Look at all the Weasel language, I read the whole thing and still came away with no substance, just the clear impression that this is not good for the common man. More fees, more reporting, more government intervention. And somehow the corrupt FDA is in on this.
The Medical Device User Fee and Modernization Act (MDUFMA) in 2002 marked the beginning of the user fee program for devices in the U.S. The additional resources provided to FDA's CDRH since the time of program enactment have enabled CDRH to stabilize, and subsequently significantly increase the Center’s staffing level, upgrade IT capabilities, and develop a number of process enhancements.
Since the creation of MDUFMA, FDA and its stakeholders (industry and later on including patient advocacy groups) have worked through growing pains to identify and develop more meaningful device performance goals and commitments. Overall, the progress made through MDUFMA and its amendments, MDUFA II and MDUFA III, has certainly provided the Center with the tools needed to develop a level of predictability, consistency, and transparency of FDA medical device processes desired by all stakeholders. Most importantly, these commitments should lead to improved access to safe and effective devices for the public!