FDA Shifts Policy: Eases Regulations on Wellness Wearables and Health Devices
The U.S. Food and Drug Administration (FDA) announced a significant policy shift on January 6, 2026. This change will limit the regulation of wearable devices and software designed to support healthy lifestyles. FDA Commissioner, Dr. Marty Makary, revealed the new guidance during a keynote address. He clarified that non-medical grade wellness wearables will not be subject to FDA regulation as long as they avoid making medical claims.
The updated guidance specifically addresses devices that provide general wellness information. These include fitness trackers, smartwatches monitoring sleep and activity, and health apps. Such devices are now exempt from stringent regulatory oversight. However, companies must avoid claiming “medical grade” accuracy or suggesting clinical interventions. For instance, devices can display blood pressure estimates but cannot advise users to change medications based on those readings.
The market responded positively to the announcement. Shares of continuous glucose monitor manufacturers, Dexcom, Abbott, and Medtronic, rose between 1% and 4%. Meanwhile, fitness smartwatch maker, Garmin, saw nearly a 3% increase. The guidance aims to encourage innovation in the rapidly growing wellness tech sector while maintaining consumer safety.
According to wellness industry analysts, this regulatory clarity could accelerate growth in the wearables market. The market is projected to reach significant expansion through 2030.
Source: FDA Guidance Documents