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Clinical Evaluation of Software as a Medical Device (SaMD)

This guidance focuses on the clinical evaluation activities needed for Software as a Medical Device (SaMD), providing a harmonized approach for demonstrating the clinical association, analytical validation, and clinical validation of SaMD. It aims to establish a common understanding of clinical evaluation principles for demonstrating safety, effectiveness and performance of SaMD.

  1. Establish clear SaMD definition statement and risk categorization
  2. Develop clinical evaluation plan covering:
    • Valid clinical association
    • Analytical validation
    • Clinical validation
  3. Generate appropriate clinical evidence based on risk category
  4. Implement independent review process for higher risk SaMD
  5. Establish continuous monitoring system for real world performance
  6. Develop post-market surveillance plan
  7. Maintain documentation of clinical evaluation process
  8. Implement change management process for SaMD modifications
  9. Ensure appropriate labeling and user instructions
  10. Establish process for ongoing assessment of clinical evidence

Key Considerations

Clinical testing

  • Clinical evaluation should be an iterative and continuous process as part of the quality management system
  • Clinical validation measures the ability of SaMD to yield clinically meaningful outputs
  • Level of clinical evaluation should be commensurate with the risk posed by the SaMD
  • Clinical validation can be demonstrated through existing data, extrapolated data, or new clinical data

Non-clinical testing

  • Analytical validation measures the ability to accurately and reliably generate intended technical output from input data
  • Verification and validation activities should be conducted as part of quality management system
  • Evidence can be generated through use of curated databases or previously collected patient data

Human Factors

  • Clinical usability and user interface considerations must be evaluated
  • Safety considerations for device users, use environments and user interfaces must be assessed

Software

  • Software verification and validation must be conducted
  • Continuous monitoring of software performance should be implemented
  • Software changes must be managed through appropriate processes

Labelling

  • Clear definition statement about intended use must be provided
  • Limitations of the SaMD relevant to clinical performance must be identified
  • Instructions for use must be appropriate for intended users

Safety

  • Safety data collection and monitoring required
  • Real world performance data should be collected to monitor safety
  • Risk assessment should be considered when conducting clinical evaluation

Other considerations

  • ISO 14155:2011: Clinical investigation of medical devices for human subjects - Good clinical practice
  • ISO 14971:2007: Application of risk management to medical devices
  • ISO 62304/A1:2015: Medical device software – Software life-cycle processes
  • IEC 62366-1:2015: Medical Devices – Part 1: Application of usability engineering to medical devices
  • ISO 82304-1:2016: Health software – Part 1: General requirements for product safety

Original guidance

  • Clinical Evaluation of Software as a Medical Device (SaMD)
  • HTML / PDF
  • Issue date: 2017-12-08
  • Last changed date: 2021-03-18
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, International
  • ReguVirta summary file ID: a7d7da9e464fd99b7718155c7fe91ca4
This post is licensed under CC BY 4.0 by the author.