FDA regulations (21 CFR Part 807[1]) require all foreign medical device establishments to designate a U.S. Agent (also called FDA US agent or FDA U.S. agent) when registering with the FDA[1].
This requirement applies to:
- Foreign medical device manufacturers placing devices on the U.S. market[1] — a FDA US agent is mandatory for registration
- Foreign specification developers developing device specifications[1] — require U.S. agent FDA services
- Foreign contract manufacturers manufacturing devices for others[1] — must appoint a FDA agent for foreign manufacturer
- Foreign repackagers/relabelers repackaging or relabeling devices[1] — need FDA US agent services
- Foreign initial distributors/importers importing devices into the U.S.[1] — require U.S. agent FDA designation
Note: The U.S. Agent must be physically located in the United States[1] and available during normal business hours[1]. This requirement applies regardless of device class or premarket approval status[1].