FDA US Agent Service
A US Agent is the person FDA contacts about your company.
FDA uses that contact for two separate purposes. The first is questions about the devices you send to the United States. The second is arranging an inspection of your establishment. They arise at different moments and for different reasons.
Every establishment outside the United States must name one. FDA will not complete your registration without it.
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.
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 factory 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. Factory 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. |
What a US Agent must do
The role has three duties, set by 21 CFR 807.40. The regulation requires nothing beyond them.
- Help FDA communicate with your company.
- Answer questions about the devices you send to the United States.
- Help FDA arrange an inspection of your factory.
That is the complete legal list. If FDA cannot reach your company directly, FDA may treat contact with your US Agent as contact with you.
What a US Agent cannot do
Appointing a US Agent completes one requirement of establishment registration. It grants no authorisation to market a device. The two are sold together often enough that the distinction is worth stating precisely.
- A US Agent is not FDA approval.
- A US Agent is not a 510(k) clearance.
- A US Agent does not let you sell a device that needs a clearance you do not have.
- A US Agent is not an importer. An importer is a different role with different duties.
FDA also sets out the limits of the role. A US Agent carries no responsibility for two things:
- Reporting adverse events to FDA.
- Sending premarket submissions such as a 510(k).
Both are separate work. If your device requires a 510(k), appointing an agent does not advance that submission by a single day. We do both, and we will tell you which one your situation actually calls for.
Do you need a US Agent?
Is your factory outside the United States?
Do you send medical devices to the United States, or plan to?
Two conditions decide it. If both are true, a US Agent is mandatory and FDA provides no exemption.
What it costs
Two separate costs are frequently quoted as one. Appointing a US Agent carries no FDA fee at all. Establishment registration carries an annual FDA fee of $13,785 from 1 October 2026, payable whoever acts as your agent.
| What you pay FDA | Until 30 Sep 2026 | From 1 Oct 2026 |
|---|---|---|
| Factory 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. 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.
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.
How to change your US Agent
Changing agent requires no consent from your current agent and no FDA fee. Three steps.
- 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.
FDA does not charge a fee to change your agent.
If your agent’s name, address or telephone number changes, FDA must be told within 10 business days. We handle that for our clients.
Your contract with your old agent is a private business matter between you and them. It does not stop FDA from accepting a new agent.
What our service includes
Everything below is covered for twelve months. Tell us where your factory is and we will send the number the same day.
- 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 within 10 business days if your details change
- Annual renewal handled before the window closes
- Registration status monitored year-round
Can one company be the US Agent for many factories?
Yes. FDA does not limit how many factories 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.
Does my US Agent need to be in the United States?
Yes. The US Agent must live in the United States or have a place of business in the United States. A post office box is not enough.
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.