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Appendix B: Number of Fees Paid Applications in FY 2009

Back to Table of Contents:  FY 2009 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 7 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 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.  The table below exhibits the rates for all types in FY 2008 (First year of MDUFMA II) and FY 2009 (Second year of MDUFMA II).


FOOD AND DRUG ADMINISTRATION
MEDICAL DEVICE USER FEE RATES
AS OF SEPTEMBER 30, 2009

Application TypeFY 2008FY 2009
Full Fee Applications$185,000$200,725
Small Business Rate$46,250$50,181
Panel Track Supplement$138,750$150,544
Small Business Rate$34,688$37,636
180-Day Supplements$27,750$30,109
Small Business Rate$6,938$7,527
Real-Time Supplements$12,950$14,051
Small Business Rate$3,237$3,513
510(k)s$3,404$3,693
Small Business Rate$1,702$1,847
30-Day Notice$2,960$3,212
Small Business Rate$1,480$1,606
513(g) Request for Classification Information$2,498$2,710
Small Business Rate$1,249$1,355
Annual Fee for Class III Periodic Report$6,475$7,025
Small Business Rate$1,619$1,756
Annual Establishment Registration$1,706$1,851
 

The next table summarizes the number of applications/fees received by FDA in each year, FY 2007 through FY 2009, for which the fees had been paid in full by the companies before September 30.


FOOD AND DRUG ADMINISTRATION
APPLICATIONS RECEIVED AND PAID FEES
AS OF SEPTEMBER 30, 2009


 

Application TypeFY 2007FY 2008FY 2009
Full Fee Applications231732
Small Business Rate2710
Panel Track SupplementCounted as Full Fee813
Small Business RateCounted as Full Fee01
180-Day Supplements96126132
Small Business Rate221818
Real-Time Supplements140165186
Small Business Rate202224
510(k)s2,7672,7812,881
Small Business Rate6498461,037
30-Day Noticen/a597596
Small Business Raten/a5971
513(g) Request for Classification Informationn/a6458
Small Business Raten/a2639
Annual Fee for Periodic Reportingn/a467460
Small Business Raten/a5070
Establishment Registrationn/a13,83514,252


Please note that the numbers 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