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# Export Certificate Review Process Guidance
- URL: https://www.fdaweb.com/export-certificate-review-process-guidance/
- Published: 2019-11-13T12:00:00.000Z
- Updated: 2026-09-14T15:52:56.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145489

FDA has issued a guidance, *Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices*, to specify the process afforded to persons denied a Certificate to Foreign Government (CFG) for a medical device. The [document](https://www.fda.gov/media/115432/download?ref=fdaweb.com) describes the information CDRH and CBER, in collaboration with the Office of Regulatory Affairs, will provide to a person whose request for a CFG for a device is denied, and the process to seek review of the denial. The guidance applies to the process for persons denied CFGs requested for FDA-approved, cleared, or exempted devices that are exported from the U.S.