But federal policy hasn’t caught up with technological advances. Wearables sit in a regulatory gray zone. The FDA categorizes them and their associated software in two categories: general wellness products and medical devices. The former have minimal oversight and no standards. The latter—products intended to diagnose, treat or prevent disease—must meet requirements for design, labeling and manufacturing.
Wearables with sophisticated sensing capabilities don’t fit within this binary framework. Their sensors are used for both purposes, so there’s often a mismatch between the actual risk and the imposed regulatory burden. Manufacturers are faced with a choice: tailor their features to the wellness category, sacrificing functionality, or accept slower product development and market entry.
With a reformed regulatory structure, Oura customers could already be benefiting from a range of advanced features, including screening for high blood pressure. Hypertension is one of the most significant risk factors for heart disease and stroke, while high blood pressure in pregnancy can signal pre-eclampsia, a complication that endangers mother and baby. Another primed capability, sleep-apnea detection, would give users an early-warning tool for a condition that often goes undiagnosed and can lead to serious complications.
Under current regulations, however, a ring with these features would need to be submitted for FDA clearance as a medical device. That’s why we’re calling for a new device classification called “digital health screeners”—software features that can warn users of trouble but stop short of diagnosis. This modernized regulatory path would offer clear guidelines, including straightforward labeling with explicit disclaimers indicating nondiagnostic intent, as well as performance standards with defined accuracy and reliability benchmarks. It would also ensure quality management and a simpler market-entry process than for higher-risk medical devices.'
