FDA Launches TEMPO Pilot for Digital Health Devices | FDA
FDA Launches Pilot Program to Accelerate Access to Digital Health Tools
Washington, D.C. – December 5, 2025 – In a move poised to reshape chronic disease management, the U.S. Food and Drug Administration (FDA) today announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot program. This voluntary initiative aims to streamline the approval process for certain digital health devices, increasing patient access to innovative technologies while maintaining rigorous safety standards.
Bridging the Gap in Chronic Care
The pilot program, developed by the FDA’s Center for Devices and Radiological Health (CDRH), will initially focus on digital health solutions targeting cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions. It represents a significant shift towards a more flexible, risk-based regulatory approach, acknowledging the rapid pace of innovation in the digital health space. The goal is to encourage the development and adoption of tools that can empower patients to actively manage their health, particularly those grappling with chronic illnesses.
“We are piloting an approach to encourage the use of digital technologies that meet people where they are,” explained FDA Commissioner Marty Makary, M.D., M.P.H. “This pilot supports innovative tools and a health care delivery model that could improve care for millions of Americans managing chronic disease.”
Chronic diseases are a leading cause of death and disability worldwide. According to the World Health Organization, they account for 74% of all deaths globally. In the United States, nearly 6 in 10 adults have a chronic disease, and 4 in 10 have two or more, contributing significantly to the nation’s healthcare costs. This pilot program directly addresses the need for more accessible and effective tools to combat this growing public health challenge.
Collaboration with CMS to Drive Real-World Evidence
The TEMPO pilot isn’t operating in a vacuum. It’s being conducted in close collaboration with the Centers for Medicare and Medicaid Services (CMS) Innovation Center (CMMI) and its Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model. Participating manufacturers will offer their devices for use within the ACCESS model, allowing for the collection of crucial real-world performance data. This data will be shared with the FDA, providing valuable insights into how these technologies perform in everyday clinical settings.
“CMS is pleased to partner with the FDA on the TEMPO pilot as we work to modernize care for people with chronic disease,” said Centers for Medicare and Medicaid Services Administrator Mehmet Oz, M.D. “Insights from this collaboration will support our efforts to build models that expand access to high-quality, technology-enabled care.”
This collaborative approach is particularly noteworthy. Traditionally, the FDA’s premarket authorization process can be lengthy and resource-intensive. By leveraging the ACCESS model, the TEMPO pilot aims to generate robust evidence of effectiveness *while* devices are being used by patients, accelerating the learning process and potentially reducing the time it takes to bring beneficial technologies to market.
Enforcement Discretion and a Focus on Innovation
A key element of the TEMPO pilot is the potential for the FDA to exercise enforcement discretion for certain regulatory requirements, such as premarket authorization and investigational device exemptions. This doesn’t mean safety standards are being lowered; rather, it allows manufacturers to collect and share real-world data demonstrating their device’s performance under specific conditions. The FDA will work closely with each participant to determine when enforcement discretion is appropriate.
“Digital health technologies are rapidly transforming how people manage chronic conditions, and we want to ensure our regulatory approach keeps pace,” said Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D. “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 pilot is designed to be flexible and iterative, aligning with the dynamic nature of digital health development. Devices included in the program could range from apps designed to help individuals manage prediabetes to more sophisticated tools for monitoring heart failure or providing remote behavioral health support. For more information on the latest advancements in digital health, see our recent coverage.
Looking Ahead: A New Era of Patient-Centered Care
The TEMPO pilot is a cornerstone of the FDA’s Home as a Health Care Hub initiative, which envisions a future where healthcare is more accessible, convenient, and personalized. The agency is now seeking statements of interest from manufacturers, with plans to select up to ten participants in each of four clinical use areas starting in January 2026.
This initiative builds upon the FDA’s experience with the Total Product Life Cycle Advisory Program (TAP), which emphasizes early collaboration and proactive input from stakeholders. The lessons learned from TAP have informed TEMPO’s emphasis on early engagement, rapid data collection, and a commitment to continuous improvement.
The TEMPO pilot represents a significant step towards a more proactive and patient-centered regulatory framework for digital health. By fostering innovation, generating real-world evidence, and collaborating with key stakeholders, the FDA is paving the way for a future where technology empowers individuals to take control of their health and live longer, healthier lives.