FDA has developed a draft guidance document that provides a risk-based framework to assist in the credibility assessment of computational modeling and simulation (CM&S), defined as trust in the predictive capability of a computational model, used to support medical device premarket submissions.
The use of CM&S (also referred to as in silico methods) in regulatory submissions is well-established and rapidly increasing and there are several ways it can potentially be used to support it, including but not limited to:
- In Silico Device Testing
- CM&S used within medical device software
- In Silico Clinical Trials
- CM&S-based qualified tools
As interest in medical device-related CM&S grows, it is important to both monitor current usage and identify areas where CM&S might be more broadly leveraged to enhance public health.
There is a need to demonstrate that the computational model is credible and even if regulatory submissions often lack a clear rationale for why models can be considered credible for the context of use, methodologies for model credibility assessment have been established in the scientific literature and continue to evolve. Demonstrating model credibility involves various activities that include verification, validation, uncertainty quantification, applicability analysis, as well as adequacy assessment.
This document is remarkably important to the In Silico World consortium since we will put great effort into the validation of many different in silico trials solutions that some of our partners are developing.
The purpose of the FDA’s guidance document is to provide a general framework for assessing CM&S credibility in medical device regulatory submissions that incorporates both traditional Verification and Validation (V&V) evidence and/or other types of supporting data. It is also 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.
Access the full document at the following link.