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 ...

Food and Drug Administration’s modernization plan for its 510(k) process may not be all sweet music to the industry. In a joint statement on Monday describing the modernization effort, Commissioner ...

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 ...