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Short answer
An FDA US agent is the single person or company in the United States that a foreign medical device establishment names when it registers with FDA. Under 21 CFR 807.40, the agent helps FDA communicate with the foreign facility, answers FDA questions about imported devices and helps schedule inspections. For a buyer, the agent is one item to confirm in a supplier’s registration record. It is not an approval, certification or quality mark. This page is general regulatory information, not legal advice.
Definition and scope
Foreign establishments that make devices imported, or offered for import, into the United States must register and list those devices with FDA. As part of registration, each foreign establishment submits the name, address and phone number of its US agent (21 CFR 807.40(b)). The agent must reside in the United States or maintain a place of business there. FDA’s US agents page adds that a post office box or an answering service alone is not sufficient.
Each foreign establishment may designate only one US agent. The agent may also serve as the establishment’s official correspondent, the person who acts as liaison between facility management and FDA. Registration and listing information must be in English (807.40(d)).
The role is deliberately narrow. FDA states that the agent has no responsibility for adverse event reporting or for 510(k) submissions. Those obligations sit with other parties and processes, so the agent should not be treated as a stand-in for the manufacturer’s quality or regulatory function.
How the US agent works in practice
What FDA can ask the agent to do
When FDA requests it, the agent assists in communicating with the foreign facility, responds to questions about the devices imported or offered for import, and assists in scheduling inspections of the facility (807.40(b)(2)).
Why communication with the agent matters
If FDA cannot reach the foreign facility directly or promptly, it may give information or documents to the US agent, and that counts as giving them to the facility. A supplier whose agent is unresponsive can therefore miss FDA communications entirely.
Changes and replacement
A change to the agent’s name, address or phone number must be reported to FDA within 10 business days of the change (807.40(b)(3)). FDA’s US agents page says that if an agent declines the role or does not respond within 10 business days, the establishment must designate a new one.
US agent compared with related roles
The rows below follow 21 CFR 807.40 and FDA’s US agents page.
| Item | What the rules say |
|---|---|
| US agent | One per foreign establishment; resides in or has a place of business in the US; assists FDA with communication, questions about imported devices and inspection scheduling. |
| Official correspondent | Liaison between facility management and FDA. The US agent may also be the official correspondent. |
| Adverse event reporting and 510(k) submissions | Not the US agent’s responsibility, according to FDA’s US agents page. |
| Registration and listing | A device generally may not be imported or offered for import unless it is listed and made at a registered foreign establishment. Devices exempt under part 812 (investigational) are an exception. |
Where it matters for lab, clinic and supply decisions
Buyers who source devices or device-type consumables from outside the US can use the following checklist during supplier onboarding. Each item maps to a requirement in 807.40; none is a judgment about product quality.
- Registration and listing. Ask whether the manufacturing site is registered and the device listed, since a device generally may not be imported otherwise (807.40(c)). See what “FDA registered” means for a medical device and the FDA registered establishment definition.
- Establishment identifier. Ask for the site’s identifier so the record can be matched to the facility that actually makes the product; see the guide to the FEI number.
- US agent on file. Ask for the agent’s name, address and phone as submitted with registration, and check it is a US address that is not just a post office box.
- One agent only. A supplier citing more than one agent for the same establishment does not match the rule that only one may be designated.
- Currency. Ask how the supplier reports agent changes, since updates are due within 10 business days.
- English-language records. Registration and listing information must be in English, so documents offered as evidence should be too.
Record the answers in your vendor file alongside the other onboarding documents; the vendor onboarding documentation checklist and the guide to importing medical devices into the US cover the surrounding steps. For the wider picture of who supplies what, see wholesale suppliers in the USA.
Common misunderstandings
- “The agent means FDA approved the product.” No. The agent is an administrative contact required by 807.40. FDA’s US agents page does not describe any certification or endorsement of agents.
- “The agent handles adverse events and 510(k)s.” FDA says the agent has no responsibility for either.
- “An address anywhere will do.” The agent must reside in the US or maintain a place of business there; a post office box or answering service alone is not enough.
- “A supplier can list several agents.” Each foreign establishment may designate only one.
FAQ
What is a US agent for FDA?
It is the one US-based person or company a foreign device establishment designates at registration to help FDA communicate with the facility, answer questions about imported devices and schedule inspections.
What are the FDA US agent requirements?
The agent must reside in the US or maintain a place of business there, and a post office box or answering service alone is not sufficient. Only one agent may be designated per foreign establishment, and the name, address and phone number are submitted with registration in English.
Does a foreign establishment have to register with FDA?
A foreign facility that makes devices imported or offered for import into the US must register and list them (807.40(a)). Devices generally may not be imported unless listed and made at a registered foreign establishment, except investigational devices under part 812.
What happens if the US agent stops responding?
If the agent declines or does not respond within 10 business days, the establishment must designate a new agent, and any change in agent details must be reported within 10 business days.
Sources
- 21 CFR 807.40, “Establishment registration and device listing for foreign establishments importing or offering for import devices into the United States”: eCFR. Text read 1 November 2026 (version dated 2025-01-01).
- FDA, “U.S. Agents” (Device Registration and Listing): fda.gov. Read 1 November 2026; the page shows a last-updated date of 23 December 2017.
