美国FDA医疗器械监管信息化情况及启示

Informatization Situation and Enlightenment of FDA Medical Device Supervision

信息技术与监管业务深度融合是美国食品药品管理局(FDA)医疗器械监管的重要特征。美国医疗器械监管信息化经过多年的发展,已形成相对复杂和较为完备的体系。本文从应用系统、数据库、数据标准等方面对美国FDA医疗器械监管信息化情况进行了梳理,分析其特点提出可借鉴启示。

The deep integration of IT and business is an important feature of US Food and Drug Administration(FDA)medical device supervision.After many years of development,FDA has formed a relatively complex and complete system about medical device supervision informatization construction.This paper illustrated the application systems,databases,data standards and other aspects,discussed the enlightenment to China.