摘要
通过探讨《组合产品上市前路径指导原则》的相关要求,分析美国食品药品管理局(Food and Drug Administration,FDA)对含药医疗器械5种典型情况的申报路径、参比器械选择的审评关注点,以期对我国以医疗器械作用为主的药械组合产品的申报注册提供参考借鉴。
By discussing the relevant requirements of the Principles of Premarket Pathways for Combination Products Guidance,this study analyzes FDA’s review concerns for premarket pathways and predicate product selection of device-led combination products’five typical situations,in order to provide reference for Chinese manufacturers and investigators in device-led combination products registration.
作者
田佳鑫
TIAN Jiaxin(Center for Medical Device Evaluation,NMPA,Beijing,100081)
出处
《中国医疗器械杂志》
2023年第5期566-570,共5页
Chinese Journal of Medical Instrumentation
关键词
组合产品
上市前路径
参比器械
combination product
premarket pathway
predicate product
