U.S. FDA Agent Service

The German American Chamber of Commerce, Inc. in New York acts as U.S. Agent for German companies towards the U.S. Food and Drug Administration (FDA).

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act/BTA) requires all domestic and foreign food facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States to register with the FDA. This requirement also applies to companies that export medical devices, cosmetics and drugs to the U.S.

For purposes of the registration, a foreign facility must designate a U.S. Agent who has a permanent physical presence in the United States. Therefore the German American Chamber of Commerce, Inc. in New York provides a U.S. FDA Agent Service for German companies. Please visit the German version of this website for further information.

Contact

Susanne Gellert, LL.M.
Vice President
Director Legal & Consulting Department
Rechtsanwältin | Attorney at Law

+1 (212) 974-8846
e-mail