浅析美国实验室研发试剂监管模式  

Ideas and Briefing about Regulatory Requirements for Laboratory Developed Tests in the US

作　　者：韩昭昭 赵阳 吕允凤 董劲春 邓刚 HAN Zhaozhao;ZHAO Yang;L Yunfeng;DONG Jinchun;DENG Gang(Center for Medical Device Evaluation,NMPA,Beijing,100081;National Medical Products Administration,Beijing,100037)

机构地区：[1]国家药品监督管理局医疗器械技术审评中心,北京市100081 [2]国家药品监督管理局,北京市100037

出　　处：《中国医疗器械杂志》2022年第5期534-537,共4页Chinese Journal of Medical Instrumentation

摘　　要：实验室研发试剂作为一类特殊的体外诊断试剂,对临床实验室的发展具有非常重要的意义。该研究旨在探索实验室研发试剂的监督管理思路。通过介绍美国实验室研发试剂的发展与监管历程,梳理目前法规监管框架,探讨实验室研发试剂监管中的相关思路。As a special kind of in vitro diagnostic devices(IVDs),laboratory developed tests(LDTs)are of great significance to the development of clinical laboratories.This study aims to explore the regulatory requirements ideas of LDTs.By introducing the development of LDTs and the changing of regulatory requirements in the United States,combing the current regulatory framework and discussing relevant ideas in the regulatory requirements of LDTs.

关 键 词：实验室研发试剂 体外诊断试剂 监督管理 

分 类 号：TU502.2[建筑科学—建筑技术科学]