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CDRH/CBER MDUFMA STAKEHOLDER MEETING AGENDA & PRESENTATION SLIDES

November 18, 2004 ♦ 9:00 a.m. - 5:00 p.m. EST

Washingtonian Marriott, Gaithersburg, Maryland

 

Please note: Copies of PowerPoint presentations and linked after each speaker. Accessible text versions are in the process of being made for each presentation. If you need assistance, prior to the posting of the accessible text version, please see this link.
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8:00 a.m. REGISTRATION
9:00 a.m.

OPENING REMARKS

  • Moderator: Mark Barnett, Assistant Director for Education and Communication, Center for Devices and Radiological Health (CDRH)
9:10 a.m.

WELCOME

  • Daniel Schultz, Director, Center for Devices and Radiological Health (CDRH)
  • Jesse Goodman, Director, Center for Biologics Evaluation and Research (CBER)
9:30 a.m.

OVERVIEW

  • Linda Kahan, Deputy Director, CDRH
  • Diane Maloney, Associate Director for Policy, CBER
  • Mark Kramer, Director, Office of Combination Products, FDA
15 Minute Break
 
10:15 a.m.

Panel 1: How is the User Fee Process Working?

Financial Aspects of User Fees

FDA Panelists:

  • Frank Claunts, Office of Management, FDA
    Presentation: [PowerPoint] [Accessible Text]
  • John Stigi, Office of Communication, Education, and Radiation Programs, CDRH

Industry Panelists:

Questions from the Audience

   
11:15 a.m.

Panel 2: Premarket Review Performance Goals

 FDA Panelists:

  • Donna-Bea Tillman, Office of Device Evaluation, CDRH
    Presentation: [PowerPoint] [Accessible Text]
  • Don St. Pierre, Office of In Vitro Diagnostic Device Evaluation and Safety, CDRH
  • Len Wilson, Office of the Center Director, CBER
    Presentation: [PowerPoint] [Accessible Text]

Industry Panelists:

 Questions from the Audience

   
12:15 p.m. - 1:30 p.m. LUNCH ON YOUR OWN
 
1:30 p.m.

Panel 3: Qualitative Performance Goals (e.g., Modular PMA Program, and GMP and BIMO Inspectional Programs)  

FDA Panelists:

Industry Panelist:

  • Susan Alpert, Advanced Medical Technology (AdvaMed)
    Presentation: [PowerPoint] [Accessible Text]

Questions from the Audience

   
2:30 p.m.

Panel 4: Third Party Inspection Program

FDA Panelists:

  • Kara Lynch, Office of Regulatory Affairs, FDA
  • John Stigi, Office of Communication, Education, and Radiation Programs, CDRH
  • Jan Welch, Office of Compliance, CDRH
    Presentation: [PowerPoint] [Accessible Text]

Industry Panelist:

  • Diane Wurzburger, Advanced Medical Technology (AdvaMed) and National Electrical Manufacturers Association (NEMA)
    Presentation: [PowerPoint] [Accessible Text]

Questions from the Audience

   
15 Minute Break
 
3:45 p.m.

Panel 5: Reuse

FDA Panelists:

  • Barbara Zimmerman, Office of Device Evaluation, CDRH
    Presentation: [PowerPoint] [Accessible Text]
  • Steve Turtil, Office of Device Evaluation, CDRH
  • Ginette Michaud, Office of the Director, CDRH
  • Larry Spears, Office of Compliance, CDRH
    Presentation: [PowerPoint] [Accessible Text]

Industry Panelists:

 Questions from the Audience

   
4:45 p.m. Additional Questions and Comments
   
5:00 p.m.

WRAP UP AND ADJOURN

Moderator: Mark Barnett, CDRH

Back to MDUFMA Home Page

Updated December 15, 2004

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