FDA Launches Digital Health Center of Excellence

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The U.S. Food and Drug Administration (FDA) launched the Digital Health Center of Excellence, which seeks to empower digital health stakeholders to advance health care by fostering responsible digital health innovation.

The Digital Health Center of Excellence seeks 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 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. It will build new capacity and leverage the strength of the FDA to ensure access to high-quality health technologies.

The Digital Health Center of Excellence will also support and encourage developers, even those who are new to the healthcare space, to translate digital advances into tools that benefit patients and consumers. 

The FDA is hosting stakeholder listening sessions on October 19, 2020 and November 12, 2020 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 program.

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