FDA Watch: Agency Targets Sale of IVD Reagents without Premarket Approval

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原文链接

NSTL

外文摘要：Distribution of diagnostics and devices without premarket approval has featured prominently on the FDA's enforcement priority list this year. The agency has issued seven warning letters related to premarket approval in 2O19 after issuing just one such warning letter in all of 2O18.

外文关键词：

TargetsReagentsApproval

出版年：

2020

Laboratory industry report

ISSN：1060-5118

年,卷(期)：2020.20(1)