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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 Type FY 2008 FY 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 Type FY 2007 FY 2008 FY 2009 Full Fee Applications 23 17 32 Small Business Rate 2 7 10 Panel Track Supplement Counted as Full Fee 8 13 Small Business Rate Counted as Full Fee 0 1 180-Day Supplements 96 126 132 Small Business Rate 22 18 18 Real-Time Supplements 140 165 186 Small Business Rate 20 22 24 510(k)s 2,767 2,781 2,881 Small Business Rate 649 846 1,037 30-Day Notice n/a 597 596 Small Business Rate n/a 59 71 513(g) Request for Classification Information n/a 64 58 Small Business Rate n/a 26 39 Annual Fee for Periodic Reporting n/a 467 460 Small Business Rate n/a 50 70 Establishment Registration n/a 13,835 14,252
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
