There is a troubling loophole in the US Food and Drug Administration’s 510(k) pathway that allows for the approval of medical devices that are at a higher risk of recall, according to results of two ...
The FDA should improve device safety by increasing the amount and availability of information about previously marketed ...
In a new final guidance issued today, the FDA announced that it will frown upon the use of multiple predicate devices in 510(k) submissions, unlike when it cleared metal-on-metal hip implants, which ...
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