Organisation

Food and Drug Administration (United States)

Discussion paper

Proposed regulatory framework for modifications to Artificial Intelligence/Machine Learning (AI/ML)-based Software as a Medical Device (SaMD)


Artificial intelligence (AI)- and machine learning (ML)-based technologies have the potential to transform healthcare by deriving new and important insights from the vast amount of data generated during the delivery of healthcare every day. Example high-value applications include earlier disease detection, more accurate diagnosis, identification of new observations or patterns on human physiology, and development...

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