Firms Must Be Proactive About Live-Case Demo Plans For IDE Devices – FDA Draft Guidance-thegraysheet: FDA wants sponsors of investigational device exemption applications to consider in advance whether the experimental device will be used in a live-case demonstration. On April 17, the agency released a draft guidance (PDF) listing the “important information that should be provided in an original investigational device exemption (IDE) application or a supplement to an IDE application when a sponsor anticipates including a live case presentation during a clinical investigation.” This guidance also provides advice to institutional review boards (IRBs) on factors to weigh when considering participation in an investigation that will include live case presentation
