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U.S. Department of Health and Human Services

Medical Devices

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Due to changes to regulatory requirements, the 2009 guidance document titled "Guidance for Industry and FDA Staff - Implementation of Medical Device Establishment Registration and Device Listing Requirements Established by the Food and Drug Administration Amendments Act of 2007" was withdrawn on May 13, 2013. The Center for Devices and Radiological Health is currently working on a new medical device establishment registration and device listing draft guidance that, when finalized, will represent the FDA’s current thinking on this topic.

Please see related links below for important Registration and Listing information.