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Recall Chances Higher For 510(k) Devices With Recalled Predicates, Studies Show

 
• By Brian Bossetta

Two studies recently published in JAMA argue that a higher recall rate tied to 510(k) devices cleared based on also-recalled predicate devices help to demonstrate 510(k) safety concerns.

• Source: Shutterstock

Research from a pair of recent studies suggests some medical devices cleared by the Food and Drug Administration through the agency’s 510(k) program could be putting patients at risk.

The authors of the two studies, both published on 10 January in the Journal of the American Medical Association (JAMA),...

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