Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a medical device imported into the United States must identify a United States Agent (U.S. Agent) for that establishment. The foreign establishment may also, but is not required to, designate its U.S. Agent as its Official Correspondent.
Moreover, foreign manufacturers, repackers, relabelers, and control laboratories involved in the manufacture, preparation, propagation, compounding, processing or testing of human or veterinary drugs and human biological products, including the manufacturers of active pharmaceutical ingredient (API)s, must have a U.S. Agent.
Therefore, the U.S. Food and Drug Administration will not confirm a registration, provide a Food Facility Registration (FFR) number, an FDA Establishment Identification (FEI) number, or provide confirmation of a registration renewal, until ITB HOLDINGS LLC confirms it has agreed to serve as U.S. Agent.
The U.S. Agent’s responsibility is to be the Foreign Facility’s contact for the FDA, in both emergencies and routine operations:
- responding to questions concerning the foreign establishment’s products that are imported or offered for import into the United States
- assisting FDA in scheduling inspections of the foreign establishment.
However, U.S. Agents have no responsibility related to reporting of adverse events under the Medical Device Reporting regulation, or submitting Premarket Notification 510(k).
When the 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 will be considered to be equivalent to providing the same information or documents to the foreign establishment.
▪ Commercial Agent.
▪ Customs Broker.
▪ Initial Importer.
▪ Importer of Record.
▪ FSVP Importer.
Unlike other companies offering FDA Registration and Compliance Services, ITB HOLDINGS LLC does not charge a separate fee for U.S. Agent.
Then, such service is always included or free, for small and large foreign companies. Get the service your company deserves, at the cost you can really afford, regardless of your size and location.