FDA Establishes Digital Health Center of Excellence

By MedTech Intelligence Staff

The center intends to facilitate partnerships, exchange knowledge and promote innovative regulatory approaches.

In an effort to advance and align digital health work across the FDA, the agency has launched a Digital Health Center of Excellence. The goal of the center is to “Empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation,” according to FDA. The center will work to help build partnerships, increase knowledge sharing and advance best practices, and innovate regulatory approaches by facilitating rapid development and regulatory review of digital health technologies.

The FDA expects that the Digital Health Center of Excellence will achieve the following:

  • Boost awareness and understanding of trends in digital health
  • Advance science and evidence for digital health technologies to meet stakeholder needs
  • Provide access to specific expertise and tools to expedite access to digital health technology
  • Align regulatory approach with international regulatory expectations and industry standards
  • Maintain consistency in applying policies and oversight related to digital health technology

“The establishment of the Digital Health Center of Excellence is part of the planned evolution of the FDA’s digital health program to amplify the digital health work that is already being done and building upon years of work at the agency,” said Jeff Shuren, M.D., J.D., director of CDRH in an agency news release. “In the last several years, we have established partnerships internally and externally to coordinate digital health activities and to promote the consistency of regulatory policy while continuing to innovate in our regulatory approaches.”


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