Senate HELP Committee Passes User Fee Package

It was a long road for the Medical Device User Fee Amendments, also known as MDUFA V, this time around. Thanks to pandemic-related delays, the US Food and Drug Administration and medtech industry didn’t even start their negotiations until about a year after what was originally planned. And then talks dragged on as the sides bickered. By the time a draft commitment letter made it to Congress, the statutory deadline was two months past.

But things have been moving a lot more smoothly since lawmakers took up user fee legislation. The House of Representatives passed the legislative package on 8 June