.1360 Visual field laser instrument. tions for cleaning and disinfection of 886.1375 Bagolini lens. reusable components; and 886.1380 Diagnostic condensing lens. (v) Information identifying compat- 886.1385 Polymethylmethacrylate (PMMA) ible cultureware and explain how they diagnostic contact lens. are used with the device. 886.1390 Flexible diagnostic Fresnel lens. 886.1395 Diagnostic Hruby fundus lens. [80 FR 10332, Feb. 26, 2015] 886.1400 Maddox lens. 886.1405 Ophthalmic trial lens set. § 884.6200 Assisted reproduction laser 886.1410 Ophthalmic trial lens clip. system. 886.1415 Ophthalmic trial lens frame. (a) Identification. The assisted repro- 886.1420 Ophthalmic lens gauge. 886.1425 Lens measuring instrument. duction laser system is a device that 886.1430 Ophthalmic contact lens radius images, targets, and controls the power measuring device. and pulse duration of a laser beam used 886.1435 Maxwell spot. to ablate a small tangential hole in, or 886.1450 Corneal radius measuring device. to thin, the zona pellucida of an em- 886.1460 Stereopsis measuring instrument. bryo for assisted hatching or other as- 886.1500 Headband mirror. sisted reproduction procedures. 886.1510 Eye movement monitor. (b) Classification. Class II (special 886.1570 Ophthalmoscope. controls). The special control is FDA’s 886.1605 Perimeter. guidance document entitled ‘‘Class II 886.1630 AC-powered photostimulator. 886.1640 Ophthalmic preamplifier. Special Controls Guidance Document: 886.1650 Ophthalmic bar prism. Assisted Reproduction Laser Systems.’’ 886.1655 Ophthalmic Fresnel prism. See § 884.1(e) for the availability of this 886.1660 Gonioscopic prism. guidance document. 886.1665 Ophthalmic rotary prism. [69 FR 77624, Dec. 28, 2004] 886.1670 Ophthalmic isotope uptake probe. 886.1680 Ophthalmic projector. 886.1690 Pupillograph. PART 886—OPHTHALMIC DEVICES 886.1700 Pupillometer. 886.1750 Skiascopic rack. Subpart A—General Provisions 886.1760 Ophthalmic refractometer. 886.1770 Manual refractor. Sec. 886.1780 Retinoscope. 886.1 Scope. 886.1790 Nearpoint ruler. 886.3 Effective dates of requirement for pre- 886.1800 Schirmer strip. market approval. 886.1810 Tangent screen (campimeter). 886.9 Limitations of exemptions from sec- 886.1840 Simulatan (including crossed cyl- tion 510(k) of the Federal Food, Drug, inder). and Cosmetic Act (the act). 886.1850 AC-powered slitlamp biomicro- scope. Subpart B—Diagnostic Devices 886.1860 Ophthalmic instrument stand. 886.1040 Ocular esthesiometer. 886.1870 Stereoscope. 886.1050 Adaptometer (biophotometer). 886.1880 Fusion and stereoscopic target. 886.1070 Anomaloscope. 886.1905 Nystagmus tape. 886.1090 Haidinger brush. 886.1910 Spectacle dissociation test system. 886.1120 Ophthalmic camera. 886.1925 Diurnal pattern recorder system. 886.1140 Ophthalmic chair. 886.1930 Tonometer and accessories. 886.1150 Visual acuity chart. 886.1940 Tonometer sterilizer. 886.1160 Color vision plate illuminator. 886.1945 Transilluminator. 886.1170 Color vision tester. 886.1190 Distometer. Subpart C [Reserved] 635

VerDate Sep<11>2014 17:19 Sep 28, 2020 Jkt 250077 PO 00000 Frm 00645 Fmt 8010 Sfmt 8006 Q:\21\21V8.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB