The pilot will evaluate a new, risk-based enforcement approach that supports digital health devices intended for use in chronic conditions.
The US Food and Drug Administration (FDA) 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.
“We are piloting an approach to encourage the use of digital technologies that meet people where they are,” says FDA Commissioner Marty Makary, MD, MPH, in a release. “This pilot supports innovative tools and a health care delivery model that could improve care for millions of Americans managing chronic disease.”
Real-World Data Focus
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.
According to a release from the FDA, this pilot will help the agency 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.
“CMS is pleased to partner with the FDA on the TEMPO pilot as we work to modernize care for people with chronic disease,” says CMS Administrator Mehmet Oz, MD, in a release. “Insights from this collaboration will support our efforts to build models that expand access to high-quality, technology-enabled care.”
Advancing Home-Based Care
Under this approach, participating manufacturers may request that the FDA exercise enforcement discretion for certain requirements, such as premarket authorization and investigational device requirements, while manufacturers collect and share real-world data demonstrating the device’s performance. The FDA says it will work with participants in the TEMPO pilot to identify the circumstances when enforcement discretion may be appropriate for that manufacturer’s device.
The FDA also notes that the pilot is designed “to align with the rapid and iterative nature of digital health development and expand patient access to innovative technologies.” Devices included in the pilot may be intended for low-acuity cardiometabolic conditions such as prediabetes, more complex cardiometabolic conditions such as heart failure, musculoskeletal issues such as back strain, and behavioral health conditions such as depression.
“Digital health technologies are rapidly transforming how people manage chronic conditions, and we want to ensure our regulatory approach keeps pace,” said CDRH director Michelle Tarver, MD, PhD, in a release. “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 TEMPO pilot is a component of the FDA’s Home as a Health Care Hub initiative. By fostering access to digital technologies that can be used safely and effectively in the home, the initiative seeks to improve outcomes and reduce the burden of chronic disease for people in the US. The pilot also draws on CDRH’s experience with the Total Product Life Cycle Advisory Program, which has shown how early collaboration and proactive input can streamline device development. The FDA says these lessons have helped shape TEMPO’s emphasis on early engagement, “sprint” discussions, and real-world data collection.
The FDA is seeking statements of interest for participation in the TEMPO pilot beginning in January 2026. The FDA plans to select up to about 10 manufacturers in each of four specific clinical use areas to participate in the pilot.
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