---
title: The US Agent Requirement: What EU Startups Need for FDA Compliance
description: Foreign manufacturers selling devices in the US must designate a US Agent to interact with FDA. Here is what the role does and how to choose one.
authors: Tibor Zechmeister, Felix Lenhard
category: FDA & International Market Access
primary_keyword: US Agent FDA EU startups
canonical_url: https://zechmeister-solutions.com/en/blog/us-agent-fda-eu-startups
source: zechmeister-solutions.com
license: All rights reserved. Content may be cited with attribution and a link to the canonical URL.
---

# The US Agent Requirement: What EU Startups Need for FDA Compliance

*By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.*

> **Any foreign manufacturer that exports medical devices to the United States must designate a US Agent — a person or entity physically located in the US — who serves as the FDA's point of contact with the foreign establishment. The role is administrative but mandatory: without a US Agent, a foreign establishment cannot complete FDA registration, and without registration, devices cannot be legally imported. The US Agent is not the same as an MDR Authorised Representative, does not share product liability in the same way, and is not a regulatory consultant. Here is what the role covers, how it differs from the EU equivalent, and how to choose one that will not become a problem later.**

**By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.**

---

## TL;DR

- A US Agent is required for any foreign establishment that manufactures medical devices for the US market. Without one, FDA establishment registration cannot be completed.
- The US Agent is the FDA's point of contact inside the United States. The agency communicates with the foreign manufacturer through the US Agent for routine matters and in urgent situations.
- The US Agent is structurally different from an MDR Authorised Representative under Article 11. The tasks, the liability, and the scope are not the same — do not assume what you learned in the EU carries over.
- Every foreign establishment designates exactly one US Agent at any given time. The designation is part of establishment registration and is updated whenever the agent changes.
- Choosing the right US Agent is a small decision with outsized consequences if it goes wrong. Cost varies widely, and the cheapest option is rarely the best one.

---

## Why this post exists

EU founders looking at the US market tend to learn about three things in their first week of FDA research: the three premarket pathways (510(k), De Novo, PMA), the Quality System Regulation at 21 CFR Part 820, and the Quality Management System Regulation harmonisation. The US Agent requirement is usually further down the list, and it usually gets discovered late — often when the founder is trying to complete establishment registration and runs into a form field that will not let them proceed without one.

The discovery is awkward because the US Agent is not a regulatory specialist decision. It is an administrative prerequisite with real legal consequences if it is handled casually. Several EU founders we have worked with treated the US Agent as a signature-on-a-form formality, picked the cheapest option on the internet, and then discovered six months later that the agent had changed email addresses, gone out of business, or simply stopped responding. Each of these situations is a compliance problem that scales in severity depending on what the FDA is trying to communicate at the time.

The purpose of this post is to cover the US Agent topic the way it should be handled: as a deliberate choice, made once, reviewed periodically, and understood clearly in relation to its European cousin.

## What a US Agent is — at the general framing level

At the general framing level, a US Agent is the person or legal entity that the FDA contacts when it needs to reach a foreign establishment. The concept exists because the FDA's jurisdiction and communication channels are domestic: the agency needs a reliable, US-based contact for every foreign manufacturer whose devices enter the country. The US Agent fills that gap.

The US Agent requirement is separate from the premarket submission (510(k), De Novo, PMA). It sits in the establishment registration layer — the part of FDA compliance that governs who is allowed to manufacture or distribute devices for the US market and where those operations are located. Any foreign establishment that is required to register with the FDA must designate a US Agent as part of that registration.

What the US Agent is not is also worth stating up front. The US Agent is not your regulatory consultant. The US Agent is not your importer. The US Agent is not a co-signer on your premarket submission. The US Agent does not review your technical documentation. The US Agent is not a quality system specialist. These are separate roles that may or may not be held by the same organisation, depending on how you structure your US-facing team, but the US Agent role itself is narrow and specific.

