FDA is applying the interactive review process to provide for and encourage informal communication between FDA and sponsors, and to facilitate timely completion of device reviews based on accurate and complete information. FDA issued a final guidance on the interactive review process in December 2007, and issued a revised edition in February 2008. The current edition of this guidance is available at: Interactive Review for Medical Device Submissions:
510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements.
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