In the U.S. medical device and IVD market, the role of U.S. Agent is critical for all non-U.S.-based organisations involved in the manufacture and distribution of imported devices.
FDA requires non-U.S. organisations required to carry out establishment registration to appoint a U.S.-based contact person to whom they can turn for any communication, without having to worry about language or time zone issues.
The U.S. Agent’s contact details are communicated by the organisation through the FDA Unified Registration and Listing System (FURLS).
In turn, within 10 working days and again via the FURLS system, the U.S. Agent must complete the confirmation process to act as the organisation’s representative.
The U.S. Agent has the following responsibilities:
- Assists FDA in communications with the organisation;
- Responds to questions regarding devices imported into the United States;
- Assists FDA in scheduling manufacturer inspections.
The U.S. Agent has no responsibility for reporting adverse events (21 CFR 803) or submitting 510(k) applications (21 CFR 807, Subpart E).
The U.S. Agent must be unique for the organisation: different U.S. Agents cannot be appointed depending on the imported devices.
For this reason, it is appropriate to separate the commercial process from the regulatory process: Thema USA, Thema’s US office, has all the necessary characteristics to perform the role of U.S. Agent, making the organisation independent of the importer and free to market the devices in full compliance with FDA regulations.