Mandatory U.S. Agent Service
To legally enter the U.S. market, your foreign facility must designate a U.S.-based agent. This agent acts as your local liaison, ensuring a physical presence is available to handle FDA inquiries and site inspection scheduling on your behalf.
Key Aspects of a U.S. Agent:
- Communication Liaison: The agent acts as the primary link between the FDA and your facility for both routine and emergency communications.
- Inspection Support: They assist the FDA in scheduling inspections of your foreign facility.
- Legal Standing: If the FDA cannot contact you directly, providing information to your U.S. Agent is legally equivalent to providing it to you.
- Availability: The agent must be available during regular U.S. business hours to answer phone calls and respond to urgent FDA inquiries.