Foreign establishments or facilities 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.
- 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.
- The U.S. Agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation.
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.
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Provide the following
- Full name of your company as registered
- Complete physical address of company
- Company Duns Number
- Name of your company’s owner or manager
- Email and telephone of owner or manager
- Products details
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.