Edwards’ Mitral Valve Repair Device Withdrawn, Under Scrutiny
This article was originally published in The Gray Sheet
Edwards Lifesciences removed a mitral valve repair device from the market in October and submitted a 510(k) for the product in the midst of an FDA inquiry into whether the device was being marketed without proper clearance
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The Iowa Republican says Northwestern Memorial Hospital may have held back materials in response to his 2008-launched inquiry into use of an Edwards Lifesciences heart valve repair device without FDA clearance or proper patient consent.
In a report to Congress, FDA stuck with device industry recommendations to merely revise its 1997 guidance on 510(k) device modifications, rather than to more thoroughly revamp the policy.
Draft guidance on when to submit a 510(k) for a change to a previously cleared device could increase the number of submissions by two- or three-fold, device makers say. Some call for draft to be withdrawn.