FDA to Remove Unregistered Medical Device Establishments from its Database
On February 7, the U.S. Food and Drug Administration (FDA) e-mailed medical device establishments that did not complete their annual registration for 2017. According to the e-mail, establishments that do not register and pay the associated fees by February 23, 2017 will have their registration removed from FDA’s database of active registrations. Medical 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.
The registration fee for the fiscal year (FY) 2017 is $3,382. Registrar Corp can help medical device establishments register 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.