Written By: Pharmacally Medical News Desk
The U.S. Food and Drug Administration has introduced a new pilot program called Technology-Enabled Meaningful Patient Outcomes (TEMPO). The goal is to make it easier for patients with chronic diseases to use innovative digital health tools, while still ensuring safety.
TEMPO was created by the FDA’s Center for Devices and Radiological Health (CDRH). It applies a risk-based approach, so lower-risk digital tools can be used in real life before going through full regulatory requirements. The program focuses on devices for cardio-kidney-metabolic conditions, musculoskeletal disorders, and behavioral health. This reflects how fast digital health technologies are evolving and how often they need real-world testing to show value.
Partnership with CMS ACCESS Model
The pilot connects closely with the CMS Innovation Center’s ACCESS model (Advancing Chronic Care with Effective, Scalable Solutions). ACCESS supports technology-enabled care for Medicare beneficiaries who are managing common chronic illnesses.
Manufacturers participating in TEMPO can have their devices included under ACCESS. In return, they must collect and share real-world performance data with both FDA and CMS. This data will help regulators understand how well these devices work in everyday use, not just in controlled studies.
CMS Administrator Mehmet Oz said the partnership helps modernize chronic disease care by expanding access to reliable technology-based solutions for older adults.
How Enforcement Discretion Works
One major feature of TEMPO is that companies can request enforcement discretion. This means the FDA may choose not to enforce certain requirements, such as:
- Premarket authorization
- Investigational Device Exemptions (IDEs)
To qualify, manufacturers must show that their device is performing as expected and is appropriate for real-world use. Eligible devices include tools for conditions like prediabetes, heart failure, back strain, depression, and other chronic issues where iterative digital innovation is common.
The program also offers early development support through “sprint discussions,” building on CDRH’s Total Product Life Cycle Advisory Program (TAP). These short, focused interactions help companies quickly address scientific or regulatory questions.
Why TEMPO Matters
TEMPO supports the FDA’s broader Home as a Health Care Hub initiative, which encourages safe use of medical technologies in home settings. By reducing barriers for well-designed digital tools, the FDA aims to improve chronic disease outcomes while lowering care burden for patients and caregivers.
FDA Commissioner Marty Makary said the program could accelerate access to promising care models for millions of people. CDRH Director Michelle Tarver noted that the pilot will generate important evidence about how digital devices perform outside traditional clinical environments.
What Happens Next
The FDA will start accepting statements of interest in January 2026. The agency plans to select up to 10 manufacturers in each of four clinical categories included in the ACCESS model.
References
FDA Launches TEMPO: A First-of-Its-Kind Digital Health Pilot to Expand Access to Chronic Disease Technologies, 05 December 2025, https://www.fda.gov/news-events/press-announcements/fda-launches-tempo-first-its-kind-digital-health-pilot-expand-access-chronic-disease-technologies
Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, Docket No. FDA-2025-N-6461, US FDA, https://public-inspection.federalregister.gov/2025-22190.pdf
Digital Health Center of Excellence, 04 December 2025, https://www.fda.gov/medical-devices/digital-health-center-excellence