§ 874.5550 21 CFR Ch. I (4–1–08 Edition) Drug Administration on or before July subpart E of part 807 of this chapter 13, 1999 for any tongs antichoke device subject to § 874.9. that was in commercial distribution [51 FR 40389, Nov. 6, 1986, as amended at 65 before May 28, 1976, or that has, on or FR 2316, Jan. 14, 2000] before July 13, 1999, been found to be substantially equivalent to a tongs antichoke device that was in commer- PART 876—GASTROENTEROLOGY- cial distribution before May 28, 1976. UROLOGY DEVICES Any other tongs antichoke device shall have an approved PMA or declared Subpart A—General Provisions completed PDP in effect before being Sec. placed in commercial distribution. 876.1 Scope. 876.3 Effective dates of requirement for pre- [51 FR 40389, Nov. 6, 1986, as amended at 64 market approval. FR 18329, Apr. 14, 1999] 876.9 Limitations of exemptions from sec- tion 510(k) of the Federal Food, Drug, § 874.5550 Powered nasal irrigator. and Cosmetic Act (the act). (a) Identification. A powered nasal irrigator is an AC-powered device in- Subpart B—Diagnostic Devices tended to wash the nasal cavity by 876.1075 Gastroenterology-urology biopsy means of a pressure-controlled pul- instrument. sating stream of water. The device con- 876.1300 Ingestible telemetric gastro- sists of a control unit and pump con- intestinal capsule imaging system. nected to a spray tube and nozzle. 876.1400 Stomach pH electrode. (b) Classification. Class I (general con- 876.1500 Endoscope and accessories. trols). The device is exempt from the 876.1620 Urodynamics measurement system. premarket notification procedures in 876.1725 Gastrointestinal motility moni- toring system. subpart E of part 807 of this chapter 876.1735 Electrogastrography system. subject to § 874.9. 876.1800 Urine flow or volume measuring [55 FR 48440, Nov. 20, 1990, as amended at 65 system. FR 2316, Jan. 14, 2000] Subpart C—Monitoring Devices § 874.5800 External nasal splint. 876.2040 Enuresis alarm. (a) Identification. An external nasal splint is a rigid or partially rigid de- Subpart D—Prosthetic Devices vice intended for use externally for im- 876.3350 Penile inflatable implant. mobilization of parts of the nose. 876.3630 Penile rigidity implant. (b) Classification. Class I (general con- 876.3750 Testicular prosthesis. trols). The device is exempt from the premarket notification procedures in Subpart E—Surgical Devices subpart E of part 807 of this chapter 876.4020 Fiberoptic light ureteral catheter. subject to the limitations in § 874.9. 876.4270 Colostomy rod. [51 FR 40389, Nov. 9, 1986, as amended at 52 876.4300 Endoscopic electrosurgical unit and FR 32111, Aug. 25, 1987; 59 FR 63009, Dec. 7, accessories. 1994; 66 FR 38801, July 25, 2001] 876.4370 Gastroenterology-urology evacuator. § 874.5840 Antistammering device. 876.4400 Hemorrhoidal ligator. 876.4480 Electrohydraulic lithotriptor. (a) Identification. An antistammering 876.4500 Mechanical lithotriptor. device is a device that electronically 876.4530 Gastroenterology-urology generates a noise when activated or fiberoptic retractor. when it senses the user’s speech and 876.4560 Ribdam. that is intended to prevent the user 876.4590 Interlocking urethral sound. from hearing the sounds of his or her 876.4620 Ureteral stent. own voice. The device is used to mini- 876.4650 Water jet renal stone dislodger sys- mize a user’s involuntary hesitative or tem. 876.4680 Ureteral stone dislodger. repetitive speech. 876.4730 Manual gastroenterology-urology (b) Classification. Class I (general con- surgical instrument and accessories. trols). The device is exempt from the 876.4770 Urethrotome. premarket notification procedures in 876.4890 Urological table and accessories. 374 VerDate Aug<31>2005 09:33 May 12, 2008 Jkt 214072 PO 00000 Frm 00384 Fmt 8010 Sfmt 8010 Y:\SGML\214072.XXX 214072 dwashington3 on PRODPC61 with CFR Food and Drug Administration, HHS § 876.3 Subpart F—Therapeutic Devices (b) The identification of a device in a regulation in this part is not a precise 876.5010 Biliary catheter and accessories. description of every device that is, or 876.5020 External penile rigidity devices. 876.5030 Continent ileostomy catheter. will be, subject to the regulation. A 876.5090 Suprapubic urological catheter and manufacturer who submits a pre- accessories. market notification submission for a 876.5130 Urological catheter and accessories. device under part 807 may not show 876.5160 Urological clamp for males. merely that the device is accurately 876.5210 Enema kit. described by the section title and iden- 876.5220 Colonic irrigation system. tification provisions of a regulation in 876.5250 Urine collector and accessories. 