Background: FY 2011 MDUFMA Financial Report
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by MDUFMA, authorizes FDA to collect fees from the medical device industry to augment appropriations spent on FDA’s medical device review process. FDA spends fee revenues and appropriations to hire, support, and maintain personnel for the review of medical device applications to ensure that safe and effective devices reach the American public more quickly.
The Medical Device User Fee Amendments of 2007 [Title II of the Food and Drug Administration Amendments Act (FDAAA) of 2007, Pub. Law 110-85] 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) of the FD&C Act. 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.
MDUFMA requires FDA to submit two reports to Congress each year, within 120 days of the end of the fiscal year:
1) a performance report; and
2) a financial report.
The FY 2011 MDUFMA Performance Report, which describes FDA’s progress in meeting the goals referred to in MDUFMA, was transmitted separately to Congress earlier this year. This report is the FY 2011 MDUFMA Financial Report, which addresses the implementation and use of medical device user fees by FDA during the period of October 1, 2010, through September 30, 2011.
As required by MDUFMA, this report presents the legal conditions that must be satisfied for FDA to collect and spend medical device user fees annually. In addition, this report presents statements of FY 2011 fee collections, cash carryover balances, obligations of user fees, and total costs of the process for the review of medical device applications from both fees and appropriations.