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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 882 - NEUROLOGICAL DEVICES Show All Parts
882.1030 ataxiagraph.  
882.1200 two-point discriminator. 75  *
882.1410 electroencephalograph electrode/lead tester.  
882.1430 electroencephalograph test signal generator.  
882.1500 esthesiometer.  *
882.1525 tuning fork.  *
882.1700 percussor.  *
882.1750 pinwheel. 44  
882.1925 ultrasonic scanner calibration test block.  
882.4030 skull plate anvil.  
882.4125 neurosurgical chair.  
882.4190 clip forming/cutting instrument.  
882.4200 clip removal instrument.  
882.4215 clip rack.  
882.4325 cranial drill handpiece (brace).  
882.4440 neurosurgical headrests.  
882.4500 cranioplasty material forming instrument.  
882.4525 microsurgical instrument.  
882.4535 nonpowered neurosurgical instrument.  
882.4600 leukotome.  
882.4650 neurosurgical suture needle. 45  
882.4750 skull punch. 11  
882.4900 skullplate screwdriver.  
882.5050 biofeedback device. (II)  
882.5320 preformed alterable cranioplasty plate. (II)  




Footnotes:

9 Exemption is limited to surgical grade stainless steel.
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 .
11 Exemption should not be confused with Sec. 882.4305.
44 510(k) exempt only if the device is made of the same material (single, surgical-grade, stainless steel alloy) that was used in the device before May 28, 1976.
45 510(k) exempt only if the device is made of the same material (single, surgical-grade, stainless steel alloy) that was used in the device before May 28, 1976.
75 510(k) exempt only if the device is made of the same material (single, surgical-grade, stainless steel alloy) that was used in the device before May 28, 1976.
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