Predetermined Change Control Plans for Artificial Intelligence and Machine Learning-Enabled Device Software Functions
This guidance provides recommendations for marketing submissions containing a Predetermined Change Control Plan (PCCP) for Artificial Intelligence-enabled Device Software Functions (AI-DSFs). The guidance applies to AI-DSFs that manufacturers intend to modify over time, whether modifications are implemented automatically, manually, or both. While broadly applicable to all AI-enabled devices, it is particularly tailored to devices incorporating machine learning.
Recommended Actions
- Develop a comprehensive PCCP containing:
- Description of Modifications
- Modification Protocol
- Impact Assessment
- Ensure PCCP includes:
- Data management practices
- Re-training protocols
- Performance evaluation methods
- Update procedures
- Establish clear acceptance criteria and performance requirements
- Define communication and transparency procedures for users
- Implement monitoring and tracking systems for:
- Safety events
- Performance issues
- Real-world data
- Maintain documentation in accordance with quality system requirements
- Consider early engagement with FDA through Q-Submission Program
- Ensure labeling remains current with modifications
- Implement version control procedures
- Establish procedures for handling deviations from authorized PCCP
Key Considerations
Clinical testing
- Clinical validation required for modifications affecting clinical performance
- Clinical testing protocols must be specified in the Modification Protocol
- Performance requirements and acceptance criteria must be pre-defined
- Clinical testing data must be representative of intended use populations
Non-clinical testing
- Analytical validation required for modifications affecting device performance
- Test protocols must be specified in the Modification Protocol
- Performance requirements and acceptance criteria must be pre-defined
- Test data must be representative of intended use conditions
Human Factors
- Impact on users must be assessed for modifications affecting user interface or workflow
- User training requirements must be specified when needed
- Communication plan for informing users about modifications required
Software
- Software verification and validation protocols required
- Data management practices must be defined
- Re-training protocols must be specified
- Performance evaluation methods must be documented
- Update procedures must be detailed
Cybersecurity
- Cybersecurity risk management required
- Validation processes must be defined
- Security controls must be specified
Labeling
- Updates to labeling required for modifications
- Performance changes must be communicated
- Version control information required
- User instructions must be updated as needed
Safety
- Safety impact assessment required
- Risk management processes must be followed
- Monitoring plan for safety required
- Adverse event tracking procedures needed
Other considerations
- Quality system requirements apply
- Documentation requirements specified
- Version control needed
- Transparency to users required
- Real-world performance monitoring recommended
Relevant Guidances
- Content of Premarket Submissions for Device Software Functions
- Predetermined Change Control Plans for Medical Device Modifications (Draft)
- Content of Premarket Submissions and Lifecycle Management for Artificial Intelligence and Machine Learning-Enabled Medical Devices (Draft)
- Off-The-Shelf Software in Medical Devices: Documentation Requirements for Premarket Submissions
- Software Validation for Medical Device Production, Quality Systems, and Device Components
- Clinical Evaluation of Software as a Medical Device (SaMD)
Related references and norms
- ISO 14971: Medical devices - Application of risk management to medical devices
- AAMI CR 34971:2022: AAMI Consensus Report - Guidance on the Application of ISO 14971 to Artificial Intelligence and Machine Learning
- IEEE 2802: Standard for Performance and Safety Evaluation of Artificial Intelligence Based Medical Devices: Terminology
- ISO 13485: Medical devices - Quality management systems - Requirements for regulatory purposes
Original guidance
- Predetermined Change Control Plans for Artificial Intelligence and Machine Learning-Enabled Device Software Functions
- HTML / PDF
- Issue date: 2024-12-04
- Last changed date: 2024-12-03
- Status: FINAL
- Official FDA topics: Medical Devices, Digital Health, Drugs, Premarket, Biologics
- ReguVirta summary file ID: 2581f61604f8b537e276c1a9b3b5611a
This post is licensed under CC BY 4.0 by the author.