The US Food and Drug Administration (USFDA) has issued its final guidance on "Marketing Submission Recommendations for a Predetermined Change Control Plan (PCCP) for Artificial Intelligence (AI)-Enabled Device Software Functions (AI-DSFs)" which provides a structured framework for manufacturers to implement and communicate modifications to AI-DSFs post-market while maintaining compliance with safety and effectiveness requirements.
Artificial intelligence-enabled device software is designed to evolve and adapt over time. This guidance establishes a clear pathway for managing these changes predictably and transparently through the PCCP mechanism, fostering innovation without compromising patient safety.
A Predetermined Change Control Plan (PCCP) is a regulatory framework that allows manufacturers to proactively outline and gain FDA approval for potential modifications to an AI-enabled device software function after the device has been cleared or approved.
The PCCP should include:
Goals and Scope: Explaining the purpose and boundaries of the planned modifications.
Verification and Validation Activities: Ensuring that all changes adhere to quality system requirements.
Traceability: Linking the modifications to safety and performance objectives.
Risk Management: Evaluating the impact of changes on device functionality and user safety.
The recommendations in this guidance are intended to support iterative improvement through modifications to AI-enabled devices while continuing to provide a reasonable assurance of device safety and effectiveness. According to this guidance, a PCCP must describe the device modifications planned, their methodology to develop, validate, and implement those modifications, and their impact. As part of a marketing submission for an AI-enabled device, FDA reviews a PCCP to ensure the device remains safe and effective without needing additional marketing submissions to implement each modification outlined in the PCCP.
This guidance applies to AI-enabled devices and device constituents of device-led combination products that have been reviewed using 510(k), De Novo, and PMA pathways. It builds on the FDA's longstanding commitment to the development and application of innovative approaches to AI-enabled device regulation.
Manufacturers must demonstrate that the changes outlined in the PCCP will not introduce unacceptable risks or compromise the device’s intended use. This involves:
Conducting risk assessments specific to the proposed changes.
Implementing robust testing and validation protocols.
Manufacturers must align their PCCPs with the FDA’s quality system regulations (21 CFR Part 820) and device-specific requirements. The FDA will evaluate the PCCP as part of the marketing submission to ensure the proposed changes are justified and sufficiently controlled.
Post-market surveillance and vigilance mechanisms are also critical to monitor real-world device performance and implement corrective actions if necessary.
For more details, refer to the full guidance:
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