Foreign establishments exporting to the United States must identify an FDA U.S. Agent during the registration process.
- Each foreign establishment may designate only one U.S. agent
- U.S. Agent as Official Correspondent
- U.S. agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation
- FDA treats representations by the U.S. Agent as those of the foreign facility, and will consider information or documents provided to the U.S. Agent the equivalent of providing the information or documents to the foreign facility
■ Food Facility Registration
■ Food Canning Establishment (FCE) Registration
■ Medical Device Establishment Registration
■ Drug Establishment Registration
■ Cosmetic Establishment Registration
We make the process very easy. Get the better service your company deserves.
Your company’s commercial business in the United States cannot be conducted through the U.S. Agent designated for the purpose of FDA Registration.
The U.S. agent acts as a link between FDA and the foreign facility for both emergency and routine communications.
■ Contact us today
Provide the following
■ Name of company as registered locally
■ Physical address of company
■ Name of owner or manager of company
■ Product details
■ DUNS Number of company
Keep in mind that our U.S. Agent Service is free when combined with
■ Food Facility Registration
■ Supplement Facility Registration
■ Food Canning Establishment (FCE) Registration
■ Cosmetic Establishment Registration
■ Drug Establishment Registration
■ Medical Device Establishment Registration.
