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 complaints shall be evaluated to determine whether or not they require reporting to FDA under 21 CFR part 804 or 803, Medical Device reporting.
根据一些行政法规,如社会保险法,复审最初由联邦地区法院负责。
Under sane administrative statutes such as the social security act review occurs initially in a federal district court.
根据2007年联邦法规的要求,FDA近期公布了一项对所有可能药物相关性不良事件的研究结果,今天公布的名单是今年季度报告中的第一个。
A 2007 federal law requires the FDA to disclose all its investigations into reports of possibly drug-related adverse events. Today's list is the first of this series of quarterly reports.
应用推荐