The TEMPO pilot, developed by FDA’s Center for Devices and Radiological Health, introduces a risk-based enforcement approach for certain digital health devices intended to improve outcomes in cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions. The program aligns with the Centers for Medicare & Medicaid Services (CMS) Innovation Center’s Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model, a new initiative launching in July 2026 to expand technology-enabled integrated care for Medicare beneficiaries. For more information on ACCESS, read key takeaways from our recent webinar, ACCESS Explained: What CMS’s New Model Could Mean for Digital Health.

The ACCESS model introduces outcome-aligned payments, recurring payments tied to measurable health outcomes rather than service volume. The ACCESS model is designed to complement traditional care by addressing gaps in chronic condition management through technology-supported care and outcome-based payment structures. Under ACCESS, clinicians can integrate technology-supported care for chronic disease management while CMS monitors performance and publishes risk-adjusted outcomes. TEMPO supports this effort by enabling manufacturers to deploy digital health devices for ACCESS-covered care under FDA enforcement discretion while collecting real-world data to inform future regulatory decisions. ACCESS applications opened January 12, 2026, and the model launches on July 5, 2026.

Chronic conditions such as prediabetes, heart failure, musculoskeletal pain, and depression affect millions of Americans. TEMPO promotes early engagement and streamlined oversight, which can speed access to digital tools that improve care and outcomes. The pilot applies lessons from FDA’s Total Product Life Cycle Advisory Program:

• Short, focused meetings to resolve issues quickly.
• Early input from clinicians, payers, and patients.
• A strong emphasis on real-world evidence.

It also aligns with FDA’s Home as a Health Care Hub initiative, which supports safe use of digital technologies in the home.

Program highlights

For manufacturers, TEMPO offers a pathway to market through regulatory flexibility. Companies whose devices are not yet FDA authorized for the intended use may request enforcement discretion for requirements such as premarket authorization, investigational device exemption rules, and informed consent obligations. In return, participants must collect real-world data during clinical use, share that data with FDA to generate real-world evidence, and later submit a marketing application. FDA stated that it will work closely with participants to define conditions for enforcement discretion, including labeling safeguards and recordkeeping standards.

Eligibility requirements

FDA plans to select about 40 manufacturers, up to 10 in each of the following four clinical areas:

• Early cardio-kidney-metabolic conditions, including hypertension, dyslipidemia, obesity, and prediabetes.
• Cardio-kidney-metabolic conditions, such as diabetes and atherosclerotic cardiovascular disease.
• Musculoskeletal disorders, particularly chronic musculoskeletal pain.
• Behavioral health conditions, such as depression and anxiety.

To qualify for TEMPO, devices must meet the definition of a medical device under the Federal Food, Drug, and Cosmetic Act; pose no serious risk to patient safety; and be intended for clinician-supervised outpatient use. FDA is open to a wide range of technologies, including wearables, connected sensors, and general-purpose computing platforms, and welcomes solutions that incorporate artificial intelligence to enhance patient outcomes.

Participants will be expected to actively monitor and analyze device performance in real-world settings, report adverse events, and provide regular progress updates. To keep development moving, FDA plans to offer “sprint” discussions, which are short, focused sessions designed to resolve regulatory questions quickly and support timely marketing submissions.

Looking forward

Interested manufacturers can act now by preparing a statement of interest that identifies the device, proposed indications, and enforcement discretion request. Manufacturers should be sure to include supporting safety data, quality system details, and a plan for real-world data collection. FDA is accepting statements of interest via email.

Separately, manufacturers should also review FDA’s updated guidance on clinical decision‑support software and non‑invasive wearable monitoring technologies to determine whether their products may fall outside the scope of medical device regulation or premarket review requirements. Products that fall within meet the specified criteria may be marketed without prior FDA submission, creating another abbreviated pathway to market outside of the TEMPO pilot. See our previous client alert for a detailed discussion of the new guidance and applicable criteria.

We will continue to monitor developments related to the TEMPO pilot and the CMS ACCESS model and assess their impact on digital health innovation. For more information, please contact any of the authors of this article or any other member of McDermott Will & Schulte’s Food, Drug & Medical Device Regulatory Practice Group.