The U.S. Food and Drug Administration (FDA) Medical Device Registration and Listing Module (DRLM) will be unavailable from 6PM EDT on Friday, September 26, 2014 until 12AM EDT on Wednesday, October 1, 2014. Users will not be able to register, list, or update information during this time. Once the DRLM is available on Wednesday, users will still be unable to update most of the information until they have completed the required annual registration renewal and have paid the associated fees.
FDA requires medical device establishments to renew their registrations with FDA every year between October 1 and December 31, even if there have been no changes. The cost of registration for fiscal year 2015 is $3,646. Specific registration requirements depend on an establishment’s functions. FDA provides a list of who must register and list on its site.
If you have any doubts about whether or not you need to annually register or list products with FDA, or if you need assistance with the FDA medical device registration process, contact Registrar Corp at 1-757-224-0177 or chat with a Regulatory Specialist any time at https://www.registrarcorp.com/livehelp.