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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 870 - CARDIOVASCULAR DEVICES Show All Parts
870.1390 trocar. (II)  
870.1875 stethoscope. (II) 83  
870.1875 stethoscope. 83  
870.2360 electrocardiograph electrode. (II)  
870.2390 phonocardiograph.  
870.2600 signal isolation system.  
870.2620 line isolation monitor.  
870.2640 portable leakage current alarm.  
870.2675 oscillometer. (II)  
870.2770 impedance plethysmograph. (II)  
870.2810 paper chart recorder.  
870.3450 vascular graft prosthesis. (II)  
870.3650 pacemaker polymeric mesh bag.  
870.3670 pacemaker charger.  
870.3690 pacemaker test magnet.  
870.3730 pacemaker service tools.  
870.3935 prosthetic heart valve holder.  
870.3945 prosthetic heart valve sizer.  
870.4200 cardiopulmonary bypass accessory equipment.  
870.4500 cardiovascular surgical instruments.  




Footnotes:

83 Electronic stethescopes are Class II, non exempt.
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