FDA Issues Draft Guidance for AI-Enabled Medical Devices: Key Recommendations and Updates
Digital Health Global
JANUARY 7, 2025
The U.S. Food and Drug Administration (FDA) released a draft guidance titled “ Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations. ” This document outlines a Total Product Lifecycle (TPLC) approach to manage and market AI-enabled medical devices, addressing the unique challenges and risks of AI technologies.
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