FDA Removes Medical Device Facility Registrations From Database for Failure to Renew
The Food and Drug Administration removed about 9 percent of medical device facility registrations from its database in March, Registrar Corp. said in a blog post. That’s likely because those approximately 2,551 establishments did not renew their registrations by Dec.…
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31, the annual deadline for facility registration renewal, the consultancy said. “When a registration is deactivated, so are the active listings associated with the registration. All propriety names and importers will be removed from the listings,” Registrar Corp. said. “Marketing a medical device in the U.S. without a valid registration and listing is a prohibited act and may result in costly detentions or refusals. Many facilities do not realize their registration is invalid until problems like these occur,” it said. “Facilities whose registrations have been removed will be required to reactivate their registration and device listings with FDA.”