U.S. Food and Drug Administration
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FDA — AI-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations

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FDA draft guidance (January 2025) on marketing submissions for AI-enabled medical device software, recommending total-product-lifecycle risk management and the documentation needed to support FDA evaluation of safety and effectiveness.

Tags

sectorhealthcaremedical devicesFDA

At a glance

Published

2025

Jurisdiction

United States

Category

Sector specific governance

Access

Public access

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FDA — AI-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations | VerifyWise AI Governance Library