FDA US Agent Service
A US Agent is the person FDA contacts about your company.
FDA uses that contact for two separate purposes: questions about the devices you send to the United States, and arranging an inspection of your establishment. Every establishment outside the United States must name one.
We act as US Agent for manufacturers entering the United States market. FDA reaches a named person, and correspondence is answered in your working hours.
- The law
- 21 CFR 807.40
- Our fee
- $1,000 a year
- FDA fee to appoint
- $0
- How many agents
- One per establishment
- Agent must be
- In the United States
- Reachable
- US business hours
Do you need a US Agent?
Two questions settle it — FDA sets no size threshold and offers no exemption to apply for.
Is your facility outside the United States?
The establishment where the device is manufactured, repackaged or relabelled.
The role has three duties.
Set by 21 CFR 807.40. The regulation requires nothing beyond them.
Communication
Help FDA communicate with your company.
Device questions
Answer questions about the devices you send to the United States.
Inspections
Help FDA arrange an inspection of your facility.
If FDA cannot reach your company directly, FDA may treat contact with your US Agent as contact with you.
It grants no authorisation to market a device.
Appointing a US Agent completes one requirement of establishment registration. A US Agent is not a 510(k) clearance. It does not let you sell a device that needs a clearance you do not have. And it is not an importer — an importer is a different role with different duties.
If your device requires a 510(k), appointing an agent does not advance that submission by a single day.
Both are separate work. We do both, and we will tell you which one your situation actually calls for.
| Responsibility | Who carries it |
|---|---|
| Communicating with FDA | Your US Agent |
| Questions about your devices | Your US Agent |
| Arranging an inspection | Your US Agent |
| Reporting adverse events to FDA | Separate work |
| Premarket submissions such as a 510(k) | Separate work |
| Importing your devices | Separate work |
A US Agent does not make your device “FDA approved.”
When FDA calls us, a person picks up.
Your US Agent must be reachable by telephone during United States business hours, either the agent or an employee of the agent. FDA does not accept a post office box as the agent address, and it does not accept an answering service.
Low-cost agents commonly fail this requirement. The failure surfaces at the worst moment: when FDA telephones about an import detention or an inspection and reaches nobody.
One fixed fee, per year.
Everything below is covered for twelve months. One number, in writing, and no FDA fee is charged to appoint an agent.
- Appointment filed the same day
- A named person, not a shared inbox
- Replies during your working hours
- We forward and explain anything FDA sends you
- We tell FDA if your details change
- Annual renewal handled before the window closes
- Registration status monitored year-round
Appoint us as your US Agent. FDA reaches a person, not a mailbox.
- $1,000
- Per year
- Filed the same day
- No FDA fee to appoint
The agent is free. The registration is not.
Appointing a US Agent carries no FDA fee at all. Establishment registration is the separate cost — its own annual FDA fee of $13,785 from 1 October 2026, payable whoever acts as your agent. In our experience, the two are often quoted as one.
| What you pay FDA | Until 30 Sep 2026 | From 1 Oct 2026 |
|---|---|---|
| Facility registration, each year | $11,423 | $13,785 |
| 510(k) submission, standard | $26,067 | $28,653 |
| 510(k) submission, small business | $6,517 | $7,163 |
These amounts are paid to FDA. They are the same whoever you hire, and our service fee is separate. If a quotation bundles the agent appointment and the registration fee into one figure, ask for them separately — one of the two is free.
Three steps, and no permission needed.
Changing agent requires no consent from your current agent and no FDA fee.
- Step 1Collect the new agent's detailsName, address, telephone number and email of your new agent.
- Step 2Update your FDA registrationSign in to your FDA account and change the US Agent details on your registration.
- Step 3The new agent confirmsFDA sends an email to the new agent. The new agent confirms. The change takes effect.
If your agent’s details change afterward, we handle FDA’s notification for you.
At a glance
| Who must have one | Every establishment outside the USA that imports devices into the United States, or offers them for import. |
|---|---|
| The law | 21 CFR 807.40 |
| How many agents | One. FDA allows each foreign establishment to name only one US Agent. |
| When it is required | Before your facility registration can be completed. Registration cannot finish without an agent. |
| Must be in the USA | The agent must live in the United States or have a place of business there. A post office box is not accepted. |
| Must answer the phone | The agent, or an employee, must be reachable by telephone during normal United States business hours. |
| What FDA charges for it | $0. Naming a US Agent is free. Facility registration is a separate fee: $13,785 per year from 1 October 2026. |
| If agent details change | FDA must be told within 10 business days. |
| To change agent | Any time. No FDA fee. You do not need permission from your current agent. |
| Our fee | $1,000 a year. See what a year includes. |
Questions people ask
Can one company be the US Agent for many facilities?
Yes. FDA does not limit how many facilities one agent may serve. But ask how many staff they have, and whether a person will answer when FDA calls.
Can we name two US Agents?
No. FDA allows each foreign establishment to name only one US Agent.
Can my importer also be my US Agent?
Yes. One company can do both jobs. The two roles are different, and FDA records them separately.
Is there a gap where we have no valid US Agent during a switch?
No re-registration is required. You update the US Agent field on your existing FDA registration, and the change takes effect once the new agent confirms — the same three steps that apply to any agent change. We manage that confirmation so it does not stall your registration.
Is the US Agent the same as the Official Correspondent?
No. The Official Correspondent is the person at your own company who deals with FDA. The US Agent must be in the United States. You may name your US Agent as your Official Correspondent, but you do not have to.
What happens if I have no US Agent?
Your registration cannot be completed. FDA can refuse your devices at the United States border.
Will my US Agent file my 510(k)?
Not as part of the US Agent role. FDA states that a US Agent has no responsibility for premarket submissions. Preparing a 510(k) is separate work. We do it, and we price it separately.
If you are already registered
Registration lapses if it is not renewed between 1 October and 31 December. A lapsed registration is not always obvious from inside the company, and devices from an unregistered establishment are subject to refusal at the border.
Your status is public. Send us your establishment name or registration number and we will tell you whether your registration is current, when it was last renewed, and which US Agent FDA has on file for you.