Executive Summary: FY 2011 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. Required under MDUFMA, this report covers activities for fiscal year (FY) 2011.
MDUFMA, as amended, specifies that the following three legal conditions must be satisfied each fiscal year in order for FDA to collect and spend MDUFMA user fees:
1. 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.
2. The fee amounts FDA can collect must be specified in appropriation acts.
3. FDA must spend at least as much from appropriated funds 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 five percent in each fiscal year.
This report explains how FDA met these three legal conditions in FY 2011. The statements and tables in the report provide data on FY 2011 medical device user fee collections, obligations, and carryover balance, as well as comparative data from earlier periods.
In FY 2011, FDA collected $69 million in medical device user fees, spent $59.3 million in user fees for the review process, and carried a cash balance of $53.9 million forward for future fiscal years.
MDUFMA user fees and appropriations in FY 2011 supported 1,275 Full-Time Equivalent (FTE) staff years, including salary and operational expenses to support the staff responsible for the process for the review of medical device applications. In this report the time worked by one full-time person for one year is referred to either as a “staff year” or as an FTE. These resources enabled FDA to achieve most of the performance goals associated with the enactment of MDUFMA and strengthen FDA’s medical device review program.