Medical Device U.S. Agent Services
Every foreign medical device establishment that registers with FDA must identify one U.S. Agent. We serve as that agent for $849 per year: confirming the designation with FDA, handling FDA communications, supporting inspection scheduling and keeping the agent details current at every annual renewal. Prepared by FDA Registration Assistance, serving 1,000+ companies across 135+ countries since 2013.
Registering a foreign device establishment? Send the establishment name, address and owner/operator details. We provide the U.S. Agent details, confirm the designation with FDA and keep it current at each renewal.
Appoint My Device U.S. AgentWhat a Device U.S. Agent Does and Does Not Do
FDA Assigns the U.S. Agent
- Assisting FDA in communications with the foreign establishment
- Responding to questions about devices imported or offered for import
- Assisting FDA in scheduling inspections of the establishment
- Receiving FDA information or documents when FDA cannot reach the establishment
Not the U.S. Agent's Job
- Medical Device Reporting under 21 CFR Part 803
- 510(k) premarket notifications
- Acting as importer of record, customs broker or distributor
- Making a device FDA approved or cleared
Sources: 21 CFR 807.40 and FDA device U.S. Agent page.
Foreign Establishments That Must Name a U.S. Agent
Any foreign establishment that manufactures, prepares, propagates, compounds or processes a device imported or offered for import into the U.S. must register, list and identify a U.S. Agent (21 CFR 807.40). FDA's registration table includes:
| Foreign Establishment Type | Registers and Names a U.S. Agent? |
|---|---|
| Manufacturer, including kit assembler | Yes |
| Contract manufacturer or packager | Yes |
| Contract sterilizer | Yes |
| Specification developer | Yes |
| Relabeler or repackager | Yes |
| Remanufacturer or single-use device reprocessor | Yes |
| Foreign exporter of devices | Yes |
| Component maker selling only to finished-device manufacturers | No |
| Device under an IDE only | No |
Source: FDA: who must register. Domestic establishments register but do not name a U.S. Agent.
Who Can Serve as a Device U.S. Agent
Presence
- Resides or keeps a place of business in the U.S.
- No post office box as the address
- Not just an answering service
- Answers the phone, or has staff who do, during business hours
Designation
- Only one U.S. Agent per foreign establishment
- Name, address, phone, fax and email submitted in registration
- Confirms FDA's email request within 10 business days
- Changes reported within 10 business days
Sources: FDA device U.S. Agent page; 21 CFR 807.40. The U.S. Agent may also serve as official correspondent, but it is optional.
How Our Device U.S. Agent Service Works
Our Fee vs. FDA's Fee
| Item | Amount | Paid To |
|---|---|---|
| Medical device U.S. Agent service | $849 per year | FDA Registration Assistance |
| Device establishment registration fee, FY 2027 | $13,785 per establishment, no small business discount | FDA |
| 510(k), De Novo or PMA fees | Only if your device needs a premarket submission | FDA |
FY 2027 runs October 1, 2026 to September 30, 2027 (FY 2027 device user fee notice). Need the registration filed too? See medical device establishment registration.
Complete Medical Device Compliance Support
Establishment Registration
Register or renew a foreign or domestic device establishment.
Device Listing
Product codes, classification and listing maintenance.
Annual Renewal
October 1 to December 31 renewal and fee workflow.
Labeling & Product Review
Labels, IFU and UDI checks before U.S. entry.
DUNS Assistance
Location-specific DUNS for registration and GUDID.
QMSR Support
Quality system work under FDA's QMSR.
Listing Certificate
Verification documents; not an FDA-issued certificate.
Import Alert & Detention
Detentions, entry documents and DWPE matters.
Laser Accession Report
Laser product reports and accession numbers.
Other programs: the FDA U.S. Agents hub covers food, drug and cosmetic U.S. Agents.
Appoint Your Medical Device U.S. Agent
FDA Registration Assistance serves as the U.S. Agent for foreign medical device establishments: a U.S.-based contact that confirms the designation with FDA, handles FDA communications within the U.S. Agent role, supports inspection scheduling and keeps the agent details current at every annual renewal.
- $849 per year for U.S. Agent service.
- Designation confirmed within FDA's 10-business-day window.
- Agree the scope, documents and pricing before any paid work begins.
Contact our specialists, email info@fdaregistrationassistance.com, or call +1 (928) 275-8333. Registration pricing · FDA U.S. Agents.
Appoint My Device U.S. AgentFDA Registration Assistance is a private consulting firm, not FDA or any government agency. FDA registration is not FDA approval, clearance or certification.
Frequently Asked Questions — Medical Device U.S. Agent Services
What is a U.S. Agent for FDA medical device registration?
A U.S. Agent is a U.S.-based person or entity designated by a foreign medical device establishment subject to FDA registration requirements. The agent must reside in the United States or maintain a place of business in the United States and must have a physical location where FDA can reach the agent; a P.O. box, mail drop, or answering service alone is not sufficient.
Who is required to designate a U.S. Agent?
Foreign establishments that manufacture, prepare, propagate, compound or process a device imported or offered for import into the United States must register, list their devices and identify a U.S. Agent (21 CFR 807.40). That covers foreign manufacturers (including kit assemblers), contract manufacturers and packagers, contract sterilizers, specification developers, relabelers and repackagers, remanufacturers, reprocessors of single-use devices and foreign exporters (FDA: who must register). A device may not be imported unless it is listed and made at a registered foreign establishment.
What are the responsibilities of a medical device U.S. Agent?
