What's Happening?
The Food and Drug Administration (FDA) has introduced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) model as a companion to the Centers for Medicare & Medicaid Services (CMS) ACCESS model. This initiative aims to select approximately 40 medical
devices that have not yet been cleared by the FDA to participate in a new chronic care model. The ACCESS model, developed by the CMS Innovation Center, seeks to provide stable, recurrent payments for technology used in treating chronic conditions such as diabetes, hypertension, chronic kidney disease, obesity, depression, and anxiety. The TEMPO pilot will allow the FDA to exercise enforcement discretion for devices in the ACCESS program that have not undergone the premarket authorization process. The FDA plans to select about 10 devices for each of the four condition categories: early cardio-kidney-metabolic, cardio-kidney-metabolic, musculoskeletal, and behavioral health. The devices must be intended for outpatient use in conjunction with a clinician and may include those leveraging artificial intelligence.
Why It's Important?
The introduction of the TEMPO model is significant as it represents a strategic effort to accelerate the availability and use of innovative medical devices for chronic disease management. By allowing certain devices to bypass the traditional premarket authorization process, the FDA aims to foster technological advancements that can improve patient outcomes. This initiative could potentially lead to more efficient and effective treatments for chronic conditions, which are a major burden on the U.S. healthcare system. The program also emphasizes the collection of real-world data to generate evidence that can inform the FDA's understanding of the benefit-risk profile of these devices. This could lead to faster regulatory approvals and broader adoption of new technologies in healthcare.
What's Next?
Manufacturers interested in participating in the TEMPO pilot can submit their requests starting January 2, 2026, with the FDA expected to respond by March 2. The selected devices will undergo a process to demonstrate safety and patient benefit, including a plan for mitigating risks and proposed performance goals. The FDA's approach to using real-world data could set a precedent for future regulatory processes, potentially influencing how new medical technologies are evaluated and approved. Stakeholders in the healthcare and medical device industries will likely monitor the outcomes of this pilot closely, as it could impact future innovation and regulatory strategies.
