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Machine Learning-Based Medical Devices: The Fda’S Regulation, Requirements, And Restrictions, Charli Beam

Journal of Law and Health

The FDA should create functional regulations for the growing number of machine learning medical devices. The healthcare system is increasingly using these devices for diagnosis. Machine learning devices trained on biased data sets are susceptible to furthering certain types of bias and generating flawed outcomes. The FDA should require ML medical devices to include a label that describes the demographics of the tested population. If manufacturers fail to include this information, the FDA could determine the label false or misleading under §502 of the FD&C Act and stop sales of the device. After approval, the FDA should use §814.89(2) and …