FDA Eases Regulations on Wellness Wearables and AI Health Devices
The U.S. Food and Drug Administration (FDA) has ushered in a new era in digital health regulation. On January 6, 2026, the FDA announced comprehensive regulatory changes that will relax oversight on low-risk wellness wearables and AI-enabled health devices.
FDA Commissioner, Dr. Marty Makary, introduced the new policy at the Consumer Electronics Show. He emphasized the agency’s commitment to “move at Silicon Valley speed” and foster an investor-friendly environment. The updated guidance broadens enforcement discretion for non-invasive wearables that estimate physiologic parameters. These include blood pressure, blood glucose, oxygen saturation, and heart rate variability, provided they are intended solely for wellness uses and not for medical diagnosis or treatment.
This policy is a significant expansion from the 2019 guidelines and could accommodate more AI-derived metrics and insights, specifically for wellness applications. Companies such as Oura and Whoop, valued at $1 billion and $3.6 billion respectively in 2025, are poised to benefit from these relaxed regulations.
The guidance further clarifies that products promoting healthy lifestyles, without making medical-grade claims, can now enter the market without FDA review. However, the agency maintains that it will prioritize enforcement against higher-risk use cases where AI outputs guide clinical care without sufficient human oversight.
Source: Statnews