小儿用医疗器械在美国上市的评价与监管

Evaluation and administration of pediatric medical devices in USA

小儿用医疗器械由于其特殊性越来越受到各个国家的重视。美国食品药品监督管理局已经对该类设备做了大量的工作。本文较详细地介绍了小儿用医疗器械在美国的上市评价及监管情况,希望通过总结阐述对此类特殊人群用医疗器械评价和监管的难点和关键点,为我国的小儿用医疗器械制造商的相关产品在美国上市提供一定的参考。

A lot of countries focus on the pediatric medical devices because of its importance.Many works has been done to this kind of medical device by FDA.In this paper,the evaluation and administration status of pediatric medical devices in USA are summarized.Guidance for industry and FDA staff： premarket assessment of pediatric medical devices is introduced.Some suggestions are also provided to the manufacturers in our country.