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

FDA announces digital health services pilot

The Food and Drug Administration announced Dec. 5 that it will launch the Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot, or TEMPO, an initiative aimed to promote access to certain digital health devices. The voluntary pilot is being launched in conjunction with the Centers for Medicare & Medicaid Services Innovation Center’s Advancing Chronic Care with Effective, Scalable Solutions Model announced Dec. 1. The AC…

FDA launches TEMPO: A first-of-its-kind digital health pilot to expand access to chronic disease technologies

WASHINGTON, USA – The US 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 device…