Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Published Date: 1/7/2025
Notice
Summary
The FDA just dropped a draft guide to help companies make and sell medical devices with AI software. It explains what info to include so the FDA can check these devices are safe and work well, plus tips on managing them from start to finish. If you’re in the AI medical device game, get ready to share your thoughts by April 7, 2025, before the rules get final—and yes, this could affect your product plans and budgets.
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Analyzed Economic Effects
6 provisions identified: 6 benefits, 0 costs, 0 mixed.
Marketing submission documentation guidance
The draft guidance explains what documentation sponsors should include in marketing submissions for devices that include AI-enabled software functions to support FDA's evaluation of safety and effectiveness. It is guidance to help manufacturers prepare the material the FDA will review.
Total product lifecycle (TPLC) recommendations
The draft guidance proposes recommendations for the design, development, and implementation of AI-enabled devices throughout the total product lifecycle (TPLC). Manufacturers may use these recommendations from early development through decommissioning.
Transparency and bias evidence expectations
The draft guidance sets out FDA's current thinking on strategies to address transparency and bias, including collecting evidence to evaluate whether a device benefits relevant demographic groups (for example, race, ethnicity, sex, and age) similarly. The goal is to help ensure AI-enabled devices remain safe and effective for their intended use across groups.
Postmarket performance monitoring plan
The draft guidance proposes an approach to postmarket performance monitoring for AI-enabled devices, including using a performance monitoring plan as a risk mitigation tool. FDA highlights performance monitoring as part of managing device risk after marketing.
Opportunity to comment by April 7, 2025
FDA is accepting public comments on the draft guidance and requests that electronic or written comments be submitted by April 7, 2025 so the Agency can consider them before it begins work on the final guidance. Comments may be submitted via https://www.regulations.gov (Docket No. FDA-2024-D-4488) or as written/paper submissions per the notice.
Draft guidance is nonbinding
The document states the draft guidance, if finalized, will represent FDA's current thinking but is not binding, and that alternative approaches that satisfy statutes and regulations may be used. The draft guidance is not for implementation at this time.
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