FDA Issues Final Guidance on Review of Denial of Medical Device Export Certificates

Before certain medical devices can be lawfully exported from the United States, some countries require American companies to obtain a Certificate to Foreign Government (CFG). The FDA recently issued a final guidance titled “Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices,” which details how to seek review of the denial of a CFG request, as well as the reasons the FDA will deny such a request and how to rectify them.