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Appendix B: Number of Fees Paid in FY 2011
Back to Table of Contents: FY 2011 MDUFMA Financial Report
MDUFMA II established fee rates for Premarket Application (PMA) and Biologics License Application (BLA) fees and for annual establishment registration fees. The rates for all other fees are statutorily set as a percent of the full PMA fee rate, which is $236,298 for FY 2011. The premarket report fee and the efficacy supplement fee are equal to the PMA fee. The panel track supplement fee is 75 percent of the PMA fee. The 180-day supplement fee is 15 percent of the PMA fee. The real-time supplement fee is seven percent of the PMA fee. The 30-day notice fee is 1.6 percent of the PMA fee. The premarket notification submission [510(k)] fee is 1.84 percent of the PMA fee. The request for classification information [513(g)] fee is 1.35 percent of the PMA fee and the fee for periodic reporting concerning class III devices is 3.5 percent of the PMA fee. Qualified small businesses (an entity that reported $100,000,000 or less in gross receipts or sales in its most recent Federal income tax return) pay 25 percent of the specified fee, except for premarket notifications [510(k)s], 30-day notices, and requests for classification they pay 50 percent of the specified rate. There is no small business rate for annual establishment registrations. Table 10 exhibits the rates for all types in FY 2010 (third year of MDUFMA II) and FY 2011 (fourth year of MDUFMA II).
Table 10
Medical Device User Fee Rates
For Fiscal Years 2010 and 2011
APPLICATION TYPE FY 2010 FY 2011 Full Fee Applications $217,787 $236,298 Small Business Rate $54,447 $59,075 Panel Track Supplement $163,340 $177,224 Small Business Rate $40,835 $44,306 180-Day Supplements $32,668 $35,445 Small Business Rate $8,167 $8,861 Real-Time Supplements $15,245 $16,541 Small Business Rate $3,811 $4,135 510(k)s $4,007 $4,348 Small Business Rate $2,004 $2,174 30-Day Notice $3,485 $3,781 Small Business Rate $1,742 $1,890 513(g) Request for Classification Information $2,940 $3,190 Small Business Rate $1,470 $1,595 Annual Fee for Class III Periodic Report $7,623 $8,270 Small Business Rate $1,906 $2,068 Annual Establishment Registration $2,008 $2,179
Table 11 summarizes the number of applications received by FDA, from FY 2009 through FY 2011, for which the fees were paid in full before September 30, 2011.
Table 11
Medical Device User Fees Collected in FY 2009, 2010 and 2011
As of September 30, 2011
| APPLICATION TYPE | FY 2009 ACTUAL | FY 2010 ACTUAL | FY 2011 ACTUAL |
|---|---|---|---|
| Full Fee Applications | 32 | 32 | 24 |
| Small Business | 10 | 8 | 7 |
| Panel Track Supplement | 13 | 11 | 7 |
| Small Business | 1 | 2 | 1 |
| 180-Day Supplements | 132 | 103 | 92 |
| Small Business | 18 | 20 | 15 |
| Real-Time Supplements | 186 | 146 | 148 |
| Small Business | 24 | 20 | 17 |
| 510(k)s | 2,881 | 2,367 | 2,428 |
| Small Business | 1,037 | 1,032 | 938 |
| 30-Day Notice | 596 | 669 | 767 |
| Small Business | 71 | 78 | 67 |
| 513(g) Request for Classification Information | 58 | 56 | 40 |
| Small Business | 39 | 25 | 35 |
| Annual Fee for Periodic Reporting | 460 | 427 | 301 |
| Small Business | 70 | 78 | 52 |
| Establishment Registration | 14,252 | 15,518 | 16,264 |
Please note that the quantity of application fees received by FDA should not be used as a surrogate for medical device review workload. Many applications submitted to FDA are not charged fees by FDA for the following reasons:
• first applications submitted by small businesses; (defined for these purposes as an entity that
reported $30,000,000 or less in gross receipts or sales in its most recent federal income tax
return);
• applications bundled under one fee because of similar medical device review issues;
• applications exempted from fees for pediatric indications;
• applications for investigational device exemptions (IDEs) and PMA supplements other than
Real-Time and 180-Day Supplements;
• other applications for which no fee is charged, such as requests for IDEs and requests for
humanitarian device exemption; and
• annual report submissions that must be examined but that have no fees associated with
them.
Next Section: Appendix C – Waivers and Reductions Granted
