Federal Register Notice: FDA is making available a draft guidance entitled Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials: Draft Guidance for Institutional Review Boards, Industry, Investigators, and Food and Drug Administration Staff. It is intended, in part, to improve the quality of information submitted by sponsors in an IDE application or supplement to an IDE application and to ensure consistency in the review of those submissions. This draft guidance is intended to clarify FDA’s regulations and policies regarding live case presentations using unapproved or uncleared investigational devices in the U.S. To download this guidance, click here. To view this notice, click here.