Process To Request a Review of the Food and Drug Administration's Decision Not To Issue Certain Export Certificates for Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Extension of Comment Period

摘要

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of August 17, 2018. FDA requested comments on the draft guidance for industry and FDA staff entitled "Process To Request a Review of FDA's Decision Not To Issue Certain Export Certificates for Devices." The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.