Digital Health Center of Excellence

UPDATE: December 9, 2025

FDA Announces a Digital Health Devices Pilot

The FDA announces the “Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot,” in connection with the Center for Medicare and Medicaid Innovation (CMMI) Advancing Chronic Care with Effective, Scalable Solutions (ACCESS) model, to promote access to certain digital health devices while safeguarding patient safety. The FDA will collect statements of interest for participation in the TEMPO pilot beginning January 2, 2026. You may find more information in the Federal Register notice here or send an email to FDA-TEMPOPilot@fda.hhs.gov.

Through the CMMI ACCESS model, the Center for Medicare and Medicaid Services (CMS) will test a new payment option that emphasizes patient outcomes. If a manufacturer seeks to offer its device for an intended use to improve patient outcomes, such that it may be used to provide care covered by the CMMI ACCESS model, the FDA generally expects the device to be FDA-authorized for that use. However, manufacturers of certain digital health devices that are not already authorized by the FDA for such use may request to participate in the FDA’s TEMPO pilot and request that the FDA exercise enforcement discretion and not enforce certain applicable requirements, such as premarket authorization requirements, when their device is offered to or by CMMI ACCESS participants for an intended use to improve patient outcomes, to be used in providing care expected to be covered by the CMMI ACCESS model.

As is often the case when the FDA exercises enforcement discretion, the FDA will work with participants in the TEMPO pilot to identify the circumstances when enforcement discretion may be appropriate for that manufacturer’s device, including, for example, when the labeling includes appropriate cautions, and when FDA requests that certain records be maintained. In addition, the FDA expects that manufacturers participating in the TEMPO pilot will collect real-world data relating to the intended uses of their devices to improve patient outcomes while offering the devices for use in providing care covered by the CMMI ACCESS model, share the data with the FDA during their participation in the TEMPO pilot, and, using the data collected during their participation in the TEMPO pilot (along with other information), seek appropriate marketing authorization from the FDA.

Upon receipt of the statement of interest, the FDA will follow up with certain potential pilot participants who reflect a broad spectrum of manufacturers to request additional information to help enable the FDA to make a decision concerning participation. The FDA expects to begin to send follow up requests around March 2, 2026.

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Our goal: Empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation.

Our objectives: The Digital Health Center of Excellence aims to:

Connect and build partnerships to accelerate digital health advancements.
Share knowledge to increase awareness and understanding, drive synergy, and advance best practices.
Innovate regulatory approaches to provide efficient and least burdensome oversight while meeting the FDA standards for safe and effective products.

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Anticipated outcomes: Through fulfilling these objectives, we anticipate the following advancements across digital health:

Strategically advance science and evidence for digital health technologies that meets the needs of stakeholders.
Efficient access to a highly specialized expertise, knowledge, and tools to accelerate access to digital health technology.
Aligned regulatory approach to harmonize international regulatory expectations and industry standards.
Increased awareness and understanding of digital health trends.
Consistent application of digital health technology policy and oversight approaches.
Reimagined medical device regulatory paradigm tailored for digital health technologies.

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