FDA's TEMPO Pilot Speeds Up Safe Digital Health Device Access
Published Date: 12/8/2025
Notice
Summary
The FDA is launching the TEMPO pilot to help get cool digital health devices to patients faster while keeping safety a top priority. Starting January 2, 2026, device makers can apply to join this program, which ties payments to real health improvements for people with chronic diseases. This means better care, new tech, and smarter spending for patients and providers alike!
Analyzed Economic Effects
5 provisions identified: 3 benefits, 1 costs, 1 mixed.
Possible Enforcement Discretion for Participants
Manufacturers may ask FDA to exercise enforcement discretion so FDA will not enforce certain legal requirements when their device is offered to or by CMMI ACCESS participants for an intended use to improve patient outcomes. FDA lists examples such as premarket authorization requirements, investigational device exemption (IDE) requirements, and requirements under 21 CFR parts 50 and 56.
Required Real-World Data Collection and Reporting
Manufacturers participating in the TEMPO pilot are expected to collect real-world data (RWD) about their device's intended use, share those data with FDA during participation, and use the data to seek marketing authorization. FDA also requests proposed interim reporting (for example, every 6 months) to report adverse events, new risks, and progress.
Limited US-Based Participant Slots
FDA currently expects to select up to about ten manufacturers based in the United States in each of four clinical use areas for the TEMPO pilot. FDA intends to select U.S.-based manufacturers to facilitate oversight such as inspections and access to records.
Pilot Focus on Four Clinical Use Areas
FDA will consider devices intended for clinician-supervised outpatient treatment in these four clinical use areas: (1) early cardio-kidney-metabolic (hypertension, dyslipidemia, obesity or overweight with marker of central obesity, or prediabetes); (2) cardio-kidney-metabolic (diabetes, chronic kidney disease, or atherosclerotic cardiovascular disease); (3) musculoskeletal (chronic musculoskeletal pain); and (4) behavioral health (depression or anxiety).
Applications Open January 2, 2026
If you make digital health devices, you can submit a "Statement of Interest for Participation in the TEMPO Pilot" starting January 2, 2026. FDA says it will begin follow-up requests to potential participants around March 2, 2026.
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