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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 892 - RADIOLOGY DEVICES Show All Parts
892.1130 nuclear whole body counter.  
892.1300 nuclear rectilinear scanner.  
892.1320 nuclear uptake probe.  
892.1330 nuclear whole body scanner.  
892.1350 nuclear scanning bed. 72  
892.1370 nuclear anthropomorphic phantom.  
892.1380 nuclear flood source phantom.  
892.1400 nuclear sealed calibration source.  
892.1410 nuclear electrocardiograph synchronizer.  
892.1420 radionuclide test pattern phantom.  
892.1640 radiographic film marking system.  
892.1700 diagnostic x-ray high voltage generator.  
892.1760 diagnostic x-ray tube housing assembly.  
892.1770 diagnostic x-ray tube mount.  
892.1830 radiologic patient cradle.  
892.1840 radiographic film.  
892.1880 wall-mounted radiographic cassette holder.  
892.1890 radiographic film illuminator.  
892.1910 radiographic grid.  
892.1920 radiographic head holder.  *
892.1940 radiologic quality assurance instrument.  *
892.1950 radiographic anthropomorphic phantom.  *
892.1960 radiographic intensifying screen.  
892.1970 radiographic ecg/respirator synchronizer.  
892.1980 radiologic table. (II)  
892.2010 medical image storage device.  
892.2020 medical image communications device.  
892.5050 medical charged-particle radiation therapy system. (II) 84  
892.5650 manual radionuclide applicator system. 81  
892.5740 radionuclide teletherapy source. 81  
892.5780 light beam patient position indicator. 73  
892.6500 personnel protective shield. 74  




Footnotes:

72 510(k) exempt only when the device is labeled with weight limit, is used with planar scanning only, and is not for diagnostic x-ray use.
73 For diagnostic purposes only, not therapeutic - the Federal Register and CFR make no distinction and are in error.
74 510(k) exempt only if the device's labeling specifies the lead equivalence.
81 Device is not exempt from the design control requirements section of the GMP.
84 The device is not exempt. Exemption applies only to the film dosimetry system (film scanning system) included as an accessory to the medical charged-particle radiation therapy system.
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