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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 890 - PHYSICAL MEDICINE DEVICES Show All Parts
890.1175 electrode cable. (II) 89  
890.1575 force-measuring platform.  
890.1600 intermittent pressure measurement system.  
890.1615 miniature pressure transducer.  
890.1925 isokinetic testing and evaluation system. (II)  
890.3025 prosthetic and orthotic accessory.  *
890.3075 cane.  *
890.3100 mechanical chair.  
890.3150 crutch.  *
890.3175 flotation cushion.  
890.3410 external limb orthotic component.  *
890.3420 external limb prosthetic component.  *
890.3475 limb orthosis.  *
890.3490 truncal orthosis.  *
890.3500 external assembled lower limb prosthesis. (II)  
890.3520 plinth.  *
890.3640 arm sling.  *
890.3665 congenital hip dislocation abduction splint.  *
890.3675 denis brown splint.  *
890.3700 nonpowered communication system.  *
890.3710 powered communication system. (II)  
890.3725 powered environmental control system. (II)  
890.3750 mechanical table.  
890.3760 powered table.  
890.3790 cane, crutch, and walker tips and pads.  *
890.3825 mechanical walker.  *
890.3910 wheelchair accessory. 71  *
890.3920 wheelchair component.  
890.3930 wheelchair elevator. (II)  
890.3940 wheelchair platform scale.  *
890.5050 daily activity assist device.  
890.5050 daily activity assist device.  *
890.5125 nonpowered sitz bath.  *
890.5150 powered patient transport. (II)  
890.5160 air-fluidized bed. (II)  
890.5170 powered flotation therapy bed. (II)  
890.5180 manual patient rotation bed.  
890.5225 powered patient rotation bed. (II)  
890.5350 exercise component.  *
890.5370 nonmeasuring exercise equipment.  *
890.5380 powered exercise equipment.  
890.5410 powered finger exerciser.  
890.5660 therapeutic massager.  
890.5700 cold pack.  *
890.5710 hot or cold disposable pack. 16  
890.5720 water circulating hot or cold pack. (II)  
890.5730 moist heat pack.  *
890.5740 powered heating pad. (II)  
890.5765 pressure-applying device.  
890.5925 traction accessory.  *
890.5940 chilling unit.  
890.5950 powered heating unit.  
890.5975 therapeutic vibrator.  




Footnotes:

16 Exemption does not apply when indicated for infants.
71 510(k) exempt as long as the device is not labeled or otherwise represented as a protective restraint.
89 Special controls: (1) performance standard under 21 CFR 898, and (2) guidance document entitled "Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.
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