Doxiverse Staff - August 2026
The FDA has selected Dexcom as the first participant in its new Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, marking the first real-world test of a regulatory approach designed to work alongside a CMS outcomes-based payment model.
Under TEMPO, the FDA may exercise enforcement discretion for certain regulatory requirements while eligible digital health technologies are used within the CMS Innovation Center's ACCESS Model and manufacturers collect real-world performance data. The approach allows selected technologies to be evaluated in clinical use while generating evidence that may later support a traditional FDA marketing submission.
Why it matters: TEMPO creates a closely coordinated pathway between FDA device oversight and Medicare payment policy. Certain new intended uses of digital health technologies may be deployed within a defined Medicare care model under FDA enforcement discretion while real-world evidence is collected, before the manufacturer obtains conventional FDA marketing authorization for that intended use. For healthcare organizations evaluating AI-enabled digital health tools, participation in TEMPO should therefore not be interpreted as equivalent to FDA clearance or approval.
What Happened
On July 22, 2026, the FDA announced Dexcom as the first manufacturer selected for the TEMPO pilot. The agency said the Dexcom Glucose Health Program will continue to be evaluated for its intended use during the pilot and is intended to address two clinical use areas within CMS's ACCESS Model.
The program is designed to help patients participating through ACCESS, along with clinicians or caregivers, monitor metabolic and nutritional status, receive tailored guidance, and access real-time data and AI-generated insights to support decision-making and behavioral changes.
The FDA says the program is also intended to aid screening for prediabetes and Type 2 diabetes using integrated digital health metrics and may contribute to improved glycemic control and lower HbA1c in people with prediabetes. These are intended uses and potential benefits being evaluated through the pilot, rather than outcomes already demonstrated by TEMPO.
Dexcom says the program combines data from its Dexcom G7 and Stelo glucose biosensors with contextual health information including nutrition, physical activity, sleep, and stress. The company describes the resulting system as an AI-powered glucose health program intended to provide clinicians and eligible users with more personalized metabolic-health insights.
Importantly, TEMPO focuses on the specific intended use being evaluated. FDA guidance states that manufacturers of digital health devices not already authorized for an intended use covered by the ACCESS clinical areas may participate in TEMPO. Participation does not amount to a blanket new FDA authorization for the technology or its intended use.
How TEMPO Connects to Medicare
TEMPO is explicitly linked to a separate CMS Innovation Center program called the ACCESS Model - Advancing Chronic Care with Effective, Scalable Solutions.
ACCESS launched on July 5, 2026, and is designed as a 10-year voluntary Medicare model testing an outcome-aligned payment approach for technology-supported chronic care. Instead of tying payment primarily to individual services, CMS is testing payments linked to measurable patient outcomes.
The model initially covers four clinical areas:
- Early cardio-kidney-metabolic (eCKM): hypertension, dyslipidemia, obesity or overweight with central obesity, and prediabetes
- Cardio-kidney-metabolic (CKM): diabetes, chronic kidney disease, and atherosclerotic cardiovascular disease
- Musculoskeletal: chronic musculoskeletal pain
- Behavioral health: depression and anxiety
The FDA plans to select up to about 10 TEMPO manufacturers in each of these four clinical use areas, with participants representing a broad range of U.S.-based manufacturers. The agency continues to accept statements of interest and has not announced a final deadline for participation.
The significance of the FDA-CMS relationship is that the two agencies are testing complementary approaches: ACCESS provides a Medicare payment framework for eligible technology-supported care, while TEMPO provides a regulatory structure for collecting real-world evidence on selected digital health technologies used within that model.
What This Means for Practices and Health Systems
For practices and health systems participating in or considering participation in ACCESS, Dexcom's selection signals that an AI-enabled glucose and metabolic health program could become part of the technology-supported care ecosystem available through the model.
The larger significance extends beyond diabetes.
Dexcom is the first test case of a new FDA-CMS coordination mechanism that could eventually include digital health technologies targeting cardiovascular and kidney disease, obesity, chronic musculoskeletal pain, depression, and anxiety.
Healthcare organizations evaluating products entering through TEMPO will need to understand an important regulatory distinction:
TEMPO participation is not the same as FDA clearance or approval.
FDA may choose not to enforce certain premarket requirements while a device is participating in the pilot under defined circumstances. The agency nevertheless expects TEMPO manufacturers to ultimately seek appropriate FDA marketing authorization, potentially using real-world data generated during the pilot along with other supporting evidence.
FDA also makes clear that the enforcement-discretion framework is tied specifically to use within ACCESS. Offering a device for the same intended use outside the ACCESS Model would fall outside TEMPO, and FDA authorization would generally be required for that use.
What's Still Unsettled
TEMPO is an enforcement-discretion pilot, not a replacement for the existing FDA device authorization system.
FDA says it will determine with individual participants when enforcement discretion may be appropriate and may elect not to enforce certain requirements, including premarket authorization requirements, while a technology participates in the pilot. Manufacturers are still expected to eventually pursue the appropriate FDA marketing authorization.
That makes the evidence generated during TEMPO particularly important. Participating manufacturers must collect, monitor, and report real-world data related to their devices' intended uses, giving FDA and CMS information about how the technologies perform outside a conventional premarket study environment.
For Dexcom specifically, the potential benefits described so far including earlier identification of metabolic disease, more personalized intervention, improved glycemic control, and lower HbA1c should be viewed as intended or potential outcomes, not as results established by the TEMPO pilot. Real-world evidence collection is part of what the program is designed to generate.
FDA has also not yet identified the full roster of TEMPO participants. As of its July 22 announcement, Dexcom was the first manufacturer selected, while additional statements of interest remained under consideration.
The Bigger Picture
TEMPO represents an unusual attempt to bring regulation, reimbursement, and real-world evidence generation closer together for digital health technologies.
Rather than treating regulatory review and Medicare payment as entirely separate processes, FDA and CMS are testing whether selected technologies can be deployed within a controlled care and payment model while evidence about their performance is generated in real-world use.
If successful, the framework could become an important model for how AI-enabled and software-driven medical technologies move from development into clinical care particularly in areas where products evolve faster than traditional evidence-generation and reimbursement pathways.
Sources
- U.S. Food and Drug Administration: FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot, July 22, 2026.
- U.S. Food and Drug Administration: TEMPO for Digital Health Devices Pilot — program information and frequently asked questions.
- Centers for Medicare & Medicaid Services: ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model.
- Dexcom: Dexcom Announced as First Participant Selected for FDA's TEMPO Digital Health Devices Pilot Program, July 22, 2026.