Draft Guidance Covers Marketing Submissions, TPLC for AI Devices

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Draft Guidance Addresses Marketing Submissions, Total Product Life Cycle for AI-Enabled Devices

Dennis Tosh

January 8, 2025 at 06:36 PM EST

In releasing much-anticipated draft guidance on medical devices with artificial intelligence (AI)-enabled software, the FDA responded to requests from many device companies for more recommendations on how to comply with the agency’s requirements throughout the life cycle of the devices. When finalized, the draft guidance document, “Artificial Intelligence-Enabled Device Soft... Read More

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Draft Guidance Addresses Marketing Submissions, Total Product Life Cycle for AI-Enabled Devices

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