The U.S. Food and Drug Administration (FDA) removed 2,546 medical device establishments from its active registration database.  As of February 19, 2018, the FDA database contained 24,578 registered establishments, compared to 27,124 registered establishments on February 2, 2018.

Why Were These Registrations Removed?

Establishments are typically removed due to failure to renew their annual FDA registrations.  FDA requires medical device establishments to renew their registrations between October 1 and December 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 can verify that your FDA medical device registration is valid for 2018 at no cost.

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EXPORT ACCESS is the Authorized Agent for UK & Ireland for REGISTRAR CORP, USA – the leading global provider of compliance services for goods entering the USA which are subject to regulation by the US Food & Drug Administration (FDA)