These complaints shall be evaluated to determine whether or not they require reporting to FDA under 21 CFR part 804 or 803, Medical Device reporting.
应对这些投诉进行评估，并根据医疗器械报告制度(联邦法规21篇804或803部)要求决定它们是否需要向FDA报告。
Basically it consists of a clamping device to hold the part in position under hardened-steel bushings through which the drill passes during the drilling operation. The drill is guided by the bushings.
它基本上由在淬硬钢衬套下将零件夹持到位的夹持装置组成，钻孔作业中钻头穿过这些衬套，通过它们来导向。
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