What Is a U.S. Agent?
A U.S. Agent is a person or company residing or maintaining a place of business in the United States who is designated by a foreign facility to act as the official point of contact between that facility and the U.S. Food and Drug Administration (FDA).
U.S. Agent designation is a legal requirement under the FD&C Act for virtually all foreign facilities that manufacture, process, pack, or hold FDA-regulated products intended for U.S. distribution. Without a valid U.S. Agent, your facility cannot legally register with the FDA.
Products That Require a U.S. Agent
- Food and dietary supplements (under the Bioterrorism Act and FSMA)
- Medical devices (under 21 CFR Part 807)
- Human and veterinary drugs (under 21 CFR Part 207)
- Cosmetics (under MoCRA 2022)
- Biologics and blood products
What Does a U.S. Agent Do?
The U.S. Agent serves as the primary liaison between your foreign facility and the FDA. Specific responsibilities include:
- FDA communications: Receiving and forwarding all official FDA communications to your facility, including correspondence, inspection notices, import alerts, and warning letters
- Emergency contact: Being available to the FDA at all times (24/7) for emergency contacts and urgent matters
- Registration facilitation: Assisting with and often processing facility registration submissions on your behalf
- Inspection coordination: Acting as liaison if the FDA requests an inspection of your foreign facility
- Prior notice: Some products require Prior Notice submissions to the FDA before each shipment — the U.S. Agent often handles these
Who Can Be a U.S. Agent?
A U.S. Agent must be:
- A person (individual or company) physically residing or maintaining a place of business in the United States
- Available to the FDA during U.S. business hours and for emergency contacts at all times
- Not a P.O. box — a physical U.S. address is required
The U.S. Agent does not need to be an FDA regulatory consultant or have any special credentials, but working with an experienced firm like Regovant ensures your Agent is familiar with FDA procedures and can handle issues efficiently.
What Happens If You Don't Have a U.S. Agent?
Operating without a valid U.S. Agent has serious consequences:
- Your facility registration cannot be completed or renewed
- U.S. Customs & Border Protection can refuse entry to your shipments
- The FDA may place your facility on an Import Alert, blocking all future imports
- You may be subject to civil penalties under the FD&C Act
Changing Your U.S. Agent
You can change your U.S. Agent at any time. To do so, you must update your FDA facility registration to reflect the new U.S. Agent's information. The change takes effect when the updated registration is submitted and confirmed.
If you change U.S. Agents, notify the FDA promptly. There should be no gap in U.S. Agent coverage, as even a brief lapse can technically put your registration into non-compliant status.
Why Choose Regovant as Your U.S. Agent?
Regovant LLC serves as U.S. Agent for facilities in over 40 countries across all FDA-regulated product categories. Our services include:
- Full FDA facility registration handling
- Prompt forwarding of all FDA communications (typically within 24 hours)
- 24/7 emergency availability as required by FDA
- Annual/biennial renewal reminders and processing
- Certificate of Registration issuance upon successful registration