What happened
The Food and Drug Administration opened its Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot to applicants on January 2, according to the agency's press announcement and a notice published in the Federal Register on December 8, 2025. The FDA first announced the pilot on December 5, 2025.
TEMPO is a voluntary program run by the FDA's Center for Devices and Radiological Health. It covers remote patient monitoring tools, remote therapeutic monitoring tools, digital therapeutics, wearables and AI-enabled software platforms intended for four specific chronic-condition categories: early cardio-kidney-metabolic risk (hypertension, dyslipidemia, obesity with a marker of central obesity, or prediabetes), established cardio-kidney-metabolic disease (diabetes, chronic kidney disease or atherosclerotic cardiovascular disease), chronic musculoskeletal pain, and behavioral health conditions including depression or anxiety, per the Federal Register notice.
The pilot runs alongside a separate initiative from the CMS Innovation Center: the Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model, announced December 1, 2025, which tests outcome-linked Medicare payments for technology-supported chronic care.
Who is affected
Digital health device manufacturers whose products fall into one of the four TEMPO clinical categories and who want to reach patients through the CMS ACCESS model are the direct audience. According to the Federal Register notice, a manufacturer selected for TEMPO may ask the FDA to exercise enforcement discretion over specific requirements, including premarket authorization, investigational device exemption rules, informed consent, and institutional review board oversight, for a device used within the ACCESS model's scope.
In exchange, participating manufacturers are expected to collect, monitor and report real-world performance data on how their devices affect patient outcomes, the notice states. The FDA and CMS have said the arrangement is meant to give both agencies a clearer picture of how these tools perform outside a controlled premarket study before any broader authorization decision is made.
Clinicians and health systems that already use remote monitoring or behavioral health software are not required to do anything differently as a result of this announcement. The pilot changes how the FDA treats a manufacturer's regulatory obligations for a specific device and use case, not the standing of currently marketed products.
What manufacturers should know
The application window opened January 2, 2026. Per the Federal Register notice, a Statement of Interest must include a description of the device and its intended use, the specific claims the manufacturer proposes to make, evidence supporting the device's safety and potential patient benefit, information on the manufacturer's quality management system, and a risk mitigation plan built around the real-world data the manufacturer will collect.
The FDA said it expects to send follow-up requests to selected applicants around March 2, 2026. The agency has not published a closing date for statements of interest.
Coverage of the rule from law firms tracking the FDA, including Morgan Lewis and Jones Day, both publishing December 2025 client alerts, characterized TEMPO as expanding on an existing FDA practice of case-by-case enforcement discretion rather than creating a new statutory authority. Morgan Lewis noted that manufacturers accepted into the pilot still operate at the FDA's discretion, meaning the agency can end enforcement flexibility for a given device if the real-world data raises concerns.
What happens next
The near-term date to watch is early March, when the FDA has said it will follow up with applicants who submitted statements of interest in the initial window. The agency has not said how many manufacturers it plans to select for the pilot's first round or when it will announce chosen participants.
Separately, the CMS ACCESS model that TEMPO is designed to support has its own participant timeline, which CMS has published independently of the FDA's pilot. How the two programs' schedules align in practice, and whether real-world data collected under TEMPO shortens the path to full authorization for any device, are open questions the agencies have not yet addressed publicly.