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FDA Cancels 31% of Medical Device Registrations for Failure to Renew

In February 2021, the U.S. Food and Drug Administration (FDA) removed 13,455 medical device establishments and their associated device listings from its registration database.  This resulted in a 31% decrease in the total number of medical device establishments registered with FDA.  

Medical device establishments are required to renew their FDA registrations annually between October 1 and December 31. FDA considers registrations that are not renewed by the deadline to be “expired” and removes establishments that did not renew from its database shortly after each renewal period. 

As of February 22, 2021, there were 29,678 registered device establishments in FDA’s database as compared to the 43,133 that were registered in December 2020.  The countries with the largest number of registrations removed were China, the United States, South Korea, Vietnam, and Turkey.  

How do I know if my registration was removed? 

FDA does not typically notify establishments when their registrations are removed. Many establishments do not realize their registrations are expired until their shipments are detained by FDA Compliance Officers at the U.S. Port of Entry. 

Registrar Corp can help verify that your registration was successfully renewed for 2021 at no cost.  Click here to verify your registration. 

What should I do if my registration was removed? 

Distributing medical devices in the United States with an expired registration is prohibited and may subject an establishment’s owner to civil or criminal penalties.  Establishments with expired registrations must re-register with FDA, obtain a new registration number, and re-list their devices prior to continuing marketing of their medical devices in the United States. 

More than 30,000 companies around the world trust Registrar Corp to manage their FDA registrations. Registrar Corp can properly re-register your establishment.  As part of our registration service, companies receive year-round regulatory support, including FDA compliance monitoring of their facility, detention assistance, and more. For more information, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at regstaging.wpengine.com/livechat.