For the detailed FDA premarket orientation in which this requirement sits, see [FDA Regulation of Medical Devices: A Primer for EU Startups](/blog/fda-regulation-medical-devices-primer-eu-startups).

## The legal role

The legal role of the US Agent is to act as the FDA's communication channel with the foreign establishment. When the FDA has a question about a registered foreign establishment — a routine follow-up, an inspection scheduling matter, a request for information in response to a complaint, or in the worst case an urgent communication about a device already on the market — the agency contacts the US Agent first.

The US Agent is expected to be reachable during US business hours and to respond to the FDA promptly. The agent is also expected to forward FDA communications to the foreign manufacturer without delay. This is why physical presence in the United States matters: a US Agent is not a mailbox, it is a responsive point of contact that the agency can reach quickly.

Each foreign establishment has exactly one US Agent at any given time. If the agent changes, the registration must be updated. If the agent is unreachable for an extended period, that is a registration problem, which in turn becomes a market access problem very quickly. The tolerance for unresponsive US Agents is low — not because the FDA is hostile, but because the entire purpose of the designation is responsiveness.

At the general framing level, the US Agent's obligations are about availability and communication rather than product decisions. The US Agent does not approve your device. The US Agent does not decide whether your labelling is adequate. The US Agent does not perform a conformity assessment. Those responsibilities remain with the manufacturer, and in the US system many of them are exercised directly by the FDA itself.

## How the US Agent differs from an MDR Authorised Representative

EU founders arriving at the US Agent requirement often assume it maps directly onto the MDR Authorised Representative. The two roles share a general purpose — both give a non-domestic regulator a local point of contact for a foreign manufacturer — but the specifics differ in ways that matter.

Under MDR Article 11, a non-EU manufacturer must designate an Authorised Representative established in the Union before placing any device on the EU market. The Authorised Representative's tasks are defined in Article 11(3) and include verifying that the EU Declaration of Conformity and the technical documentation have been drawn up, keeping the documentation available for competent authorities, responding to competent authority requests, and terminating the mandate if the manufacturer acts non-compliantly. Article 11(5) further provides that the Authorised Representative is jointly and severally liable with the manufacturer in relation to defective devices under the applicable product liability framework. (Regulation (EU) 2017/745, Article 11.)

The US Agent role is lighter in scope. At the general framing level, the US Agent is a communication channel, not a legal review function. The US Agent does not verify technical documentation before market entry. The US Agent does not carry joint and several product liability in the way an EU Authorised Representative does under the MDR framework. The US Agent's role is structured around FDA communication and establishment registration support rather than ongoing documentation custody.

This difference has two consequences for EU founders. First, the US Agent cannot be the person you rely on to catch regulatory problems with your device — that is not what the role is designed to do, and a US Agent who is not also a separate regulatory consultant is not paid for that work. Second, the liability profile is different enough that contract language written for an Authorised Representative mandate does not transfer to a US Agent engagement without revision. Do not copy one into the other.

For the Authorised Representative side of this comparison see [Authorised Representatives Under MDR: When You Need One and How to Choose](/blog/021-authorized-representatives) and the companion post on [MDR obligations for importers and distributors](/blog/022-mdr-importers-distributors).

## Choosing a US Agent

Choosing a US Agent is a narrow procurement decision with a few specific criteria that matter more than the headline price.

**Responsiveness.** The single most important quality of a US Agent is that they answer the phone. An agent that does not respond to the FDA within a reasonable window is worse than no agent at all, because the foreign establishment has now designated someone the FDA cannot reach. Ask for references. Ask how they handle after-hours communications. Ask what their average response time is on FDA correspondence.

**Stability.** The agent must still exist in two, three, five years. Small one-person operations have failed the EU founders we have worked with before — the individual closed the business, moved, or simply stopped responding, and the manufacturer only discovered it when an FDA communication went unanswered. Favour agents with institutional stability over pure price.

