Devices

Computational Modeling Credibility Guidance

FDA has published a draft guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions, to provide a risk-based framework that can be used in the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. The document defines credibility as trust in the predictive capability of a computational model used to support medical device submissions.

For this guidance, CM&S refers to first principles-based computational models and not statistical or data-driven models. The document is intended to help improve the consistency and transparency of CM&S evidence, to increase confidence in the use of CM&S in regulatory submissions, and to facilitate improved interpretation of CM&S evidence submitted in regulatory submissions reviewed by FDA staff.

In the guidance are Introduction, Background, Scope, Definitions, Generalized Framework for Assessing Credibility of Computational Modeling in a Regulatory Submission, Key Concepts for Assessing Credibility of Computational Modeling in a Regulatory Submission, and two appendices.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome