Medical Device
U.S. Agent Services
Required for all foreign medical device establishments registering with the FDA — FDA Registration Assistance serves as your designated U.S. Agent under 21 CFR Part 807, managing all FDA communications on your behalf.
What Is a U.S. FDA Agent & Who Is Required to Appoint One
A U.S. FDA Agent is a U.S.-based representative required for all foreign medical device establishments that manufacture, package, label, or process medical devices intended for import or sale in the United States. Under 21 CFR Part 807, every foreign facility must designate a U.S. Agent as part of their FDA Medical Device Establishment Registration — serving as the official point of contact between the foreign establishment and the U.S. Food and Drug Administration (FDA).
FDA Registration Assistance acts as your designated U.S. FDA Agent — managing all FDA communications, supporting inspection coordination, and ensuring your foreign establishment remains fully compliant with FDA medical device regulations year after year.
- Required for all foreign medical device establishments
- U.S. Agent must be designated at time of FDA registration
- Agent receives FDA communications on behalf of facility
- Change of U.S. Agent requires FDA registration update
- FDA Registration Assistance serves as your U.S. Agent
Our Medical Device U.S. Agent Services
Everything medical device manufacturers need to register and remain compliant with the FDA — from initial establishment registration and device listing to annual renewal and ongoing FDA compliance support, handled end-to-end by experienced FDA regulatory specialists.
Designated U.S. Agent
FDA Registration Assistance serves as your officially designated U.S. FDA Agent — listed in your FDA Medical Device Establishment Registration as your U.S.-based representative for all FDA communications and regulatory matters.
FDA Communication Management
FDA Registration Assistance manages all FDA communications on behalf of your foreign establishment — responding promptly to FDA inquiries, relaying regulatory information, and ensuring your facility is always reachable through a qualified U.S. representative.
Inspection Coordination Support
FDA Registration Assistance assists the FDA in scheduling inspections of your foreign medical device facility — coordinating logistics, communicating timelines, and ensuring your establishment is prepared and responsive to FDA inspection requests.
Ongoing Compliance Support
FDA Registration Assistance provides year-round regulatory compliance support — including registration maintenance, annual renewal coordination, and guidance on FDA medical device requirements — keeping your foreign establishment continuously compliant.
Trusted FDA Medical Device U.S. Agent Specialists
Helping foreign medical device establishments maintain compliant, responsive U.S. Agent representation — ensuring uninterrupted FDA communication and registration compliance year after year.
How Our Medical Device U.S. Agent Service Works
A simple four-step process to appoint FDA Registration Assistance as your U.S. FDA Agent and keep your foreign establishment fully compliant.
Submit Your Establishment Details
Provide your foreign facility name, address, and ownership information. FDA Registration Assistance reviews your establishment profile and prepares your U.S. Agent appointment for inclusion in your FDA Medical Device Establishment Registration.
U.S. Agent Appointment Prepared
FDA Registration Assistance prepares your complete U.S. Agent designation — compiling all required information, confirming compliance with 21 CFR Part 807, and coordinating your agent appointment with your FDA establishment registration filing.
Agent Listed in FDA Registration
FDA Registration Assistance is officially listed as your U.S. Agent in your FDA Medical Device Establishment Registration — establishing your facility's compliant U.S. point of contact for all FDA communications, inquiries, and inspection coordination.
Ongoing Agent & Compliance Support
FDA Registration Assistance maintains your U.S. Agent designation year after year — managing FDA communications, supporting annual registration renewals, and keeping your foreign establishment continuously compliant with FDA medical device regulations.
Complete FDA Medical Device Registration Solutions
We offer a full range of FDA medical device registration and compliance services — from establishment registration and device listing to U.S. Agent services and annual renewals.
Medical Device Establishment Registration
Register your foreign or domestic medical device establishment with the FDA — required annually for all device manufacturers and distributors under 21 CFR Part 807.
Medical Device Listing
List your medical devices with the FDA alongside your establishment registration — required for all devices manufactured or distributed for the U.S. market.
Medical Device Labeling & Product Review
Ensure your medical device labels and product documentation meet FDA labeling requirements — reviewed by experienced FDA regulatory specialists.
Medical Device DUNS Request Assistance
Obtain your DUNS Number required for FDA Medical Device Establishment Registration — fast and accurate assistance to keep your registration on track.
Medical Device U.S. Agent Services
Designate FDA Registration Assistance as your official U.S. Agent — legally required for all foreign medical device establishments registering with the FDA.
Medical Device Listing Certificate
Obtain your official FDA Medical Device Listing Certificate confirming your device is registered and listed with the FDA — for clients, distributors, and partners worldwide.
QMS / cGMP Support
Establish and maintain your Quality Management System (QMS) and current Good Manufacturing Practices (cGMP) to meet FDA medical device quality requirements.
Medical Device Annual Establishment Renewal
Ensure your FDA Medical Device Establishment Registration is renewed on time every fiscal year — avoiding compliance gaps, enforcement risk, and marketing disruptions.
Import Alert & Device Detention Resolution
Get expert help resolving FDA medical device import alerts and detention notices — restoring your device's ability to enter U.S. commerce as quickly as possible.
