November 16, 2023

Today FDA published the Final Guidance “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions”. This document presents a general framework for risk-informed credibility assessment of computational modeling and is applicable to any physics-based or mechanistic (i.e., first principles-based) computational model, and any medical device regulatory application of these models. The guidance is closely related to the ASME V&V40 Standard. It was published in Draft form in December 2021 and has been revised and improved based on the numerous public comments received. Some key changes include clarification of the scope of the guidance and on the relationship to ASME V&V40, and revisions to the categorization of credibility evidence.

We will be presenting a webinar on the guidance on January 11th. Please see here for details.

We hope the guidance will be useful, whether in regulatory submissions to CDRH or otherwise. I know it would be beneficial to everyone in the community for there to be multiple, publicly available, examples of the guidance process being followed using real simulation results and experimental/clinical data. If you are interested in developing such a document using your model, please let me know and we could discuss collaboration.

Please share with anyone who might find this useful.

Thanks,

Pras  – on behalf of the OSEL Credibility of Computational Models Team: Kenny Aycock, Brent Craven and Pras Pathmanathan

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Pras Pathmanathan, PhD

Senior Scientist

Division of Biomedical Physics (DBP)
Office of Science and Engineering Laboratories (OSEL)
Center for Devices and Radiological Health (CDRH)