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Medical Devices / Regulatory Affairs

FDA Issues Draft Guidance on Export Certificates for Devices

Aug. 27, 2018
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The FDA released a new draft guidance on its review process for a Certificate to Foreign Government (CFG) and listed the reasons it may deny a request.

Some reasons for a denial include an injunction or seizure action under the Food, Drug and Cosmetic Act, a Class I or Class II recall, or if an establishment violates good manufacturing practices.

In case of a denial, the agency will notify the requestor in writing and identify the finding that serves as the basis for the denial. In cases where the denial is specifically because of a facility’s noncompliance with GMPs, the agency will also provide a “substantive summary” of the GMP failures identified.

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