FDA Guidance and Regulatory Science Tools for Computational Modeling in Medical Devices

Computational modeling and simulation (CM&S) can be used in medical device regulatory submissions to support device safety or effectiveness, and CM&S algorithms can be implemented in medical device software. This session discusses how the FDA Center for Devices and Radiological Health has developed guidance and regulatory science tools to assist manufacturers when assessing the credibility of their computational models. It covers traditional applications of CM&S, novel applications such as digital twins and in silico clinical trials, and the intersection of CM&S and AI.