FDA opens a CMS-linked side door: Use of digital health devices before authorization under the TEMPO pilot

ACCESS and the push for tech-enabled care for chronic disease

FDA’s introduction of the TEMPO pilot follows CMS’s plan to launch the ACCESS model on July 1, 2026. The ACCESS model, CMS states on its website, is a 10-year voluntary payment model that will test “an outcome-aligned payment approach in Original Medicare to expand access to new technology-supported care options that help people improve their health and prevent and manage chronic disease.”

The model focuses on chronic conditions affecting more than two-thirds of Medicare beneficiaries, including hypertension, diabetes, chronic musculoskeletal pain, and depression, and introduces “outcome-aligned payments”—recurring payments tied to whether participating organizations achieve “measurable health outcomes” rather than the volume of services delivered. Medicare Part B enrolled providers and suppliers, other than durable medical equipment and laboratory suppliers, are eligible to participate in the ACCESS model.

CMS expects that ACCESS participants will “offer integrated, technology-supported care,” including digital technologies such as telehealth, wearables, and apps, and the use of both FDA-authorized devices and devices subject to FDA enforcement discretion. ACCESS participants are expected to share care plans and updates with the patient’s referring physician, and Medicare will pay the referring physician a fee for co-management services.

TEMPO and a targeted enforcement-discretion pathway

Developed by FDA’s Center for Devices and Radiological Health, the TEMPO pilot will operate “in connection with” the ACCESS model to “promote access to certain digital health devices while safeguarding patient safety.” Key elements from FDA’s press release and Federal Register notice include:

• Scope and purpose. The pilot is geared toward (1) manufacturers of certain digital health devices (2) that want ACCESS participants to offer their devices for an intended use that would generally require premarket authorization but (3) do not yet have authorization. The pilot provides such manufacturers an optional pathway to have their devices “used in providing care expected to be covered by” the ACCESS model subject, instead, to FDA enforcement discretion.
• Enforcement discretion. TEMPO participants may ask FDA to not enforce “certain applicable requirements”—such as premarket authorization—when their devices are used by or offered to ACCESS participants for “an intended use to improve patient outcomes.” Consistent with its usual practice when exercising enforcement discretion, FDA will work with TEMPO participants to identify device-specific conditions under which enforcement discretion may be appropriate, such as labeling and record-keeping.
• Real-world data collection requirement. FDA “expects” TEMPO participants to “collect real-world data relating to the intended uses of their devices” under the ACCESS model. It also expects that participants will share those data with FDA during the pilot and use them to generate real-world evidence to support a marketing submission for full authorization—a point consistent with FDA’s recent, broader emphasis on the use of real-world data and evidence to inform FDA decision-making. The ACCESS model FAQs likewise add that the use of TEMPO devices must be “consistent with any plan for mitigating risks to patients and collecting, monitoring, analyzing, and reporting real-world performance data that the manufacturer has discussed with FDA.”

• Participation and selection mechanics.
  • FDA will begin accepting statements of interest on January 2, 2026, with follow-up requests to potential participants expected to start around March 2, 2026.
  • It plans to select “up to about ten” U.S. manufacturers of digital health products that:
  • (1) meet the definition of a device under the Food, Drug, and Cosmetic Act, including those that are AI-enabled and that rely on off-the-shelf platforms such as wearables; and
  • (2) “are intended to be used in conjunction with clinician-supervised outpatient treatment to patients with conditions in one of the following four CMMI ACCESS clinical use areas”:
  • (i) early cardio-kidney-metabolic (hypertension, dyslipidemia, obesity or overweight with marker of central obesity, or prediabetes);
  • (ii) cardio-kidney-metabolic (diabetes, chronic kidney disease, or atherosclerotic cardiovascular disease);
  • (iii) musculoskeletal (chronic musculoskeletal pain); or
  • (iv) behavioral health (depression or anxiety).
  • In selecting participants, FDA has communicated that it will consider whether the use of the digital health device presents “a potential for serious risk to the health, safety, or welfare of patients.”
• Disclosure under ACCESS. ACCESS participants choosing to use a TEMPO device must obtain “enhanced consent” from beneficiaries “informing them that the device is participating in an FDA pilot and that certain data will be shared with FDA,” consistent with applicable privacy and security requirements.

In short, the TEMPO pilot provides a structured enforcement-discretion pathway for certain digital health devices to be used within the ACCESS model while companies gather real-world evidence to support eventual marketing authorization. FDA notes also that companies in the program would also be able to engage in sprint discussions with the agency to resolve specific topics, comparable to the sprint discussions associated with breakthrough designation, as we wrote about here and here.

What we still don’t know

FDA’s notice, while helpful in understanding the pilot’s contours, still leaves several open questions:

• Selection criteria and process. FDA has not specified how it will evaluate applicants beyond assessing the potential for serious risk to patient health, safety, and welfare, as noted above.
• Enforcement discretion conditions. Although FDA says it will identify device-specific conditions for enforcement discretion, the full scope of general oversight, if any, is unclear. Beyond the investigational device provisions, this program may allow for commercial use, and associated commercialization and promotion of products, that typically would be prohibited under the device regulations. It is unclear whether FDA will require any routine reporting of safety, performance, or quality-related activities along with participation in the program. It is also unclear whether enforcement discretion will extend to compliance with the quality system regulation. The Federal Register notice seems to indicate that the extent of the discretion may vary for different devices in the program.
• Real-world data sufficiency. FDA notes that real-world data from TEMPO participation may—indeed, should—support future marketing submissions, requesting that companies submit in their proposal a timeline for submission of a marketing application based on the data collection, while also noting that additional data beyond the real-world data may be required. Use of real-world data in the medical device space to support marketing applications has lagged, with FDA strongly preferring prospective trials aimed at a specific outcome measure; therefore, the value of this real-world data alone to support an application remains to be seen.
• Duration and impact. The notice does not specify how long a device can remain under TEMPO enforcement discretion or the process for manufacturers to exit (or be removed from) the TEMPO pilot and how that may affect associated care under the ACCESS model. Although FDA cautions in its Federal Register notice that “[p]articipation in the TEMPO pilot is not an indication of whether FDA will issue a positive decision for any future marketing submission,” the downstream regulatory consequences of inconclusive or negative real-world data are otherwise unclear, along with whether companies could engage in multiple or serial trials under the program.

For digital health manufacturers focused on chronic disease management, the combination of the ACCESS model and TEMPO pilot may create a new pathway to scale technology-enabled care before premarket authorization while minimizing regulatory risk, provided companies are prepared to operate under oversight and generate submission-quality real-world evidence. A compelling statement of interest will require careful articulation of how the device will improve patient outcomes, alignment with the ACCESS model, and a robust plan for safety, risk mitigation, data collection, and a future marketing submission. It will also require quick action, with statements accepted starting January 2, 2026.

If you would like help preparing a statement of interest, please contact the authors or the Hogan Lovells attorney with whom you usually work.

Authored by Lina Kontos, Kristin Zielinski Duggan, Stuart Langbein, Beth Roberts, and Elizabeth Halpern.