FDA Publishes Draft AI/ML-Enabled Medical Device Guidance. I

FDA Publishes Draft AI/ML-Enabled Medical Device Guidance. Is it Everything We Hoped? | King & Spalding

First mentioned in a 2019 discussion paper entitled “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical...

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, Agency Artificial Intelligence Machine Learning , Regulatory Framework , Machine Learning , Based Software , Medical Device , Change Control , Action Plan ,

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