作者: Susie Park , Gary P. Siskin , Meridith J. Englander , Kenneth D. Mandato , Allen Herr
DOI: 10.1016/J.JVIR.2015.05.028
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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.