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Webinar Materials:

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Summary:

On November 12, 2020, the U.S. Food and Drug Administration (FDA) hosted a virtual listening session for digital health device manufacturers, developers, health care providers, researchers, and other stakeholders to learn about the Digital Health Center of Excellence (DHCoE). The FDA discussed the purpose and functions of the DHCoE and focused on collecting feedback from attendees.

Background:

On September 22, 2020, the FDA established the Digital Health Center of Excellence (DHCoE). The DHCoE is part of the planned evolution of the Digital Health Program in the Center for Devices and Radiological Health. It marks the beginning of a comprehensive approach to digital health technology, setting the stage for advancing and realizing the potential of digital health. 

The DHCoE will empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation. Its objectives include:

• Connecting and building partnerships to accelerate digital health advancements.
• Sharing knowledge to increase awareness and understanding, drive synergy  , and advance best practices.
• Innovating regulatory approaches to provide efficient and least burdensome oversight while meeting FDA standards.

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