US FDA Launches TEMPO Pilot Program

By Stuart Goldman

Background  

On December 5, 2025, the U.S. FDA announced the launch of its Technology‑Enabled Meaningful Patient Outcomes (TEMPO) pilot program. A voluntary, first-of-its-kind collaboration between the FDA Center for Devices and Radiological health (CDRH) and the Centers for Medicare and Medicaid Services (CMS) Innovation Center (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model. 

TEMPO offers a risk-based, enforcement-discretion pathway for digital health devices targeting chronic conditions – such as cardiometabolic, musculoskeletal, and behavioral health – allowing manufacturers to collect real-world data while supporting patient safety and bridging to FDA authorization.

Highlights of the TEMPO Pilot Program

• Evaluates digital health devices that support cardio‑kidney‑metabolic, musculoskeletal, and behavioral health conditions by allowing enforcement discretion on premarket and investigational requirements while real‑world data is gathered.
• Aligns with CMS’s ACCESS model, which ties payments to measurable patient outcomes and expands access to tech-enabled chronic care.
• FDA will select up to ~10 U.S.-based manufacturers in each of four clinical areas, starting January 2026, with selections emphasizing safety and diversity of participants.
• Emphasizes early engagement through “sprint” discussions and requires real-world performance data collection to support eventual marketing submissions.

Benefits of the TEMPO Pilot Program

• Accelerated Access – Patients with chronic conditions gain earlier access to innovative digital health technologies without waiting for full FDA clearance.
• Real-World Evidence Generation – Manufacturers can collect real-world performance data to support future regulatory submissions, improving evidence quality.
• Collaborative Model –Aligns FDA and CMS efforts, linking regulatory flexibility with reimbursement incentives tied to patient outcomes.
• Innovation Encouragement – Reduces regulatory burden, allowing development of novel solutions for underserved chronic disease areas.

Challenges of the TEMPO Pilot Program

• Safety Oversight – Enforcement discretion may raise concerns about ensuring patient safety during early deployment.
• Data Quality and Standardization – Real-world data can be variable; supporting consistency and reliability for regulatory decisions is complex.
• Equitable Participation – Selecting diverse manufacturers and patient populations while maintaining fairness could be challenging.
• Integration with Care Models – Aligning new technologies with existing clinical workflows and reimbursement structures may require significant coordination.

Concluding remarks

The TEMPO Pilot Program represents a major step toward accelerating access to safe, innovative digital health tools for chronic disease management while fostering real-world evidence generation and outcome-based reimbursement. 

The pilot is only available to U.S.-based manufacturers, and manufacturers who are interested should review the FDA TEMPO Pilot Program Notice on how to request to participate. The success of the program will require balancing regulatory flexibility with robust safety oversight and data integrity.