FDA launches TEMPO digital health pilot

The US FDA has announced the launch of the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, designed to promote safe access to digital health devices.

The pilot, developed by the FDA’s Center for Devices and Radiological Health (CDRH), will evaluate a new enforcement approach intended to support digital health devices across cardio-kidney-metabolic, musculoskeletal and behavioural health conditions.

Manufacturers participating in the TEMPO pilot will offer devices intended to provide care under the Centers for Medicare and Medicaid Services (CMS) Innovation Center (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model. At the same time, they will collect, monitor and report real-world performance data about these devices.

The pilot will improve FDA and CMS understanding of how digital health technologies perform and how they could be used for other chronic diseases in the future.

TEMPO was developed as part of the FDA’S Home as a Health Care Hub initiative, aiming to relocate health and wellness to the spaces where people live and work.

Safe and effective digital technologies have the potential to greatly reduce the burden of chronic disease in the US. The CDRH’s experience with the Total Product Life Cycle Advisory Program (TAP), has shown how early collaboration can streamline the development of medical technologies, informing TEMPO’s focus on early engagement and extensive data collection.

Michelle Tarver, CDRH Director, said: “Digital health technologies are rapidly transforming how people manage chronic conditions, and we want to ensure our regulatory approach keeps pace.

“The TEMPO pilot will allow us to responsibly encourage innovation while collecting real-world evidence that may help us better understand how these devices perform for patients in their everyday lives.”

The FDA plans to select around ten manufacturers for participation in each of four specified clinical use areas in the pilot, and is currently seeking statements of interest. TEMPO will begin in January 2026.
CMS administrator Mehmet Oz said: “Insights from this collaboration will support our efforts to build models that expand access to high-quality, technology-enabled care.”