FDA Seeks More Comments on Draft Guidance on Denial of Medical Device Export Certificates

The Food and Drug Administration is allowing more time for comments on a recently issued draft guidance document on agency decisions not to issue export certificates for medical devices. FDA can refuse to issue an export certificate in cases in which there is an ongoing injunction proceeding, seizure action or class I or II recall associated with a device, or the device establishment is not in compliance with FDA quality system regulations, it said. Exporters denied a certificate can request an FDA review of additional information. Facilities that have received an FDA inspectional observations form can still obtain export certificates by submitting a plan of correction to the relevant FDA office, the draft guidance said. An extra 30 days are available to submit comments, which are now due Nov. 15.