FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices

Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device’s Total Product Life Cycle.

Feb 9, 2025 - 21:45
 0
FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled Medical Devices
Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device’s Total Product Life Cycle.