• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Device Exemptions 510(k) and GMP Requirements

  • Print
  • Share
  • E-mail
-

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 and list the generic category or classification name. Registration and listing information is submitted by using FDA’s Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM) at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053185.htm

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 Show All Parts
876.1075 gastroenterology-urology biopsy instrument. 26  
876.1400 stomach ph electrode.  
876.1500 endoscope and accessories. (II) 27  
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)  
876.4020 fiberoptic light ureteral catheter. (II)  
876.4270 colostomy rod. (II)  
876.4370 gastroenterology-urology evacuator. (II) 29  
876.4370 gastroenterology-urology evacuator. 29  
876.4400 hemorrhoidal ligator. (II)  
876.4500 mechanical lithotriptor. (II)  
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.  
876.4770 urethrotome. (II)  
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.  
876.5210 enema kit.  *
876.5250 urine collector and accessories. (II)  
876.5250 urine collector and accessories.  
876.5250 urine collector and accessories.  *
876.5365 esophageal dilator. (II)  
876.5450 rectal dilator.  
876.5520 urethral dilator. 33  
876.5540 blood access device and accessories. 34  
876.5665 water purification system for hemodialysis. (II)  
876.5820 hemodialysis system and accessories. 35  
876.5895 ostomy irrigator. (II)  
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).
-
-