FDA Lowers User Fees in FY2012 (written by Lauren Uzdienski @ HealthPointCapital)
The FDA will offset excessive user fee payments with a small reduction in fees for devicemakers in FY2012, according to documents released on Monday. Over the past few fiscal years, the agency has collected $9.5 million beyond what was appropriated, and this will be returned to industry in the form of a 7% reduction in most fees, including registration and application submission fees.
The annual registration fee, which is paid by each manufacturer and is not adjusted for small businesses, will be $2,029 in FY2012, down 7% from $2,179 in FY2011. In FY2012, 510(k) submissions will cost large manufacturers $4,049 per submission and small manufacturers (less than $100 million in sales, or $30 million if it’s a first filing) $2,024 per submission, down from $4,348 and $2,174, respectively. PMA submission fees will also decline by 7%, to $220,050 for large manufacturers and $55,013 for small manufacturers. For comparison, FY2011 rates are detailed here.
FY2012 is the last year of the current MDUFA authorization, the legislation that permits the collection of user fees. Industry and the FDA are beginning their negotiations to re-authorize the program, and currently, contentious points include the speed at which the FDA reviews submissions and the unknowns in the regulatory process, such as 510(k) reform. User fees currently cover about 20% of the device division’s budget.