Zdrowie i gospodarka · 23/12/2021

FDA Releases Draft Guidance on Assessing Credibility of Computational Modeling and Simulation in Medical Device Submissions

The Food and Drug Administration (FDA) has released a draft guidance to improve the consistency and transparency of reviewing computational modeling evidence in medical device submissions, providing a risk-based framework for assessing the credibility of computational modeling and simulation (CM&S) used in these submissions.