FDA’s TEMPO Pilot: Boosting Access to Digital Chronic Disease Tools

The FDA has introduced a new pilot program called TEMPO. This program will allow selected digital health technologies for chronic diseases to be used in real-world care while manufacturers gather evidence on their performance. The initiative aims to see whether defined regulatory flexibility can help bring digital tools into clinical settings sooner, especially for conditions requiring ongoing monitoring and long-term self-management.

Chronic diseases like diabetes, heart failure, hypertension, musculoskeletal conditions and behavioral health conditions such as depression affect millions of Americans and lead to many preventable hospitalizations. Many patients face challenges in getting continuous follow-up, and healthcare providers often lack real-time data to adjust care.

Digital health tools can support home-based management, but most require premarket authorization before they can influence outcomes in routine practice.

Reviews show increased use of digital technologies in clinical studies, particularly for continuous monitoring and remote data collection. A paper in Neurology on ALS also showed that digital tools can capture important information that traditional clinic visits often miss.

Over the last decade, the FDA has explored several approaches that use earlier or real-world evidence in narrow, well-defined settings, including accelerated approval for drugs using surrogate endpoints, oncology review pilots and digital health experiments such as Pre-Cert.

TEMPO, which stands for Technology-Enabled Meaningful Patient Outcomes, focuses on digital health devices used in managing chronic diseases. These might include software-based monitoring tools, connected sensors or app-supported behavioral interventions that help clinicians track disease trends between visits.

Under this pilot, the FDA may choose to relax certain premarket requirements so selected devices can be used in a closely managed care and payment environment while evidence is gathered.

The pilot is being launched with the Centers for Medicare & Medicaid Services through the ACCESS Model, a new chronic care payment initiative linking recurring payments to measurable improvements in patient outcomes.

Devices under TEMPO would only be used within participating ACCESS organizations. Manufacturers must collect data on device performance, safety and clinical impact during the model period.

Data may include patterns in symptom control, adherence, functional status or condition-specific measures relevant to conditions such as diabetes, heart failure, hypertension and depression. The FDA noted that the pilot will help evaluate how digital tools perform in real-life settings, where patient behavior, technology reliability and care team workflows can differ greatly.

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TEMPO is not a pathway for authorization. Devices chosen for the pilot will still need to complete their standard regulatory submissions if developers seek full market clearance or authorization. Participation does not guarantee future approval. The pilot instead provides a structured environment for testing real-world use while maintaining safeguards around oversight, data monitoring and participant protections.

The FDA stated that there will be limited manufacturer selection, with the agency accepting statements of interest starting January 2, 2026.

Companies selected for the pilot must work with ACCESS participants, follow data collection requirements and report safety findings according to existing regulations.

For clinicians and health systems, the pilot points to a potential shift toward more continuous, tech-enabled care models. Organizations involved in ACCESS may integrate selected digital tools into care plans, where real-time data could help with earlier interventions or more individualized therapy adjustments. Implementation will require attention to workflow design, staff training and patient usability, reflecting the practical aspects of technology-enabled chronic care.

Earlier this year, the FDA described a plausible-mechanism approach for certain small-population therapies (March 2025). This approach allows initial approval based on limited but clinically meaningful evidence supported by a strong biological rationale, followed by mandatory post-market data collection.

Both initiatives, while separate and aimed at different product types, explore how earlier, real-world evidence collection might support regulatory decision-making under defined safeguards.

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