The US Food & Drug Administration (FDA) has announced a voluntary pilot to promote access to certain digital health devices while safeguarding patient safety.

The Technology-Enabled Meaningful Patient Outcomes (Tempo) 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 behavioural health conditions.

“We are piloting an approach to encourage the use of digital technologies that meet people where they are,” said FDA commissioner Marty Makary. “This pilot supports innovative tools and a healthcare delivery model that could improve care for millions of Americans managing chronic disease.”

Participating manufacturers of certain digital health devices will offer devices for an intended use to provide care 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.

“CMS is pleased to partner with the FDA on the Tempo pilot as we work to modernise care for people with chronic disease,” said Centers for Medicare & Medicaid Services (CMS) administrator Mehmet Oz. “Insights from this collaboration will support our efforts to build models that expand access to high-quality, technology-enabled care.”

Under this approach, participating manufacturers may request that the FDA exercise enforcement discretion for certain requirements, such as premarket authorisation and investigational device requirements, while manufacturers collect and share real-world data demonstrating the device’s performance. The FDA will work with participants in the Tempo pilot to identify the circumstances when enforcement discretion may be appropriate for that manufacturer’s device.

This 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 behavioural 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 Center for Devices & Radiological Health (CDRH) director Michelle Tarver. “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 a component of the FDA’s Home as a Health Care Hub initiative (www.fda.gov/medical-devices/home-health-and-consumer-devices/home-health-care-hub), which aims to bring health and wellness to people where they live, work and play. 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 USA.

The pilot also draws on CDRH’s experience with the Total Product Life Cycle Advisory Program (www.fda.gov/medical-devices/how-study-and-market-your-device/total-product-life-cycle-advisory-program-tap), which has shown how early collaboration and proactive input can streamline device development. These lessons have helped shape Tempo’s emphasis on early engagement, sprint discussions and real-world data collection.

The FDA (www.fda.gov) is seeking statements of interest for participation in the Tempo pilot beginning in January 2026. The FDA plans to select up to about ten manufacturers in each of four specific clinical use areas to participate in the pilot. For more information, see public-inspection.federalregister.gov/2025-22190.pdf.