Every foreign medical device establishment that registers with FDA must name one US agent, who lives or has a place of business in the United States. The agent helps FDA reach you, answers questions about your imported devices and helps schedule inspections, but does not report adverse events or submit 510(k)s.
Key takeaways
- FDA allows one US agent per foreign establishment. The agent needs a US address and a real person, not a post office box or an answering service.
- Your agent has 10 business days to confirm the appointment in FDA's system, and changes to the agent's contact details must be reported within 10 business days.
- You need a US agent when you register, which must happen before your device is imported, not before 510(k) clearance.
- We ran the numbers on FDA's registration data: 15,523 foreign establishments name a US agent, and the busiest agent service represents 1,186 of them.
- From October 1, 2026, the annual establishment registration fee is $13,785. FDA charges no separate fee for a US agent.
What is an FDA US agent?
A US agent is the person FDA contacts in the United States about a foreign device establishment. FDA's regulations define it as a person residing or maintaining a place of business in the US whom a foreign establishment designates as its agent [1].
Mailboxes and answering services do not count. The definition excludes mailboxes, answering machines or services, and any place where the agent is not physically present [1]. FDA adds that the agent cannot use a post office box as an address [2].
You can have only one. Each foreign establishment may designate only one US agent [1]. You may also make that agent your official correspondent, the contact for registration and listing matters, but you do not have to [1, 2].
This guide covers medical devices. Food facilities and drug establishments name US agents under separate rules, in 21 CFR 1.227 and 21 CFR 207.69 [12].
Who needs a US agent?
Every foreign establishment that must register with FDA needs one, because the US agent is part of the registration [1]. The rule covers establishments that manufacture, prepare, propagate, compound or process a device that is imported or offered for import into the US [1].
FDA's table of who must register covers these foreign establishment types [3]:
| Establishment type | Registration and US agent needed? |
|---|---|
| Manufacturer, including kit assembler | Yes |
| Contract manufacturer or contract packager | Yes |
| Contract sterilizer | Yes |
| Foreign exporter of devices to the US | Yes |
| Relabeler or repackager | Yes |
| Specification developer | Yes |
| Remanufacturer, or reprocessor of single-use devices | Yes |
| Custom device manufacturer | Yes |
| Maker of accessories or components packaged or labeled for end users | Yes |
| Establishment that keeps complaint files for devices | Yes |
| Maker of components sold only to a finished device manufacturer | No |
| Device only under study with an investigational device exemption (IDE) | No |
If you only supply components to a finished device manufacturer, you do not register, so you do not need a US agent [3]. Our guide to FDA registration and listing explains the full process.
When do you need a US agent?
You need one when you first register your establishment. Registration is due within 30 days of starting an operation that requires it [1].
Register before your first shipment. No device may be imported or offered for import unless it is listed and made at a registered foreign establishment [1]. FDA says this obligation must be met before distribution in the US [4].
A 510(k) is a separate step. Registration, and with it your US agent, is required before your device is imported or distributed in the US, not before 510(k) clearance [1, 4]. FDA also states that the US agent has no responsibility for submitting 510(k)s [2].
Renew every year. Annual registration runs from October 1 to December 31 [1]. For fiscal year 2027, which starts on October 1, 2026, the annual establishment registration fee is $13,785 [5]. FDA's fee schedule has no separate charge for naming a US agent [5]. See our FDA user fees page for all current fees.
What does a US agent do, and what does it not do?
A US agent has three duties, all performed when FDA asks [1]:
- Help FDA communicate with the foreign establishment.
- Answer questions about the establishment's devices that are imported or offered for import.
- Help FDA schedule inspections of the establishment.
Your agent can receive FDA documents for you. If FDA cannot contact your establishment directly or quickly, it may send information or documents to your US agent [1]. That counts as providing them to you [1]. In effect, a document in your agent's inbox can count as delivered to you.
FDA says the agent's responsibilities are limited [2]:
| Task | Who handles it |
|---|---|
| Help FDA communicate with your establishment | Your US agent |
| Answer questions about your imported devices | Your US agent |
| Help FDA schedule inspections of your establishment | Your US agent |
| Report adverse events under 21 CFR Part 803 | Not your US agent |
| Submit 510(k)s | Not your US agent |
Your importer is a separate role. In your registration, you must report the importers you know of, and each person who imports or offers your devices for import, such as brokers [1]. Our guide to importing medical devices explains the importer's duties.
How does FDA confirm your US agent?
When you name a US agent in your registration, FDA asks for the agent's name, address, phone and fax numbers, and email address [2]. FDA's system then emails the agent a request to confirm that it has agreed to act for you [2]. The agent must complete this confirmation [6].
The agent has 10 business days. If the agent declines, or does not respond within 10 business days, FDA notifies your official correspondent or owner operator, who must name a new agent [2]. If the confirmation is not completed, FDA may designate your establishment as "failed to register" [6].
