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

Fraya King, David C. Klonoff, David Ahn, Saleh Adi, Erika Gebel Berg, Jiang Bian, Kong Chen, Andjela Drincic, Michael Heyl, Michelle Magee, Shelagh Mulvaney, Yarmela Pavlovic, Priya Prahalad, Michael Ryan, Ashutosh Sabharwal, Shahid Shah, Elias Spanakis, Bradley Merrill Thompson, Michael Thompson, Jing Wang

Research output: Contribution to journalArticle

1 Scopus citations

Abstract

Diabetes Technology Society (DTS) convened a meeting about the US Food and Drug Administration (FDA) Digital Health Software Precertification Program on August 28, 2018. Forty-eight attendees participated from clinical and academic endocrinology (both adult and pediatric), nursing, behavioral health, engineering, and law, as well as representatives of FDA, National Institutes of Health (NIH), National Telecommunications and Information Administration (NTIA), and industry. The meeting was intended to provide ideas to FDA about their plan to launch a Digital Health Software Precertification Program. Attendees discussed the four components of the plan: (1) excellence appraisal and certification, (2) review pathway determination, (3) streamlined premarket review process, and (4) real-world performance. The format included (1) introductory remarks, (2) a program overview presentation from FDA, (3) roundtable working sessions focused on each of the Software Precertification Program’s four components, (4) presentations reflecting the discussions, (5) questions to and answers from FDA, and (6) concluding remarks. The meeting provided useful information to the diabetes technology community and thoughtful feedback to FDA.

Original languageEnglish (US)
Pages (from-to)128-139
Number of pages12
JournalJournal of Diabetes Science and Technology
Volume13
Issue number1
DOIs
Publication statusPublished - Jan 1 2019

    Fingerprint

Keywords

  • FDA precertification
  • device
  • real-world data
  • software

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Bioengineering
  • Biomedical Engineering

Cite this