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dc.contributor.authorKing, F.
dc.contributor.authorKlonoff, D.C.
dc.contributor.authorAhn, D.
dc.date.accessioned2019-09-13T14:49:32Z
dc.date.available2019-09-13T14:49:32Z
dc.date.issued2019
dc.identifier.urihttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85059458326&doi=10.1177%2f1932296818810436&partnerID=40&md5=03b4b2ae99c7e8a67e2e639894601bf1
dc.identifier.urihttp://hdl.handle.net/10713/10603
dc.description.abstractDiabetes 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.en_US
dc.description.urihttps://doi.org/10.1177/1932296818810436en_US
dc.language.isoen-USen_US
dc.publisherSAGE Publications Inc.en_US
dc.relation.ispartofJournal of Diabetes Science and Technology
dc.subjectdeviceen_US
dc.subjectFDA precertificationen_US
dc.subjectreal-world dataen_US
dc.subjectsoftwareen_US
dc.titleDiabetes Technology Society Report on the FDA Digital Health Software Precertification Program Meetingen_US
dc.typeArticleen_US
dc.identifier.doi10.1177/1932296818810436
dc.identifier.pmid30394807


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