FDA US Agent with Inspection Support

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].