US FDA Agent Requirements

A US FDA Agent (also called a US Agent) is a person or entity located in the United States who has been designated by a foreign establishment to act as its representative with the FDA.

US FDA Agent designation is a mandatory requirement. Registration cannot be completed for a foreign establishment without a valid US Agent. The agent must be located in the United States and must be available during normal business hours to receive communications from FDA.

Who needs a US FDA Agent? All foreign establishments registering with FDA for: food facility registration, drug establishment registration, medical device establishment registration, and cosmetic facility registration under MoCRA.

LMG provides US FDA Agent services to foreign establishments across all product categories — food, dietary supplements, drugs, biologics, medical devices, and cosmetics. LMG also serves as the U.S. agent for Drug Master File (DMF) holders.

• The US FDA Agent must be located in the United States
• The agent must be available to receive FDA communications during business hours
• The agent can receive official correspondence from FDA on behalf of the foreign establishment
• The agent must be designated by name in the FDA registration
• LMG serves as US FDA Agent for clients in 150+ countries