A U.S. agent may be an individual, partnership, corporation, or association. A U.S. agent must
have a place of business or residence in the United States and be physically present in the United
States. For example, a foreign facility may use its U.S. importer as its U.S. agent. As established
in 21 CFR 1.227, the U.S. agent acts as a communications link between FDA and a foreign
facility for both routine and emergency communications. The U.S. agent will be the person FDA
contacts when an emergency occurs, unless the registration specifies another emergency contact.
In functioning as the communications link with FDA, a U.S. agent may choose to initiate
communications with FDA, and FDA may likewise choose to initiate communications with the
U.S. agent. Further, as stated in the definition for “U.S. agent” in 21 CFR 1.227, FDA will treat
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.
