Resources

This page lists resources on computational modeling and simulation for medical device applications developed in recent years. It is aimed at anyone seeking to understand this landscape, whether from academia, other healthcare/engineering domains, or the medical device field itself. One goal is to communicate documents that community members may not be aware of. Journal publications and device-/field-specific resources are excluded. It will be updated periodically.

As a starting point, consider providing this page to your preferred AI assistant and asking how these documents could be useful to you. (The usual caveats about AI use apply).

This is a personal curation, not an official FDA or CDRH resource list. Views are my own and do not represent FDA or HHS. For official FDA positions, refer to FDA.gov directly.

^★Led   ^♦Contributor   ^†Provided feedback

Standards

• ASME V&V 40 - Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices^♦(2018)
• ASME VVUQ 40.1^† (2026) - provides an example of following ASME V&V40.

FDA Guidance and Tools

• Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions^★ (2023)
  • FDA Webinar on Credibility Guidance (“Speciality Topics” section, “Regulatory Science Tools” sub-section)
• Reporting Computational Modeling Studies in Medical Device Submissions^♦ (2016)
• CDRH Medical Device Development Tools - some MDDTs are CM&S-based
• OSEL Regulatory Science Tools - filter by “Computer Model” for CM&S RSTs
  • My RSTs: patient-specific modeling workflow, electrophysiology model verification, epidemiological model validation, among others. If an RST is used in a regulatory submission, please cite as per instructions
  • see also Publications - several papers are not RSTs but may still be useful, especially in silico clinical trial or patient-specific models publications

Books

• Towards Good Simulation Practice^♦ (2024) - an open access book discussing possible good simulation practices.
• ASME Book on CM&S for Medical Devices^♦ (forthcoming)

White Papers and Reports

• FDA, Successes and Opportunities in Modeling & Simulation for FDA^★ (2022) - provides an overview of how CM&S is relevant to FDA, across all Centers
• Reagan-Udall Foundation, Regulatory Science Accelerator Computational Modeling & Simulation in FDA-Regulated Products (2023-24) - multiple reports
• MDIC, Landscape Report & Industry Survey on the Use of Computational Modeling & Simulation in Medical Device Development (2023)
• National Academies, Foundational Research Gaps and Future Directions for Digital Twins (2024)
• InSilicoUK, Cross-regulator workshop report (2024)
• KPMG/InSilicoUK In Silico Regulatory Evidence Utilisation within the Life Science Sector (2024)
• InSilicoUK, Unlocking the power of computational modelling and simulation across the product lifecycle in life sciences: A UK Landscape Report (2023)

Select AI/ML Resources

• FDA, Digital Health and Artificial Intelligence Glossary
• FDA, AI/ML-Enabled Medical Device List
• FDA, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions (2024)
• FDA, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (2025; Draft Guidance)
• FDA, Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products^† (2025; Draft Guidance)
• FDA, Health Canada, MHRA, Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles (2024)
• IMDRF, Good Machine Learning Practice for Medical Device Development: Guiding Principles (2025)