Navigating FDA Export Certificates: Timelines, Fees, and 2024 Updates

Medical Device Global Market Access · Sep 8, 2025 · 2m

This episode demystifies the process of obtaining a Certificate to Foreign Government (CFG), also known as a Free Sale Certificate (FSC), from the US FDA. We cover the official timelines for issuance, the specific government fees you can expect to pay, and the critical procedural shift to electronic-only certificates that took effect in early 2024. Learn the essential details to plan your international market submissions effectively and avoid costly delays. • What is the official FDA term for a “Free Sale Certificate”? • How long does the FDA have to issue an export certificate once…