Local modeling

Assessing the Credibility of Computer Modeling and Simulation in Medical Device Submissions

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All written comments should be identified by the file number of this document: FDA-2021-D-0980


File number:
FDA-2021-D-0980
Issued by:

Guidance Dissemination Office

Center for Devices and Radiation Health

This draft guidance document provides FDA recommendations on a risk-based framework that can be used in the credibility assessment of computer modeling and simulation (CM&S) used in medical device regulatory submissions. . These tips apply 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.