December 8, 2025- The U.S. Food and Drug Administration 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.
In collaboration with the Centers for Medicare and Medicaid Services (CMS) Innovation Center (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model, under the TEMPO pilot participating manufacturers of certain digital health devices will offer devices for an intended use to provide care covered by the CMMI ACCESS model while collecting, monitoring, and reporting real-world performance data.
This pilot will help the FDA and CMS better understand how digital health technologies perform in real-life settings and how they may support efforts to improve care for people living with chronic diseases. The pilot supports CMS’s ACCESS Model, which aims to increase beneficiary access to technology-enabled, integrated care.