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

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 most EHRs are not medical devices requiring FDA approval and oversight. However, if an EHR provides clinical decision support, it may require some FDA review.

These findings were included in “Policy For Device Software Functions & Mobile Medical Applications: Guidance For Industry & Food . . .