FDA Launches TEMPO Digital Health Pilot

The U.S. FDA has launched the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a new initiative aimed at accelerating safe access to digital health technologies while strengthening real-world evidence generation. Developed by the FDA’s Center for Devices and Radiological Health (CDRH), the pilot will test a new enforcement and oversight approach for digital health devices used in cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.

Manufacturers selected for TEMPO will offer devices intended for care delivery under CMS’s Innovation Center ACCESS model while simultaneously collecting, monitoring, and reporting real-world performance data. This dual pathway is designed to give both FDA and CMS a clearer understanding of how digital health tools perform at scale and how they might be applied to other chronic diseases in the future. The program aligns with the FDA’s Home as a Health Care Hub initiative, which aims to shift more care into home and community settings.

CDRH leaders noted that early collaboration—mirroring lessons from the agency’s Total Product Life Cycle Advisory Program (TAP)—can streamline innovation and ensure technologies meet safety and efficacy expectations. Michelle Tarver, CDRH Director, emphasized the importance of keeping regulatory frameworks aligned with rapid advancements in digital health, saying the pilot will help encourage responsible innovation while generating meaningful real-world evidence. CMS Administrator Mehmet Oz said insights from the collaboration will strengthen future models that expand access to technology-enabled care.

TEMPO will begin in January 2026. The FDA plans to select about ten manufacturers in each of four clinical areas and is now accepting statements of interest.