FDA removed 10% of medtech establishments from its registration database: Here’s why

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David Lennarz, Registrar Corp.

FDAThe U.S. FDA has removed 2,546 medical device establishments from its active registration database.  As of Feb. 19, the FDA database contained 24,578 registered establishments, compared to 27,124 registered establishments on Feb. 2.

So why did FDA remove the registrations?

Establishments are typically removed due to failure to renew their annual FDA registrations.  FDA requires medical device establishments to renew their registrations between Oct. 1 and Dec. 31 of each year.  Within two or three months, FDA typically removes any establishments that do not properly renew.

Establishments located outside of the United States must designate a U.S. Agent for FDA communication as part of their annual registration.  During the recently passed renewal period, listed U.S. Agents were required to confirm their designation with FDA.  If a U.S. Agent failed to confirm their designation, FDA did not consider the establishment’s registration complete.

Marketing a medical device in the United States without a valid FDA registration is a prohibited act that may result in detention or refusal of shipments and other FDA enforcement actions.  Many establishments do not realize that their FDA medical device registration is invalid until their shipments are detained.

Registrar Corp. has an online form to help companies verify their registration.

David Lennarz is VP at Registrar Corp. (Hampton, Va.). His previous experience includes working as a technical expert for the U.S. Food and Drug Administration’s Foreign Facility Registration Verification Program operated by FDA’s Division of Field Investigations.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.

 

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Comments

  1. Hello David.
    Thanks for further explanation regarding annual FDA registration and the requirement for a US Agent spokesman.

    As a Strategic Account Manager with OMRON-Microscan, providing off-line, in-line and on-press ISO/IEC bar code verification for GS1 and other symbologies, it’s important to point out the reasons and processes to be / remain FDA compliant.

    Appreciate the mind share.

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