Lexology February 24, 2025
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (draft AI-enabled device guidance) and Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products (draft AI drug guidance).
In the draft AI-enabled device guidance, FDA describes the data and information it expects device sponsors to include in their marketing submissions for AI-enabled devices. FDA also offers recommendations for lifecycle management of AI models in the guidance and includes example submission materials to illustrate how device sponsors might operationalize the draft guidance. Drawing on risk-based frameworks from the device context,...
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