美国食品药品监督管理局外周血栓清除器械临床评价要求分析  

Analysis of clinical evaluation requirements for peripheral blood thrombolysis devices of US Food and Drug Administration

作　　者：程玮璐 许菱丹 王泽华 刘英慧 Cheng Weilu;Xu Lingdan;Wang Zehua;Liu Yinghui(Center for Medical Device Evaluation,National Medical Products Administration,Beijing 100081,China;Yangtze River Delta Center for Medical Device Evaluation and Inspection of National Medical Products Administration,Shanghai 201210,China)

机构地区：[1]国家药品监督管理局医疗器械技术审评中心,北京100081 [2]国家药品监督管理局医疗器械技术审评检查长三角分中心,上海201210

出　　处：《中国医学装备》2025年第2期154-160,共7页China Medical Equipment

摘　　要：为探索外周及肺血管血栓清除器械的临床评价要求,检索其在美国食品药品监督管理局(FDA)的上市情况,汇总整理其相关文件的上市前研究内容,基于其目前官网公开资料,梳理FDA外周及肺血管血栓清除器械的3大类(抽吸导管类、取栓支架类和机械血栓清除系统类)产品510(k)上市前通知中的临床试验设计情况,分析该类器械FDA临床评价监管要求,为相关产品研发人员及临床研究人员对于外周血栓清除器械的上市前临床评价提供参考。[Objective]In order to explore the regulatory requirements for clinical evaluation about peripheral and pulmonary thrombus removal apparatus,the marketing status of these apparatuses in the Food and Drug Administration(FDA)of United States was searched,and the pre-marketing research contents of relevant documents were summarized and organized.Based on the current public information on their official website,the clinical trial designs of FDA's three main categories of peripheral and pulmonary thrombus removal apparatuses(aspiration catheter,thrombectomy stent and mechanical thrombus removal system)in 510(k)pre-marketing notice were sorted out,and the regulatory requirements of FDA clinical evaluation about this kind of apparatus were analyzed,which could provide references for researchers and developers of relevant products,and clinical researchers about the pre-marketing clinical evaluation of peripheral blood thrombolysis apparatus.

关 键 词：外周血栓清除器械 肺血栓清除器械 医疗器械 临床评价 

分 类 号：R197.39[医药卫生—卫生事业管理]