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www.fdanews.com/articles/145819-mdufa-despite-broad-agreement-510-k-safety-concerns-remain

MDUFA: Despite Broad Agreement, 510(k) Safety Concerns Remain

April 23, 2012
Stakeholders agree on the majority of the Medical Device User Fee Act (MDUFA) reauthorization legislation now before Congress, but that didn’t make a House health subcommittee hearing on device and drug user fees smooth sailing. Instead, the April 18 discussion renewed concerns about device safety questions — specifically, the FDA’s ability to remove devices from the market if they are found substantially equivalent to a product with a known flaw. Legislation proposed by House Democrats has sought to close this perceived loophole.
Devices & Diagnostics Letter