Changes have their own deadline. You or your agent must report any change to the agent's name, address or phone number within 10 business days [1].
How do you choose a US agent?
Start with FDA's requirements, then judge how well the agent will work for you. These are the points to check:
- A real person in the US during business hours. FDA says the agent cannot use only an answering service, and must answer the phone, or have an employee who does, during normal business hours [2].
- Agreement before you register. Confirm the agent will accept the role and complete FDA's confirmation within 10 business days [2].
- How they pass on FDA contact. Ask how quickly they forward an FDA call or email to you, and in which language. When FDA cannot reach you directly, documents it gives your agent count as given to you [1].
- How many other companies they represent. Some agents act for hundreds of establishments (see below). Ask who will handle your file.
- Help with inspections. Your agent helps FDA schedule inspections [1], so ask how they will coordinate one with you.
- Clear terms for changes. Agree who reports changes to FDA within 10 business days, and what happens if either side ends the arrangement [1].
The market is concentrated. We measured this in FDA's registration files dated September 21, 2026 [7]. They list 15,523 foreign establishments, each with a US agent. We grouped agents by email domain, or by name where the agent uses a free email service, and found about 4,448 distinct agents. The busiest represents 1,186 foreign establishments. Fifteen agents each represent 100 or more, and together they act for 24.6% of all foreign establishments. All 15 are service firms or trade bodies acting for many unrelated companies, not a manufacturer's own US office. At the other end, 19.1% of foreign establishments use an agent that represents no other establishment in the file.
Complizen acts as US agent for foreign manufacturers. FDA reaches a named person in the US, and we answer FDA correspondence in your working hours.
What should you know in each priority market?
We measured, for each market, how many establishments are in FDA's registration file and how concentrated their choice of US agent is. The table also shows how many 510(k)s FDA cleared for applicants there. The last column shows the time gap to US Eastern Time, the time zone of FDA's headquarters in Silver Spring, Maryland [1, 9].
| Market | Establishments in FDA's file | Distinct US agents | Share with the top 5 agents | 510(k) clearances since January 1, 2023 | Hours ahead of US Eastern (summer/winter) |
|---|---|---|---|---|---|
| South Korea | 894 | 320 | 29.0% | 684 | 13/14 |
| Taiwan | 624 | 317 | 29.3% | 212 | 12/13 |
| Japan | 533 | 243 | 18.8% | 244 | 13/14 |
| India | 388 | 175 | 37.1% | 82 | 9.5/10.5 |
| Malaysia | 254 | 133 | 28.7% | 57 | 12/13 |
| Turkey | 92 | 63 | 35.9% | 27 | 7/8 |
| UAE | 14 | 13 | Too few to compare | 0 | 8/9 |
| Saudi Arabia | 3 | 2 | Too few to compare | 1 | 7/8 |
Sources: our analysis of FDA's registration and US agent files, September 21, 2026 [7]; FDA's 510(k) data through openFDA, updated September 14, 2026 [8]; time gaps from the IANA time zone database [9].
- South Korea, Taiwan, Japan and Malaysia: your working day ends before FDA's begins. Agree how your agent will reach you overnight, and who on your team will respond.
- South Korea: 894 establishments are registered, and Korean applicants received 684 510(k) clearances since January 1, 2023, the most of any priority market [7, 8]. The five busiest agents for Korean establishments work almost entirely for Korean clients: 259 of their 268 foreign clients are Korean [7].
- Japan: agent choice is the least concentrated of the priority markets. The top 5 agents represent 18.8% of Japanese establishments, and one of the five is a Japanese group's own US subsidiary acting mainly for the group's sites [7]. A US subsidiary can be your agent if it meets FDA's requirements.
- India: agent choice is the most concentrated of the markets with more than 100 establishments. The top 5 agents represent 37.1% of Indian establishments [7]. Four of them are service firms with more than 100 foreign clients each, so ask how many clients yours serves [7].
- Turkey: at 7 to 8 hours ahead, your afternoon overlaps with FDA's morning, which makes same-day replies easier.
- UAE and Saudi Arabia: only 17 establishments from the two countries are in FDA's file [7]. You need a US agent only if your establishment registers with FDA. Importing FDA-cleared devices into the Gulf does not require one.
What happens if your registration or US agent lapses?
Your devices can be stopped at the US border. Importing a device without establishment registration and listing is illegal under the FD&C Act, as FDA's Import Alert 99-34 states [4]. Under that alert, FDA may detain shipments from firms on its Red List without physical examination [4].
Refusing an inspection can stop all your products. FDA may contact a foreign manufacturer to schedule an inspection, but it is not required to [10]. If a firm refuses to permit an FDA inspection, FDA may detain all of its products under Import Alert 89-16 [10]. Your agent helps FDA schedule inspections, which is one more reason to choose one that responds quickly.
