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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 874 - EAR, NOSE, AND THROAT DEVICES Show All Parts
874.1050 audiometer. (II) 82  
874.1060 acoustic chamber for audiometric testing.  
874.1070 short increment sensitivity index (sisi) adapter.  
874.1080 audiometer calibration set.  
874.1100 earphone cushion for audiometric testing. 22  
874.1500 gustometer.  
874.1500 gustometer.  *
874.1600 olfactory test device. (II)  
874.1800 air or water caloric stimulator.  
874.1925 toynbee diagnostic tube.  
874.3300 hearing aid.  
874.3305 wireless air-conduction hearing aid. (II)  
874.3375 battery-powered artificial larynx.  
874.3540 prosthesis modification instrument for ossicular replacement surgery. 23  
874.3540 prosthesis modification instrument for ossicular replacement surgery. 23  *
874.3900 nasal dilator.  
874.4100 epistaxis balloon.  
874.4140 ear, nose, and throat bur.  
874.4175 nasopharyngeal catheter.  
874.4350 ear, nose, and throat fiberoptic light source and carrier.  
874.4420 ear, nose, and throat manual surgical instrument. 24  
874.4750 laryngostroboscope.  
874.4770 otoscope. 25  
874.4780 intranasal splint.  
874.4800 bone particle collector.  
874.5220 ear, nose, and throat drug administration device.  *
874.5300 ear, nose, and throat examination and treatment unit.  
874.5550 powered nasal irrigator.  
874.5800 external nasal splint.  
874.5840 antistammering device.  




Footnotes:

5 Exemption is limited to air-conduction hearing aids.
22 510(k) exempt only if the device is made of the same materials that were used in the device before May 28, 1976.
23 510(k) exempt only if the device is made of the same materials that were used in the device before May 28, 1976.
24 510(k) exempt only if the device is made of the same materials that were used in the device before May 28, 1976.
25 510(k) exempt only when used in the external ear canal.
82 Otoacoustic emission devices are not exempt.
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