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 Precision Solutions as your 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.
Please note that the Precisoin Solutions 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)
* Please note that we do NOT provide FDA Agent representation for FOOD or PHARMACEUTICAL companies.