**Conflict of interest hygiene.** Some US Agents are affiliated with consultancies, importers, or distributors. This is not automatically bad, but it does create conflict of interest situations you should be aware of. If your US Agent is also your importer, consider whether that combined relationship is what you actually want.

**Scope clarity.** Get the scope of the engagement in writing. What is included in the base fee. What counts as an additional service. Whether the agent handles establishment registration updates or only forwards FDA communications. Whether they will respond to FDA communications outside US business hours. Whether they notify you if their own contact details change.

**Contract exit terms.** Make sure you can change agents cleanly. The ability to switch is your main lever if the agent's service quality deteriorates. A contract with aggressive lock-in terms for a role this narrow is a warning sign.

For a broader discussion of picking US-side partners see [Regulatory strategy for EU and US markets](/blog/regulatory-strategy-startups-targeting-eu-us-markets) and [FDA classification for EU startups](/blog/fda-device-classification-startups).

## Cost framing

US Agent fees span a wide range. At the low end, basic US Agent services — essentially a mailbox and a phone number with FDA communication forwarding — can be a few hundred to low four-digit dollars per year. At the higher end, agents that bundle establishment registration management, regulatory correspondence handling, and related administrative services charge several thousand dollars per year or more.

The price range is legitimate. A basic service is legitimately cheap because the workload is low in normal operation. A higher-priced service is legitimately more expensive because it includes genuine administrative work. The wrong move is choosing on price without understanding what is in scope. The second wrong move is over-paying for "US Agent" services that are really regulatory consulting bundled under a different label — if you want regulatory consulting, buy regulatory consulting explicitly, not hidden inside a US Agent contract.

For an EU startup with a single device and a single US manufacturing registration, the US Agent line item is small relative to the total US market access budget. The decision that matters is fit, not dollars saved.

## Common mistakes

- **Treating the US Agent as an afterthought.** The agent is discovered late, picked in a hurry, and the relationship is never reviewed again until it fails.
- **Confusing the US Agent with an Authorised Representative.** The two roles are not the same. Do not write one contract using the other as a template.
- **Choosing the cheapest option without reference checks.** The cost of a non-responsive agent during an FDA communication event is much higher than the savings from the cheapest annual fee.
- **Bundling too many roles in one provider.** A single provider doing US Agent, import broker, and regulatory consulting can work, but it can also mask conflicts and obscure accountability. Bundle deliberately, not by accident.
- **Forgetting to update the designation when the agent changes.** When an agent moves or is replaced, the establishment registration has to be updated. A stale registration creates a compliance problem that is easy to avoid and embarrassing to explain.

## The Subtract to Ship angle on US Agents

The Subtract to Ship framework for MDR strips every activity that does not trace to a specific regulatory obligation. Applied to the US Agent decision, the subtraction is different: the US Agent is itself a required obligation, so it is not a candidate for cutting. What gets subtracted is the surrounding noise — the bundled services you do not need, the consulting upsells that arrive under the "US Agent" label, the contractual complexity that does not serve a specific function.

The right Subtract to Ship posture on the US Agent is: designate one competent, stable, responsive agent under a clean contract with clear scope, then stop thinking about it. The only activity that survives the subtraction is the base service and an annual review. Everything else gets cut until it earns its place. See [The Subtract to Ship framework for MDR](/blog/subtract-to-ship-framework-mdr) for how this discipline applies across the whole regulatory plan.

## Reality Check — Where do you stand on US Agent readiness?

1. Do you currently have a designated US Agent on file with the FDA, or is the role still vacant?
2. If you have an agent, do you know their full legal name, physical US address, and the specific contract terms that govern the relationship?
3. When was the last time you confirmed that your US Agent is still operating and reachable at the contact details on file?
4. Do you have a process in place to update the FDA registration promptly if the agent changes or becomes unreachable?
5. Have you confirmed in writing what the agent does and does not do, so that you are not relying on them for services they are not contracted to provide?
6. If the FDA sent a communication to your US Agent today, are you confident you would be notified within one business day?
7. Are you treating the US Agent as a narrow administrative role, or have you accidentally loaded it with expectations it was never designed to meet?

