Updated document issued 2/28/2008 is at the link provided.
Congress reauthorized Medical Device User Fee Modernization Act in the Food and Drug Administration Amendments Act of 2007 effective October 1, 2007 that authorizes FDA to continue to collect user fees and established the framework for a more aggressive set of performance goals. To meet these goals, FDA is implementing a formalized interactive review process with a primary focus on resolving minor issues informally for specific medical device premaket submissions: 510(k)s, PMAs, PMA supplements, BLAs and BLA supplements. Although the primary focus of interactive review between FDA and the applicant is on resolving minor issues informally, when appropriate FDA should also informally communicate major issues to the applicant. Many aspects of this guidance document informal practices that have been used at reviewer discretion in the past. The full guidance is at the link provided.