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Content of Premarket Submissions and Lifecycle Management for Artificial Intelligence and Machine Learning-Enabled Medical Devices (DRAFT)

This guidance provides recommendations for lifecycle management and marketing submission content for AI-enabled device software functions. It covers documentation requirements for premarket submissions (510(k), De Novo, PMA, HDE, BLA) and lifecycle considerations for AI-enabled devices, including transparency and bias control throughout the total product lifecycle (TPLC). The guidance applies to devices that include one or more AI-enabled device software functions to achieve their intended purpose.

This is a draft guidance. Not for implementation.

  1. Develop comprehensive documentation of AI model development, validation and risk management
  2. Implement rigorous data management practices including data quality controls and bias assessment
  3. Establish performance monitoring plan for post-market surveillance
  4. Design transparent user interfaces and labeling that clearly communicate device capabilities and limitations
  5. Conduct appropriate clinical and non-clinical validation studies with independent test datasets
  6. Implement cybersecurity controls specific to AI-enabled devices
  7. Create detailed labeling including model characteristics, performance metrics and limitations
  8. Establish change management procedures for software updates
  9. Consider transparency and bias throughout device lifecycle
  10. Engage early with FDA through Q-Submission program for novel approaches or technologies

Key Considerations

Clinical testing

  • Clinical validation studies should demonstrate device performance across intended use population and subgroups
  • Study protocols and statistical analysis plans should be pre-specified
  • Independent test datasets should be used for validation
  • Human-device team performance should be evaluated when appropriate

Non-clinical testing

  • Software verification and validation testing required
  • Model development and testing data should be independent
  • Precision studies (repeatability/reproducibility) may be needed
  • Bench testing and simulations may be appropriate based on device risk

Human Factors

  • Human factors validation required for devices with critical tasks
  • Usability evaluation recommended to assess information interpretation and user interface
  • User tasks and knowledge tasks should be evaluated throughout device use continuum
  • Training program effectiveness should be validated if used as risk control

Software

  • Software documentation per “Content of Premarket Submissions for Device Software Functions” guidance
  • Model architecture and development process should be described
  • Software version history and changes should be documented
  • Quality system considerations for software development

Cybersecurity

  • Cybersecurity controls for AI-specific risks like data poisoning, model inversion, evasion attacks
  • Security testing including malformed input and penetration testing
  • Data vulnerability and leakage prevention controls
  • Secure update mechanisms

Labelling

  • Clear description of AI use and model characteristics
  • Performance metrics and limitations
  • User instructions and training requirements
  • Risk information and warnings
  • Model development and validation data descriptions

Safety

  • Comprehensive risk assessment required
  • Risk controls for AI-specific hazards
  • Performance monitoring plan recommended
  • Change management procedures

Other considerations

  • ANSI/AAMI/ISO 14971: Medical devices - Applications of risk management to medical devices
  • ANSI/AAMI HE75: Human factors engineering - Design of medical devices
  • AAMI CR34971: Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning

Original guidance

  • Content of Premarket Submissions and Lifecycle Management for Artificial Intelligence and Machine Learning-Enabled Medical Devices
  • HTML / PDF
  • Issue date: 2025-01-07
  • Last changed date: 2025-01-06
  • Status: DRAFT
  • Official FDA topics: Medical Devices, Digital Health, Postmarket, Drugs, Premarket, Biologics
  • ReguVirta summary file ID: 5ff8871fa2a74f5278ff55b31ac20ecc
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