FDA guidance on computational modeling for medical device submissions
In November 2023 FDA published guidance on “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.” Computational modeling and simulation can be used in a variety of ways in medical device applications, including to perform in silico device testing or as part of software embedded in a device. This guidance provides a risk-informed framework for credibility assessment of computational modeling and simulation used in medical device regulatory submissions. The guidance is intended to promote consistency and facilitate efficient review of medical device submissions, to increase confidence in the use of computational modeling and simulation in regulatory submissions, and to facilitate improved interpretation of computational modeling and simulation credibility evidence submitted in regulatory submissions. The guidance will be discussed in a presentation at the January 2024 ICCVAM Communities of Practice webinar.