Appealing a denial of a drug/medical device export certificate: FDA final guidance

Drug and medical device manufacturers seeking to export a product from the United States may need to obtain from the U.S. Food and Drug Administration (FDA) a Certificate to Foreign Government (CFG) in order to satisfy the requirements of the importing jurisdiction. Newly released final guidance explains on what basis the agency will deny an export certificate request and outlines the procedure for appealing an adverse decision.

On 14 November 2019 FDA published the final guidance document, "Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices" (final guidance), which updates a draft version released 17 August 2018. The final guidance clarifies and details the agency's decision-making and provision of information for a denial of a CFG. The guidance also establishes a process for seeking a review of a denial.

Read More: Appealing a denial of a drug/medical device export certificate: FDA final guidance


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