U.S. FDA Agent for Medical Devices

USA Authorized Representative: Key Information

The FDA requires an agent to confirm that they agree to act in this role. If the agent declines or does not respond within 10 business days, the foreign establishment must designate another agent.

What Is a U.S. Agent?

A U.S. Agent is the U.S.-based contact designated by a qualifying foreign medical device establishment in its FDA registration information. The agent helps FDA communicate with the foreign establishment and responds to FDA questions about the establishment’s devices imported or offered for import into the U.S.

 The FDA describes the agent’s responsibilities as limited. Designating a U.S. Agent does not automatically make that company the device’s importer, distributor or U.S. regulatory authorization holder. The manufacturer and agent should agree in writing on the scope of any additional services.

Is a U.S. Agent the Same as an EU Authorized Representative?

No. “U.S. Agent” is the FDA’s term for this role. It is not the same legal role as an EU Authorized Representative under the EU Medical Device Regulation.

The FDA describes the U.S. Agent’s duties as communications and assistance with inspection scheduling. The U.S. Agent is not responsible for submitting 510(k) Premarket Notifications or reporting adverse events under the Medical Device Reporting regulation.

Is a U.S. Agent Required?

A foreign establishment covered by the FDA requirement must identify a U.S. Agent as part of its initial and updated registration information. The agent must either reside in the United States or maintain a U.S. place of business. It must be reachable by telephone during normal business hours; a P.O. box or answering service alone does not meet the FDA’s stated requirements.

What Does the U.S. Agent Do?

The FDA lists these responsibilities for a U.S. Agent:

• Assist with FDA communications: Help FDA communicate with the foreign establishment.
• Respond to FDA questions: Respond to questions concerning the establishment’s devices imported or offered for import into the United States.
• Assist with inspection scheduling: Help FDA arrange inspections of the foreign establishment.
• Receive communications when needed: If FDA cannot contact the foreign establishment directly or promptly, it may provide documents or information to the U.S. Agent. FDA considers that equivalent to providing them to the foreign establishment.
• Confirm the appointment: Respond to FDA’s electronic verification request to confirm consent to act as the agent.

The role does not automatically include product submissions, importer responsibilities, complaint handling or adverse-event reporting. The foreign manufacturer remains responsible for meeting applicable FDA requirements.

U.S. Agent, Establishment Registration, Device Listing and FDA Authorization Are Different

These terms describe different regulatory activities:

U.S. Agent designation

Identifies the U.S.-based contact for the qualifying foreign establishment.

Establishment registration

Provides FDA with information about the establishment. Device establishments required to register generally renew their registration annually.v

Device listing

Identifies devices and activities associated with establishments required to list.

Premarket submission or authorization

Depending on device type and applicable exemptions, a device may require a 510(k), De Novo request, Premarket Approval (PMA) or another regulatory pathway before it can be marketed.

 FDA states that establishment registration and device listing do not denote FDA approval, clearance or authorization. FDA also does not issue registration certificates to medical device facilities.

U.S. Agent Appointment and FDA Registration Process

1. Confirm which establishment needs an agent

Review the foreign manufacturer’s activities and the device’s route to the U.S. market. The FDA’s requirements depend on establishment activity and device status.

2. Select an eligible U.S. Agent

Confirm that the proposed agent resides in the U.S. or maintains a physical place of business there, can be reached during normal business hours and agrees to take on the role.

3. Define the service scope

Document the agent’s communication and inspection-scheduling responsibilities. Agree separately on any additional support, such as registration coordination or regulatory consulting.

4. Submit the agent details through FDA’s system

The foreign establishment submits the agent’s contact details through FURLS as part of establishment registration. Only one U.S. Agent may be designated for each foreign establishment. The agent must complete FDA’s consent verification.

5. Complete applicable establishment registration and device listing

Determine which establishments must register, which must list devices and which must pay the establishment fee. The requirements vary by establishment activity.

6. Assess the device’s separate premarket requirements

Determine whether the device is exempt from premarket review or requires a 510(k), De Novo request, PMA or another pathway. The U.S. Agent designation does not provide or replace product clearance or approval.

7. Maintain accurate registration information

FDA requires annual verification of registration information for establishments that must register. Review the contact details and agent appointment when information changes.

How OMC Medical Can Support Your U.S. Market Entry

OMC Medical can help manufacturers plan the regulatory work around their U.S. Agent appointment, including:

• Reviewing whether the foreign establishment is subject to the U.S. Agent requirement.
• Helping define the roles of the manufacturer, U.S. Agent and U.S. importer.
• Coordinating U.S. Agent appointment details and FDA consent confirmation through an eligible U.S.-based arrangement, where included in the agreed scope.
• Supporting FDA establishment registration and device listing coordination.
• Helping assess whether the device may require a 510(k), De Novo request, PMA or another pathway.
• Organizing registration and submission information and helping track FDA communications.
• Clarifying which FDA fee applies to the establishment or product submission, separately from private service fees.

Looking for a U.S. Authorized Representative?

Plan your FDA U.S. Agent appointment alongside establishment registration, device listing and any required product authorization. Contact OMC Medical to discuss your establishment and device pathway.

Book a Free Consultation

 Call: +44 208 066 7260

Email: sales@omcmedical.com