If more than two of these questions are uncomfortable to answer, the US Agent decision deserves a dedicated hour of attention before any other FDA work proceeds.

## Frequently Asked Questions

**Is the US Agent the same as a US importer?**
No. The US Agent is a communication contact between the FDA and the foreign establishment. The importer is a separate role in the supply chain — the entity that brings the device into the United States commercially. One organisation can hold both roles, but they are structurally and legally distinct, and conflating them causes contract and accountability problems later.

**Can an EU-based employee serve as a US Agent?**
No. The US Agent must be physically located in the United States. That is the purpose of the designation — to give the FDA a domestic contact. An EU employee, no matter how senior or well-informed, cannot fulfill the role from outside the country.

**Is the US Agent liable for my device's safety?**
At the general framing level, the US Agent does not carry the same joint and several product liability that an MDR Authorised Representative carries under Article 11(5). The US Agent's role is organised around communication and registration support rather than conformity review, and the liability profile reflects that narrower scope. For specific liability questions on your US Agent contract, work with US counsel.

**Do I need a US Agent if I only export one device once?**
Any foreign establishment that is required to register with the FDA for devices entering the US market must designate a US Agent. One-off or limited exports still go through the same registration framework. The short version is: if the device is reaching US patients, the US Agent requirement applies.

**Can I change my US Agent later?**
Yes. The designation is not permanent, and you can switch agents when the current one is no longer the right fit. The change must be reflected in the FDA registration, and clean contract exit terms make the switch easier. This is why exit terms matter at the point of signing the original engagement.

## Related reading

- [Authorised Representatives Under MDR: When You Need One and How to Choose](/blog/021-authorized-representatives) — the EU comparison anchor under MDR Article 11.
- [MDR Obligations for Importers and Distributors](/blog/022-mdr-importers-distributors) — the EU supply chain roles that sit alongside the Authorised Representative.
- [Non-EU Manufacturers Selling into the EU Market](/blog/049-non-eu-manufacturers) — the reverse direction of the same pattern.
- [Switzerland and the MDR: The Swiss Authorised Representative Question](/blog/050-switzerland-mdr) — a useful case study of how regional designations interact.
- [FDA Regulation of Medical Devices: A Primer for EU Startups](/blog/fda-regulation-medical-devices-primer-eu-startups) — the orientation primer in which this post sits.
- [FDA Device Classification for EU Startups](/blog/fda-device-classification-startups) — how FDA classes are determined (post 602).
- [The 510(k) Pathway for EU Startups](/blog/510k-pathway-eu-startups) — predicate strategy and submission content (post 604).
- [FDA Establishment Registration and Device Listing for Foreign Manufacturers](/blog/fda-establishment-registration-foreign-manufacturers) — the registration layer the US Agent sits inside (post 612).
- [The Subtract to Ship Framework for MDR](/blog/subtract-to-ship-framework-mdr) — the methodology behind this blog, applied here to the narrow US Agent decision.

## Sources

1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR), Article 11 (Authorised Representative). Official Journal L 117, 5.5.2017.
2. U.S. Food and Drug Administration — general public guidance on the US Agent role for foreign establishments. Referenced at the general framework level only. https://www.fda.gov/medical-devices

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*This post is part of the FDA & International Market Access series in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. A note on the limits of our expertise: Tibor's authority is in the EU MDR and the Notified Body system. This post covers the US Agent requirement at the orientation level that EU founders need to make sensible early decisions. For specific US Agent contract review, establishment registration mechanics, or any dispute-level question about FDA communications, work with a US regulatory specialist or US counsel who practises inside the FDA system daily.*

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*This post is part of the [FDA & International Market Access](https://zechmeister-solutions.com/en/blog/category/fda-international) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*