Access Unlocked Part 2: FDA Launches TEMPO Pilot to Advance Digital Health Under CMMI’s ACCESS Model

On Friday December 5, 2025, the Food and Drug Administration (FDA) a regulatory notice announcing the Technology-Enabled Meaningful Patient Outcomes (TEMPO) Pilot in connection with Center for Medicare and Medicaid Innovation (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) Model, aiming to expand access to innovative digital health devices while safeguarding patient safety. See Manatt’s detailed analysis of the ACCESS Model . There is a tight timeframe to express interest in the TEMPO Pilot as Statements of Interest are due January 2, 2025.

TEMPO Pilot Overview:

FDA generally expects devices used under the CMMI ACCESS model to be authorized for their intended use. However, manufacturers of certain digital health devices that are not yet authorized may still apply to participate in the TEMPO Pilot and request FDA to exercise enforcement discretion, allowing the devices to be offered to ACCESS participants without FDA premarket authorization for improving patient outcomes while care is covered by the model. As part of this pilot, FDA anticipates that participating manufacturers will collect real-world data during clinical use, which can generate real-world evidence to inform the benefit-risk profile of their devices and support FDA’s future review. Manufacturers must share such data with FDA during the TEMPO Pilot and, using the collected information along with other required materials, seek appropriate marketing authorization for their devices. Essentially, the TEMPO Pilot may be a glidepath to FDA approval, although as noted below, it’s not a guarantee.

FDA plans to limit participation in the TEMPO Pilot to ten U.S.-based manufacturers in each of the four clinical use cases (so up to 40 may be selected in total):

• Early cardio-kidney-metabolic conditions (e.g., hypertension, obesity, pre-diabetes)
• Cardio-kidney-metabolic conditions (e.g., diabetes)
• Chronic musculoskeletal pain
• Behavioral health (e.g., depression, anxiety)

FDA will select digital health devices that pose no serious risk to patient health, safety, or welfare. Eligible products, including AI-enabled tools, must meet the definition of a device under the federal Food, Drug, and Cosmetic Act (FD&C Act) and be intended for clinician-supervised outpatient treatment in one of the four CMMI clinical areas.

ACCESS participants who use a device in the TEMPO Pilot must obtain enhanced consent from beneficiaries, informing them that the device is part of an FDA pilot and that specific data will be shared with the FDA, as required by federal privacy and security laws.

Relevant Timeline for Interested Manufacturers

Manufacturers must submit a Statement of Interest to FDA by January 2, 2026 to participate in the TEMPO Pilot. The Statement of Interest should include a description of the device along with its intended use and proposed claims, evidence of safety and potential patient benefit, details on the manufacturer’s quality management system, and a risk mitigation plan that includes real-world data collection and monitoring. Interested manufacturers should also submit proposed performance goals, a statistical analysis plan, a timeline for marketing submission, and an interim reporting plan for adverse events, risks, and progress updates.

FDA will send follow-up requests for additional information around March 2, 2026. FDA will notify manufacturers of its decision after reviewing their statements of interest. Pilot participants will be encouraged to join “sprint” discussions—short, focused engagements (e.g., 45 days) to resolve specific topics related to marketing submissions. While data collected during the TEMPO Pilot can support a future submission, additional data may be required, and FDA notes that participation does not guarantee FDA approval.