FDA Finalizes That Fitness Apps, EHRs Are Outside Regulatory Scope For Medical Devices

Article December 9, 2019

On September 27, 2019, the U.S. Food & Drug Administration (FDA) finalized policy regarding fitness apps and electronic health records (EHRs). The FDA has determined that fitness apps (including trainers, step counters, exercise timers, food trackers, and others) will not be considered medical devices requiring FDA approval and oversight. The FDA has also determined that…

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