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US: FDA outlines framework for assessing credibility by computational modeling and simulation

2022/01/05  US FDA

FDA has developed this draft guidance document to assist industry and FDA staff in assessing the credibility of computational modeling, defined as trust in the predictive capability of a computational model, used to support medical device premarket submissions (i.e., Premarket Approval (PMA) Applications, Humanitarian Device Exemptions (HDEs), Investigational Device Applications (IDEs), Premarket Notifications (510(k)s), and De Novo requests ) or qualification of Medical Device Development Tools (MDDTs); (refer to FDA’s guidance titled “Qualification of Medical Device Development Tools”). Computational models can be used in a variety of ways in medical device regulatory submissions, including to perform ‘in silico’ device testing or to influence algorithms within software embedded in a device. Regulatory submissions often lack a clear rationale for why models can be considered credible for the context of use (COU). This guidance provides 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. For the purposes of this guidance, CM&S refers to first principles-based (e.g., physics-based or mechanistic) computational models, and not statistical or data-driven (e.g., machine learning or artificial intelligence) models. This guidance is intended to help improve the consistency and transparency of the review 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. Throughout this guidance, the terms “FDA,” “the Agency,” “we,” and “us” refer to the Food and Drug Administration and the terms “you” and “yours” refer to medical device manufacturers.

For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database.

The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law. FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidance means that something is suggested or recommended, but not required.

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