As wearable and software-enabled technologies increasingly estimate physiological parameters such as oxygen saturation, blood pressure, and heart rate variability, regulatory classification has become a critical design consideration. The FDA’s General Wellness: Policy for Low Risk Devices clarifies when products using non-invasive sensing—such as optical sensing—may be considered general wellness products rather than regulated medical devices.  For developers conducting a cl

A Familiar Framework with Important Regulatory Implications   In January 2026, the FDA released a draft guidance titled “ Cuffless Non-Invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation .” The document outlines FDA’s current recommendations on how cuffless blood pressure (BP) devices—both intermittent and continuous—should be clinically evaluated to support premarket submissions.  For developers already working in this space, the guidance

“Usability testing of wearable medical device in a clinical trial" Introduction: Usability as a Core Component of Clinical Success The...