This post was written by Erin Janssen.
On July 13, 2012, FDA issued draft guidance entitled “Medical Devices: The Pre-submission Program and Meetings with FDA Staff.” The new draft guidance outlines recommendations for sponsors and FDA staff and managers as well as expected timeframes for scheduling meetings. In addition, the guidance describes the procedures that CDRH and CBER intend to follow when manufacturers, their representatives, or application sponsors request a meeting with review staff, either as the preferred method of feedback in response to a pre-submission request, or to discuss to an existing regulatory submission. Finally, the guidance recommends how to prepare for meetings with FDA staff. When final, the new guidance document will supersede 1999 guidance entitled “Pre-IDE Program: Issues and Answers – Blue Book Memo D99-1.” Although comments may be submitted on any guidance at any time, interested parties should submit comments on the draft guidance by October 11, 2012.