Frequently Asked Questions — Medical Device U.S. Agent Services
Find answers to the most common questions about FDA Medical Device Establishment Registration, annual renewal requirements, and how FDA Registration Assistance helps device companies stay compliant.
What is a U.S. FDA Agent?
A U.S. FDA Agent is a U.S.-based representative designated by a foreign medical device establishment to serve as the official point of contact with the U.S. Food and Drug Administration (FDA). The U.S. Agent must be physically located in the United States and available to the FDA during normal business hours.
Who is required to appoint a U.S. FDA Agent?
All foreign medical device establishments — including manufacturers, packagers, labelers, and distributors — that import or intend to import medical devices into the United States are required to designate a U.S. FDA Agent as part of their FDA Medical Device Establishment Registration under 21 CFR Part 807.
What are the responsibilities of a U.S. FDA Agent?
Under FDA regulations, a U.S. FDA Agent has four core responsibilities: (1) assisting the FDA with communications involving the foreign establishment; (2) responding to FDA inquiries about the foreign facility and its devices; (3) assisting in scheduling FDA inspections of the foreign facility; and (4) receiving FDA information or documents on behalf of the foreign establishment when the FDA cannot contact the facility directly.
Does the U.S. FDA Agent replace the importer or distributor?
No. The U.S. FDA Agent is not the importer of record and does not replace customs brokers, U.S. distributors, or importers. The agent's role is limited to FDA regulatory communications and does not involve commercial import or distribution activities.
Is the U.S. FDA Agent legally responsible for the foreign establishment's compliance?
No. The U.S. FDA Agent is not legally responsible for the foreign establishment's regulatory compliance or product quality. However, information or documents provided to the U.S. Agent are considered legally equivalent to being provided directly to the foreign establishment.
Can the FDA contact the U.S. FDA Agent instead of the foreign facility?
Yes. If the FDA cannot reach the foreign establishment promptly or directly, it may communicate through the U.S. FDA Agent. Any communications received by the U.S. Agent are considered legally equivalent to communications delivered directly to the foreign facility.
Can a foreign establishment change its U.S. FDA Agent?
Yes. A foreign medical device establishment may change its U.S. FDA Agent at any time by updating its FDA Medical Device Establishment Registration to reflect the new agent's information. FDA Registration Assistance can assist with the agent change and registration update process.
What happens if a foreign establishment does not appoint a U.S. FDA Agent?
Failure to designate a qualified U.S. FDA Agent may result in delays or rejection of your FDA Medical Device Establishment Registration, inability to legally import medical devices into the United States, and increased regulatory and enforcement risk including import detentions and compliance actions.
How much does U.S. FDA Agent service cost?
FDA Registration Assistance charges $849 USD per year for U.S. FDA Agent services for medical device establishments. This annual fee covers your designated U.S. Agent, FDA communication management, inspection coordination support, and ongoing compliance assistance for your foreign establishment.
Does a domestic U.S. establishment need a U.S. FDA Agent?
No. The U.S. FDA Agent requirement applies only to foreign medical device establishments. Domestic U.S. manufacturers and distributors are not required to appoint a U.S. Agent, as they are already located within the United States and can communicate directly with the FDA.
Can an employee of the foreign establishment serve as the U.S. FDA Agent?
Yes, provided that individual is physically located in the United States and is available to the FDA during normal business hours. However, most foreign establishments prefer to designate a professional regulatory firm such as FDA Registration Assistance to ensure consistent availability and expert handling of FDA communications.
Does the U.S. FDA Agent need to be renewed annually?
The U.S. FDA Agent designation itself does not expire independently, but your FDA Medical Device Establishment Registration must be renewed annually (October 1 – December 31 each year). Your U.S. Agent information must remain accurate and current in your registration at all times. FDA Registration Assistance manages annual renewal coordination as part of its U.S. Agent services.
What information is required to designate a U.S. FDA Agent?
To designate a U.S. FDA Agent in your FDA Medical Device Establishment Registration, you must provide the agent's full legal name or company name, U.S. physical address (not a P.O. Box), phone number, and email address. FDA Registration Assistance provides all required agent information upon appointment.
Can one U.S. FDA Agent represent multiple foreign establishments?
Yes. A single U.S. FDA Agent may represent multiple foreign medical device establishments simultaneously. FDA Registration Assistance currently serves as U.S. Agent for medical device establishments in over 135 countries, managing FDA communications and compliance support for each facility individually.
Does the U.S. FDA Agent handle import paperwork or customs clearance?
No. The U.S. FDA Agent's role is strictly limited to FDA regulatory communications and does not include customs clearance, import documentation, or commercial distribution activities. Import-related functions are handled separately by the importer of record, customs broker, or U.S. distributor.
How do I appoint FDA Registration Assistance as my U.S. FDA Agent?
Simply complete the contact form on this page or reach out directly to FDA Registration Assistance. Provide your foreign facility name, address, and any existing FDA registration details, and our team will prepare your U.S. Agent appointment and coordinate it with your FDA Medical Device Establishment Registration immediately.
Appoint Your U.S. FDA Agent Today
Submit your foreign establishment details and FDA Registration Assistance will prepare your U.S. Agent appointment and coordinate it directly with your FDA Medical Device Establishment Registration — ensuring your facility has a compliant, responsive U.S.-based FDA representative.
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