The FDA has published its final guidance Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions. The final guidance provides a framework that manufacturers can use to show that computational models used to support regulatory submissions are credible. It is intended to help improve the consistency and transparency of FDA reviews of regulatory submissions that include CM&S methods and applies to CM&S models that are physics-based or mechanistic. It does not apply to standalone machine learning or artificial intelligence-based models.
The document provides recommendations for using 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 to show CM&S credibility.
The FDA will host a webinar on January 11, 2024, for industry and others interested in learning more about the guidance.
Download the final guidance here.