美国医疗器械上市后安全性监测框架及特点

The Framework and Characteristics of FDA Medical Device Post-market Safety Program

通过解读美国食品药品监督管理局"确保上市医疗器械的安全性:器械和放射健康中心(CDRH)医疗器械上市后安全性监测计划"的工作报告,了解其开展上市后监测工作框架、流程及特点,以期对我国的医疗器械上市后监测工作体系的建立和完善有所启示。

After reviewing the FDA＇s report of medical device post-market something about the Structure and procedures of FDA in this area. Aims safety program, We know to give some apocalypse about the medical device post-market safety program for our country.