Medical Device Establishment Registration Opens Oct. 1, Requires Higher Fee
The annual period for importers and manufacturers (foreign and domestic) of medical devices intended for commercial distribution in the U.S. to register their establishments with the Food and Drug Administration opens Oct. 1 and runs through Dec. 31. The fee for this registration has increased 37 percent for fiscal year 2018 to $4,624. There are no fee waivers or reductions for small establishments, businesses, or groups.
Most establishments required to register must also list the devices they make and the activities performed on those devices at that establishment. If a device requires premarket approval or notification before being marketed in the U.S., the owner/operator should also provide the FDA premarket submission number.
Sandler, Travis & Rosenberg’s FDA Solutions Group offers registration and other related services for those involved in the production and distribution of medical devices. For more information, please contact Shelly Garg at (305) 894-1043.