About FDA
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FY 2009 MDUFMA Financial Report
Required By The
Medical Device User Fee
and Modernization Act of 2002
As Amended
Food and Drug Administration
Department of Health and Human Services
September 2010
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Printable Version of FY 2009 MDUFMA Financial Report
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Table of Contents
Executive Summary: FY 2009 MDUFMA Financial Report Background Meeting the Statutory Conditions for User Fees in FY 2009 User Fee Collections Obligation of User Fee Collections Carryover Balances Total Cost of the Process for the Review of Medical Device Applications Performance Goals Management Challenges for FY 2010
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Appendices
Appendix A: Statutory Conditions for Collection and Use of Fees Appendix B: Number of Fees Paid Applications in FY 2009 Appendix C: Waivers, Reductions, and Exemptions Appendix D: Allowable and Excluded Costs for the Process for the Review of Medical Device Applications Appendix E: Development of Costs for the Process for the Review of Medical Device Applications
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