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U.S. FDA Purges its Online Medical Device Establishment Database

The U.S. Food and Drug Administration recently removed medical device companies that failed to renew their FDA Medical Device Establishment Registrations by December 31 from the online Medical Device Establishment Database.

The U.S. Food and Drug Administration (FDA) requires an annual renewal of Medical Device Establishment Registrations. Each year, the U.S. FDA requires medical device registrations to be renewed between October 1 and December 31. Medical Device establishments that did not renew their registration with the FDA by December 31 may be prohibited from marketing their devices in the USA.

This year, the Food and Drug Administration Safety and Innovation Action (FDASIA) imposed several new Medical Device Establishment Registration and Listings requirements. Some of the new medical device requirements include (but are not limited to):

  1. All proprietary names under which a medical device is marketed must be reported, at a minimum, when a medical device is first listed and during the annual update of registration and listing information.
  2. All contract manufacturers and sterilizers of finished medical devices must register and list regardless of whether they put the medical device into commercial distribution or return the medical device to the manufacturer or specification developer.
  3. Initial importers must identify the manufacturers of the medical devices they are importing.
  4. Foreign establishments that are exporting medical devices or offering medical devices for export to the U.S. must identify all known U.S. importers of their devices.
  5. All establishments that are required to register must now pay an annual registration user fee.

Medical device companies that failed to renew their FDA Medical Device Establishment Registrations by December 31 have been removed from the FDA’s online Medical Device Establishment Database. Medical Device companies wishing to verify that their establishments are still registered should check the FDA’s Medical Device Establishment Registration database. Registrar Corp team of regulatory specialists helps Medical Device Establishments Re-Register.

Registrar Corp is a FDA regulatory compliance firm that assists companies with their Medical Device Registrations, Renewals, and other FDA requirements. For more information FDA’s Safety and Innovation Act (FDASIA) or any FDA regulation, please contact Registrar Corp 24/7 at Live Help or call us at +1-757-224-0177.