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Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Part Two

Key provisions of the FDA’s proposed regulatory framework of software that uses and adapts to artificial intelligence and machine learning

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Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)

The FDA has a new proposal for approving AI and ML software that looks at the total product lifecycle from development to post-market uses and the adaptations the software learns

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FDA Policy on When Software that Uses Artificial Intelligence and Machine Learning qualifies as a Medical Device

As more artificial intelligence products become available, the FDA is reevaluating its approval criteria. For now, De novo approval and 501(k) are being used along with premarket approval.

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A Benevolent Artificial Intelligence Will Usher In Utopia

A benevolent AI (artificial intelligence) could usher in utopia... but will augmented intelligence destroy it?