What Does an FDA U.S. Agent Service Include? A 2026 Price and Scope Comparison

“What do we actually get for the annual agent fee?”

It’s a fair question, and it’s a harder one to answer than it should be. The FDA U.S. Agent market ranges from $99 a year to $2,500 a year, and that range doesn’t reflect one service sold at different prices. It reflects several different services sold under the same name. A $99 listing and a $650 package can both call themselves “U.S. Agent service,” and still have almost nothing else in common.

Here’s what our own service includes, what it doesn’t, and how that compares to five other providers whose pricing is publicly available as of August 2026.

What “U.S. Agent” legally requires, and what it doesn’t

The FDA U.S. Agent role exists to solve one specific problem: a foreign facility needs a person or business physically located in the United States who FDA can contact. By regulation, that agent has to be reachable for routine communications and available to help coordinate things like inspection scheduling.

That’s the floor. It’s also, unfortunately, often the ceiling on the cheapest end of the market. A designation, a U.S. address, and a promise to forward emails satisfies the letter of the requirement while leaving the actual compliance task, registration, renewals, product listings, label review, Prior Notice, FSVP, sitting with the foreign facility or whoever on their team is expected to notice a forwarded email and know what it means.

What our $295 U.S. Agent fee covers, and what it doesn’t

FDA Entry Point charges $295 per facility per year for U.S. Agent service across food, drugs, cosmetics, and medical devices. That fee covers:

• U.S. Agent designation in the applicable FDA registration
• Active handling of FDA communications, not just forwarding them
• Annual agent coverage and renewal tracking, so the designation doesn’t lapse
• Confirmation documentation alongside applicable registration workflows

It does not cover facility or establishment registration, product listing, label review, Prior Notice filings, SPL or GUDID/UDI submissions, FSVP responsibility, or FDA’s own government user fees. Those are priced separately, and we publish those prices too: $249 for food facility registration, $30 per Prior Notice filing, and $249 for a food label review ($449 for cosmetic, drug, or device label review).

We built it this way on purpose. A single flat number that excludes most of the actual compliance work isn’t transparency. Our position is that if a service is excluded from the base fee, the buyer should be able to see its price before they need it, not after.

How that compares across the market in 2026

We looked at current, publicly published pricing from five other providers: FDABasics, Axentra, Orionex, Registrar Corp, and FDAImports. Here’s what we found.

Two things stand out. First, four of the six providers, including us, publish a real number. Two route pricing through a sales conversation. Second, and this is the more useful test, publishing a number isn’t the same as publishing the full picture. Our pricing page is the only one in this set that breaks out the agent fee, food registration, Prior Notice, and label review as separate line items a buyer can price out in advance.

We’re not the cheapest option in the market and we’re not trying to be. The lowest published starting price we found across the broader market is closer to $99. What we’re built around is a full-stack relationship: one U.S. Agent that stays with you across food, drugs, cosmetics, and devices, with the adjacent work priced openly instead of buried in a quote form.

The $99 mailbox-tier trap

The math on a rock-bottom agent looks better on paper than it works out in practice. The gap between a $99 mailbox-tier agent and our $295 agent-only fee (registration, listings, and label work still priced separately on both sides) is $196 a year, about $16 a month. Between a $150 agent and ours, it’s $145 a year, about $12 a month.

That’s a real saving, right up until something goes wrong. FDA generally gives a facility about 10 business days to respond to a detention notice, sometimes stretched to 20 calendar days with weekends and delivery time factored in. Miss that window and the shipment can be refused, after which the goods generally have to be exported or destroyed within 90 days. A U.S. Agent whose entire job is forwarding an email, unread and unexplained, doesn’t help you hit that deadline. One missed renewal or one mishandled notice can wipe out several years of the savings in a single incident.

A minimum-tier agent can be a reasonable choice for a facility with an experienced in-house regulatory team that already owns every registration, renewal, and FDA response, and that only needs a name on the form. For most foreign manufacturers making their first U.S. shipments, or running multiple product lines without dedicated regulatory staff, it’s the wrong tradeoff.

Questions to ask any provider before you sign

A quoted price isn’t comparable to another quoted price until you know what it excludes. Before signing with any U.S. Agent provider, ask:

1. Is the fee per facility, per legal entity, or per registration, and does it renew automatically?
2. Is facility registration included, or billed separately?
3. What does Prior Notice cost per shipment, and does one shipment with multiple products create multiple billable filings?
4. Does the agent explain a communication and its deadline, or only forward it?
5. What happens to prepaid fees if you cancel or switch providers mid-term?
6. Which FDA government fees, if any, are outside the provider’s fee entirely?

Where FDA Entry Point fits

We built our pricing to answer the question we get asked every week before it needs to be asked. The $295 annual fee buys an active U.S. Agent relationship: real communication handling and renewal tracking, not just a forwarding address, with registration, listings, label review, Prior Notice, and FSVP work available under the same relationship and priced separately so you can see the total cost before you commit to it.

If your facility makes food, cosmetics, drugs, or medical devices and you want one compliance partner across all of it instead of a different agent for each vertical, see our full pricing breakdown or get in touch and we’ll walk you through exactly what applies to your facility.

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