Medical Device Exemptions 510(k) and GMP Requirements

Introduction

Following is a breakdown of 510(k) exempt and Good Manufacturing Practice (GMP)/Quality System exemptions listed by device class. All devices in this list are 510(k) exempt unless further qualified by a footnote. Only devices annotated by (*) are also exempt from GMP except for general recordkeeping requirements and compliant files.

Class I Devices

FDA has exempted almost all class I devices (with the exception of Reserved Devices from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. Some 510(k) exemptions annotated with "\#\" are with certain limitations as noted in the footnotes. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR xxx.9, where xxx refers to Parts 862-892.

If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and FDA clearance is not required before marketing the device in the U.S. However, these manufacturers are required to register their establishment by submitting Form FDA 2891, "Initial Registration of Device Establishment," and list the generic category or classification name of the device by submitting Form FDA 2892, "Device Listing."

IMPORTANT NOTE: Only the class I devices with an asterisk (*) are also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.

Class II Devices

The Food and Drug Administration (FDA) has also published a list of class II (special controls) devices (those devices are annotated as "(II)"), subject to certain limitations, that are now exempt from the premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet a requirement of the Modernization Act. Class II devices are annotated "(II)". Please note that class II devices are NOT exempt from GMP requirements.

PART 876 - GASTROENTEROLOGY-UROLOGY DEVICES

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876.1075	gastroenterology-urology biopsy instrument. ²⁶
876.1400	stomach ph electrode.
876.1500	endoscope and accessories. ²⁷
876.1620	urodynamics measurement system. (II)
876.1800	urine flow or volume measuring system. (II)
876.2040	enuresis alarm. (II)
876.4370	gastroenterology-urology evacuator. (II) ²⁹
876.4370	gastroenterology-urology evacuator. ²⁹
876.4530	gastroenterology-urology fiberoptic retractor.
876.4560	ribdam.
876.4590	interlocking urethral sound.
876.4650	water jet renal stone dislodger system. (II)
876.4680	ureteral stone dislodger. (II)
876.4730	manual gastroenterology-urology surgical instrument and accessories.
876.4890	urological table and accessories. (II) ³⁰
876.4890	urological table and accessories. ³⁰
876.5020	external penile rigidity devices. (II)
876.5030	continent ileostomy catheter.
876.5090	suprapubic urological catheter and accessories. (II) ³¹
876.5090	suprapubic urological catheter and accessories. ³¹
876.5130	urological catheter and accessories. ³²
876.5160	urological clamp for males. ⁶
876.5210	enema kit. ^*
876.5250	urine collector and accessories. (II)
876.5250	urine collector and accessories.
876.5250	urine collector and accessories. ^*
876.5450	rectal dilator.
876.5520	urethral dilator. ³³
876.5540	blood access device and accessories. ³⁴
876.5820	hemodialysis system and accessories. ³⁵
876.5900	ostomy pouch and accessories.
876.5920	protective garment for incontinence. ^*
876.5970	hernia support. ^*
876.5980	gastrointestinal tube and accessories. (II)

Footnotes:

⁶	Exemption does not include devices for internal use or devices used for females.
¹⁰	The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory is exempt from the premarket notification procedures .
²⁶	Only biopsy forceps cover and the nonelectric biopsy forceps are 510(k) exempt.
²⁷	Only photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope are 510(k) exempt.
²⁹	Only the manually powered gastroenterology-urology evacuator is Class I.
³⁰	Only the manually powered table (and accessories) and the stirrups for an electrically powered table is Class I.
³¹	Only the catheter punch instrument, nondisposable cannula and trocar, and gastrourological trocar are 510(k) exempt.
³²	Only the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder are 510(k) exempt.
³³	Only the urethrometer, urological bougie, filiform and filiform follower, and metal or plastic urethral sound are 510(k) exempt.
³⁴	Only the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device are 510(k) exempt.
³⁵	Only accessories that are remote from the extracorporeal blood system and the dailysate delivery system, such as unpowered dialysis chair, hemodialysis start/stop tray, dialyzer holder set, and dialysis tie gun and ties are exempt from 510(k).