On January 6, 2025, the U.S. Food & Drug Administration released two draft guidance documents on artificial intelligence (AI). The first, “AI-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” offers guidance to support the safety and effectiveness of AI-enabled devices throughout their lifecycle, including design, development, maintenance, and documentation. It also outlines when and how device sponsors should describe post-market performance monitoring in marketing submissions.
The second, “Considerations for the Use of AI to Support Regulatory Decision-Making for Drug and Biological Products,” provides recommendations on the use of AI for the development of drug and biological products. The guidance outlines recommendations on using AI to assess the safety, effectiveness, and quality of drugs and biological products.
Read the AI-enabled Device Guidance.
Read the Drug and Biological Product Guidance.
Last Updated on January 12, 2025 by Aimed Alliance
