Background

The Food and Drug Administration has made available a draft guidance (see attached) on the information that will be provided to a person whose request for a certificate to foreign government has been denied as well as the process for seeking review of such a denial. This draft guidance applies to medical devices manufactured in a registered establishment (i.e., FDA-approved, -cleared, or -exempted devices) that are exported from the U.S. Comments on this guidance, which is not final or in effect at this time, are due by Oct. 16.

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