Latest posts
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Artificial Intelligence and Machine Learning Software as a Medical Device 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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Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
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Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations
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Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products