Pt. 878 21 CFR Ch. I (4–1–11 Edition) generated using electrostatic spark dis- 878.3925 Plastic surgery kit and accessories. charge (spark gap), electromagneti- cally repelled membranes, or piezo- Subpart E—Surgical Devices electric crystal arrays, and focused 878.4010 Tissue adhesive. onto the stone with either a specially 878.4011 Tissue adhesive with adjunct wound designed reflector, dish, or acoustic closure device for topical approximation lens. The shock waves are created of skin. under water within the shock wave 878.4014 Nonresorbable gauze/sponge for ex- generator, and are transferred to the ternal use. 878.4015 Wound dressing with poly (diallyl patient’s body using an appropriate dimethyl ammonium chloride) acoustic interface. After the stone has (pDADMAC) additive. been fragmented by the focused shock 878.4018 Hydrophilic wound dressing. waves, the fragments pass out of the 878.4020 Occlusive wound dressing. body with the patient’s urine. 878.4022 Hydrogel wound dressing and burn (b) Classification. Class II (special dressing. controls) (FDA guidance document: 878.4025 Silicone sheeting. ‘‘Guidance for the Content of Pre- 878.4040 Surgical apparel. 878.4100 Organ bag. market Notifications (510(k)’s) for 878.4160 Surgical camera and accessories. Extracorporeal Shock Wave 878.4200 Introduction/drainage catheter and Lithotripters Indicated for the Frag- accessories. mentation of Kidney and Ureteral 878.4300 Implantable clip. Calculi.’’) 878.4320 Removable skin clip. 878.4340 Contact cooling system for aes- [65 FR 48612, Aug. 9, 2000] thetic use. 878.4350 Cryosurgical unit and accessories. PART 878—GENERAL AND PLASTIC 878.4370 Surgical drape and drape acces- sories. SURGERY DEVICES 878.4380 Drape adhesive. 878.4400 Electrosurgical cutting and coagu- Subpart A—General Provisions lation device and accessories. 878.4410 Low energy ultrasound wound Sec. cleaner. 878.1 Scope. 878.4440 Eye pad. 878.3 Effective dates of requirement for pre- 878.4450 Nonabsorbable gauze for internal market approval. use. 878.9 Limitations of exemptions from sec- 878.4460 Surgeon’s glove. tion 510(k) of the Federal Food, Drug, 878.4470 Surgeon’s gloving cream. and Cosmetic Act (the act). 878.4480 Absorbable powder for lubricating a surgeon’s glove. Subpart B—Diagnostic Devices 878.4490 Absorbable hemostatic agent and 878.1800 Speculum and accessories. dressing. 878.4493 Absorbable poly(glycolide/L-lactide) Subpart C [Reserved] surgical suture. 878.4494 Absorbable poly(hydroxybutyrate) Subpart D—Prosthetic Devices surgical suture produced by recombinant DNA technology. 878.3250 External facial fracture fixation ap- 878.4495 Stainless steel suture. pliance. 878.4520 Polytetrafluoroethylene injectable. 878.3300 Surgical mesh. 878.4580 Surgical lamp. 878.3500 Polytetrafluoroethylene with car- 878.4630 Ultraviolet lamp for dermatologic bon fibers composite implant material. disorders. 878.3530 Silicone inflatable breast pros- 878.4635 Ultraviolet lamp for tanning. thesis. 878.4660 Skin marker. 878.3540 Silicone gel-filled breast prosthesis. 878.4680 Nonpowered, single patient, port- 878.3550 Chin prosthesis. able suction apparatus. 878.3590 Ear prosthesis. 878.4683 Non-Powered suction apparatus de- 878.3610 Esophageal prosthesis. vice intended for negative pressure 878.3680 Nose prosthesis. wound therapy. 878.3720 Tracheal prosthesls. 878.4700 Surgical microscope and acces- 878.3750 External prosthesis adhesive. sories. 878.3800 External aesthetic restoration pros- 878.4730 Surgical skin degreaser or adhesive thesis. tape solvent. 878.3900 Inflatable extremity splint. 878.4750 Implantable staple. 878.3910 Noninflatable extremity splint. 878.4760 Removable skin staple. 392 VerDate Mar<15>2010 12:50 Apr 27, 2011 Jkt 223072 PO 00000 Frm 00402 Fmt 8010 Sfmt 8010 Y:\SGML\223072.XXX 223072 WReier-Aviles on DSKGBLS3C1PROD with CFR Food and Drug Administration, HHS § 878.3 878.4780 Powered suction pump. this part, but shall state why the de- 878.4800 Manual surgical instrument for vice is substantially equivalent to general use. other devices, as required by § 807.87 of 878.4810 Laser surgical instrument for use in this chapter. general and plastic surgery and in der- matology. (c) To avoid duplicative listings, a 878.4820 Surgical instrument motors and ac- general and plastic surgery device that cessories/attachments. has two or more types of uses (e.g., 878.4830 Absorbable surgical gut suture. used both as a diagnostic device and as 878.4840 Absorbable polydioxanone surgical a therapeutic device) is listed in one suture. subpart only. 878.4930 Suture retention device. (d) References in this part to regu- 878.4950 Manual operating table and acces- latory sections of the Code of Federal sories and manual operating chair and accessories. Regulations are to chapter I of title 21 878.4960 Operating tables and accessories unless otherwise noted. and operating chairs and accessories. (e) Guidance documents referenced in 878.5000 Nonabsorbable poly(ethylene this part are available on the Internet terephthalate) surgical suture. at http://www.fda.gov/cdrh/guid- 878.5010 Nonabsorbable polypropylene sur- ance.html. gical suture. 