The readers digest version is that MDUFA is Medical Device User Fee Amendment. It is a way for fees to be collected to fund FDA reviewing medical devices. This summer's version of MDUFA put some time tables on the FDA reviews. In simple terms the idea is industry pays a fee to fund reviews of devices and the FDA has a clock running to do those reviews.
Why does it matter in diabetes land? When and if there is a requirement for BG meters to be +/- 15% the regulatory review of those new meter will be funded by fees paid by industry and the FDA will do the reviews timely. PWD get more accurate meters. Yay.
Mass Device reports on a Bloomberg Newsweek story (sorry I haven't found that Bloomberg/NW piece yet) that the deal may be in trouble due to congress's in ability to act on the budget. The FDA can't spend the user fee money without trigger funding from Congress.
The $610 million deal between the FDA and the medical device industry is in jeopardy as Congress dithers over the federal watchdog agency's budget, meaning that product reviews for devices and drugs could slow or even grind to a halt, according to Bloomberg BusinessWeek.
That's because the FDA can't spend a dime of the user fee money until it receives trigger funding from Congress, an FDA spokeswoman told the news service. With Democrats and Republicans perpetually at odds on Capitol Hill, this time over a proposed $1.2 trillion in budget cuts over the next decade, that all-too-familiar Beltway stasis "could result in the loss of whole user fee programs, programs that have become essential to public health and medical product innovation," the spokeswoman wrote in an e-mail.More: https://www.massdevice.com/news/medical-devices-fdas-user-fee-deal-rocks