The FDA has issued a Draft Guidance for Industry and Food and Drug Administration Staff entitled “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions" that is open for comments.
This draft guidance document provides the FDA’s recommendations on a risk-based framework that can be used in the credibility assessment of computational modeling and simulation (CM&S) used in medical device regulatory submissions. This guidance applies to physics-based, mechanistic, or other first principles-based models. The recommendations are intended to promote consistency and facilitate efficient review of medical device submissions.
The Avicenna Alliance is willing to submit an answer by combining the feedback of its members, including the views of the academic side of the community, represented by the VPHi membership. If you're interested in contributing to the response, please get in touch with us, by sending an email to email@example.com.
The internal deadline to submit your comments is 4 March 2022.