Devices

Device Computational Modeling Credibility Guide

FDA has published a guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions, to assist the medical device industry in assessing the credibility of computational modeling used to support medical device PMA, HDE, and IDE applications, 510(k)s, and de novo classification requests, or qualification of Medical Device Development Tools. In the context of the document, FDA says, credibility is defined as the trust in the predictive capability of a computational model.

The guidance is intended to help improve the consistency and transparency of the review of computational modeling and simulation to increase confidence in the use of those techniques in regulatory submissions, and to facilitate improved interpretation of the credibility evidence in submissions reviewed by FDA staff, the agency says.

The guidance includes an 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