Sen. Grassley Seeks More Documents From Northwestern On Edwards’ Valve Inquiry
This article was originally published in The Gray Sheet
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.
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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.
Sen. Chuck Grassley, R-Iowa, is questioning why FDA does not play a more active role in determining when a change to a device requires a new 510(k)
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