MDUFMA Stakeholder Meeting

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FDA > CDRH > MDUFMA > Stakeholder Meeting to Discuss the Possible Implementation of Two Review Performance Goals in the Medical Device User Fee and Modernization Act of 2002; Public Meeting

Stakeholder Meeting to Discuss the Possible Implementation of Two Review Performance Goals in the Medical Device User Fee and Modernization Act of 2002; Public Meeting - May 22, 2006

This public meeting was held on May 22, 2006, at 9200 Corporate Blvd. Room 20B, Rockville, MD 20850. Its purpose was to consult with our stakeholders and to determine whether the following two goals are appropriate for implementation in FY 2007:

50% of the premarket approval applications received in fiscal year (FY) 2007 will have an FDA decision in 180 days and
80% of the premarket notifications will have an FDA decision in 90 days.

Information Available:

Attendees
Agenda
Individual Presentations
Transcript

Attendees

First Name	Last Name	Organization
Mark	Barnett	FDA
Bob	Britain	NEMA
Bob	De Luca	FDA
Chris	Delport	MDMA
Sara	Doll	FDA
David	Douglas	Delphi Ventures
Brian	Fortier	Aorta Medical Inc.
Jori	Frahler	MDMA
Linda	Kahan	FDA
Paul	Kim	Foley Hoag LLP
Joanne	Less	FDA
Diane	Maloney	FDA
Mark	McCarty	Medical Device Daily
Scott	Mindrebo	Cyberonics, Inc.
James	Norman	FDA
Matthew	Perrone	FDC Reports
Phil	Phillips	Becker & Associates Consulting, Inc.
Lynne	Rice	FDA
Karen	Riley	World Medical Technology News
Tim	Ritter	Booz Allen Hamilton
Marjorie	Shulman	FDA
Kelly	Sloan	NVCA
Min	Song	Booz Allen Hamilton
Donna-bea	Tillman	FDA
Janet	Trunzo	AdvaMed
Lindsey	Wade	National Research Center for Women & Families
Robin	Wiley	Cook Group, Inc.
Diana	Zuckerman	National Research Center for Women & Families

Agenda

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. MEETING INTRODUCTION
Linda Kahan, Deputy Director, CDRH

Presentations

9:20– 9:40 a.m. – Donna-Bea Tillman, Director, Office of Device Evaluation, CDRH [PDF]

OPEN SESSION

David L. Douglass, National Venture Capital Association (NVCA) [PDF]
Jori Frahler, Medical Device Manufacturers Association (MDMA)
Janet Trunzo, Advanced Medical Technology (AdvaMed)
Diana Zuckerman, National Research Center for Women & Families

Final Comments/Wrap-Up/Adjourn
Mark Barnett, CDRH

Individual Presentations

Transcript

May 22, 2006

Updated July 6, 2006

horizonal rule

Center for Devices and Radiological Health / CDRH