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虽然国产医疗器械的市场之路面临诸多烦忧,但就全球范围而言,不少国家都对创新性技术和产品采取以正向鼓励为原则的适度监管。美国的LDT模式就是其中的一种。在美国,核酸检测试验一般分为三类,食品药品管理局(FDA)批准的项目、修改FDA批准的项目,以及实验室开发诊断试剂监管模式(Laboratory Developed Test,LDT)。FDA批准的项目,一般由公司将检测试剂做成试剂盒进行申报,经FDA验证后,批准在临床实验室采用;LDT是各个实验室自己建立,
Although the market for domestic medical devices is facing many troubles, many countries worldwide take moderate supervision of innovative technologies and products based on the principle of positive encouragement. The United States LDT model is one of them. In the United States, nucleic acid test tests are generally divided into three categories, FDA approved projects, modifications to FDA approved programs, and laboratory development of Laboratory Developed Tests (LDTs). FDA approval of the project, the general test reagent will be made by the company to declare the kit, approved by the FDA, approved for use in clinical laboratories; LDT is to establish their own laboratories,