FDA Alerts Industry On GUDID Compliance

Companies that the FDA believes are out of compliance with GUDID are getting letters from the agency – including some firms that should be UDI-exempt.

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The US Food and Drug Administration is sending out letters to alert device manufacturers to potential problems with information in the Global Unique Device Identification Database (GUDID).

The letters specifically address an apparent mismatch between device establishment registration and listing records and UDI information loaded into GUDID,...

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