Fee: $849 USD
(One-Time Fee)
U.S. FDA Agent Services for Medical Device Establishments
A U.S. FDA Agent is required for all foreign medical device establishments that are engaged in the manufacturing, packaging, labeling, or processing of medical devices and intend to import or market those devices in the United States.
As part of FDA Medical Device Establishment Registration, foreign facilities must designate a United States Agent (U.S. FDA Agent) who serves as the official point of contact between the facility and the U.S. Food and Drug Administration (FDA).
Failure to appoint or maintain a U.S. FDA Agent may result in:
Delays or rejection of FDA establishment registration
Inability to legally import medical devices into the U.S.
Increased regulatory and enforcement risk
Responsibilities of a U.S. FDA Agent
The role of a U.S. FDA Agent is defined by FDA regulations and is limited to the following four core responsibilities:
Assisting the FDA with communications involving the foreign medical device establishment.
Responding to FDA inquiries related to the foreign establishment and its medical devices.
Assisting the FDA in scheduling inspections of foreign medical device facilities.
Receiving FDA information or documents on behalf of the foreign establishment if the FDA is unable to contact the facility directly or in a timely manner.
Any information or documents provided to the U.S. FDA Agent are considered legally equivalent to being provided directly to the foreign establishment.
Why a Reliable U.S. FDA Agent Matters
A qualified U.S. FDA Agent helps ensure:
Prompt and accurate FDA communication
Faster response to regulatory requests
Reduced risk of registration delays or enforcement action
Ongoing compliance with FDA medical device regulations
U.S. FDA Agent Services
FDA Registration Assistance is committed to providing dependable, professional U.S. FDA Agent services for foreign medical device manufacturers and establishments.
Our services include:
Acting as your designated U.S. FDA Agent
Managing FDA communications on your behalf
Supporting FDA inspection coordination
Ongoing regulatory compliance assistance
To appoint FDA Registration Assistance as your United States Agent, please contact us today.
Frequently Asked Questions (FAQ)
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 communicate with the FDA.
Who is required to have a U.S. FDA Agent?
All foreign medical device manufacturers, packers, and labelers importing devices into the United States must appoint a U.S. FDA Agent.
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, distributors, or importers.
Can the FDA contact the U.S. FDA Agent instead of the facility?
Yes. If the FDA cannot reach the foreign establishment promptly, communication through the U.S. FDA Agent is considered legally valid.
Can a company change its U.S. FDA Agent?
Yes. A medical device establishment may change its U.S. FDA Agent at any time by updating its FDA registration.
Can FDA Registration Assistance act as my U.S. FDA Agent?
Yes. FDA Registration Assistance provides professional U.S. FDA Agent services for medical device establishments worldwide.
Contact FDA Registration Assistance
Appoint a trusted U.S. FDA Agent and ensure uninterrupted compliance with FDA medical device regulations.
