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Artificial Intelligence/Machine Learning (AI/ML)-Based.:Jf/<X
Software as a Medical Device (SaMD) Action Plan
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Proposed Regulatory Framework for Modifications to Artificial
Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) - Discussion Paper and Request for Feedback
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IMDRF SAMD Definitions
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Deciding When to Submit a
510(k) for a Software Change to an
Existing Device