FDA Encourages Innovation by Relaxing Regulations for Wellness Wearables
In a significant step towards fostering innovation in the health and wellness sector, the U.S. Food and Drug Administration (FDA) declared on January 6, 2026, a considerable relaxation in regulatory supervision for low-risk wearable health devices and wellness products. This announcement, made at the CES 2026 technology conference in Las Vegas, signifies a crucial shift in the regulation of wellness technology.
The revised policy implies that wearable devices monitoring metrics such as heart rate, physical activity, sleep patterns, blood oxygen levels, and other noninvasive health indicators will face less stringent premarket review requirements, provided they refrain from making medical claims. FDA Commissioner Marty Makary expressed that the agency intends to keep pace with the “speed of Silicon Valley” to stimulate innovation while ensuring patient safety.
Key players in the wellness wearables market welcomed the news. Companies like the Finnish firm Oura, valued at $1 billion in 2025, and subscription-based Whoop, valued at $3.6 billion, are anticipated to benefit from the more transparent regulatory landscape. The market response was immediate, with shares of glucose monitor manufacturers Abbott, Medtronic, and Dexcom rising between 1% and 4%, while fitness smartwatch maker Garmin experienced a nearly 3% increase.
The guidance further clarifies that products intended for general wellness, rather than diagnosing or treating specific medical conditions, will continue to be exempt from stringent regulatory oversight. Nonetheless, devices making medical claims or used for critical clinical decision-making will still necessitate full FDA approval.
Source: https://www.consumeraffairs.com/news/fda-relaxes-rules-for-wearable-health-devices-010726.html