The U.S. Food and Drug Administration (FDA) recently removed from its database of active registrations all medical device establishments that did not register for 2017. Owners or operators of device establishments must register annually with FDA. In early February, the Agency warned industry that it would remove all establishments that had not registered for 2017 by February 23.
Devices manufactured, prepared, propagated, compounded, or processed in an unregistered establishment are misbranded and thus subject to regulatory action if sold in the United States. Registrar Corp is urging medical device companies to confirm their establishments are listed in FDA’s database as registered for 2017 before continuing business as usual: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm
The registration fee for fiscal year (FY) 2017 is $3,382. Registrar Corp can help medical device establishments verify that their registrations were completed for 2017 as well as register device establishments with FDA and facilitate payment of the associated fees. For assistance, contact +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.