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FDA Treatment of AI, Machine Learning Software as a Medical Devic

FDA Treatment of AI, Machine Learning Software as a Medical Devic
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Rob Califf , Digital Health Center , Us Congress , Software Precertification Pilot Program , National Evaluation System , Drug Administration , Machine Learning , Medical Devices Workshop , Current Medical Device , Federal Food , Cosmetic Act , Different Regulatory Pathway , Without Legislation Authorizing , New Regulatory ,

FDA Needs a New Approach to AI/ML-Enabled Medical Devices | Mintz - Health Care Viewpoints

We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital. ....

Rob Califf , Digital Health Center , Health Care Viewpoints , Us Congress , National Evaluation System , Drug Administration , Software Precertification Pilot Program , Machine Learning , Medical Devices Workshop , Current Medical Device , Federal Food , Cosmetic Act , Different Regulatory Pathway , Without Legislation Authorizing , New Regulatory ,