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U.S. Department of Health and Human Services

Medical Devices

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Important Reminders about Registration and Listing

Reminders:

  • All device establishments must complete their annual registration for each Fiscal Year between October 1 and December 31.
  • FDA is aware that various firms may be offering their services to assist domestic and/or foreign facilities to register with FDA. Please note that these firms are not affiliated with FDA, nor has the agency contracted with any firms to register facilities. FDA does not use any outside contractors to notify or bill regulated industry about the need to register. FDA does not require firms to hire someone to complete the on-line registration process.
  • FDA is aware that some browsers, and equipment may not operate correctly with our system. These include MAC personal computers, Internet Explorer 8.0, wide screen monitors, and browsers such as Firefox or Google browser (CHROME).
  • FDA communicates with registered medical device establishments by email. In order to receive electronic communications from FDA, be sure to set your spam filters to accept email from any @fda.gov, @cdrh.fda.gov, or @fda.hhs.gov email address.