U.S. Agent vs. Official Correspondent: What Is the Difference?

The U.S. Agent is a person or company in the United States that a foreign establishment names so FDA can reach it. The Official Correspondent is the contact who manages the establishment's registration and listing with FDA and can be located anywhere. For foreign device establishments, one firm can serve both roles if it agrees to.

U.S. Agent

• Must live in or keep a place of business in the U.S. (21 CFR 807.40(b); 21 CFR 1.227)
• FDA contacts the agent about the establishment, including emergencies and inspection scheduling
• For food facilities, FDA treats a message to the agent as a message to the facility

Official Correspondent

• Responsible for registration and listing information, and receives FDA correspondence about it (21 CFR 807.3)
• Can be an employee of the foreign firm

Related: FDA renewal deadline calendar · Do I need a U.S. Agent? · US Agent Desk pricing

General information, not legal advice. Last reviewed October 21, 2026.