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

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    Author
    King, F.
    Klonoff, D.C.
    Ahn, D.
    Date
    2019
    Journal
    Journal of Diabetes Science and Technology
    Publisher
    SAGE Publications Inc.
    Type
    Article
    
    Metadata
    Show full item record
    See at
    https://doi.org/10.1177/1932296818810436
    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. Copyright 2018 Diabetes Technology Society.
    Keyword
    device
    FDA precertification
    real-world data
    software
    Identifier to cite or link to this item
    https://www.scopus.com/inward/record.uri?eid=2-s2.0-85059458326&doi=10.1177%2f1932296818810436&partnerID=40&md5=03b4b2ae99c7e8a67e2e639894601bf1; http://hdl.handle.net/10713/10603
    ae974a485f413a2113503eed53cd6c53
    10.1177/1932296818810436
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    UMB Open Access Articles 2019

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