Some U.S. law firms are charging fees to serve as a foreign facility’s U.S. agent. Some of these firms have the word “FDA” in their name. Must a foreign facility use one of these firms as its U.S. agent?

No. FDA does not recommend or endorse any particular firm, organization, person, or company
to serve as a foreign facility’s U.S. agent. FDA is not affiliated with any firm offering its services
as a U.S. agent. As we stated in Question C.7.1 in this document, a U.S. agent may be an
individual, partnership, corporation, or association. The U.S. agent must have a place of business
or residence in the United States and be physically present in the United States.