Latest posts
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Global Approach to Software as a Medical Device
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What are examples of Software as a Medical Device?
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Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations
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Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
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Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles
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FDA Digital Health and Artificial Intelligence Glossary – Educational Resource
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Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products (March 2023)
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Good Machine Learning Practice for Medical Device Development: Guiding Principles
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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