What's Happening?
The Food and Drug Administration (FDA) has introduced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot program, designed to work alongside the Centers for Medicare & Medicaid Services (CMS)
ACCESS model. This initiative aims to select approximately 40 medical devices that have not yet received FDA clearance to participate in the chronic care Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model. The TEMPO pilot will allow these devices to be used in outpatient settings under certain conditions, focusing on areas such as cardio-kidney-metabolic, musculoskeletal, and behavioral health. The FDA plans to use real-world data to assess the benefit-risk profiles of these devices, potentially aiding in their future authorization.
Why It's Important?
The introduction of the TEMPO model is significant as it represents a shift towards integrating real-world data in the evaluation of medical devices, which could accelerate the approval process for innovative technologies. This initiative could benefit patients with chronic conditions by providing earlier access to potentially life-improving devices. It also encourages manufacturers to gather more evidence on their products, which could lead to more informed regulatory decisions. The program's focus on diverse device categories highlights the FDA's commitment to addressing a wide range of chronic health issues, potentially improving patient outcomes and reducing healthcare costs.
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 agency will select devices based on their potential to meet clinical outcomes and their ability to be used in outpatient settings. This pilot could lead to broader adoption of real-world evidence in regulatory processes, influencing future FDA policies and potentially setting a precedent for other regulatory bodies worldwide.
