About FDA
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FY 2011 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 2011
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Printable Version of FY 2011 MDUFMA Financial Report
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Table of Contents
- Executive Summary
- Background
Meeting the Legal Conditions for User Fees in FY 2011 - User Fee Collections
- User Fee Obligations
- Full-Time Equivalents
- Carryover Balances
- Collections Ceilings, Collections Realized, and Offset
- Reserves and Balance Available for Allocation
- Total Costs of the Process for the Review of Medical Device Applications
Management Challenges for FY 2012
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Appendices
- Appendix A: Conditions for Assessment and Use of Fees
Appendix B: Number of Fees Paid in FY 2011 - Appendix C: Waivers and Reductions Granted
- 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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