Assessing the Credibility of Computational Modeling and Simulation in Medical Device submissions

Draft guidance issued by FDA


Few days ago the FDA distributed the draft document that, when finalized, would guide industry and FDA staff in the credibility assessment of computational modeling and simulation (CM&S). At the moment the draft is not for implementation.


The use of in silico methods in regulatory submissions is rapidly increasing and in medical device regulatory submissions computational models can be used in many ways, e.g. to perform in silico device testing, in silico clinical trials, or implemented as device software functions, or as CM&S-based qualified tools.

In all cases, there is a need to demonstrate that the computational model is credible, where credibility is defined as trust in the predictive capability of a computational model, used to support medical device premarket submission or qualification of Medical Device Development Tools.


The news is particularly relevant for our consortium that is putting considerable effort in the validation of the UISS-TB computational modeling framework (used to reproduce the human immune system and the interactions with tuberculosis disease and vaccine), and in the in silico augmented clinical trial model.


The FDA document aims at providing a more general framework for demonstrating CM&S credibility in medical device regulatory submissions by taking into account key concepts from the recognized standard by the American Society of Mechanical Engineers (ASME) V&V 40 Assessing Credibility of Computational Modeling through Verification and Validation, and incorporating other non-traditional evidence.


When finalized, the guidance will help improve the consistency and transparency of the review of CM&S evidence, ultimately increasing the confidence in the use of CM&S in regulatory submissions.


The document is available for download on the FDA website at this link


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