The U.S. Food and Drug Administration (FDA) unveiled the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot on December 5, 2025. This groundbreaking initiative is aimed at increasing patient access to digital health technologies for chronic disease management while maintaining patient safety. Clinicians, regulatory professionals, and medical device manufacturers are likely to find this pilot particularly relevant to their work.
What changed?
The FDA, through its Center for Devices and Radiological Health (CDRH), has introduced a voluntary pilot program designed to create a new regulatory pathway. Known as TEMPO, this program will evaluate risk-based enforcement for digital health devices aimed at improving outcomes for patients with chronic diseases such as heart failure, prediabetes, and behavioral health conditions. Manufacturers participating in TEMPO may qualify for enforcement discretion on certain regulatory requirements while collecting real-world data on their devices’ performance.
How will the TEMPO pilot work?
The TEMPO program is a collaboration between the FDA and the Centers for Medicare and Medicaid Services (CMS), specifically its Innovation Center’s Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model. Under TEMPO, eligible manufacturers can work closely with both agencies to deploy digital health devices that align with the ACCESS model’s goals of increasing patient access to integrated, technology-enabled care. These tools must provide data on their real-world safety and performance during the pilot period to better inform future regulatory decisions.
Manufacturers may seek FDA enforcement discretion for premarket requirements such as premarket authorization and investigational device exemptions. This flexibility is intended to support innovative product development while ensuring the safety and efficacy of devices deployed under TEMPO.
Streamlining regulation for real-world applications
The TEMPO pilot emphasizes early engagement and uses an iterative approach to regulatory decisions. Building upon lessons from the Total Product Life Cycle Advisory Program (TAP), the FDA is seeking to improve collaboration with industry while generating valuable real-world evidence about how these devices work in everyday settings.
Which clinical conditions are targeted?
The TEMPO pilot focuses on four critical areas of chronic disease management:
- Cardio-kidney-metabolic conditions: Devices addressing conditions such as prediabetes and heart failure.
- Musculoskeletal conditions: Therapies for issues like back strain and joint pain.
- Behavioral health: Tools designed for the management of depression or anxiety.
This targeted approach enables the FDA to explore how digital health technologies can be optimized for widespread use in these specific patient populations.
Bringing care into the home
The TEMPO pilot is part of the FDA’s broader “Home as a Health Care Hub” initiative, which encourages the adoption of safe, effective digital health technologies in home settings. This initiative is designed to shift care delivery models, making them more accessible and potentially reducing the burden of chronic diseases across the U.S. population.
FAQs
- What is the timeline for the TEMPO pilot?
The FDA will start accepting statements of interest from manufacturers in January 2026. - How many manufacturers will be selected?
The pilot plans to select up to 10 manufacturers per clinical use area. - What kind of devices are eligible?
Devices focusing on cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions will be considered. - What are the benefits for participating manufacturers?
Manufacturers may gain regulatory flexibility and an opportunity to provide real-world evidence supporting their technologies.
Conclusion
The TEMPO pilot represents a significant step forward in regulatory innovation, aiming to facilitate the adoption of advanced digital health technologies for managing chronic diseases. Stakeholders in regulatory affairs, clinical development, and health care delivery models should closely monitor its progress as manufacturers prepare to submit their interest starting in January 2026.
Disclaimer
This content is intended for informational purposes only and should not be considered legal or regulatory advice. Stakeholders should consult appropriate legal professionals for specific guidance.