FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled …

Guidance Shares Strategies to Address Transparency and Bias, while Providing Key Considerations and Recommendations on Product Design, Development and Documentation
SILVER SPRING, Md., Jan. 6, 2025 /PRNewswire/ — Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device’s Total Product Life Cycle. The guidance, if finalized, would be the first guidance to […]
FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled …