Why US Agent Service Is Required
Any foreign facility involved in manufacturing, preparing, propagating, compounding, or processing medicines, medical devices, or dietary supplement products imported into the US must appoint a US Agent as its official correspondent. Legally, the US Agent must have a residence in the US and be physically present. Responsibilities of the US Agent include:
- Helping the FDA communicate with the foreign company
- Being available in an emergency for the FDA
- Serving on behalf of the foreign facility to interact with the FDA
- Responding to questions concerning the foreign establishment’s drug, device or supplement products
In case of being unable to contact the foreign company expeditiously or directly, the FDA provides documents or information to the US Agent. Such action is considered equivalent to providing the same information or documents to a foreign establishment.