Information Related to MDUFMA II

• Federal Register Notice
• News Release
• Fact Sheet
• Comparison of Quantitative Decision Goals
• Information Related to the MDUFMA FY 2007 180-Day PMA Goal [PDF]
• Pre-recorded Video Presentations
  The following video presentations on the medical device user fee program are designed to give the public more background information on the program. These pre-recorded seminars are in Windows Media Video format, are free of charge, and can be viewed at any time.
  • Overview of User Fees and the Reauthorization Process (Malcolm Bertoni)
    This presentation provides a general overview of what user fee programs are, how user fee programs work at the U.S. Food and Drug Administration (FDA), and the process to be followed as we work to support congressional reauthorization of the Medical Device User Fee Program in the year 2012. The presentation provides a general overview of how we will engage various stakeholder groups in the reauthorization process, beginning with the September 14, 2010 Medical Device User Fee Program’s Public Meeting.
  • Device Development and Activities Supported by the Medical Device User Fee Program (Donald St. Pierre)
    This presentation provides an overview of how FDA regulates all types of medical devices and the role of the medical device user fee program in the process.
  • Medical Device Review Program Performance (Barbara Zimmerman)
    This presentation provides a history of the evolution of the medical device user fee program. It also includes a detailed review of FDA’s medical device review performance under the current medical device user fee program which runs from 2007 through 2012.