Retail Health

FDA reclassifies non-invasive wellness wearables as consumer products

The FDA updated guidance to classify non-invasive wearables estimating blood pressure, glucose, and HRV as general wellness products rather than regulated medical devices.

The numbers

  • 2019 Year of last FDA guidance update differentiating general wellness devices.
  • 2022 Year of last FDA guidance update for clinical decision support software.

Sources

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