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414 Part 876—Gastroenterology- Urology

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414 Part 876—Gastroenterology- Urology Pt. 876 21 CFR Ch. I (4–1–16 Edition) (b) Classification. Class II (special 876.9 Limitations of exemptions from sec- controls). The special controls for this tion 510(k) of the Federal Food, Drug, device are: and Cosmetic Act (the act). (1) The patient contacting compo- Subpart B—Diagnostic Devices nents must be demonstrated to be bio- compatible. 876.1075 Gastroenterology-urology biopsy (2) Non-clinical performance testing instrument. must demonstrate that the device per- 876.1300 Ingestible telemetric gastro- forms as intended under anticipated intestinal capsule imaging system. 876.1330 Colon capsule endoscopy system. conditions of use. The following per- 876.1400 Stomach pH electrode. formance characteristics must be dem- 876.1500 Endoscope and accessories. onstrated: 876.1620 Urodynamics measurement system. (i) Mechanical integrity testing (e.g., 876.1725 Gastrointestinal motility moni- tensile strength testing, fatigue test- toring system. ing) and 876.1735 Electrogastrography system. (ii) Shelf life testing. 876.1800 Urine flow or volume measuring (3) The technical specifications must system. include pressure measurement accu- Subpart C—Monitoring Devices racy to characterize device perform- ance. 876.2040 Enuresis alarm. (4) Clinical performance testing must 876.2050 Prostate lesion documentation sys- document any adverse events observed tem. during clinical use, and demonstrate Subpart D—Prosthetic Devices that the device performs as intended under anticipated conditions of use. 876.3350 Penile inflatable implant. (5) Labeling must include the fol- 876.3630 Penile rigidity implant. lowing: 876.3750 Testicular prosthesis. (i) Appropriate warnings and pre- Subpart E—Surgical Devices cautions, (ii) A detailed summary of the clin- 876.4020 Fiberoptic light ureteral catheter. ical testing pertinent to use of the de- 876.4270 Colostomy rod. vice including a detailed summary of 876.4300 Endoscopic electrosurgical unit and the device-related complications or ad- accessories. verse events, 876.4370 Gastroenterology-urology evacuator. (iii) Detailed instructions on how to 876.4400 Hemorrhoidal ligator. fit the device to the patient, and 876.4480 Electrohydraulic lithotriptor. (iv) Instructions for reprocessing of 876.4500 Mechanical lithotriptor. any reusable components. 876.4530 Gastroenterology-urology (6) Patient labeling must be provided fiberoptic retractor. and must include: 876.4560 Ribdam. (i) Relevant warnings, precautions, 876.4590 Interlocking urethral sound. 876.4620 Ureteral stent. and adverse effects/complications, 876.4650 Water jet renal stone dislodger sys- (ii) Information on how to correctly tem. wear the device, 876.4680 Ureteral stone dislodger. (iii) The potential risks and benefits 876.4730 Manual gastroenterology-urology associated with the use of the device, surgical instrument and accessories. (iv) Alternative treatments, and 876.4770 Urethrotome. (v) Reprocessing instructions. 876.4890 Urological table and accessories. [80 FR 46194, Aug. 4, 2015] Subpart F—Therapeutic Devices 876.5010 Biliary catheter and accessories. PART 876—GASTROENTEROLOGY- 876.5015 Pancreatic drainage stent and de- UROLOGY DEVICES livery system. 876.5020 External penile rigidity devices. Subpart A—General Provisions 876.5025 Vibrator for climax control of pre- mature ejaculation. Sec. 876.5030 Continent ileostomy catheter. 876.1 Scope. 876.5090 Suprapubic urological catheter and 876.3 Effective dates of requirement for pre- accessories. market approval. 876.5130 Urological catheter and accessories. 414 VerDate Sep<11>2014 17:25 Jun 08, 2016 Jkt 238077 PO 00000 Frm 00424 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT 31 lpowell on DSK54DXVN1OFR with $$_JOB Food and Drug Administration, HHS § 876.3 876.5140 Urethral insert with pump for blad- vices intended for human use that are der drainage. in commercial distribution. 876.5160 Urological clamp for males. (b) The identification of a device in a 876.5210 Enema kit. 876.5220 Colonic irrigation system. regulation in this part is not a precise 876.5250 Urine collector and accessories. description of every device that is, or 876.5270 Implanted electrical urinary con- will be, subject to the regulation. A tinence device. manufacturer who submits a pre- 876.5280 Implanted mechanical/hydraulic market notification submission for a urinary continence device. device under part 807 may not show 876.5310 Nonimplanted, peripheral electrical merely that the device is accurately continence device. described by the section title and iden- 876.5320 Nonimplanted electrical continence tification provisions of a regulation in device. 