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Navigating regulatory and policy challenges for AI enabled combination devices.

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第一作者： Snigdha,Santra

第一单位： Chugai Pharma, Berkeley, NJ, United States.

作者： Snigdha,Santra ^[1] ; Preet,Kukreja ^[2] ; Kinshuk,Saxena ^[3] ; Sanyam,Gandhi ^[4] ; Om V,Singh ^[5]

作者单位： Chugai Pharma, Berkeley, NJ, United States. ^[1] Department of Population Health, Episcopal Health Services, New York, NY, United States. ^[2] Business Strategy Department, Novartis Pharmaceuticals, Hanover, NJ, United States. ^[3] Takeda Research Center, Cambridge, MA, United States. ^[4] Advance Academic Programs, Krieger School of Arts and Sciences, Johns Hopkins University, Washington, DC, United States. ^[5]

关键词 AI policy frameworks AI regulatory challenges AI regulatory frameworks AI-enabled combination devices AI-enabled medical devices FDA AI regulations

DOI 10.3389/fmedt.2024.1473350

PMID 39669903

发布时间 2024-12-14

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