Final Guidance on Live Case Presentations During IDE Clinical Trials

Today, the U.S. Food and Drug Administration (FDA) issued the final guidance Live Case Presentations During Investigational Device Exemption (IDE) Clinical Trials.  A live case presentation is a live or pre-recorded broadcast of a surgical procedure or procedure done through the skin (percutaneous).  This presentation is typically narrated by the person performing the procedure or a commentator other than the person performing the procedure.  In some cases, expert panel or audience interaction may occur.

Read the Final Guidance  Facts about this final guidance This final guidance provides: measures recommended to ensure adequate human subject protection, follow-up, and reporting for live case presentations; factors for IRBs, industry, clinical investigators, and FDA staff to consider when evaluating the appropriateness of a live case presentation within a clinical investigation; and important information about a live case presentation that should be submitted to the FDA when requesting approval to conduct a live case presentation within a clinical investigation under an IDE application.