Required by the

Medical Device User Fee Act

As amended

Food and Drug Administration

Department of Health and Human Services

April 2017

Printable Version of FY2016 MDUFA Financial Report

• Printable Version of the FY2016 MDUFA Financial Report

Table of Contents

• Executive Summary-FY2016 MDUFA Financial Reports
• Background-FY2016 MDUFA Financial Report
• Legal Conditions-FY2016 MDUFA Financial Report
• User Fee Collections-FY2016 MDUFA Financial Report
• User Fee Obligations-FY2016 MDUFA Financial Report
• Carryover Balances-FY2016 MDUFA Financial Report
• Collections Realized-FY2016 MDUFA Financial Report
• Reserves and Balance Available for Allocation-FY2016 MDUFA Financial Report
• Total MDUFA Program Costs
• Full-Time Equivalent-FY2016 MDUFA Financial Report

Appendices

• Appendix A-Conditions for Assessment and Use of Fees
• Appendix B-Fees, Waivers, and Reductions
• Appendix C-Allowable and Excluded Costs for the MDUFA Program
• Appendix D-Development of Costs for the MDUFA Program