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Reporting of Computational Modeling and Simulation Studies in Medical Device Submissions

This guidance provides recommendations for formatting, organizing, and content of reports for computational modeling and simulation (CM&S) studies used to support medical device submissions. It covers how to report CM&S studies and their outcomes when used to evaluate device safety and effectiveness, but does not address whether CM&S tools may be considered medical devices themselves. The guidance does not establish the amount or type of verification and validation needed, nor does it address how to conduct CM&S studies. It focuses solely on reporting guidelines and highlights common modeling issues.

  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

  • 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

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 summary file ID: ae5b978662d1d8e33afc27c8ab0685d5
This post is licensed under CC BY 4.0 by the author.