User Fee Collections in FY 2010
MDUFMA directs FDA to receive fees from medical device applications as well as annual establishment registration fees and periodic report fees through FY 2012. The statute directs FDA to set the fee rate for each application type and for periodic reports as a percentage of the standard fee for a PMA. For FY 2010, MDUFMA II specifies that the standard fee for a PMA is $217,787 and that the device establishment fee is $2,008. FDA then sets the other fees based on the percentages specified in the statute. 
Under MDUFMA, medical device user fees continue to remain available to FDA for use in future years for the medical device review process if they are not obligated at the end of the fiscal year. Cash balances carried to the next fiscal year are provided in table 3 on page 5, in the section Carryover Balances. Table 1 shows the amount of user fees FDA has collected over the most recent two fiscal years.
Statement of Medical Device Fee Collections
As of September 30, 2010
|FY 2009||FY 2010|
|Total Fees Collected||$59,731,482||$$,949,587|
1Unearned Fees are fees collected for applications that had not been received by FDA as of September 30, 2010 or for FY 2010 establishment fees received without identification of the remitter. They are included above in the 'Total Fees Collected' amounts.
Note that user fees collected (the first line in table 1) are initially credited to the year the fee is received. However, the revenues may be reassigned to the year the application is received, if that is different. This is referred to as the cohort year. Last year’s report showed $62,011,733 of fees collected in FY 2009, of which $5,610,279 was shown as “unearned income” since the application for which the fee was paid had not been received by the end of FY 2009. The FY 2009 total fees collected line is decreased to $59,731,482 in this report, and all but $3,379,163 of the unearned income reported last year has now been either refunded or credited to the year the application was actually received.
The total fees collected line for FY 2010, when seen in next year’s FY 2011 report, will also be different than the figure shown here—reflecting both the refund or reassignment of unearned income, and the refunds that will be made over the next 12 months. Totals reported for each year are net of any refunds for that year, as of September 30, but do not take into account any refunds that may be made after September 30. Information on the number of each type of fee received in FY 2010 is contained in Appendix B.
A summary of FY 2010 waivers, reductions, and exemptions is provided in Appendix C.