By Wyatt Sage, FDA Entry Point | Published October 8, 2026 | Last updated October 8, 2026
Short answer: A U.S. Agent is the person or company in the United States that The FDA can contact on behalf of a foreign facility. Providers bundle very different things under the same name, so prices and scope vary widely. Of the providers compared below, the two that publish a price list $250 to $299 per year. At FDA Entry Point, the U.S. Agent fee is $295 per facility per year, and registration, listing, label review, Prior Notice, and government fees are billed separately.
What a U.S. Agent is required to do
Foreign facilities that register with The FDA (food, drugs, medical devices, and cosmetics under MoCRA) must designate a U.S. Agent. At minimum, the agent:
- Acts as the communication link between The FDA and the foreign facility
- Answers questions from The FDA about the facility’s products imported or offered for import
- Helps The FDA schedule inspections
- Is physically present in the United States and reachable during business hours
That is the legal floor. Everything else is a service decision, and it is where providers differ.
What providers add on top
| Service layer | Why it matters |
|---|---|
| Forwarding of correspondence from The FDA | The minimum. Without it, notices sit unread |
| Active escalation of urgent notices (detentions, inspection requests, recalls) | Response windows are short and fixed. A forwarded email is not a response |
| Renewal and deadline tracking | Registrations must be renewed on a set cycle. A missed renewal can hold up shipments |
| Inspection scheduling support | The agent is The FDA’s contact for scheduling |
| Registration, listing, and amendments | Often a separate fee, sometimes a separate vendor |
| Label review, Prior Notice, FSVP | Almost always separate |
Price and scope comparison
Prices below are publicly listed figures, checked on October 8, 2026. “Not published” means the provider does not list U.S. Agent pricing on its public pages.
| Provider | Listed U.S. Agent price | What the listing says is included | Notes |
|---|---|---|---|
| FDA Entry Point | $295 per facility per year | Designation, active handling of FDA communications, renewal tracking, confirmation documents | Registration, listing, label review, Prior Notice, FSVP, and government fees billed separately |
| FDABasics | $299 per year, or $250 per year on a 2-year contract | Designation, forwarding of FDA communications, inspection scheduling assistance, registration, renewal, and deadline management | |
| FDAImports | Not published | Not published | |
| Registrar Corp | Not published | Registration updates, verification of facility identifiers, Prior Notice filing assistance, detention assistance, and access to its Automated Compliance for Exporters platform | Its U.S. Agent page states that no part of fees paid is refunded if either party terminates |
| Axentra | Not published | Not published | |
| Orionex | Not published | Not published |
Six questions to ask before you sign
- What exactly does the annual fee cover, and what is billed separately?
- Who reads and acts on correspondence from The FDA, and how fast do they respond?
- Do you escalate urgent notices by phone, or only forward email?
- Who tracks my renewal dates, and how do I get proof they were filed?
- What does Prior Notice, label review, or a listing update cost?
- What are the cancellation terms, and who holds my registration if I leave?
How we approach it
FDA Entry Point is a boutique firm. You work with one accountable contact instead of several vendors, and the U.S. Agent role is active: we receive, read, and escalate what The FDA sends. Our $295 fee covers the agent role only. Registration, listing, label review, Prior Notice, FSVP, and government fees are scoped and priced separately unless they are included in a written quote.
If you want to see what your facility would need beyond the agent role, see our U.S. Agent services or review our pricing.
FAQ
What is a U.S. Agent for The FDA?
A U.S. Agent is a person or company located in the United States that a foreign facility designates as its contact with The FDA. The agent helps with communications and inspection scheduling.
Who needs a U.S. Agent?
Foreign facilities registered with The FDA, including food, drug, medical device, and cosmetic facilities.
How much does a U.S. Agent cost?
Of the providers compared in this article, the two that publish a U.S. Agent price list $250 to $299 per year. FDA Entry Point charges $295 per facility per year for the agent role, with other services billed separately.
Is a U.S. Agent the same as an FSVP importer?
No. The U.S. Agent is the registration contact. FSVP is a separate food safety verification duty that falls on the U.S. importer.
Can I switch my U.S. Agent?
Yes. The new agent is designated through your registration. Contact us and we can walk you through the change.