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Technical Considerations for Physiologic Closed-Loop Control Medical Devices

This guidance addresses technical considerations for medical devices employing Physiologic Closed-Loop Control (PCLC) technology, which automatically adjusts or maintains physiologic variables through delivery/removal of energy or articles using feedback from physiologic sensors. The guidance applies to premarket submissions (510(k)s, De Novo requests, PMAs, HDEs) but excludes specific considerations for active implantable devices and machine learning aspects.

  1. Perform comprehensive risk analysis considering patient, device and use-related hazards
  2. Define and validate system specifications including:
    • Control algorithm performance
    • Sensor and actuator requirements
    • Safety features and fallback modes
    • User interface design
  3. Develop verification and validation plan including:
    • Non-clinical testing strategy
    • Human factors validation approach
    • Performance testing across conditions
  4. Create documentation package including:
    • Device description and specifications
    • Risk management file
    • V&V test results
    • Labeling and training materials
  5. Consider submitting Q-submission to FDA to obtain feedback on:
    • Testing strategies
    • Clinical study designs
    • Use of computational models
  6. Implement quality system controls for:
    • Design changes
    • Component compatibility
    • Post-market surveillance

Key Considerations

Non-clinical testing

  • Perform bench, computational, animal testing as appropriate based on device risks
  • For animal testing: justify model selection, identify physiologic differences vs humans
  • For computational models: validate model credibility, perform uncertainty quantification
  • Consider hardware-in-the-loop testing with computational patient models
  • Verify and validate system performance across expected conditions and disturbances

Human Factors

  • Conduct testing in simulated and/or actual use environments
  • Evaluate automation-related hazards like complacency and automation bias
  • Validate that users can recognize and respond to unsafe conditions
  • Develop appropriate training programs covering device operation and limitations
  • Consider simulation-based training for automation interaction

Software

  • Verify control algorithms meet specifications
  • Validate software safety features and fallback modes
  • Test software across all modes and parameter combinations
  • Consider software aspects of system integration

Cybersecurity

  • Consider cybersecurity threats and vulnerabilities
  • Implement appropriate security controls
  • Address security in risk management

Labeling

  • Include IEC 60601-1-10 required information
  • Describe system components, specifications and limitations
  • Detail operating conditions, modes and user responsibilities
  • Provide instructions for programming and maintenance
  • Include data logging and safety feature information

Safety

  • Implement appropriate fallback modes
  • Include system safety features and alarms
  • Define entrance/exit criteria for modes
  • Constrain delivered energy/article within safe limits
  • Maintain data logging capabilities

Other considerations

  • IEC 60601-1-10: Medical electrical equipment - Requirements for physiologic closed-loop controllers
  • IEC 60601-1-8: Requirements for alarm systems in medical equipment
  • ISO 14971: Application of risk management to medical devices
  • ANSI/AAMI/UL 2800-1: Standard for Safety for Medical Device Interoperability
  • ANSI/AAMI 2700-1: Requirements for integrated clinical environment
  • ASME V&V 40: Verification and Validation for Medical Devices

Original guidance

  • Technical Considerations for Physiologic Closed-Loop Control Medical Devices
  • HTML / PDF
  • Issue date: 2023-09-29
  • Last changed date: 2023-10-06
  • Status: FINAL
  • Official FDA topics: Medical Devices, Digital Health, Premarket, Combination Products, Clinical - Medical
  • ReguVirta summary file ID: df32254dd474f28f629c3e8397bd40bd
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