U.S. Agent to the FDA

for Medical Devices and IVDs Manufacturers

A Federal Food and Drug Agency Agent (U.S. Agent) is the representative for Medical Devices and IVDs companies without a presence in the United States. Companies without a presence in the U.S. are required by the FDA to appoint a Registered FDA U.S. Agent. Your FDA US Agent must be a United States Resident or maintain a place of business within the United States. The U.S. agent cannot use a post office box as an address. The U.S. agent cannot use just an answering service. They must be available to answer the phone or have an employee available to answer the phone during normal business hours. Without a U.S. facility, you will be unable to register your facility, list your products, or submit the FDA marketing authorization applications without designating a U.S. Agent.

The U.S. Food and Drug Administration Agent requires any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States Agent (U.S. Agent) for that establishment

Responsibilities of the U.S. Agent:

assisting FDA in communications with the foreign establishment
responding to questions concerning the foreign establishment’s devices that are imported or offered for import into the United States
assisting FDA in scheduling inspections of the foreign establishment and
if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment

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What constitutes a Foreign Facility?

The FDA requires all foreign establishments who manufacturer any of the following must have a designated agent in the USA:

Medical device companies / manufacturers
Human drug companies / manufacturers
Animal drug manufacturers / companies
Biological manufacturers / companies

Please note that the U.S. agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation (21 CFR Part 803), or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E).

What Does Your U.S. Agent Do for You?

The responsibilities set down by the U.S. FDA, state a U.S. Agent is responsible for the following:

U.S. Agent Program for Medical Device Manufacturers
Keeping a physical office presence in the United States
Provide updates of the establishment registration and product listings
To be responsible to provide communications between the FDA, and the Company, such as upcoming inspections of the foreign site

In Addition to the U.S. Agent’s responsibilities, the foreign facility has the following responsibilities:

Provide their U.S. Agent update of changes to the Establishment registration (e.g. address, change in ownership)
Notify their Agent of new products or changes to their currently listed products (e.g. dropping them from the product line)
Notify their Agent of any changes in telephone and/or fax numbers, and for any change in their email address(es)

Why appoint MDSS as your U.S. Agent?

With a quarter century of experience as a European Authorized Representative for Medical Devices, IVDs and Cosmetics Manufacturers, MDSS has the professional experience, knowledge, and drive to make certain acting as your U.S. Agent will lead to your success in the United States.

Our fully staffed office in the United States is capable of handling all your U.S. FDA needs, with the same efficiency, confidentiality, and speed as our offices in Europe, United Kingdom and Switzerland.