FDA Eases Regulations on Wellness Wearables in Significant Policy Change
WASHINGTON – The U.S. Food and Drug Administration (FDA) has announced a major policy shift. It will now limit its stringent regulation of wellness wearable devices and health-tracking software. The FDA has issued new guidance to clarify its regulatory approach for low-risk general wellness products.
The updated guidance, released on January 6, 2026, provides clarity on FDA’s compliance policy for products that promote healthy lifestyles. These include fitness trackers, sleep monitors, and wellness apps. This regulatory shift is expected to significantly boost the wellness technology sector. Major players like Oura (valued at $1 billion in 2025) and Whoop (valued at $3.6 billion) are set to particularly benefit.
According to industry experts, consumers are becoming more proactive with these devices. “We’re not just looking at the data, we’re making new habits based on it,” said Olivia Houghton, head of beauty and wellness at consultancy The Future Laboratory. Research shows that 87 percent of users report making behavioral changes like improved sleep habits and increased exercise frequency based on wearable data.
The guidance represents a major policy update aimed at promoting innovation in the health technology space while maintaining appropriate safety standards. This decision comes at a time when technological wearables that track sleep, exercise, and blood oxygen levels are becoming increasingly widespread in 2026. Consumers are seeking more data-driven approaches to wellness management.
Source: Business of Fashion