876.5270 Implanted electrical urinary con- this part, but shall state why the de- tinence device. vice is substantially equivalent to 876.5280 Implanted mechanical/hydraulic other devices, as required by § 807.87. urinary continence device. (c) To avoid duplicative listings, a 876.5310 Nonimplanted, peripheral electrical gastroenterology-urology device that continence device. has two or more types of uses (e.g., 876.5320 Nonimplanted electrical continence used both as a diagnostic device and as device. 876.5365 Esophageal dilator. a therapeutic device) is listed only in 876.5450 Rectal dilator. one subpart. 876.5470 Ureteral dilator. (d) References in this part to regu- 876.5520 Urethral dilator. latory sections of the Code of Federal 876.5540 Blood access device and accessories. Regulations are to chapter I of title 21, 876.5600 Sorbent regenerated dialysate de- unless otherwise noted. livery system for hemodialysis. (e) Guidance documents referenced in 876.5630 Peritoneal dialysis system and ac- cessories. this part are available on the Internet 876.5665 Water purification system for at http://www.fda.gov/cdrh/guid- hemodialysis. ance.html. 876.5820 Hemodialysis system and acces- [52 FR 17737, May 11, 1987; 52 FR 22577, June sories. 12, 1987, as amended at 69 FR 77623, Dec. 28, 876.5830 Hemodialyzer with disposable in- 2004] sert (Kiil type). 876.5860 High permeability hemodialysis system. § 876.3 Effective dates of requirement 876.5870 Sorbent hemoperfusion system. for premarket approval. 876.5880 Isolated kidney perfusion and A device included in this part that is transport system and accessories. classified into class III (premarket ap- 876.5885 Tissue culture media for human ex proval) shall not be commercially dis- vivo tissue and cell culture processing tributed after the date shown in the applications. 876.5895 Ostomy irrigator. regulation classifying the device unless 876.5900 Ostomy pouch and accessories. the manufacturer has an approval 876.5920 Protective garment for inconti- under section 515 of the act (unless an nence. exemption has been granted under sec- 876.5955 Peritoneo-venous shunt. tion 520(g)(2) of the act). An approval 876.5970 Hernia support. under section 515 of the act consists of 876.5980 Gastrointestinal tube and acces- FDA’s issuance of an order approving sories. 876.5990 Extracorporeal shock wave an application for premarket approval lithotripter. (PMA) for the device or declaring com- pleted a product development protocol AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, (PDP) for the device. 360j, 360l, 371. (a) Before FDA requires that a device SOURCE: 48 FR 53023, Nov. 23, 1983, unless commercially distributed before the otherwise noted. enactment date of the amendments, or a device that has been found substan- Subpart A—General Provisions tially equivalent to such a device, has an approval under section 515 of the act § 876.1 Scope. FDA must promulgate a regulation (a) This part sets forth the classifica- under section 515(b) of the act requir- tion of gastroenterology-urology de- ing such approval, except as provided vices intended for human use that are in paragraph (b) of this section. Such a in commercial distribution. regulation under section 515(b) of the 375 VerDate Aug<31>2005 09:33 May 12, 2008 Jkt 214072 PO 00000 Frm 00385 Fmt 8010 Sfmt 8010 Y:\SGML\214072.XXX 214072 dwashington3 on PRODPC61 with CFR § 876.9 21 CFR Ch. I (4–1–08 Edition) act shall not be effective during the extent that misdiagnosis as a result of grace period ending on the 90th day using the device would not be associ- after its promulgation or on the last ated with high morbidity or mortality. day of the 30th full calendar month Accordingly, manufacturers of any after the regulation that classifies the commercially distributed class I or II device into class III is effective, which- device for which FDA has granted an ever is later. See section 501(f)2)(B) of exemption from the requirement of the act. Accordingly, unless an effec- premarket notification must still sub- tive date of the requirement for pre- mit a premarket notification to FDA market approval is shown in the regu- before introducing or delivering for in- lation for a device classified into class troduction into interstate commerce III in this part, the device may be for commercial distribution the device commerically distributed without when: FDA’s issuance of an order approving a (a) The device is intended for a use PMA or declaring completed a PDP for different from the intended use of a le- the device. If FDA promulgates a regu- gally marketed device in that generic lation under section 515(b) of the act type of device; e.g., the device is in- requiring 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