Background: FY 2010 MDUFMA Financial Report
MDUFMA authorized FDA to collect fees from the medical device industry to augment appropriated funds for the medical device review process from FY 2003 through FY 2007. MDUFMA also required increasing funding from appropriations each year. FDA used the additional funds from fees and appropriations to support the process for the review of medical device applications as defined in MDUFMA, so that safe and effective devices reached the American public more quickly.
The Medical Device User Fee Amendments of FY 2007 (Title II of the Food and Drug Administration Amendments Act (FDAAA) of 2007) amended MDUFMA and extended its authorization for an additional five years, through FY 2012. This reauthorization is referred to as MDUFMA II.
Under MDUFMA II, companies must pay application fees when submitting certain device applications to FDA. Fee-paying applications include premarket applications (PMAs); product development protocols (PDPs); premarket reports (PMRs); modular PMAs; biologics license applications (BLAs); certain supplements to all of these applications; premarket notification submissions (510(k)s); 30-day notices of changes to manufacturing procedures or methods of manufacture affecting device safety and effectiveness; and requests for classification information under section 513(g). In addition, under MDUFMA II, firms must pay an annual fee for each establishment subject to a registration fee and a fee for periodic reports regarding Class III devices. The fees for a PMA and for device establishment registration are specified in the statute for each year through FY 2012. Fees for other application types and for periodic reports are fixed in statute as a percent of the PMA fee for each year. Each year in August, FDA publishes all fee rates for the next fiscal year based on the percentages specified in the statute.
MDUFMA requires FDA to submit two reports to Congress each fiscal year: 1) a performance report is to be sent within 120 days after the end of each fiscal year; and 2) a financial report is also to be sent within 120 days after the end of each fiscal year. FDA is separately transmitting the FY 2010 MDUFMA Performance Report that discusses FDA’s progress in meeting the goals referred to in MDUFMA. This report is FDA’s FY 2010 MDUFMA Financial Report covering the period October 1, 2009 through September 30, 2010.
As required by MDUFMA, this report presents the statutory conditions or “triggers” that must be satisfied as a condition for FDA to be able to collect and spend the fees, and explains how they were met in FY 2010. This report describes the process for the review of medical device applications, as defined in MDUFMA, and provides the total costs of this process in FY 2010, including costs paid from both fee collections and appropriations. The report also presents the FY 2010 fee collections, obligations, and carryover balances.