878.5020 Nonabsorbable polyamide surgical [53 FR 23872, June 24, 1988, as amended at 67 suture. FR 77676, Dec. 19, 2002] 878.5030 Natural nonabsorbable silk surgical suture. § 878.3 Effective dates of requirement 878.5035 Nonabsorbable expanded polytetra- for premarket approval. fluoroethylene surgical suture. A device included in this part that is 878.5040 Suction lipoplasty system. classified into class III (premarket ap- Subpart F—Therapeutic Devices proval) shall not be commercially dis- tributed after the date shown in the 878.5070 Air-handling apparatus for a sur- regulation classifying the device unless gical operating room. the manufacturer has an approval 878.5350 Needle-type epilator. under section 515 of the act (unless an 878.5360 Tweezer-type epilator. exemption has been granted under sec- 878.5650 Topical oxygen chamber for ex- tremities. tion 520(g)(2) of the act). An approval 878.5900 Nonpneumatic tourniquet. under section 515 of the act consists of 878.5910 Pneumatic tourniquet. FDA’s issuance of an order approving an application for premarket approval AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. (PMA) for the device or declaring com- pleted a product development protocol SOURCE: 53 FR 23872, June 24, 1988, unless (PDP) for the device. otherwise noted. (a) Before FDA requires that a device EDITORIAL NOTE: Nomenclature changes to commercially distributed before the part 878 appear at 73 FR 35341, June 23, 2008. enactment date of the amendments, or a device that has been found substan- Subpart A—General Provisions tially equivalent to such a device, has an approval under section 515 of the § 878.1 Scope. act, FDA must promulgate a regula- (a) This part sets forth the classifica- tion under section 515(b) of the act re- tion of general and plastic surgery de- quiring such approval, except as pro- vices intended for human use that are vided in paragraphs (b) and (c) of this in commercial distribution. section. Such a regulation under sec- (b) The identification of a device in a tion 515(b) of the act shall not be effec- regulation in this part is not a precise tive during the grace period ending on description of every device that is, or the 90th day after its promulgation or will be, subject to the regulation. A on the last day of the 30th full calendar manufacturer who submits a pre- month after the regulation that classi- market notification submission for a fies the device into class III is effec- device under part 807 cannot show tive, whichever is later. See section merely that the device is accurately 501(f)(2)(B) of the act. Accordingly, un- described by the section title and iden- less an effective date of the require- tification provision of a regulation in ment for premarket approval is shown 393 VerDate Mar<15>2010 12:50 Apr 27, 2011 Jkt 223072 PO 00000 Frm 00403 Fmt 8010 Sfmt 8010 Y:\SGML\223072.XXX 223072 WReier-Aviles on DSKGBLS3C1PROD with CFR § 878.9 21 CFR Ch. I (4–1–11 Edition) in the regulation for a device classified commercially distributed devices with- into class III in this part, the device in that generic type or, in the case of may be commercially distributed with- in vitro diagnostic devices, only to the out FDA’s issuance of an order approv- extent that misdiagnosis as a result of ing a PMA or declaring completed a using the device would not be associ- PDP for the device. If FDA promul- ated with high morbidity or mortality. gates a regulation under section 515(b) Accordingly, manufacturers of any of the act requiring premarket ap- commercially distributed class I or II proval for a device, section 501(f)(1)(A) device for which FDA has granted an of the act applies to the device. exemption from the requirement of (b) Any new, not substantially equiv- premarket notification must still sub- alent, device introduced into commer- mit a premarket notification to FDA cial distribution on or after May 28, before introducing or delivering for in- 1976, including a device formerly mar- troduction into interstate commerce keted that has been substantially al- for commercial distribution the device tered, is classified by statute (section when: 513(f) of the act) into class III without (a) The device is intended for a use any grace period and FDA must have different from the intended use of a le- issued an order approving a PMA or de- gally marketed device in that generic claring completed a PDP for the device type of device; e.g., the device is in- before the device is commercially dis- tended for a different medical purpose, tributed unless it is reclassified. If or the device is intended for lay use FDA knows that a device being com- where the former intended use was by mercially distributed may be a ‘‘new’’ health care professionals only; device as defined in this section be- (b) The modified device operates cause of any new intended use or other using a different fundamental sci- reasons, FDA may codify the statutory entific technology than a legally mar- classification of the device into class keted device in that generic type of de- III for such new use.