Yes. A foreign facility may change its U.S. agent at any time. Under 21 CFR 1.234(a), updates
to required information, including the U.S. agent designation by foreign facilities, must be made
within 60 calendar days of the change. At this time, updates may be submitted electronically at
https://www.access.fda.gov . If you do not have access to the Internet, you also may update the
U.S. agent information through the paper system, as explained in section II.E.3 in this document.
After January 4, 2020, you must submit updates electronically, unless FDA has granted a waiver
under 21 CFR 1.245 (see also section II.N of this document for a discussion on waivers).
