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Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices (from Catapult’s regulatory round-up – November 2023)

The FDA has reissued a guidance that describes the information that the Center for Devices and Radiological Health (CDRH), 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 (Certificate to Foreign Government) or CFG-NE    (Certificate to Foreign Government for Device Not Exported) for a device is denied, and the process for seeking review of such a denial. Section 801(e)(4)(A)(ii) of the FD&C Act applies to export certificates for devices, as well as other FDA-regulated products, that are exported from the United States. Such FDA export certifications provide information on a product and/or establishment’s regulatory or marketing status, based on available information at the time FDA issues the certification.

Published on the 5th of december 2023. Read Catapult’s full regulatory round-up here.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (21 mai 2024). Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices (from Catapult’s regulatory round-up – November 2023). ELSIBI. Consulté le 18 février 2025 à l’adresse https://doi.org/10.58079/11p05


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