FDA details recommendations for live case presentations during medical device clinical trials in final guidance

This month, the U.S. Food and Drug Administration (FDA or the agency) issued a final guidance on live case presentations as part of clinical trials conducted under an approved (or conditionally approved) investigational device exemption (IDE).

A live case presentation involves treatment of a human subject with an investigational device and is a live or prerecorded broadcast of that investigational surgical or percutaneous procedure, typically narrated. To fully leverage live case presentations, sponsors should engage with FDA early in development, even where specific details about the live case presentation may not yet be known. The final guidance provides a viable pathway for sponsors to utilize this important study recruitment tool, and may signal FDA's acceptance of some level of non-promotional scientific exchange by medical device clinical trial sponsors. As described below, FDA intends to focus its review on the risk analysis, the informed consent, and the impact of live case presentations on the study design and data analysis, rather than on whether the live case demonstration amounts to promotion of the investigational device in violation of the Federal Food, Drug, and Cosmetic Act.

Read More: FDA details recommendations for live case presentations during medical device clinical trials in final guidance


Download PDF Share Back To Listing
Loading data