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Diabetes Technology Society Report on the FDA Digital Health Software Precertification Program Meeting.

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The Diabetes Technology Society (DTS) met with the US Food and Drug Administration (FDA) to discuss the Digital Health Software Precertification Program. Feedback focused on improving the FDA

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Area of Science:

  • Digital health technology
  • Medical device regulation
  • Diabetes management

Background:

  • The US Food and Drug Administration (FDA) proposed a Digital Health Software Precertification Program.
  • A meeting was convened by the Diabetes Technology Society (DTS) on August 28, 2018.
  • Attendees included experts in endocrinology, nursing, behavioral health, engineering, law, and representatives from FDA, NIH, NTIA, and industry.

Framework:

  • The FDA's Digital Health Software Precertification Program aims to streamline premarket review.
  • Key components discussed included excellence appraisal, certification, review pathway determination, and real-world performance.
  • The program seeks to adapt regulatory oversight for rapidly evolving digital health technologies.

Implementation:

  • Roundtable working sessions focused on the four core components of the precertification program.
  • Discussions involved providing input and feedback to the FDA on their proposed program.
  • The meeting format facilitated interactive dialogue between stakeholders and the FDA.

Implications:

  • The meeting provided valuable insights for the diabetes technology community.
  • Thoughtful feedback was delivered to the FDA to inform the development of the Digital Health Software Precertification Program.
  • This initiative aims to foster innovation while ensuring the safety and effectiveness of digital health software.