美国FDA突破性器械项目政策介绍及对我国的启示

The Policy Introduction of FDA’s Breakthrough Device Program and Its Enlightenment to China

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.