FDA issues final guidance: Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions

On Thursday, the FDA issued this final guidance: Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions. Medical device manufacturers are using computational modeling and simulation (CM&S), also called in silico methods, increasingly to help streamline device development and premarket evaluation.

The final guidance: 

• Provides a framework that manufacturers can use to show that computational models used to support regulatory submissions are credible. 
• Intends to help improve the consistency and transparency of FDA reviews of regulatory submissions that include CM&S methods.
• Applies to CM&S models that are physics-based or mechanistic. It does not apply to standalone machine learning or artificial intelligence-based models.
• Provides a framework for demonstrating CM&S credibility through key concepts from the the FDA-recognized standard American Society of Mechanical Engineers (ASME) V&V 40-2018 Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices.

On January 11, 2024, the FDA is hosting a webinar for industry and others interested in learning more about the guidance.