FDA: Draft Guidance Will Spur Development of AI/Machine-Learning Devices, Reduce Sponsor Burden

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FDA: Draft Guidance Will Spur Development of AI/Machine-Learning Devices, Reduce Sponsor Burden

Agency Would Not Require New Submissions for Device Modifications Included in Predetermined Plan

Dennis Tosh

April 5, 2023 at 11:31 AM EST

New draft guidance intended to promote the development of safe and effective medical devices that use artificial intelligence (AI) and machine learning (ML) models trained by ML algorithms will help spur the expansion of personalized medicine, promote health equity and eliminate the need for additional marketing submissions to the FDA to cover planned ML-driven modifications, ... Read More

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FDA: Draft Guidance Will Spur Development of AI/Machine-Learning Devices, Reduce Sponsor Burden

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