Inspections may also come without notice. On May 6, 2025, FDA announced its intent to expand unannounced inspections at foreign facilities that make medical products [11]. FDA said foreign firms had often had weeks to prepare, and that it conducts about 3,000 foreign inspections a year in more than 90 countries [11]. Do not rely on your agent's scheduling call as your warning. Keep your site ready.
Our guide to FDA import alerts explains how firms are added to and removed from these lists. For the wider route to the US, see our international market entry path.
Frequently asked questions
Does every foreign medical device company need an FDA US agent?
Every foreign establishment that must register with FDA needs one. That includes manufacturers, contract manufacturers, contract sterilizers, exporters, relabelers and specification developers. Makers of components sold only to a finished device manufacturer do not register, so they do not need a US agent.
Can I have more than one US agent?
No. FDA allows each foreign establishment to designate only one US agent. A company with several registered establishments names an agent for each one, and it can be the same agent. You may also make your US agent your official correspondent for registration and listing matters, but FDA does not require it.
Can my US distributor be my US agent?
Yes, if it meets FDA's requirements. The agent must live or have a place of business in the US and have a person who answers during business hours. The US agent is a separate role from importer, so report your importers in your registration as well.
What does a US agent actually do?
When FDA asks, the agent helps FDA communicate with your establishment, answers questions about your imported devices and helps schedule inspections. If FDA cannot reach you directly or quickly, documents it gives your agent count as given to you. FDA says the agent's responsibilities are limited to these tasks.
Is a US agent responsible for adverse event reports or 510(k)s?
No. FDA states that the US agent has no responsibility for reporting adverse events under the Medical Device Reporting regulation, or for submitting 510(k) premarket notifications. Plan those tasks separately from your US agent arrangement. The agent's role is limited to helping FDA communicate with you, answering device questions and helping schedule inspections.
How long does a US agent have to confirm?
Ten business days. FDA's system emails the agent a request to confirm that it has agreed to act for you. If the agent declines or does not respond within 10 business days, FDA notifies your company, which must name a new agent.
When should I appoint my US agent?
Before you register your establishment, because the agent is part of your registration. Registration is due within 30 days of starting an operation that requires it, and no device may be imported until it is listed and made at a registered establishment.
Do I need a US agent before submitting a 510(k)?
No. Registration, and with it the US agent, is required before your device is imported or distributed in the US, not before 510(k) clearance. FDA also states that the US agent has no responsibility for submitting 510(k)s, so the two are separate steps.
How much does an FDA US agent cost?
FDA charges no fee for naming a US agent. Agents set their own service fees. The FDA fee you pay is the annual establishment registration fee, which is $13,785 for fiscal year 2027, starting on October 1, 2026. Annual registration is due between October 1 and December 31 each year.
How do I change my US agent?
Update your registration in FDA's system with the new agent's details. FDA's system then asks the new agent to confirm that it has agreed to act for you. Any change to the agent's name, address or phone number must be reported within 10 business days.
What happens if my US agent stops responding?
Replace it quickly. When FDA cannot reach you directly, it may still send documents to your agent, and those count as given to you. Name the new agent in your registration, and report the change within 10 business days. FDA's system then asks the new agent to confirm.
Can a US agent use a PO box or answering service?
No. FDA's definition excludes mailboxes, answering machines and answering services. FDA also says the agent cannot use a post office box as an address, and must answer the phone, or have an employee who does, during normal business hours. A voicemail box alone does not meet the requirement.
References
- eCFR. 21 CFR Part 807, Establishment Registration and Device Listing, including sections 807.3(s), 807.22, 807.40 and 807.41. Accessed September 26, 2026.
- FDA. U.S. Agents. Content current as of December 23, 2017.
- FDA. Who Must Register, List and Pay the Fee. Content current as of September 27, 2018.
- FDA. Import Alert 99-34: Detention without physical examination of drugs or medical devices from firms without a valid registration and/or listing. Published September 17, 2026.
- Federal Register. Medical Device User Fee Rates for Fiscal Year 2027, 91 FR 48134. Published July 30, 2026.
- FDA. Device Registration and Listing: An Introduction, Part 2. CDRH Learn presentation by Elias Mallis, Division of Industry and Consumer Education. Slides dated October 16, 2023.
- FDA. Establishment Registration and Medical Device Listing Files for Download, Registration and US Agent files dated September 21, 2026.
- openFDA. Device 510(k) API. Data updated September 14, 2026.
- IANA. Time Zone Database. Accessed September 26, 2026.
- FDA. Import Alert 89-16: Detention without physical examination of products from medical device firms refusing FDA foreign establishment inspection. Published September 11, 2025.
- FDA. FDA Announces Expanded Use of Unannounced Inspections at Foreign Manufacturing Facilities. Press release, May 6, 2025.
- eCFR. 21 CFR 1.227, food facility registration definitions and 21 CFR 207.69, drug establishment official contact and US agent. Accessed September 26, 2026.