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

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。

Abstract: 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.