Devices

Lifecycle Recommendations for AI-Enabled Devices

FDA has published a draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations, providing lifecycle management and marketing submission recommendations consistent with a total product lifecycle (TPLC) approach for AI-enabled devices. The document has recommendations on the contents of marketing submissions for devices that include AI-enabled device software functions including documentation and information that will support the agency’s review. It also has recommendations for the design and development of AI-enabled devices that manufacturers may consider using throughout the TPLC.

FDA says the recommendations reflect a comprehensive approach to the lifecycle management of AI-enabled devices throughout the TPLC. The guidance also has the agency’s current thinking on strategies to address transparency and bias throughout the TPLC of AI-enabled devices, including by collecting evidence to evaluate whether a device benefits all relevant demographic groups similarly, to help ensure that these devices remain safe and effective for their intended uses.

The guidance contains an Introduction, Scope, TPLC Approach: General Principles, How to Use This Guidance: Overview of AI-Enabled Device Marketing Submission Content Recommendations, Device Description, User Interface and Labeling, Risk Assessment, Data Management, Model Description and Development, Validation, Device Performance Monitoring, Cybersecurity, Public Submission Summary, and Six Appendices.

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