In a recent statement, The U.S. Food and Drug Administration (FDA) has introduced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot, a groundbreaking initiative aimed at expanding access to digital health tools for chronic disease management while maintaining patient safety.
Developed by the FDA’s Center for Devices and Radiological Health (CDRH), TEMPO will test a risk-based regulatory approach for digital health devices targeting cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions. The program seeks to accelerate innovation by allowing select manufacturers to operate under enforcement discretion for certain requirements, such as premarket authorization, while collecting real-world performance data.
The pilot is closely aligned with the Centers for Medicare & Medicaid Services (CMS) ACCESS Model, which promotes technology-enabled, integrated care for beneficiaries. Through this collaboration, participating companies will provide devices for approved uses and share data on outcomes, helping regulators and payers better understand how these technologies perform in everyday settings.
“Digital health is transforming chronic care, and our regulatory framework must keep pace,” said Michelle Tarver, M.D., Ph.D., Director of CDRH. The initiative also supports the FDA’s Home as a Health Care Hub strategy, which emphasizes care delivery where patients live and work.
TEMPO will initially select up to ten manufacturers in each of four clinical areas, including low-acuity cardiometabolic conditions like prediabetes, complex conditions such as heart failure, musculoskeletal issues, and behavioral health disorders. Applications open in January 2026.
By fostering early engagement and leveraging real-world evidence, TEMPO aims to streamline development, expand access, and improve outcomes for millions of Americans living with chronic disease.
