Latest posts
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Guideline for AI-based medical devices and IVD
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Guideline for AI for medical products
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Software and artificial intelligence (AI) as a medical device
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Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations
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Characterization Considerations for Medical Device Software and Software-Specific Risk
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Regulatory Considerations on Artificial Intelligence for Health
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Pre-market guidance for machine learning-enabled medical devices
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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