FDA's Gatekeeper: A Guide to the U.S. Agent for Foreign MedTech Companies

Medical Device Global Market Access · Oct 5, 2025 · 2m

This episode breaks down the mandatory FDA requirement for foreign medical device manufacturers to appoint a U.S. Agent. We explore the specific roles, responsibilities, and qualifications of a U.S. Agent, clarifying their function as the essential communication link between your company and the FDA. Learn the key differences between a U.S. Agent and an Official Correspondent and understand the strategic considerations when choosing your representative to ensure smooth entry into the U.S. market. Key Questions: • What is the primary role of an FDA U.S. Agent? • Is appointing a U.S. Agent an…