Medical Device U.S. Agent Services
Annual U.S. Agent representation for applicable foreign medical device establishments, with FDA communication support, designation confirmation, inspection-scheduling assistance, and annual registration coordination.
What Is a Medical Device U.S. Agent & Who Needs One?
A medical device U.S. Agent is the U.S.-based liaison identified by an applicable foreign establishment as part of FDA device establishment registration. FDA uses the U.S. Agent to support communications with the foreign establishment, questions about imported devices, and inspection scheduling.
Each foreign establishment may designate only one U.S. Agent. The agent must reside in the United States or maintain a place of business in the United States and must have a physical location that is more than a mailbox, mail drop, or answering service.
- Designation is submitted electronically through FDA's FURLS/DRLM registration workflow.
- FDA sends the U.S. Agent an electronic request to confirm the designation.
- If the agent does not confirm within 10 business days, the establishment must designate a new agent.
- The U.S. Agent may also be the official correspondent, but FDA does not require the roles to be combined.
- Registration and U.S. Agent designation do not mean FDA approval or clearance of the establishment or its devices.
Medical Device U.S. Agent Support
The service is built around the responsibilities FDA assigns to a device U.S. Agent, plus the practical registration support needed to keep the designation current.
U.S. Agent Designation & Confirmation
We provide the U.S. Agent information required for your foreign establishment registration and complete FDA's electronic confirmation process after the designation is submitted.
FDA Communication Management
We receive, route, and help coordinate FDA communications involving the foreign establishment within the scope of the U.S. Agent role, including time-sensitive regulatory correspondence.
Inspection Scheduling Support
We assist FDA and the foreign establishment with inspection scheduling and related communication. The establishment remains responsible for its operations, records, quality system, and inspection readiness.
Annual Agent & Registration Coordination
We review the U.S. Agent information used in annual establishment registration and coordinate updates when the foreign establishment's contact or registration information changes.
The FDA Requirements That Matter Most
A focused summary of the current medical device U.S. Agent framework.
How Our Medical Device U.S. Agent Service Works
A four-step process that preserves your existing page flow while aligning the service with FDA's actual designation process.
Submit Establishment Details
Provide the foreign establishment name, physical address, owner/operator information, and current FDA registration details if available.
Designation Prepared
We provide the U.S. Agent name, U.S. physical address, phone, and email information needed for the registration record.
FDA Confirmation Completed
After FDA sends the verification request, we confirm the designation through the applicable FDA electronic system.
Annual Representation Maintained
We support FDA communications and inspection scheduling and coordinate review of agent information with the annual registration cycle.
Complete FDA Medical Device Compliance Solutions
We offer a full range of medical-device compliance services, including establishment registration, device listing, U.S. Agent representation, labeling support, annual renewal, and import-resolution assistance.
Medical Device Establishment Registration
Register or renew an applicable foreign or domestic medical device establishment with FDA and coordinate the registration information required in FURLS/DRLM.
Medical Device Listing
Prepare and maintain applicable FDA device listings with product-code and classification support for devices associated with registered establishments.
Medical Device Labeling & Product Review
Review medical device labels, packaging, IFU, UDI/GUDID considerations, and applicable FDA labeling requirements before U.S. market entry.
Medical Device DUNS Request Assistance
Assist with obtaining or verifying location-specific DUNS information used in FDA medical-device registration, GUDID, and related CDRH workflows.
Medical Device U.S. Agent Services
Annual U.S. Agent representation for applicable foreign medical device establishments, including FDA communications and inspection-scheduling support.
Medical Device Listing Certificate
Professional verification documentation prepared from applicable FDA registration and listing records for commercial and compliance purposes; not an FDA-issued certificate.
QMSR / Quality System Support
Support for medical-device quality-system requirements under FDA's current Quality Management System Regulation and applicable ISO 13485-aligned processes.
Medical Device Annual Establishment Renewal
Coordinate annual FDA establishment-registration review, user-fee workflow, U.S. Agent information, and linked device-listing maintenance.
Import Alert & Device Detention Resolution
Case-specific assistance for medical-device import detentions, entry documentation, corrective actions, and Import Alert or DWPE matters.
Laser Accession Report & Submission
Prepare the FDA Laser Product Report / Radiation Safety Product Report, coordinate CDRH submission, and follow the accession number for applicable laser products.
Frequently Asked Questions — Medical Device U.S. Agent Services
Answers to the most common questions about appointing and maintaining a U.S. Agent for a foreign medical device establishment.
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 medical device establishments subject to 21 CFR Part 807 registration requirements must identify a U.S. Agent as part of their establishment registration. This includes applicable foreign manufacturers and other foreign establishments whose activities require registration when devices are imported or offered for import into the United States.
What are the responsibilities of a medical device U.S. Agent?
FDA describes four core responsibilities: assisting FDA communications with the foreign establishment; responding to questions about devices imported or offered for import into the United States; assisting FDA in scheduling inspections of the foreign establishment; and receiving information or documents from FDA when FDA cannot contact the foreign establishment directly or expeditiously.
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 sends an electronic verification request to the U.S. Agent. The agent 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 establishment and a new U.S. Agent must be designated to satisfy the registration obligation.
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 specifically notes that the U.S. Agent has no responsibility for adverse-event reporting under 21 CFR Part 803 or for submitting 510(k) Premarket Notifications under 21 CFR Part 807, Subpart E. Those obligations remain with the appropriate responsible parties.
How much does Medical Device U.S. Agent service cost?
FDA Registration Assistance charges $849 per year for Medical Device U.S. Agent service. This is our professional service fee for maintaining the designation, managing FDA communications within the U.S. Agent role, supporting inspection scheduling, and coordinating annual agent-information review. It is separate from any FDA establishment registration user fee that may apply.
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 U.S.-presence requirements. The individual must reside in the United States or maintain a place of business in the United States, have a physical location that FDA can visit, and be reachable during normal business hours. A mail drop or answering service alone is not acceptable.
Can a foreign establishment change its U.S. Agent?
Yes. The foreign establishment can update its registration information in FURLS/DRLM to identify a new U.S. Agent. The newly designated agent must then complete FDA's confirmation process. We can coordinate the change so the registration record is updated accurately.
Does the U.S. Agent designation need to be reviewed during annual registration?
Yes. Foreign establishments review and verify their registration information annually, including U.S. Agent information. Device establishment registration information is generally reviewed during the annual October 1 through December 31 registration period. Our professional U.S. Agent service is billed annually at $849 per year.
What information is needed to designate a U.S. Agent?
FDA requests the U.S. Agent's name, U.S. address, telephone number, fax number if applicable, and email address as part of the foreign establishment's registration information. We provide the required agent details and coordinate the electronic confirmation of the designation.
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.
Appoint Your Medical Device U.S. Agent
Send your foreign establishment details and we will coordinate the U.S. Agent designation, FDA confirmation, and annual representation.
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