FDA To Rescind A 510(k): Rare Action Targets ReGen's Menaflex Device
This article was originally published in The Gray Sheet
Executive SummaryFDA says it will seek to rescind a much-scrutinized 510(k) clearance of an implantable knee device, initiating a rarely used regulatory authority that some in industry argue does not exist.
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The device center is dropping seven controversial 510(k) reform-related proposals, including creating a “class IIb” category of devices, following pushback from industry. But some of the matters are under consideration on Capitol Hill.