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。
These requirements include establishment registration, medical device listing, quality system, medical device reporting, premarket approval or clearance, labeling and U. s. agent requirements.
这些规定包括工厂的注册，医疗设备清单，质量系统，医疗设备报告，售前批准或者认可，商标及美国代理的要求。
These requirements include establishment registration, medical device listing, quality system, medical device reporting, premarket approval or clearance, labeling and U. s. agent requirements.
这些规定包括工厂的注册，医疗设备清单，质量系统，医疗设备报告，售前批准或者认可，商标及美国代理的要求。
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