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 5 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
MDUFMA requires FDA to submit two reports to Congress each fiscal year: 1) a
performance report is to be sent within 60 days after the end of each fiscal year, and 2) a
financial report is to be sent within 120 days after the end of each fiscal year. FDA is
separately transmitting the FY 2009 MDUFMA Performance Report that discusses
FDA’s progress in meeting the goals referred to in MDUFMA. This report is FDA’s
FY 2009 MDUFMA Financial Report covering the period October 1, 2008 through
September 30, 2009.
As required by MDUFMA, this report presents the statutory conditions or “triggers” that
must be met as a condition for FDA to be able to collect and spend the fees, and explains
how they were met in FY 2009. This report describes the process for the review of
medical device applications, as defined in MDUFMA, and states the total costs of this
process in FY 2009, including costs paid from both fee collections and appropriations.
The report also presents the FY 2009 fee collections, obligations, and carryover balances.