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U.S. Department of Health and Human Services

Medical Device Exemptions 510(k) and GMP Requirements

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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 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES Show All Parts
880.2200 liquid crystal forehead temperature strip. (II)  
880.2400 bed-patient monitor.  
880.2700 stand-on patient scale.  *
880.2720 patient scale.  
880.2740 surgical sponge scale.  
880.2740 surgical sponge scale.  *
880.2900 clinical color change thermometer.  
880.2910 clinical electronic thermometer. (II)  
880.2920 clinical mercury thermometer. (II)  
880.2930 apgar timer.  *
880.5075 elastic bandage.  
880.5075 elastic bandage.  *
880.5090 liquid bandage. 8  
880.5100 ac-powered adjustable hospital bed. (II)  
880.5110 hydraulic adjustable hospital bed.  
880.5120 manual adjustable hospital bed.  *
880.5140 pediatric hospital bed. (II)  
880.5150 nonpowered flotation therapy mattress.  *
880.5160 therapeutic medical binder.  *
880.5180 burn sheet.  
880.5210 intravascular catheter securement device.  
880.5240 medical adhesive tape and adhesive bandage.  
880.5270 neonatal eye pad.  *
880.5300 medical absorbent fiber.  *
880.5420 pressure infusor for an i.v. bag.  
880.5440 intravascular administration set. (II)  
880.5475 jet lavage. (II)  
880.5500 ac-powered patient lift. (II)  
880.5510 non-ac-powered patient lift.  
880.5550 alternating pressure air flotation mattress. (II)  
880.5560 temperature regulated water mattress.  
880.5630 nipple shield.  
880.5640 lamb feeding nipple.  *
880.5740 suction snakebite kit.  
880.5780 medical support stocking. (II) 42  
880.5780 medical support stocking. 42  *
880.5820 therapeutic scrotal support.  *
880.5950 umbilical occlusion device.  
880.5960 lice removal kit.  
880.6025 absorbent tipped applicator.  *
880.6050 ice bag.  *
880.6060 medical disposable bedding.  *
880.6070 bed board.  *
880.6080 cardiopulmonary resuscitation board.  *
880.6085 hot/cold water bottle.  *
880.6140 medical chair and table.  *
880.6150 ultrasonic cleaner for medical instruments.  
880.6185 cast cover.  *
880.6190 mattress cover for medical purposes.  *
880.6200 ring cutter.  *
880.6230 tongue depressor.  *
880.6250 patient examination glove.  
880.6265 examination gown.  *
880.6280 medical insole.  
880.6310 medical device data system.  
880.6320 ac-powered medical examination light.  
880.6350 battery-powered medical examination light.  *
880.6430 liquid medication dispenser.  
880.6430 liquid medication dispenser.  *
880.6450 skin pressure protectors.  *
880.6710 medical ultraviolet water purifier. (II)  
880.6730 body waste receptacle.  *
880.6740 vacuum-powered body fluid suction apparatus. (II)  
880.6760 protective restraint.  
880.6775 powered patient transfer device. (II)  
880.6785 manual patient transfer device.  *
880.6800 washers for body waste receptacles.  *
880.6820 medical disposable scissors.  
880.6890 general purpose disinfectants.  
880.6900 hand-carried stretcher.  *
880.6910 wheeled stretcher. (II)  
880.6960 irrigating syringe.  *
880.6970 liquid crystal vein locator.  
880.6980 vein stabilizer.  *
880.6990 infusion stand.  
880.6991 medical washer. (II)  
880.6992 medical washer-disinfector. (II)  




Footnotes:

8 Exemption is limited to uses as a skin protectant.
42 Only stockings for general medical purposes are 510(k) and GMP.
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