Reporting of Computational Modeling and Simulation Studies in Medical Device Submissions

What You Need to Know? 👇

What are the key components required in a computational modeling and simulation (CM&S) report for medical device submissions?

A CM&S report must include 15 sections: Executive Summary, Background/Introduction, Code Verification, System Configuration, Governing Equations/Constitutive Laws, System Properties, System Conditions, System Discretization, Numerical Implementation, Validation, Results, Discussion, Limitations, Conclusions, and References. Each section requires specific details about assumptions, simplifications, and rationale.

How should validation be approached for computational models in medical device regulatory submissions?

Validation requires comparing computational model results with experimental data (in vivo, ex vivo, or in vitro comparators). You must describe the validation method, provide quantitative comparisons of quantities of interest, discuss agreement levels, and explain why the validation approach is appropriate for your specific context of use.

What level of detail is needed for code verification in CM&S studies?

Code verification must include software quality assurance (SQA) and numerical code verification (NCV). Describe verification activities, reference available documentation from software developers, and provide rationale for code applicability to your computational domain. Include justification for numerical settings whether default or modified.

How should mesh refinement and convergence studies be documented?

Document the mesh refinement methodology, report criteria used to determine adequate discretization, provide representative images of discretization in critical areas, and demonstrate that quantities of interest are independent of element size. Include convergence analysis showing solution stability as discretization is refined.

What specific information is required for system properties in different CM&S modalities?

Requirements vary by modality: fluid dynamics needs viscosity and density; solid mechanics requires elastic modulus and material properties; electromagnetics needs conductivity and permittivity; ultrasound requires acoustic properties; heat transfer needs thermal conductivity and capacity. Always identify sources and provide rationale for property selection.

How should limitations and assumptions be addressed in CM&S reports?

Systematically document all assumptions and simplifications made throughout the study. Explain how these might affect computational model output, result interpretation, and relevance to context of use. If conclusions depend significantly on assumptions, perform sensitivity analyses on associated parameters to assess their impact.

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What You Need to Do 👇

Recommended Actions

1. Establish a standardized CM&S report template following the guidance outline
2. Document verification activities:
   • Software quality assurance
   • Numerical code verification
   • Calculation verification
3. Implement validation process:
   • Select appropriate comparator (bench, in vivo, literature)
   • Document validation methodology
   • Compare and analyze results
4. Create detailed documentation of:
   • System configuration and geometry
   • Material properties and governing equations
   • Boundary conditions and discretization
   • Numerical implementation
5. Perform and document:
   • Sensitivity analyses for critical parameters
   • Uncertainty analyses
   • Convergence studies
6. Prepare comprehensive results presentation:
   • Quantitative results with clear labels
   • Multiple formats (tables, graphs)
   • Critical values highlighted
7. Document limitations and assumptions:
   • Clear rationale for simplifications
   • Impact on results
   • Uncertainties discussion
8. Link conclusions to regulatory objectives:
   • Address context of use
   • Support safety/effectiveness claims
   • Highlight key findings

Key Considerations

Non-clinical testing

• CM&S studies should be reported with an executive summary including context of use, scope, type of analysis, conclusions and keywords
• Code verification through software quality assurance and numerical code verification must be documented
• System configuration, governing equations, properties, conditions and discretization must be described in detail
• Validation approach and results must be documented with comparator data
• Results must be presented quantitatively with sufficient detail

Software

• Software tools used (commercial, open source, or custom) must be identified
• Code verification activities must be documented
• Numerical implementation methodology must be described
• Solver parameters and convergence criteria must be specified

Safety

• Safety factors and analysis must be reported when relevant
• Critical stresses, strains, forces or displacements must be documented
• Limitations that could affect safety must be discussed

Other considerations

• Assumptions and simplifications must be documented with rationale
• Sensitivity analyses should be performed for critical parameters
• Uncertainties must be discussed and their impact on results analyzed
• Conclusions must relate to regulatory objectives

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Relevant Guidances 🔗

• Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions
• Technical Considerations for Additive Manufactured Medical Devices
• Design Controls for Medical Device Manufacturers

Related references and norms 📂

• ASME V&V 10-1-2012: Verification & Validation Guide
• ASME V&V 20-2009: Verification & Validation Standard
• IEEE 1597.1-2008: Standard for Validation of Computational Electromagnetics Computer Modeling and Simulations

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Original guidance

• Reporting of Computational Modeling and Simulation Studies in Medical Device Submissions
• HTML / PDF
• Issue date: 2016-09-21
• Last changed date: 2019-03-17
• Status: FINAL
• Official FDA topics: Medical Devices, Premarket Approval (PMA), 510(k), Premarket, Investigational Device Exemption (IDE)
• ReguVirta ID: ae5b978662d1d8e33afc27c8ab0685d5