Retail HealthFriday, November 6, 2026
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.
