The US Food and Drug Administration (FDA) has announced the launch of the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a new initiative aimed at promoting safe and effective access to digital health technologies for chronic disease management.
How TEMPO Works
Developed by the FDA Center for Devices and Radiological Health (CDRH), the pilot will test a new enforcement approach to support digital health devices across cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions. Participating manufacturers will provide devices under the CMS Innovation Center ACCESS model.
Manufacturers will collect, monitor, and report real-world performance data, helping the FDA and CMS better understand how digital health technologies perform in everyday patient settings.
Part of a Broader Initiative
TEMPO is part of the FDA broader Home as a Health Care Hub initiative, which seeks to shift care delivery closer to where people live and work. Michelle Tarver, Director of CDRH, said the pilot will allow the FDA to responsibly encourage innovation while collecting real-world evidence on patient outcomes.
What Comes Next
The FDA plans to select approximately ten manufacturers in each of four clinical use areas. The TEMPO pilot is scheduled to begin in January 2026.
