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.
Recommended Actions
- Establish a standardized CM&S report template following the guidance outline
- Document verification activities:
- Software quality assurance
- Numerical code verification
- Calculation verification
- Implement validation process:
- Select appropriate comparator (bench, in vivo, literature)
- Document validation methodology
- Compare and analyze results
- Create detailed documentation of:
- System configuration and geometry
- Material properties and governing equations
- Boundary conditions and discretization
- Numerical implementation
- Perform and document:
- Sensitivity analyses for critical parameters
- Uncertainty analyses
- Convergence studies
- Prepare comprehensive results presentation:
- Quantitative results with clear labels
- Multiple formats (tables, graphs)
- Critical values highlighted
- Document limitations and assumptions:
- Clear rationale for simplifications
- Impact on results
- Uncertainties discussion
- 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
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
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
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