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.
Related Articles
-
Change control plans for AI/ML, remanufacturing of devices and medical device shortages are among the guidances the FDA Center for Devices and Radiological Health (CDRH) is prioritizing in 2024. The agency is seeking stakeholder feedback on the list of guidance…
-
The guidance defines SLA and non-SLA laser products and provides information on how to request a variance or exemption from SLA class limits.
-
Companies must now electronically submit all FDA 510(k) submissions using the eSTAR platform. Dr. Dhriti Roy, vice president of Regulatory Affairs Transformation at Essenvia and faculty at Oxford University’s MedTech innovation platform, highlights the benefits and challenges of eSTAR, as…
-
“Content of Premarket Submissions for Device Software Functions” covers recommended documentation sponsors should include in premarket submissions for FDA’s evaluation of safety and effectiveness of device software functions. The agency is hosting a webinar for industry on July 20 to…
