Medical Device User Fee Act (MDUFA)
Medical Device User Fee and Modernization Act (MDUFMA)
Overview
Home Page
Summary of the Medical Device User Fee and Modernization Act of 2002
Comparison of Quantitative Decision Goals in MDUFMA I and II
Background on MDUFMA
MDUFMA Frequently Asked Questions
Guidance Documents
FY 2011 Medical Device Small Business Qualification and Certification (pdf), August 2, 2010
Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs and BLA Supplements (describes the roles of both FDA and Industry in an interactive review process of specific medical device submission types)
Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs and BLA Supplements (describes the roles of both FDA and Industry in an interactive review process of specific medical device submission types)
Forms
Create MDUFMA User Fee Cover sheet
FY 2011 Medical Device Small Business Qualification and Certification (pdf)
FY 2011 Medical Device Small Business Qualification and Certification (pdf)
User Rates and Fees
Assessing User Fees: PMA Supplement Definitions, Modular PMA Fees, BLA and Efficacy Supplemental Definitions, Bundling Multiple Devices in a Single Application, and Fees for Combination Devices
FY 2011 User Fee Letter (pdf)
Device Facility User Fee and Registration
Premarket Notification 510(k) fees
Premarket Approval fees
FY 2011 User Fee Letter (pdf)
Device Facility User Fee and Registration
Premarket Notification 510(k) fees
Premarket Approval fees
Related Information
FDA News Release, April 16, 2007
Fact Sheet
Comparison of Quantitative Decision Goals
Information related to the MDUFMA FY 2007 180-day PMA Goal (pdf)
Prerecorded Video Presentations (wmv format)
Comparison of Quantitative Decision Goals
Information related to the MDUFMA FY 2007 180-day PMA Goal (pdf)
Prerecorded Video Presentations (wmv format)
Overview of User Fees and the Reauthorization Process (Malcolm Bertoni)
Device Development and Activities supported by the Medical Device User Fee Program (Donald St. Pierre)
Medical device Review Program Performance (Barbara Zimmerman)
Device Development and Activities supported by the Medical Device User Fee Program (Donald St. Pierre)
Medical device Review Program Performance (Barbara Zimmerman)
MDUFA III Reauthorization
Industry Discussions
Minutes from Negotiation Meeting on MDUFA III Reauthorization, January 26, 2011
Minutes from Negotiation Meeting on MDUFA III Reauthorization, February 9, 2011
Minutes from Negotiation Meeting on MDUFA III Reauthorization, February 23, 2011
Minutes from Negotiation Meeting on MDUFA III Reauthorization, March 7, 2011
Minutes from Negotiation Meeting on MDUFA III Reauthorization, February 9, 2011
Minutes from Negotiation Meeting on MDUFA III Reauthorization, February 23, 2011
Minutes from Negotiation Meeting on MDUFA III Reauthorization, March 7, 2011
Stakeholder Discussions
Minutes from Stakeholder Meeting on MDUFA III Reauthorization, January 13, 2011
Minutes from Stakeholder Meeting on MDUFA III Reauthorization, February 16, 2011
Minutes from Stakeholder Meeting on MDUFA III Reauthorization, March 22, 2011
Minutes from Stakeholder Meeting on MDUFA III Reauthorization, February 16, 2011
Minutes from Stakeholder Meeting on MDUFA III Reauthorization, March 22, 2011
MDUFMA Reports
August 2004 GAO report discusses FDA's progress towards achieving MDUFMA's performance goals (pdf)
Latest Quarterly Report on Progress Towards Achieving MDUFMA Performance Goals (actions through Sept. 30, 2006) (pdf)
Latest Quarterly Update on FDA Progress Towards Achieving MDUFMA Performance Goals (actions through Sept. 30, 2006) (pdf)
FY 2008 MDUFMA Performance Report
Agenda and Materials From January 28, 2009 FDA Performance Report
Agenda and Materials From May 4, 2009 FDA Performance Report
Agenda and Materials From August 4, 2009 FDA Performance Report
Agenda and Materials From November 17, 2009 FDA Performance Report
Agenda and Materials From January 26, 2010 FDA Performance Report
Agenda and Materials From April 20, 2010 FDA Performance Report
Agenda and Materials From July 29, 2010 FDA Performance Report
Agenda and Materials From October 27, 2010 FDA Performance Report
Agenda and Materials From January 26, 2011 FDA Performance Report (pdf)
Latest Quarterly Report on Progress Towards Achieving MDUFMA Performance Goals (actions through Sept. 30, 2006) (pdf)
Latest Quarterly Update on FDA Progress Towards Achieving MDUFMA Performance Goals (actions through Sept. 30, 2006) (pdf)
FY 2008 MDUFMA Performance Report
Agenda and Materials From January 28, 2009 FDA Performance Report
Agenda and Materials From May 4, 2009 FDA Performance Report
Agenda and Materials From August 4, 2009 FDA Performance Report
Agenda and Materials From November 17, 2009 FDA Performance Report
Agenda and Materials From January 26, 2010 FDA Performance Report
Agenda and Materials From April 20, 2010 FDA Performance Report
Agenda and Materials From July 29, 2010 FDA Performance Report
Agenda and Materials From October 27, 2010 FDA Performance Report
Agenda and Materials From January 26, 2011 FDA Performance Report (pdf)
Annual Reports to Congress
Performance Reports
Financial Reports
Device Cost Analysis
Public Meetings
Public Workshops
Identifying Unmet Public Health Needs and Facilitating Innovation in Medical Device Development, June 24, 2010
Medical Device User Fee Program Public Meeting, September 14, 2010
Public Meeting
Incorporation of New Science Into Regulatory Decision making within the Center for Device and Radiological Health, February 9, 2010
Converged Communications and Health Care Devices Impact on Regulation, July 26-27, 2010
Converged Communications and Health Care Devices Impact on Regulation, July 26-27, 2010
Town Hall Discussions With the Director of CDRH and Other Senior Center Management
Bloomington Minnesota: May 18, 2010
Boston, Massachusetts: June 22, 2010
Los Angeles, California: October 7, 2010
Boston, Massachusetts: June 22, 2010
Los Angeles, California: October 7, 2010