Frank Pallone actually said...

the statute outlines a detailed process for reauthorization that requires FDA to not only negotiate with industry to develop recommendations...

if we do not reauthorize MDUFA by September 30th, CDRH would lose about one-third of its personnel.

I appreciate the opportunity today to discuss the reauthorization of the Medical Device User Fee Amendments.

MDUFA has been a success in addressing these issues, reducing the average total time to a decision on a pre-market approval in 2015 by 35 pe...