TY - JOUR
T1 - Diabetes Technology Society Report on the FDA Digital Health Software Precertification Program Meeting
AU - King, Fraya
AU - Klonoff, David C.
AU - Ahn, David
AU - Adi, Saleh
AU - Berg, Erika Gebel
AU - Bian, Jiang
AU - Chen, Kong
AU - Drincic, Andjela
AU - Heyl, Michael
AU - Magee, Michelle
AU - Mulvaney, Shelagh
AU - Pavlovic, Yarmela
AU - Prahalad, Priya
AU - Ryan, Michael
AU - Sabharwal, Ashutosh
AU - Shah, Shahid
AU - Spanakis, Elias
AU - Thompson, Bradley Merrill
AU - Thompson, Michael
AU - Wang, Jing
N1 - Funding Information:
The author(s) received no financial support for the research, authorship, and/or publication of this article. Abbott Diabetes Care, Ascensia Diabetes Care, and Intel each provided a grant to the Diabetes Technology Society to support the meeting project.
Publisher Copyright:
© 2018 Diabetes Technology Society.
PY - 2019/1/1
Y1 - 2019/1/1
N2 - 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.
AB - 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.
KW - FDA precertification
KW - device
KW - real-world data
KW - software
UR - http://www.scopus.com/inward/record.url?scp=85059458326&partnerID=8YFLogxK
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U2 - 10.1177/1932296818810436
DO - 10.1177/1932296818810436
M3 - Article
C2 - 30394807
AN - SCOPUS:85059458326
SN - 1932-2968
VL - 13
SP - 128
EP - 139
JO - Journal of diabetes science and technology
JF - Journal of diabetes science and technology
IS - 1
ER -