FDA's Approach to AI-Enabled Devices
The FDA's recommendations in this draft guidance are based on its experience reviewing AI-enabled devices and current regulatory science research. For reference, devices incorporating one or more AI-enabled device software functions (AI-DSFs) are referred to as AI-enabled devices.
Supporting AI Development Through Clear Guidelines
To support the continued development of AI-enabled devices, this guidance outlines the documentation and information requirements for marketing submissions, facilitating FDA review of AI-DSFs.
Total Product Lifecycle (TPLC) Approach
Emphasizing a Total Product Lifecycle (TPLC) approach, this guidance provides recommendations for marketing submissions, risk management, and lifecycle development. It details best practices for documentation, design, deployment, maintenance, and performance management to ensure device safety and effectiveness.
Key Documentation Requirements
Additionally, the guidance outlines requirements for key documentation, including Device Description, User Interface, Labeling, Risk Assessment, Data Management, Cybersecurity, and Validation Reports.