Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions
FDA Law Blog
JANUARY 2, 2022
Lenz, Principal Medical Device Regulation Expert — On December 23, 2021, CDRH released as a draft guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions (Draft Guidance). NIH, Computational Modeling (May 2020). Similar techniques can be used to model complex biological systems.
Let's personalize your content