876.5365 Esophageal dilator. this part, but shall state why the de- 876.5450 Rectal dilator. vice is substantially equivalent to 876.5470 Ureteral dilator. other devices, as required by § 807.87. 876.5520 Urethral dilator. (c) To avoid duplicative listings, a 876.5530 Implantable transprostatic tissue gastroenterology-urology device that retractor system. has two or more types of uses (e.g., 876.5540 Blood access device and accessories. used both as a diagnostic device and as 876.5600 Sorbent regenerated dialysate de- a therapeutic device) is listed only in livery system for hemodialysis. one subpart. 876.5630 Peritoneal dialysis system and ac- cessories. (d) References in this part to regu- 876.5665 Water purification system for latory sections of the Code of Federal hemodialysis. Regulations are to chapter I of title 21, 876.5820 Hemodialysis system and acces- unless otherwise noted. sories. (e) Guidance documents referenced in 876.5830 Hemodialyzer with disposable in- this part are available on the Internet sert (Kiil type). at http://www.fda.gov/MedicalDevices/ 876.5860 High permeability hemodialysis system. DeviceRegulationandGuidance/ 876.5870 Sorbent hemoperfusion system. GuidanceDocuments/default.htm.. 876.5880 Isolated kidney perfusion and [52 FR 17737, May 11, 1987; 52 FR 22577, June transport system and accessories. 12, 1987, as amended at 69 FR 77623, Dec. 28, 876.5885 Tissue culture media for human ex 2004; 78 FR 18233, Mar. 26, 2013] vivo tissue and cell culture processing applications. § 876.3 Effective dates of requirement 876.5895 Ostomy irrigator. for premarket approval. 876.5900 Ostomy pouch and accessories. 876.5920 Protective garment for inconti- A device included in this part that is nence. classified into class III (premarket ap- 876.5930 Rectal control system. proval) shall not be commercially dis- 876.5955 Peritoneo-venous shunt. tributed after the date shown in the 876.5970 Hernia support. regulation classifying the device unless 876.5980 Gastrointestinal tube and acces- sories. the manufacturer has an approval 876.5990 Extracorporeal shock wave under section 515 of the act (unless an lithotripter. exemption has been granted under sec- tion 520(g)(2) of the act). An approval AUTHORITY: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371. under section 515 of the act consists of FDA’s issuance of an order approving SOURCE: 48 FR 53023, Nov. 23, 1983, unless an application for premarket approval otherwise noted. (PMA) for the device or declaring com- pleted a product development protocol Subpart A—General Provisions (PDP) for the device. (a) Before FDA requires that a device EDITORIAL NOTE: Nomenclature changes to commercially distributed before the part 876 appear at 73 FR 35341, June 23, 2008. enactment date of the amendments, or a device that has been found substan- § 876.1 Scope. tially equivalent to such a device, has (a) This part sets forth the classifica- an approval under section 515 of the act tion of gastroenterology-urology de- FDA must promulgate a regulation 415 VerDate Sep<11>2014 17:25 Jun 08, 2016 Jkt 238077 PO 00000 Frm 00425 Fmt 8010 Sfmt 8010 Q:\21\21V8.TXT 31 lpowell on DSK54DXVN1OFR with $$_JOB § 876.9 21 CFR Ch. I (4–1–16 Edition) under section 515(b) of the act requir- ably foreseeable characteristics of ing such approval, except as provided commercially distributed devices with- in paragraph (b) of this section. Such a in that generic type or, in the case of regulation under section 515(b) of the in vitro diagnostic devices, only to the act shall not be effective during the extent that misdiagnosis as a result of grace period ending on the 90th day using the device would not be associ- after its promulgation or on the last ated with high morbidity or mortality. day of the 30th full calendar month Accordingly, manufacturers of any after the regulation that classifies the commercially distributed class I or II device into class III is effective, which- device for which FDA has granted an ever is later. See section 501(f)2)(B) of exemption from the requirement of the act. Accordingly, unless an effec- premarket notification must still sub- tive date of the requirement for pre- mit a premarket notification to FDA market approval is shown in the regu- before introducing or delivering for in- lation for a device classified into class troduction into interstate commerce III in this part, the device may be 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
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