The FDA’s draft guidance outlines lifecycle management recommendations for AI-enabled medical devices, emphasizing safety, transparency, and cybersecurity while inviting public comments to refine the framework by April 7, 2025.
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The FDA’s draft guidance outlines lifecycle management recommendations for AI-enabled medical devices, emphasizing safety, transparency, and cybersecurity while inviting public comments to refine the framework by April 7, 2025.
View full story…