In early February, the U.S. Food and Drug Administration (FDA) sent e-mails to medical device establishments that had not yet renewed their FDA registrations for fiscal year (FY) 2016. The e-mails state that “Failure to complete your annual registration by February 22nd, 2016, will result in your establishment being removed from FDA’s database of active registrants.”
FDA requires medical device establishments to renew their registrations between October 1 and December 31 each year as well as pay an annual registration fee. The registration fee for FY 2016 is $3,845. There is no reduced fee for small businesses.
Manufacturing or distributing medical devices in the United States without an active FDA registration is a prohibited act. Unregistered establishments that manufactured or distribute devices may find their products detained or face other regulatory consequences. Registrar Corp can help device establishments ensure they are actively registered with U.S. FDA. For those that are not, we can help register and list devices with FDA.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.