FDA Picks Dexcom as First TEMPO Pilot Participant

FDA has a name for the first company to test its newest bet on digital health oversight. On 22 July 2026, the agency announced that Dexcom's Glucose Health Program is the inaugural participant in the Technology-Enabled Meaningful Patient Outcomes — TEMPO — pilot, a program built around enforcement discretion rather than premarket clearance, run in step with the Centers for Medicare & Medicaid Services' ACCESS Model.

A pilot built to move at software speed

TEMPO exists because FDA's ordinary premarket pathways were not built for how digital health devices actually change. Software-driven products iterate continuously; a device cleared once and locked to its labeling can fall behind the version patients are actually using within months. The 8 December 2025 Federal Register notice frames TEMPO as a way to align oversight with that pace: FDA evaluates a risk-based enforcement-discretion approach for devices intended to improve outcomes in four chronic-disease categories — early cardio-kidney-metabolic conditions (hypertension, dyslipidemia, obesity or overweight with a marker of central obesity, or prediabetes), cardio-kidney-metabolic conditions (diabetes, chronic kidney disease, or atherosclerotic cardiovascular disease), musculoskeletal conditions (chronic musculoskeletal pain), and behavioral health (depression or anxiety). The pilot runs as a companion to the CMS Innovation Center's ACCESS Model, whose first cohort of care began in July 2026, so a device's regulatory pathway and its reimbursement pathway move in parallel rather than in sequence.

What selection actually buys a manufacturer

Selection is not a 510(k) clearance or a de novo grant. FDA said it will continue to evaluate the Dexcom Glucose Health Program for its intended use throughout the pilot — the review is ongoing, not resolved. What TEMPO offers instead is enforcement discretion: FDA will decline to enforce certain marketing requirements, including standard device labeling and premarket authorization, while a manufacturer participates. The trade is real-world data. Participants must collect, monitor and report performance data on their devices as used in actual patient care under the ACCESS Model, generating the evidence FDA says it needs to judge whether these technologies deliver in practice rather than in a controlled study. CDRH Director Michelle Tarver, M.D., Ph.D., framed the stakes in FDA's announcement: “For the millions of Americans living with chronic conditions, access to the right technology at the right time can be life-changing. The selection of our first TEMPO participant marks a meaningful milestone as we pilot an approach, in partnership with the CMS Innovation Center, to meet patients where they are and generate the real-world evidence needed to ensure these technologies truly deliver for them.”

Why Dexcom, and why glucose

• The product: Dexcom's Glucose Health Program is intended to enable patients aligned to the ACCESS Model, and their clinicians or caregivers, to monitor metabolic and nutritional status and receive tailored, data-driven guidance.
• The clinical fit: the program addresses two ACCESS Model use areas — serving as an aid in screening for prediabetes and type 2 diabetes, and contributing to improved glycemic control and lower HbA1c in people with prediabetes.
• The company's framing: Dexcom president and chief executive Jake Leach said, “Glucose is one of the body's most powerful health signals, providing immediate insight into a person's overall health.”
• The eligibility filter: TEMPO restricts participation to U.S.-based manufacturers, which FDA says facilitates its oversight of participants, including inspections and access to records — a filter every other applicant now has to clear too.

What it means for the next applicant

TEMPO is a pilot, and Dexcom is one selection out of roughly forty slots FDA has described across four clinical categories. But the shape of the deal is now visible: enforcement discretion in exchange for real-world evidence, packaged around a CMS payment model rather than a standalone FDA authorization. For manufacturers building toward the remaining early cardio-kidney-metabolic, musculoskeletal, and behavioral-health slots, Dexcom's selection is the first working example of what FDA is actually asking for — and the first test of whether real-world data collected this way will hold up as the pilot runs.