FDA released its final guidance Feb. 14 titled “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with FDA Staff,” which provides an overview of the methods available for companies to seek feedback from FDA on device submissions reviewed by CDRH and the Center for Biologics Evaluation and Research. The guidance also provides recommendations on the type of information that should be included in a pre-submission package. Further, it lists the procedures CDRH and CBER staff should follow when meeting with manufacturers.
FDA issued the draft version last July. (See Also see "FDA Addresses Pre-Submission Meetings In Draft Guidance" - Medtech Insight, 16 July, 2012..) The agency says it received 17...