https://www.fda.gov/regulatory-information/search-fda-guidance-documents/process-request-review-fdas-decision-not-issue-certain-export-certificates-devices?utm_campaign=2019-11-13%20FDA%20Issues%20Final%20Guidance%20on%20Export%20Certificates%20for%20Medical%20Devices&utm_medium=email&utm_source=Eloqua

FDA Issues Final Guidance on Export Certificates for Medical Devices

Today, the U.S. Food and Drug Administration (FDA) issued the final guidance: Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices to explain why the FDA may deny issuing a Certificate to Foreign Government (CFG) to medical device manufacturers, and what steps manufacturers can take to request a review of the denial.

Read the Guidance Facts about the final guidance  This final guidance: Provides transparency to the medical device industry on the FDA’s decision-making for a Certificate to Foreign Government denial. Describes the information that the FDA will provide to a firm whose request for a Certificate to Foreign Government for a device is denied. Describes the process to request a review of the denial. Explains how to contact FDA staff if there are questions.   Questions?  If you have questions about this final guidance, contact the Division of Industry and Consumer Education.