FDA and CMS launch TEMPO pilot to test real-world use of digital health devices

Through the TEMPO pilot and CMS’s ACCESS model, the US regulator will allow limited, supervised use of certain digital health devices while real-world data (RWD) are generated to inform future regulatory and payment decisions.

The US Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) and the Centers for Medicare and Medicaid Services (CMS) have announced a coordinated, first-of-its-kind pilot designed to test whether real-world use of digital health devices can support both evidence generation and access within the Medicare program. The initiative links the FDA’s Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot (TEMPO) with the CMS’s Center for Medicare and Medicaid Innovation (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model. Full details of the pilot were published in the Federal Register on December 8, 2025.

TEMPO is a voluntary FDA pilot that applies targeted, risk-based enforcement discretion to allow certain digital health devices to be used in routine, clinician-supervised outpatient or home-based care before full FDA marketing authorization. The pilot focuses on four clinical areas aligned with the ACCESS model: early cardio-kidney-metabolic conditions, established cardio-kidney-metabolic conditions, musculoskeletal conditions, and behavioral health conditions. Eligible technologies may include software, wearable, sensor-based, or AI-enabled devices.

Participation in TEMPO is limited to US-based manufacturers, with up to 10 permitted per clinical use area. As part of the pilot, manufacturers must collect RWD on device performance for the intended use while the devices are integrated into care delivered under the CMS ACCESS model. Participating manufacturers must share this data with the FDA and use the resulting evidence, together with other required information, to support an appropriate FDA marketing authorization submission. The FDA stresses that TEMPO does not constitute a coverage pathway or an alternative approval route and does not guarantee clearance, approval, or payment.

In parallel, CMS’s ACCESS model introduces outcome-aligned payments for managing qualifying chronic conditions in Medicare beneficiaries. Reimbursement will be tied to achieving measurable health outcomes, with CMS monitoring quality and performance, and retaining the ability to terminate organizations that fail to meet required standards.

By running TEMPO alongside ACCESS, FDA and CMS aim to observe how digital health devices perform in real clinical settings and assess whether structured real-world evidence (RWE) generation can support both regulatory decision-making and value-based payment models. The approach seeks to address a long-standing challenge in digital health, where developers struggle to generate outcomes evidence without real-world use, while providers and payers are hesitant to adopt technologies lacking regulatory authorization and demonstrated value.

The FDA will begin accepting statements of interest for TEMPO on January 2, 2026, with follow-up requests expected from March 2026. CMS is expected to open applications for the ACCESS model in early 2026, with the first performance period beginning July 1, 2026.