FDA Relaxes Rules for Wellness Wearables and Clinical Software

The U.S. Food and Drug Administration has issued two new guidance documents that reduce regulatory oversight for certain wellness devices and clinical decision support (CDS) software, marking a shift toward a more flexible approach to digital health and artificial intelligence.

Announced by FDA Commissioner Marty Makary at the Consumer Electronics Show, the updates clarify that some wearable products tracking heart rate, blood pressure or blood glucose can qualify as general wellness tools, as long as they are intended for non-medical use and rely on validated measurements. Devices marketed for nutrition tracking or lifestyle awareness—rather than diagnosis or treatment—may fall outside FDA enforcement, though higher-risk technologies remain regulated.

Separately, the FDA revised its stance on CDS software, exempting tools that provide recommendations to clinicians, provided they are not used for critical or time-sensitive decisions. Software analyzing existing reports, rather than generating diagnoses from raw medical data, may also avoid regulation.

Together, the changes signal a deregulatory push aimed at encouraging innovation in health technology and AI.

12-01-2026