FDA will not complete a registration or provide a registration number until ITB HOLDINGS LLC confirms it has agreed to serve as the U.S. Agent for a foreign facility or establishment.
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.
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 APIs, must have a U.S. Agent.
The foreign establishment may also, but is not required to, designate its U.S. Agent as its Official Correspondent.
ITB HOLDINGS LLC is the U.S. Agent of companies in Canada, Mexico, Brazil, Australia, New Zealand, India, Pakistan, South Korea, Japan, China, Russia, Portugal, Greece, Spain, France, Belgium, Netherlands, Switzerland, Sweden, United Kingdom, Ireland, among more than 100 countries.
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
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.
U.S. Agents have no responsibility related to reporting of adverse events under the Medical Device Reporting regulation, or submitting 510(k) Premarket Notifications.
■ Commercial Agent
■ Customs Broker
■ Initial Importer
■ Importer of Record
■ FSVP Importer
U.S. Agent Service is always included, and therefore free, when one of our services is requested.
Switching U.S. Agent for the purpose of FDA Registration? Contact ITB HOLDINGS LLC, today.