What is an FDA U.S. Agent?
A U.S. Agent is the person or company in the United States that FDA contacts about a foreign facility. FDA uses the U.S. Agent to reach you quickly, ask questions about products you ship to the U.S., and help schedule inspections. When FDA can't reach your facility directly, information it gives your U.S. Agent counts as given to you.
The U.S. Agent is a point of contact. It does not take over your legal responsibility for your products, and it is not your importer.
Who needs one?
| Facility outside the U.S. that… | Rule |
|---|---|
| Makes, packs or holds food or dietary supplements for the U.S. | 21 CFR 1.227 |
| Manufactures or processes cosmetics for the U.S. | MoCRA, FD&C Act § 607 |
| Makes or exports medical devices to the U.S. | 21 CFR 807.40 |
| Makes, repacks or relabels drugs for the U.S. | 21 CFR 207.69 |
What FDA expects from a U.S. Agent
- Lives in, or has a place of business in, the United States
- Has a real U.S. address. A P.O. box is not accepted.
- Answers FDA personally during business hours. An answering service alone is not accepted.
- Confirms to FDA that it agreed to act for your facility. FDA sends a verification request, and the registration can be cancelled if the agent doesn't confirm.
What Regovant does as your U.S. Agent
- Confirms our appointment to FDA when it asks
- Receives FDA calls, emails and letters about your facility
- Forwards them to you by email promptly, with a short note on what FDA is asking
- Helps coordinate if FDA schedules an inspection
- Reminds you before your registration needs renewing
Switching your U.S. Agent to Regovant
- Send us your current registration number through our registration form and choose "Update to an existing registration".
- We update your registration with Regovant's details. FDA then asks us to confirm.
- We confirm and send you an updated certificate of registration.
Your previous agent doesn't need to do anything, but it's polite to let them know.
U.S. Agent, importer and FSVP importer: what's the difference?
- U.S. Agent: FDA's contact in the U.S. for a foreign facility. Required for registration. This is what we provide.
- Importer of record: the party that brings the goods through U.S. Customs and pays duties. Usually your buyer or their customs broker.
- FSVP importer: for food, the U.S. owner or consignee who must verify that foreign suppliers meet U.S. safety rules. If there is no U.S. owner or consignee, a U.S. agent or representative the foreign owner chooses can take this role. See our FSVP importer service.
Questions
How much does a U.S. Agent cost?
Ours is included in the registration price: $269 per year for a food facility. See what a U.S. Agent should include and the hidden fees to watch for. Already have an agent? See how to switch.
Is the U.S. Agent the same as an importer of record?
No. The U.S. Agent is FDA's contact for your facility. The importer of record handles customs entry for each shipment. They can be different companies.
Can my U.S. customer or distributor be my U.S. Agent?
Yes, if they agree and meet FDA's requirements. Many companies prefer an independent agent so FDA messages don't depend on one customer.
Can I buy U.S. Agent service without registration?
Our U.S. Agent service is provided together with a registration we file or update for you. Contact us if your situation is different.
Is the U.S. Agent responsible for my products?
No. The U.S. Agent is FDA's point of contact and passes FDA's messages to you quickly. Your company stays responsible for its products and its registration.
Can one U.S. Agent cover several of our facilities?
Yes. We can act as U.S. Agent for every facility you register with us, each with its own registration.