FDA US Agent for Foreign Medical Device Manufacturers
Last reviewed:
Foreign medical device manufacturers who market their products in the United States must retain a US Agent throughout the device life cycle. The US Agent serves as the primary point of contact between the FDA and the manufacturer.
What is an FDA US Agent for a foreign device establishment?
A foreign establishment subject to FDA registration must identify a US Agent. The agent assists the US FDA in communications with that foreign establishment, responds to questions about imported devices and helps arrange inspections. If FDA cannot reach the establishment directly, communications delivered to the agent can be treated as delivered to the establishment.
The FDA’s US Agent requirements specify that the agent must reside or maintain a place of business in the United States. A post office box or answering service alone is insufficient. The agent or an employee must be available to answer the telephone during normal business hours. The foreign establishment remains responsible for its regulatory obligations.
US Agent versus other FDA roles
| Role | Main function | What the role does not automatically include |
|---|---|---|
| US Agent | US communications contact for a foreign registered establishment | 510(k) preparation, adverse-event reporting or product importation |
| Official correspondent | Maintains delegated establishment-registration and listing information | A requirement to be based in the US or to act as importer |
| Initial importer | Performs the regulated initial-importer activity and its associated obligations | Representation of every foreign manufacturer as US Agent |
| Submission consultant | Supports a specific premarket filing under the agreed authorization | Appointment as the establishment’s US Agent |
One organization may perform more than one role if it meets the requirements, but define each scope explicitly. FDA states that the US Agent role itself does not carry responsibility for MDR submissions or 510(k) submissions. Separate services can be agreed without confusing those regulatory roles.
Appointment, consent and changes
Enter the agent’s current contact information in the foreign establishment’s registration record through FDA Industry Systems. FDA asks the designated agent to confirm consent. If the agent declines or does not respond within 10 business days, the owner/operator or official correspondent is notified and must designate a new agent.
Confirm consent and working communications before relying on the appointment for a shipment. Maintain controlled instructions for changing the agent, updating contacts and forwarding urgent FDA communications. The account owner should retain access to its records and a documented handover process.
Choosing an independent agent or distributor
A qualified US distributor can serve as agent, but assess availability, escalation procedures and commercial dependencies. An independent arrangement can simplify a distributor change; it does not remove the need to assign importer, complaint, recall and reporting responsibilities across the supply chain.
The agreement should state contacts, business-hour coverage, urgent escalation, inspection coordination, confidentiality, record access, service fees and termination/handover duties. Avoid broad claims that an agent is either responsible for all product compliance or immune from every form of liability. Contractual duties and other business activities require their own assessment.
Connect representation with launch readiness
An agent appointment does not approve the product. Confirm the device’s classification, marketing authorization where required, registration/listing, labeling and QMSR readiness. Pure Global can support the US Agent and official-correspondent functions within a defined service scope; testing, premarket submissions and government fees should be identified separately in the proposal.
Regulatory Update · Oct 17, 2026FDA Toxicology 510(k) ExemptionsRegulatory Update · Sep 17, 2026FDA Buffy Coat System GuidanceRegulatory Update · Aug 13, 2026FDA QMSR Warning Letters on Risk and Design ChangesRegulatory Update · Aug 9, 2026FDA FY 2027 Medical Device User FeesBlog · Oct 14, 202621 CFR 820 to ISO 13485 CrosswalkBlog · Oct 14, 2026FDA Cleared vs Approved vs GrantedBlog · Oct 14, 2026FDA Inspection Readiness ChecklistBlog · Oct 14, 2026FDA Medical Device Classification GuideVideo · Oct 16, 2026FDA Small Business DeterminationVideo · Oct 16, 2026FDA PMA: Premarket Approval ExplainedFDA US Agent & Registration Support for a Simple Flat Fee
Plan your device registration, local representation and ongoing compliance with Pure Global.
Frequently asked questions
Yes, if it satisfies FDA’s US presence, availability and consent requirements. Define the agent role separately from importing and distribution, with a handover and communications process if the commercial relationship changes.
Not by virtue of being the US Agent. FDA expressly separates the agent’s communications role from Part 803 reporting. The manufacturer and other mandatory reporters must assign their reporting duties correctly.
Yes. The official correspondent and US Agent are different roles. The US Agent must meet the US-presence requirements, while the correspondent manages registration/listing information under the owner/operator’s authorization.
Single Process,
Multiple Markets
When you partner with Pure Global, a single registration process opens doors to multiple countries. Our global subsidiaries make this streamlined path possible.
Let's Talk,
Anywhere You Are.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
Contact us