In March 2019, the U.S. Food and Drug Administration (FDA) removed approximately 2,551 medical device establishment registrations from its database, a decrease of 9% from the 27,289 registrations that were in the database in February 2019.
Why Did FDA Remove These Registrations?
Establishments that manufacture or distribute medical devices intended for use in the U.S. are required to renew their FDA registrations between October 1st and December 31st of each year. As part of registration renewal, establishments must also pay the annual establishment registration fee. Failure to successfully renew and pay the fee during this period will result in having an invalid registration. FDA removes any registrations that were not renewed from its databases after the annual renewal period.
Establishments selling medical devices must appoint an Official Correspondent at the time of registration. Foreign establishments who export to the United States must also designate a U.S. Agent for FDA communications. U.S. Agents must confirm their designation or FDA may consider the registration incomplete. FDA removes any registrations that are incomplete or invalid from its databases after the annual renewal period.
What Does This Mean For Registrations That Were Removed?
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.
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. Facilities whose registrations have been removed will be required to reactivate their registration and device listings with FDA.
Registrar Corp can verify whether a medical device registration is valid for 2019 at no cost. If your registration is invalid, Registrar Corp can reactivate your FDA registration. Registrar Corp can also act as your Official Correspondent and U.S. Agent for FDA communications. For additional questions or assistance with FDA medical device regulations, call: +1-757-224-0177 or chat with a Regulatory Advisor 24/7: www.registrarcorp.com/livehelp.