摘要
重点介绍美国FDA鼓励治疗或诊断危害生命或不可逆衰老疾病的医疗器械快速上市的政策--突破性器械项目,该相关制度设计和经验值得我国在制定、完善临床急需医疗器械相关规定时予以借鉴。
This article focuses on the FDA’s expedited policies of more effective treatmentor diagnosis of life-threatening or irreversibly debilitating diseases or conditions which are subject to review under a premarket approval application(PMA), premarket notification(510(k)), or De Novo classification request. The design and experience should be used for reference in the formulation and improvement of relevant regulations of clinical medical devices in urgent need in China.
作者
仉琪
姜雨萌
李耀华
ZHANG Qi;JIANG Yu-meng;LI Yao-hua(Center for Medical Device Evaluation of NMPA,Beijing 100081)
出处
《中国医疗器械信息》
2020年第1期1-3,共3页
China Medical Device Information
关键词
突破性器械
临床急需
附条件批准
breakthrough devices program
urgent clinical needs
conditional approval