PubMed

FDA認可された骨科装置およびそのリコールの分析

PMID: 26984921 · 2016-03-16

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学術誌The Journal of bone and joint surgery. American volume

年2016-03-16

PMID26984921

抄録

The U.S. Food and Drug Administration (FDA) evaluates medical devices by two main pathways. The more stringent Premarket Approval (PMA) review requires clinical trials, and the Premarket Notification 510(k) process generally exempts devices from clinical trials if they prove to be substantially equivalent to existing devices. We hypothesized that orthopaedic devices are more likely to be cleared through the 510(k) process and thus are more susceptible to being recalled. Using the FDA's public da

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