Home » MDUFA: Despite Broad Agreement, 510(k) Safety Concerns Remain
MDUFA: Despite Broad Agreement, 510(k) Safety Concerns Remain
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
Devices & Diagnostics Letter
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