CFR 21-803.52-2014
食品和药物. 第803部分:医疗器械报告. 第803.52节:如果我是一个制造商,必须我在个人的不良事件报告提交什么信息?
Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.52:If I am a manufacturer, what information must I submit in my individual adverse event reports?