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Early Feasibility Studies for Cardiovascular Devices in the United States

David R. Holmes,Andrew A. Farb,Robert Chip Hance,Martin B. Leon,Pamela Goldberg,Bram D. Zuckerman,Aaron V. Kaplan,Liliana Rincon-Gonzalez,Jon Hunt,Jaime Walkowiak,Michael J. Mack

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY（2020）

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关键词
Congressional 21st Century Cures Act,early feasibility studies,IRB delays,study reimbursement,unmet clinical needs
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