10/26/2021
https://congress.gov...
"the statute outlines a detailed process for reauthorization that requires FDA to not only negotiate with industry to develop recommendations, but also to solicit public input."
"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 percent over 6 years."