FDA Advances Wellness Wearables with Major Regulatory Overhaul
The U.S. Food and Drug Administration (FDA) has unveiled a significant shift in its oversight of health and wellness wearables. On January 6, 2026, the FDA issued updated guidance, allowing a broader range of consumer devices to bypass the costly regulatory review process before hitting the market.
FDA Commissioner Dr. Marty Makary announced these policy changes at the Consumer Technology Association’s CES conference. He emphasized that the agency is “cutting red tape on wearables for general wellness.” The revised guidance now clarifies that non-invasive products estimating metrics such as blood pressure, oxygen saturation, blood glucose, and heart rate variability can be classified as general wellness products, rather than regulated medical devices.
This category includes a variety of sensor-based technologies, such as smartwatches, smart rings, patches, and more. These devices promote general wellness by tracking metrics like heart rate during workouts, sleep patterns, and caloric intake. These changes are a part of the Department of Health and Human Services’ Make America Healthy Again agenda.
The market response to this announcement was immediate and positive. Shares of continuous glucose monitor manufacturers such as Abbott, Medtronic, and Dexcom closed between 1% and 4% higher following the announcement. Fitness smartwatch maker Garmin also saw a rise, with shares nearly 3% higher. This guidance reflects the FDA’s effort to balance encouraging innovation in wearable health technology while maintaining safeguards against misuse of health data.
Source: Fierce Healthcare