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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