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FDA Guidance on Machine Learning and Augmented Intelligence

My question for the MedX Open-Source Brainstorming Event: Can someone explain the new FDA guidance for ML and AI software medical devices?

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Gunjan Siroya

Jul 19, 2019

Hi Ed,

In addition to Victoria's good summary and links, I've shared a post that has visuals and over simplification of the proposed regulatory framework for modifications of AI and ML based SaMD (as shared by Victoria). See https://www.linkedin.com/feed/update/urn:li:activity:6524385035989106689