Executive Summary: FY 2009 MDUFMA Financial Report
The Medical Device User Fee and Modernization Act (MDUFMA) of 2002, as amended, requires the Food and Drug Administration (FDA) to report annually on the financial aspects of its implementation of MDUFMA. This is the annual financial report to Congress that covers activities for fiscal year (FY) 2009.
MDUFMA, as amended, specifies that three conditions must be satisfied in order for FDA to collect and spend MDUFMA fees each year:
- Within FDA’s salaries and expenses appropriation, the amount appropriated for devices and radiological health, excluding fees, each year must be at least $205,720,000, multiplied by an adjustment factor specified in MDUFMA.
- The fee amounts that FDA can collect must be specified in the Appropriation Acts.
- FDA must spend at least as much from appropriated funds, exclusive of user fees, for the review of medical device applications as it spent in FY 2002, multiplied by the adjustment factor specified in MDUFMA.
MDUFMA also contains a provision that FDA must spend at least as much on medical device inspections as it spent in FY 2002, increased by 5 percent in each fiscal year.
This report explains how FDA met the statutory conditions in FY 2009. The report also provides information on user fee collections, expenditures, and carryover balances. In FY 2009, FDA net collections totaled $61.8 million from fees. FDA obligated $47.3 million from MDUFMA collections to support FDA’s medical device review program. FDA carried forward into FY 2010 a balance of $37.8 million—about $13 million more than the carryover balance brought forward into FY 2009. (It was expected that carryover balances would grow through 2010, and be drawn down in the final 2 years of the program (2011-2012)). About 66 percent of the total expenses for the medical device review program in FY 2009 went for employee pay and benefit costs. The remaining 34 percent was spent on operating and infrastructure costs necessary to support the medical device review program.
MDUFMA fees, along with the increased appropriations from Congress, enabled FDA to dedicate 280 more full-time equivalents (FTEs) to the medical device review program in FY 2009 than the 829 FTE used in FY 2002—the year before MDUFMA was enacted. An additional 75 contractor staff-years were also dedicated to the device review program in FY 2009 compared with FY 2002. These resources have enabled FDA to achieve the performance goals associated with the enactment of MDUFMA and strengthen FDA’s medical device review program.