Business · 14/11/2019

FDA Issues Final Guidance on Requesting Review of Export Certificate Denial for Devices

The Food and Drug Administration (FDA) has released a final guidance document outlining the process for requesting a review of a denied Certificate to Foreign Government (CFG) for a device, in compliance with the FDA Reauthorization Act of 2017 (FDARA). The guidance provides information on the review process and procedures for seeking a review of a denied CFG request.