FDA Restricts Oversight of Wellness Wearables in Major Policy Shift
In a landmark move for the health and beauty technology sector, the U.S. Food and Drug Administration (FDA) unveiled new guidance on January 6, 2026. This confirms their decision to restrict oversight of wearable devices and software designed to promote healthy lifestyles. This revised policy offers vital clarity for the burgeoning wellness wearables market, which includes devices that monitor sleep, exercise, blood oxygen levels, and other health indicators.
FDA Commissioner Dr. Marty Makary expressed that the agency’s goal is to strike a balance between fostering innovation and safeguarding patient safety. The guidance expands on the existing policy that classifies low-risk wellness tools as non-medical devices, provided they do not make claims related to disease diagnosis or treatment. As such, products like fitness applications and activity trackers that promote exercise or provide general health information will continue to be exempt from stringent regulatory scrutiny.
The market reacted favorably to the announcement, with shares of companies such as Oura (valued at $1 billion in 2025) and Whoop poised to benefit. The guidance permits non-invasive products that estimate physiological parameters including blood pressure, blood glucose, and oxygen saturation for wellness uses to be classified as general wellness products. This is subject to their intended use being strictly wellness-focused and their compliance with specific safety criteria.
Source: AHA