FDA Publishes Final Guidance on Assessing Credibility of CM&S in Device Submissions
FDA Publishes Final Guidance on Assessing Credibility of CM&S in Device Submissions The FDA has published its final guidance Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions. The final guidance provides a framework that manufacturers can use to show that computational models used to support regulatory submissions are credible. It …
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