A Federal Food and Drug Agency Agent ( FDA US 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 US 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 FDA requires all foreign establishments who manufacturer any of the following must have a designated agent in the USA: 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). The responsibilities set down by the U.S. FDA, state a U.S. Agent is responsible for the following: In Addition to the U.S. Agent’s responsibilities, the foreign facility has the following responsibilities: 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.US Agent to the FDA
for Medical Devices and IVDs Manufacturers
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 FDA US Agent:
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