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FDA launches Digital Health Center of Excellence

Today, the U.S. Food and Drug Administration (FDA) launched the Digital Health Center of Excellence. This new Center of Excellence seeks to empower digital health stakeholders to advance health care by fostering responsible and high-quality digital health innovation.

The Digital Health Center of Excellence aims to connect and build partnerships among stakeholders 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 FDA standards.

The Digital Health Center of Excellence will align and coordinate digital health work across the FDA and is part of the planned evolution of the Digital Health program in the FDA’s Center for Devices and Radiological Health. A key benefit of the Digital Health Center of Excellence is that it will support and encourage developers—including those who are new to the health care space—to translate digital advances into tools that benefit patients and consumers.

This announcement marks the beginning of a comprehensive approach to digital health technology, setting the stage to advancing and realizing the potential of digital health. The Digital Health Center of Excellence will build new capacity and leverage the strength of the FDA to ensure access to high-quality health technologies. In addition to current efforts, such as the Pre-Cert Pilot Program, the new FDA Digital Health Center of Excellence introduces new initiatives such as the Digital Health Network of Experts and Digital Health Partnerships to advance the field of digital health.

Visit the Digital Health Center of Excellence »

Upcoming stakeholder listening sessions
On October 19, 2020 and November 12, 2020, the FDA will host listening sessions for digital health stakeholders and others interested in learning more about the Digital Health Center of Excellence. The listening sessions will also provide an opportunity for interested stakeholders to ask questions about the newly launched Digital Health Center of Excellence.

If you have questions about the Digital Health Center of Excellence, email



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