The ABCs of the FDA: A Primer on the Role of the United States Food and Drug Administration in Medical Device Approvals and IR Research

作者: Susie Park , Gary P. Siskin , Meridith J. Englander , Kenneth D. Mandato , Allen Herr

DOI: 10.1016/J.JVIR.2015.05.028

关键词:

摘要: The role of the US Food and Drug Administration (FDA) in medical device regulation is important to device-driven specialties such as interventional radiology. Whether it through industry-sponsored trials during approval process for new devices or investigator-initiated research prospectively evaluating existing established procedures, interaction with FDA an integral part performing significant This article reviews potential areas interface between radiology, understanding these necessary continue innovation that hallmark this specialty.

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