MEDICAL DEVICES ESTABLISHMENT REGISTRATION, DEVICE LISTING AND U.S.-AGENT SERVICE

Establishments engaged in the manufacturing or other activities of medical devices to be marketed in the US need to register the facility, list the devices and name an agent for communication purposes.

Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the FDA.  (Title 21 CFR Part 807).

Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a U.S. agent for that establishment.

*FY fee