An article published last week in MassDevice highlights the twists and turns (and resulting consensus) between FDA and medical device industry players in a series of February meetings targeting the medical device user fees program.
Among the meetings’ accomplishments, FDA and device industry leaders agreed to eliminate several exceptions from the Medical Device User Fee & Modernization Act; they developed a new fee structure to include adjustments for inflation; and they settled a discretionary fee waiver for tests developed in the lab.
After a tentative pledge to double medical device user fees from just under $300 million to just under $600 over the next 5 years, all eyes are on FDA to meet new performance goals and communicate more effectively with industry. To read more about the meetings and their results and implications, read the full MassDevice story here.