FDA released a new Draft Guidance document, “Assessing the Credibility of Computational Modeling and Simulation in Medical Device Regulatory Submissions”.
This Draft Guidance is the first general model credibility guidance to be released by the FDA’s Center for Devices and Radiological Health (CDRH), and follows the Guidance on Reporting of Computational Modeling in 2016 and ASME V&V40 Standard in 2018. The Draft Guidance provides a generalized framework, based on the V&V40 framework, for demonstrating model credibility in regulatory submissions, across a wide range of medical device applications. The Draft Guidance is the result of a large amount of internal work over recent years and I’m delighted to finally announce its release.
The document is available here. The public comment period is 60 days – closing date Feb 22nd, 2022