Digital Health Center of Excellence

UPDATE: February 3, 2026

FDA Launches a Digital Health Devices Pilot

The FDA launched 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.

Key dates:

January 2, 2026: The FDA began receiving statements of interest for participation in the TEMPO pilot.
Around March 2, 2026: The FDA will begin sending follow up requests to certain potential pilot participants to request additional information to help enable the FDA’s decision concerning participation.

For more information about the TEMPO pilot and how to submit a statement of interest, refer to the Federal Register notice. For answers to commonly asked questions, visit the FDA’s TEMPO for Digital Health Devices Pilot Frequently Asked Questions webpage.

To learn more about the CMMI ACCESS model, visit the Centers for Medicare and Medicaid Services website.

Digital Health Center of Excellence Feature Graphic

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.

Learn More About Our Services

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.

About Our Evolution

Sub-Topic Paragraphs