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FDA Issues Draft Guidance on AI-Enabled Device Software Lifecycle Management
January 07, 2025

WASHINGTON, Jan. 7 (TNSFR) -- The U.S. Food and Drug Administration (FDA) has released draft guidance detailing recommendations for the lifecycle management and marketing submissions of artificial intelligence (AI)-enabled device software functions. The guidance outlines the agency's expectations regarding documentation and information necessary to evaluate the safety and effectiveness of such devices.

It emphasizes a Total Product Lifecycle (TPLC) approach, encouraging sponso . . .

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