USA – Guidance : Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices

The FDA is issuing this guidance document to comply with section 704 of the FDA Reauthorization Act of 2017 (FDARA) (Public Law 115-52), which amended section 801(e)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to specify the process afforded to persons denied a Certificate to Foreign Government (CFG) for a device.

This guidance describes the information that the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), in collaboration with the Office of Regulatory Affairs (ORA), will provide to a person whose request for a CFG for a device is denied, and the process for seeking review of such a denial…