• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

About FDA

  • Print
  • Share
  • E-mail

Appendix B: Number of Fees Paid Applications in FY 2010 (MDUFMA, FY 2010)

Back to Table of Contents: FY 2010 MDUFMA Financial Report

 

Under MDUFMA II, fee rates for PMA and BLA fees and for annual establishment registration are set in the statute. The rates for all other fees are statutorily set as a percent of the full PMA fee rate. 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 $30,000,000 or less in gross receipts or sales in its most recent Federal income tax return) pay 25 percent of the specified fee, except that 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 2009 (Second year of MDUFMA II) and FY 2010 (Third year of MDUFMA II).  
 
 
Table 10
Medical Device User Fee Rates
As of September 30, 2010
 
Application Type
FY 2009
FY 2010
Full Fee Applications
$200,725
$217,787
Small Business Rate
$50,181
$54,447
Panel Track Supplement
$150,544
$163,340
          Small Business Rate
$37,636
$40,835
180-Day Supplements
$30,109
$32,668
Small Business Rate
$7,527
$8,167
Real-Time Supplements
$14,051
$15,245
Small Business Rate
$3,513
$3,811
510(k)s
$3,693
$4,007
Small Business Rate
$1,847
$2,004
30-Day Notice
$3,212
$3,485
Small Business Rate
$1,606
$1,742
513(g) Request for Classification Information
$2,710
$2,940
Small Business Rate
$1,355
$1,470
Annual Fee for Class III Periodic Report
$7,025
$7,623
Small Business Rate
$1,756
$1,906
Annual Establishment Registration
$1,851
$2,008
 
 
Table 11 summarizes the number of applications/fees received by FDA in each year,FY 2008 through FY 2010, for which the fees had been paid in full by the companies before September 30.
 
Table 11
Applications for which fees were Paid and Establishment and Report Fees
Paid As of September 30, 2010
 
Application Type
FY 2008 Actual
FY 2009 Actual
FY 2010 Actual
Full Fee Applications
17
32
32
Small Business
7
10
8
Panel Track Supplement
8
13
11
Small Business
0
1
2
180-Day Supplements
126
132
103
Small Business
18
18
20
Real-Time Supplements
165
186
146
Small Business
22
24
20
510(k)s
2,781
2,881
2,367
Small Business
846
1,037
1,032
30-Day Notice
597
596
669
Small Business
59
71
78
513(g) Request for Classification Information
64
58
56
Small Business
26
39
25
Annual Fee for Periodic Reporting
467
460
427
Small Business
50
70
78
Establishment Registration
13,835
14,252
15,518

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;
  • applications bundled under one fee because of similarity of medical device review issues;
  • applications exempted from fees for pediatric indications;
  • applications for IDEs and PMA supplements other than Real-Time and 180-Day Supplements;
  • other applications for which no fee is charged, such as requests for investigational device exemption 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, Reductions, and Exemptions