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Medical Device Establishment Registration and Device Listing Requirements

June 06, 2023 (1 min read)

This checklist covers FDA medical device facility registration and medical device listing requirements. Failure to register and list with the FDA may render a device misbranded, adulterated, or both. In addition, failure to register a facility and list a medical device could lead to medical devices being denied entry into the United States and further regulatory action against the device establishment.

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