General Wellness: Policy for Low Risk Devices; Guidance for Industry and Food and Drug Administration Staff

Ben Mbouombouo, Co-Founder of LifePlus Inc, is seeking clarification on whether specific biomarkers (blood glucose, blood pressure, oxygen saturation, and respiration rate) can be displayed on a general wellness device. He notes that these values are intended solely for wellness purposes like weight management and sleep management, rather than for disease diagnosis.

Researchers from Duke University's BIG IDEAs Lab argue that the proposed guidance is insufficient because it lacks clear validation requirements for products that mimic clinical values. They express concern that the guidance fails to address informational and behavioral safety risks, such as false reassurance from inaccurate wellness data, and request more rigorous standards and clearer definitions to distinguish wellness products from medical devices.

The commenters, including medical professionals, argue that the proposed guidance contains loopholes that could lead to consumer confusion between wellness and medical devices. They express specific concerns regarding the lack of clarity on clinical validation requirements, the potential for products to imply medical use while avoiding specific terminology, and the absence of data privacy and cybersecurity protections.