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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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Digital Health Center of Excellence

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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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