With the use of computational modeling and simulation (CM&S) in medical device submissions on the rise, the US Food and Drug Administration (FDA) last month issued draft guidance detailing a risk-based framework for how to assess the credibility of such models.
Within the 36-page guidance, the agency lays out a nine-step generalized framework for assessing the credibility of computational modeling in a regulatory submission and provides additional details on the key concepts involved in the assessment.
While the guidance is based heavily on the FDA-recognized standard American Society of Mechanical Engineers (ASME) V&V 40 Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices, the framework it provides is more general.
“ASME V&V 40 assumes the ability to perform traditional validation activities, that is, comparison of model predictions against well-controlled validated experiments. For computational models used in regulatory submissions, there are often many different sources of evidence that are available to support model credibility,” such as clinical studies, model calibration results and population-level validation results…