FDA and industry have agreed to a draft commitment letter and proposed legislative language to reauthorize device-related FDA user fees.
The commitment, detailed in documents released by FDA last week, comes one month after the parties reached an agreement “in principle” on Medical Device User Fee Act III reauthorization. Under the agreement, device industry fees to FDA will total $595 million from fiscal 2013 through 2017, enabling CDRH to hire more than 200 employees. The amount is more than double the $287 million paid by industry under the current five-year program, which expires September 30