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David R. Bassett, Patty S. Freedson and Dinesh John

moderate-risk Class II medical devices (e.g., automated blood pressure monitors, blood glucose meters, and pulse oximeters; FDA News, 2015 ). Legislation was passed (H.R. 34—21st Century Cures Act) requiring these general wellness products to be low-risk and noninvasive. Since activity trackers are now