The FDA has named the first company in a pilot program that takes a different approach to regulating digital health devices, letting certain products reach patients while evidence about them is gathered in real use rather than beforehand.
The agency announced on July 22 that Dexcom, a maker of continuous glucose monitors, is the first participant in the Technology-Enabled Meaningful Patient Outcomes pilot, known as TEMPO. The company will run a glucose health program that combines data from its sensors with information on nutrition, physical activity, sleep, and stress.
That sequencing is the part worth understanding. Traditional device review asks a manufacturer to demonstrate safety and effectiveness before the product reaches patients. TEMPO reverses part of that order for a narrow set of products, under conditions the agency defines.
The First Company Through the Door
Dexcom was selected for its Glucose Health Program, which the FDA says it will continue to evaluate for its intended use during the pilot. The program is aimed at two clinical use areas and is intended to help identify and manage prediabetes and type 2 diabetes.
The company described the arrangement as advancing its regulatory pathway for earlier intervention and screening. That framing comes from the manufacturer and reflects its commercial interest, which is worth noting rather than adopting. A company selected for a favorable regulatory pathway has obvious reasons to describe it enthusiastically.
The FDA's own framing is more procedural. Center for Devices and Radiological Health Director Michelle Tarver said that for people living with chronic conditions, "access to the right technology at the right time can be life-changing," and described the selection as a milestone in piloting an approach developed with the CMS Innovation Center.
The agency has indicated additional manufacturers may be selected.
A Pilot Built Around a Medicare Payment Model
TEMPO does not stand alone. It was created alongside a Medicare payment experiment, and the two are designed to work together.
The CMS Innovation Center's ACCESS Model, short for Advancing Chronic Care with Effective, Scalable Solutions, began enrolling its first cohort in July 2026. It covers technology-supported care for certain cardio-kidney-metabolic, musculoskeletal and behavioral health conditions, and bases payment on patient health improvements rather than on individual services delivered.
The pairing creates a loop. A device reaches patients through the Medicare model, the care delivered generates data on what actually happens to those patients, and the FDA and CMS both use that data. The FDA assesses safety and effectiveness. CMS assesses whether the approach is worth paying for.
The logic behind it is that digital health products change constantly. Software updates monthly in ways a hip implant does not, and a review process built around a fixed device struggles with a product that is different by the time review concludes.
Premarket Review Is the Part Worth Watching
The substantive regulatory change is that the pilot would allow certain digital health devices to be exempted from FDA premarket authorization requirements while real-world data is collected, as Healthcare Dive reported.
Premarket review exists because a manufacturer's confidence in its own product is not evidence. Relaxing it, even inside a bounded pilot, is a meaningful step and should be described as one rather than as a routine modernization.
Two things are true at once here. Real-world evidence has genuine advantages over premarket studies, which are conducted in selected populations under controlled conditions that often do not resemble ordinary care. And real-world evidence arrives after patients have used the product, which means any problem it detects has already occurred in someone.
Whether that tradeoff is acceptable depends on the risk profile of the specific device and on how quickly signals get acted upon. A glucose monitoring program that produces a misleading screening result carries different consequences than an implantable cardiac device would. Selecting a lower-risk category first is a defensible way to start.
The FDA has not published details of what monitoring thresholds would trigger intervention, or what happens to patients using a device if a pilot product is withdrawn.
Nothing Changes for Patients This Month
For anyone managing diabetes or prediabetes, this announcement changes nothing about currently available products or how they are prescribed.
Dexcom's existing continuous glucose monitors remain regulated as they were. The pilot concerns a specific program the company intends to offer, and the FDA says it will continue evaluating its intended use during the pilot itself. Availability would run through the ACCESS Model rather than through ordinary prescribing.
Anyone who encounters this program through a Medicare care arrangement in the coming year is entitled to ask their clinician what the device does, what evidence supports it, and whether participation is optional. Those questions apply to any technology introduced through a payment model rather than through a standard prescription.
Nobody should change diabetes management, glucose monitoring, or medication based on a regulatory announcement. Those decisions belong with the treating clinician.
Questions the Pilot Is Designed to Answer
The honest summary is that TEMPO is an experiment about how to regulate, running inside an experiment about how to pay.
What the FDA and CMS will learn is whether real-world evidence collected through a value-based payment arrangement is good enough to support regulatory decisions, and whether it arrives fast enough to catch problems. Neither question has an answer yet, because the first participant was named two weeks ago.
The confirmed fact is that the FDA selected Dexcom as the first TEMPO participant on July 22, in connection with the CMS ACCESS Model. The people most affected are Medicare beneficiaries with chronic conditions who may encounter these devices through that model. The most reasonable action is none, beyond asking questions if the program is offered. The central uncertainty is whether post-market evidence collection provides oversight comparable to premarket review, which is the question the pilot exists to test.
Frequently Asked Questions
What is the TEMPO pilot?
The FDA's Technology-Enabled Meaningful Patient Outcomes pilot for digital health devices, developed with the CMS Innovation Center. It allows certain digital health devices to reach patients while real-world evidence on their performance is collected.
Who was selected?
Dexcom, for its Glucose Health Program, which aims to identify and manage prediabetes and type 2 diabetes.
What is the ACCESS Model?
A CMS Innovation Center payment model covering technology-supported care for certain cardio-kidney-metabolic, musculoskeletal and behavioral health conditions, which bases payment on patient health improvements. Its first cohort began in July 2026.
Does this mean devices skip FDA review entirely?
No. The pilot would exempt certain devices from premarket authorization requirements while data is collected under FDA oversight. The agency says it will continue evaluating the Dexcom program's intended use during the pilot.
Does this change my current glucose monitor?
No. Existing continuous glucose monitors remain regulated as before. This concerns a specific program offered through a Medicare model.
Should I do anything differently?
No. If the program is offered to you through a Medicare care arrangement, ask your clinician what it does, what evidence supports it, and whether participation is optional.
Will other companies join?
The FDA has indicated additional manufacturers may be selected for the pilot.
