U.S. Agent Representation to the FDA for Medical Device, IVDD, and Pharmaceutical Manufacturers and Companies
A Federal Food and Drug Agency Agent (U.S. Agent) is the representative for Medical Device, IVDD, and Pharmaceutical 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 U.S. Agent. Your FDA U.S. Agent must be a United States Resident or maintain a place of business within the United States.
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
The U.S. agent must either reside in the U.S. or maintain a place of business in the U.S. 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.
The responsibilities of the U.S. agent are limited and include:
- 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
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 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
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 Pharmaceutical / 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 Device, IVDD, and Pharmaceutical 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 and the United Kingdom.
Do not hesitate to contact us, so we can provide all the information necessary to show you why selecting MDSS as your U.S. Agent will be the right choice for your company.