December 2025 — Washington, D.C. — The U.S. The Food and Drug Administration (FDA) has formally announced the launch of the Technology‑Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, marking a significant shift in how digital health technologies for chronic disease care may reach patients and markets. TEMPO is being introduced in coordination with the Centers for Medicare & Medicaid Services (CMS) Innovation Center’s ACCESS model (Advancing Chronic Care with Effective, Scalable Solutions). ACCESS is a chronic care framework that ties Medicare reimbursement to measurable patient outcomes rather than traditional fee‑for‑service models.
WHAT IS FDA TEMPO PILOT ?
A voluntary pilot targeting digital health devices intended to improve real‑world outcomes for chronic care conditions such as cardio‑kidney‑metabolic, musculoskeletal, and behavioral health.Designed to evaluate a risk‑based enforcement approach, where participating manufacturers may request that fda tempo pilot exercise enforcement discretion for certain regulatory requirements such as premarket authorization while devices are used under the CMS ACCESS model.Â
Who Can Join
- FDA will begin accepting Statements of Interest from manufacturers starting January 2, 2026.
- The agency plans to select up to ~10 manufacturers for each defined clinical area of the pilot.Â
WHAT MANUFACTURERS MUST DO UNDER DIGITAL HEALTH DEVICE REGULATION
Participating companies will be expected to:
- Collect and report real‑world performance data on how their device performs in day‑to‑day clinical settings.
- Work closely with the FDA to determine appropriate situations where enforcement discretion may be applied.
- Ensure patient safety and transparency while technology is in use.
WHY THIS MATTERS FOR MANUFACTURERS
Faster Patient Access
TEMPO offers a pathway for devices particularly digital tools with potential outcome benefits to be used in real‑world care settings before full FDA clearance, potentially accelerating adoption and data generation.
Real‑World Evidence Focus
The pilot acknowledges the value of real‑world evidence (RWE) in understanding how digital health technologies perform outside clinical trials. Manufacturers can leverage RWE to support future full regulatory submissions.
Alignment With Payment Innovation
By linking device use to CMS’s ACCESS model which emphasizes outcome‑aligned payments, manufacturers may find new pathways to integration into care delivery systems that reward measurable health improvements.
Regulatory Flexibility With Oversight
Although enforcement discretion may ease some premarket regulatory burdens temporarily, participants must still comply with safety expectations and data reporting. This is not a permanent bypass of regulatory requirements.
What Manufacturers Should Do Next
Prepare now for the January 2026 Statement of Interest window by: Reviewing device use cases where TEMPO may be applicable (e.g., chronic disease monitoring tools, sensor platforms, software‑based therapeutic guidance).Mapping real‑world evidence collection plans. Assessing alignment with CMS ACCESS patient outcomes goals.
In Summary
The FDA’s TEMPO Pilot signals a new regulatory direction that embraces real‑world data and outcome‑based innovation for digital health. For medical device manufacturers, especially those in digital therapeutics and chronic care solutions, TEMPO offers a strategic opportunity to accelerate patient access while contributing to evidence generation that could shape future regulatory pathways.As this pilot rolls out in early 2026, stakeholders across industry, clinical practice, and reimbursement networks will be watching closely.