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MDUFA Agreement Progresses, But Sticking Points Remain

January 16, 2012
FDA-industry negotiations to reauthorize the Medical Device User Fee Act (MDUFA) went down to the wire last week, as CDRH seemed destined to miss a Jan. 15 due date for sending a commitment letter to Congress. But the last-minute release of a batch of recent meeting minutes suggests there is hope. The deadline for outlining an agreement and setting user fees for the next five years was mandated in the current iteration of the act. Congress has already scheduled the first MDUFA hearing this year for mid-February.
Devices & Diagnostics Letter