The U.S. Food and Drug Administration (FDA) has announced a first-of-its-kind regulatory pilot called Technology-Enabled Meaningful Patient Outcomes (TEMPO) aimed at promoting patient access to certain digital health technologies while maintaining safety and real-world monitoring.
Glimpse:
TEMPO is a voluntary pilot for digital health device manufacturers developed by the FDA’s Center for Devices and Radiological Health (CDRH). In collaboration with the Centers for Medicare and Medicaid Services (CMS) Innovation Center, the pilot evaluates novel regulatory approaches that align with patient care needs, particularly for chronic conditions such as cardio-kidney-metabolic diseases, musculoskeletal issues and behavioral health.
The FDA has launched the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, marking a major step toward expanding patient access to digital health innovations in the United States. Designed by the agency’s Center for Devices and Radiological Health (CDRH) in partnership with the CMS Innovation Center’s ACCESS model, TEMPO encourages manufacturers to bring certain digital health tools into real-world care settings while collecting data on performance and patient outcomes. participating manufacturers may apply to have traditional regulatory requirements such as premarket authorization and investigational device rules exercised with enforcement discretion while they collect real-world evidence demonstrating how devices perform in everyday clinical use. This approach aims to reflect the rapid, iterative nature of digital health development and could speed patient access without sacrificing safety.
Eligible devices in the pilot are intended for use in managing common chronic conditions, including cardio-kidney-metabolic conditions (e.g., hypertension, diabetes), chronic musculoskeletal pain, and behavioral health (e.g., depression and anxiety) all areas covered under the ACCESS model. The FDA expects to select up to about ten manufacturers in each target category to participate, with statements of interest invited starting January 2026.
The pilot aligns with the FDA’s broader efforts to modernise digital health regulation and support technology-enabled care particularly in settings like the home as part of the Home as a Health Care Hub initiative. By generating and evaluating real-world data, the FDA and CMS hope to deepen understanding of how digital devices impact patient outcomes, ultimately shaping more flexible, evidence-based regulatory pathways.
“We are piloting an approach to encourage the use of digital technologies that meet people where they are and support innovative tools that could improve care for millions managing chronic disease.”
By
HB Team
