FDA Launches TEMPO: A First-of-Its-Kind Digital Health Pilot to Expand Access to Chronic Disease Technologies

The U.S. Food and Drug Administration today announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a voluntary pilot designed to promote access to certain digital health devices while safeguarding patient safety.Developed by the FDA’s Center for Devices and Radiological Health (CDRH), the pilot will evaluate a new, risk-based enforcement approach that supports digital health devices intended for use to improve patient outcomes in cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.“We are piloting an approach to encourage the use of digital technologies that meet people where they are,” said FDA Commissioner Marty Makary,...