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A new Food and Drug Administration ("FDA") pilot opens the door for digital health devices without FDA premarket authorization to be used to provide care paid under the Center for Medicare and Medicaid Innovation ("CMMI") Advancing Chronic Care with Effective, Scalable Solutions ("ACCESS") model.
On December 5, 2025, the FDA announced the voluntary Technology‑Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot ("TEMPO"), a new risk-based enforcement approach intended to support the use of digital health devices. By enabling earlier market entry and FDA review of real-world data, TEMPO may reshape the current state of competition in the digital health device market and shift the FDA's expectations for premarket authorization of such devices.
Under TEMPO, manufacturers may request that the FDA not enforce certain previously applicable requirements, including FDA premarket authorization, investigational device exemption requirements, or requirements under 21 CFR Parts 50 and 56, when their device is offered to be used to manage qualifying chronic conditions paid under the CMMI ACCESS model. If selected by FDA, manufacturers must then share real-world data collected from the devices with FDA to support FDA's assessment of the device's safety, performance, and potential future application for FDA premarket authorization. Such data will also be used to support broader efforts by FDA and CMS to improve care for people living with chronic disease.
Any digital health product is eligible for selection by FDA under TEMPO if it: (i) meets the definition of a device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (including those that are artificial intelligence-enabled); and (ii) is intended to be used with clinician-supervised outpatient treatment on patients experiencing chronic conditions in any of the following clinical use areas: early cardio-kidney-metabolic, cardio-kidney-metabolic, musculoskeletal, or behavioral health. These digital health devices may rely on off-the-shelf platforms such as general-purpose computing platforms or wearable products (that may or may not be wearable devices subject to FDA clearance or pre-market approval).
The FDA currently expects to select up to 10 U.S.-based manufacturers in each of the above clinical use areas. Additionally, the FDA hopes to include participating manufacturers of various sizes, types, and maturities. Manufacturers interested in TEMPO should draft statements of interest following the procedures described in this Federal Register notice. The FDA will review these statements starting on January 2, 2026, and expects to send follow-up requests to certain applicants around March 2, 2026.
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