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.
What You Need to Know? 👇
What are the key components that define a physiologic closed-loop controlled (PCLC) medical device?
A PCLC device consists of three essential components: physiologic-measuring sensors that monitor patient variables, control algorithms that process feedback and make automated decisions, and actuators that deliver or remove energy or substances based on the algorithm’s output.
How should manufacturers address automation-related use errors in PCLC device design?
Manufacturers must consider automation bias, complacency, loss of situational awareness, and skill degradation. Design should include transparent user interfaces, appropriate training programs, and human factors testing to evaluate user responses during both normal operation and fault conditions.
What verification and validation activities are required for PCLC devices under FDA guidance?
Verification must demonstrate sensors, actuators, and control algorithms meet specifications. Validation should confirm the device performs safely across patient variability, disturbances, and worst-case conditions. This includes testing fallback modes, user interfaces, and system integration performance.
When should computational modeling be used in PCLC device development and testing?
Computational models can supplement or replace animal/clinical studies when properly validated. They’re particularly useful for stress-testing across wide scenarios, evaluating patient variability, and identifying unsafe conditions early in development while reducing costs and improving efficiency.
What specific labeling requirements apply to PCLC devices beyond standard medical device labeling?
Labeling must include detailed descriptions of all components, operating modes, entrance/exit criteria, fallback modes, user responsibilities, alarm conditions, and validated operating conditions. It should provide sufficient information for users to understand device limitations and appropriate responses.
How do risk management considerations differ for PCLC devices compared to traditional medical devices?
PCLC devices require analysis of patient-related hazards (inter/intra-patient variability), device-related hazards (component failures, communication issues), and use-related hazards (automation bias, reduced situational awareness). Risk management must address the complex interactions between automated systems and human operators.
What You Need to Do 👇
Recommended Actions
- Perform comprehensive risk analysis considering patient, device and use-related hazards
- Define and validate system specifications including:
- Control algorithm performance
- Sensor and actuator requirements
- Safety features and fallback modes
- User interface design
- Develop verification and validation plan including:
- Non-clinical testing strategy
- Human factors validation approach
- Performance testing across conditions
- Create documentation package including:
- Device description and specifications
- Risk management file
- V&V test results
- Labeling and training materials
- Consider submitting Q-submission to FDA to obtain feedback on:
- Testing strategies
- Clinical study designs
- Use of computational models
- 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
- Consider system integration aspects
- Address interoperability if applicable
- Define user interface requirements
- Consider environmental factors
Relevant Guidances 🔗
- Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions
- Content of Premarket Submissions for Device Software Functions
- Applying Human Factors Engineering and Usability Engineering to Medical Devices
- Cybersecurity in Medical Devices: Design, Implementation, and Premarket Submissions
- Design Considerations and Recommendations for Interoperable Medical Devices
Related references and norms 📂
- 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 ID: df32254dd474f28f629c3e8397bd40bd