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Analyse von FDA-zugelassenen Orthopädischen Geräten und ihren Rückrufen.

PMID: 26984921 · 2016-03-16

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ZeitschriftThe Journal of bone and joint surgery. American volume

Jahr2016-03-16

PMID26984921

Zusammenfassung

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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