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Appendix C: Waivers, Reductions, and Exemptions

Back to Table of Contents:  FY 2009 MDUFMA Financial Report


MDUFMA directs FDA to waive the first premarket application fee from a qualified small business and an application fee submitted solely for pediatric indications.  It also directs FDA to reduce fees for subsequent applications from qualified small businesses in all categories except the annual establishment registration fee.  In addition, FDA does not collect fees for the following application types:
 

  • Applications for Humanitarian Device Exemptions (HDE) submitted under section 520(m);
  • Applications submitted under section 351 of the Public Health Service (PHS) Act for a product licensed for further manufacturing use only;
  • Applications submitted by a state or federal government entity for devices that are not intended for commercial distribution; and
  • 510(k)s submitted to certified third-party reviewers, rather than to FDA.


FDA provides a summary of MDUFMA fee waivers, reductions, and exemptions granted in FY 2009 in this appendix. 

FDA responded to thousands of e-mails and phone calls from companies asking for information regarding the small-business waiver for MDUFMA fees.  After carefully reviewing the requests from companies, FDA waived 15 fees for first-time submissions of PMAs or BLAs, and reduced a total of 1,270 fees.  The following table portrays the number of small-business application fees that were waived or reduced by FDA, and the value of each category in FY 2009.

  
FOOD AND DRUG ADMINISTRATION
FY 2009 SMALL BUSINESS FEE WAIVERS AND REDUCTIONS GRANTED
AS OF SEPTEMBER 30, 2009

CategoryNumberAmountTotal Value
Full Fees Waived15$200,725$3,010,875
Full Fees Reduced10$150,544$1,505,440
Panel Track Supplements Reduced 1$112,908$112,908
180-Day Supplements Reduced18$22,582$406,476
Real-Time Supplements Reduced24$10,538$252,912
510(k)s Fees Reduced1037$1,846$1,914,302
30-day Notice Fees Reduced71$1,606$114,026
513(g)s Fees Reduced39$1,355$52,845
Annual Periodic Report Fees Reduced70$5,269$368,830
Total1,285n/a$7,738,614

Note: Amount of reduction per fee type  =  full fee rate - small business

FDA collected $61,729,920 in fee revenue during FY 2009.  Had there been no small-business waivers and reductions, FDA would have collected an additional $7,738,614, or an additional 12.5 percent of collections. 

FDA received four HDE applications and 40 supplements in FY 2009.  None of these are subject to MDUFMA fees.  FDA does not know if any of them would have been submitted had they been subject to a fee.  Therefore, FDA does not know the extent to which this exemption resulted in any loss of revenue.

CBER received no exemption requests in FY 2009 for applications submitted under section 351 of the PHS Act for a product licensed for further manufacturing use only. 

FDA did not receive any requests from State or Federal government entities for exemptions in FY 2009 for products that were not intended for commercial distribution. 

FDA granted exemptions for pediatric indications in FY 2009 to 10 510(k)s, 3 real-time  supplements, one 180-day supplement, and 1 panel-track supplement.  The total value of these exemptions was $259,709.

FDA received 282 510(k) submissions subject to third-party review in FY 2009 compared to 235 in FY 2007 and 304 in FY 2008.  FDA exempted fees for these 282 submissions.  The total value of these exemptions in FY 2009 was $963,894 – assuming that 15 percent of the third-party submissions would have paid the reduced small business fee.
 

FOOD AND DRUG ADMINISTRATION
SUMMARY AND TOTAL VALUE OF ALL FEE WAIVERS,
REDUCTIONS, AND EXEMPTIONS GRANTED
AS OF SEPTEMBER 30, 2009


ReasonFY 2008FY 2009
Small Business$5,755,408$7,738,614
Govt. Sponsored Application not for Commercial Distribution$34,558$0
Pediatric Indications$305,028$259,709
510(k)s Reviewed by Third-Party Review$1,225,760$963,894
Total Value$7,320,754$8,962,217

Next Section:  Appendix D - Allowable and Excluded Costs for the Process for the Review of Medical Device Applications