FDA describes four responsibilities: assisting FDA in communications with the foreign establishment; responding to questions about the establishment's devices that are imported or offered for import; assisting FDA in scheduling inspections of the establishment; and receiving information or documents when FDA cannot contact the establishment directly or expeditiously, which counts as delivery to the establishment (21 CFR 807.40, FDA device U.S. Agent page).
Can a foreign establishment designate more than one U.S. Agent?
No. FDA states that each foreign medical device establishment may designate only one U.S. Agent. The establishment may also designate that same person or entity as its official correspondent, but doing so is optional.
Does the U.S. Agent have to confirm the designation with FDA?
Yes. FDA's system sends an email verification request to the U.S. Agent, who must confirm consent to act for the foreign establishment. If the agent denies the designation or does not respond within 10 business days, FDA notifies the official correspondent or owner/operator, and a new U.S. Agent must be designated to satisfy the registration obligation (FDA device U.S. Agent page).
Is a U.S. Agent the same as the official correspondent?
No. The roles are distinct. A foreign establishment may choose to designate its U.S. Agent as its official correspondent, but FDA does not require the two roles to be held by the same person or entity.
Does the U.S. Agent replace the importer, customs broker, or distributor?
No. A U.S. Agent is a regulatory liaison for FDA communications. The role does not make the agent the importer of record, customs broker, initial importer, distributor, or commercial representative unless a separate agreement establishes one of those roles.
Is the U.S. Agent responsible for Medical Device Reporting or submitting a 510(k)?
No. FDA states that the U.S. Agent has no responsibility for adverse event reporting under the Medical Device Reporting regulation (21 CFR Part 803) or for submitting 510(k) premarket notifications (21 CFR Part 807, Subpart E) (FDA device U.S. Agent page). Those obligations remain with the manufacturer or other responsible party.
How much does Medical Device U.S. Agent service cost?
FDA Registration Assistance charges $849 per year for medical device U.S. Agent service. That covers maintaining the designation, handling FDA communications within the U.S. Agent role, supporting inspection scheduling and reviewing agent information at each annual registration. It is separate from FDA's annual establishment registration fee, which is $13,785 for FY 2027 and is paid to FDA (FY 2027 device user fee notice).
Does a domestic U.S. medical device establishment need a U.S. Agent?
No. The U.S. Agent requirement applies to foreign establishments that are subject to the applicable FDA device registration requirements. A domestic U.S. establishment is already located in the United States and does not designate a U.S. Agent for that domestic establishment.
Can an employee or individual serve as the U.S. Agent?
Yes, if the person meets FDA's presence requirements: the individual must reside or keep a place of business in the United States, cannot use a post office box or only an answering service, and must answer the phone, or have an employee who does, during normal business hours (FDA device U.S. Agent page).
Can a foreign establishment change its U.S. Agent?
Yes. The foreign establishment updates its registration in FDA's registration system to name the new U.S. Agent, and the new agent completes FDA's confirmation. Changes to the U.S. Agent's name, address or phone number must be reported to FDA within 10 business days (21 CFR 807.40). We coordinate the change so the record is updated without a gap.
Does the U.S. Agent designation need to be reviewed during annual registration?
Yes. Device establishments renew registration every year between October 1 and December 31 and review all registration information, including the U.S. Agent, at that time. Our U.S. Agent service is billed annually at $849 per year.
What information is needed to designate a U.S. Agent?
FDA asks for the U.S. Agent's name, address, telephone and fax numbers, and email address as part of the foreign establishment's registration (FDA device U.S. Agent page). We provide our agent details and complete the electronic confirmation.
Can one U.S. Agent represent multiple foreign medical device establishments?
Yes. FDA's rules do not limit a qualified U.S. Agent to representing only one foreign establishment. The agent must still be able to satisfy FDA's communication and availability requirements for every establishment represented.
How do I appoint FDA Registration Assistance as my U.S. Agent?
Submit your foreign establishment name, physical address, owner or operator details, and any existing FDA registration information through the form on this page. We will provide the U.S. Agent details needed for your registration, coordinate the FDA confirmation request, and begin annual representation once the engagement is finalized.
Does having a U.S. Agent mean my device is FDA approved or cleared?
No. Registration, listing and U.S. Agent designation do not mean FDA approved or cleared the establishment or its devices, and implying it is misleading (21 CFR 807.39). Your device still needs any 510(k), De Novo or PMA that applies to it.
Can the U.S. Agent be the initial importer?
It can be the same company, but the roles are separate. The initial importer is a U.S. establishment that registers on its own and has its own obligations (FDA: who must register); being named U.S. Agent does not make a company the importer, and importing does not make it the U.S. Agent.
What is the FDA device establishment registration fee for FY 2027?
$13,785 per establishment for October 1, 2026 to September 30, 2027, with no small business discount on the establishment fee (FY 2027 device user fee notice). The fee is paid to FDA for each registration year and is separate from U.S. Agent service.
What happens if my U.S. Agent becomes unresponsive?
FDA may be unable to reach your establishment about imports or inspections, and a registration with an invalid agent is incomplete. Replace the agent, update the registration and have the new agent confirm, so FDA always has a valid contact.
Appoint Your Medical Device U.S. Agent
Tell us what your company makes, sells, or distributes, where each product is manufactured or packed, your U.S. importer or buyer arrangement, label readiness, and target shipment date.
Submitting this inquiry does not purchase a service or authorize paid work. Our team can discuss the scope and required materials before you commission assistance. Fields marked with an asterisk are required.