U. S. Agent
Section 417 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) requires that any establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device imported into the United States must register with FDA and identify:
- the name and address of the establishment; and
- the name of the United States agent for the establishment.
On November 27, 2001, FDA published the final regulation implementing these requirements (Federal Register, Vol 66). The effective date of the regulation was February 11, 2002. For devices, all foreign establishments must notify FDA of the name, address and phone number of their United States agent. The regulation (21 CFR 807.40) states that each foreign establishment may designate only one United States agent who is either a resident of the United States or maintains a place of business in the United States. The foreign establishment may, but is not required to, designate its United States agent as its Official Correspondent.