Appendix C: Waivers, Reductions, and Exemptions (MDUFMA, FY 2010)
MDUFMA directs FDA to waive the first premarket application fee from a qualified small business and the fee for an application 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) of the FD&C Act;
- 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.
In this appendix FDA provides a summary of MDUFMA fee waivers, reductions, and exemptions granted in FY 2010.
FDA responded to thousands of e-mails and phone calls from companies asking for information regarding the small-business waiver or reduction of MDUFMA fees. After carefully reviewing the requests from companies, FDA waived 16 fees for first-time submissions of PMAs or BLAs, and reduced a total of 1,279 fees. Table 12 displays the number of small-business application fees that were waived or reduced by FDA, and the value of each such waiver or reduction in FY 2010.
FY 2010 Small Business Fee Waivers and Reductions Granted
As of September 30, 2010
Amount Reduced per Fee
Full Fees Waived
Full Fees Reduced
Panel Track Supplements Reduced
180-Day Supplements Reduced
Real-Time Supplements Reduced
510(k)s Fees Reduced
30-day Notice Fees Reduced
513(g)s Fees Reduced
Annual Periodic Report Fees Reduced
Note: Amount of reduction per fee type = full fee rate - small business fee rate
FDA collected $63,537,742 in fee revenue during FY 2010. Had there been no small-business waivers or reductions, FDA would have collected an additional $8,370,548, or an additional 13 percent of collections.
FDA received 7 HDE applications and 60 supplements in FY 2010. 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 2010 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 2010 for products that were not intended for commercial distribution.
FDA granted exemptions for pediatric indications in FY 2010 to one original premarket application, seven 510(k)s, two real-time supplements, two 180-day supplements, and one panel-track supplement. The total value of these exemptions was $505,002.
FDA received 244 510(k) submissions subject to third-party review in FY 2010 compared to 304 in FY 2008 and 282 in FY 2009. FDA exempted fees for these 244 submissions. The total value of these exemptions in FY 2010 was $831,015 – assuming that 30 percent (the same percent of total 2010 510(k)s submitted that paid the small business rate) of the third-party submissions would have paid the reduced small business fee.
Summary and Total Value of All Fee Waivers,
Reductions, and Exemptions Granted
As of September 30, 2010
Govt. Sponsored Application not for Commercial Distribution
510(k)s Subject to Third-Party Review