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U.S. Department of Health and Human Services

Medical Devices

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Public Workshop - Center for Devices and Radiological Health's Innovation Initiative, March 15, 2011

The purpose of the public workshop is to solicit public feedback on select actions outlined in the Center for Devices and Radiological Health’s (CDRH) "Medical Device Innovation Initiative" (report). FDA is seeking input on a number of identified challenges associated with incentivizing innovation, and the proposed solutions. In addition, the agency requests comments on the Innovation Pathway proposed under the initiative.


Date, Time and Location

This meeting will be held March 15, 2011, 8:00 am - 5:30 pm at the following location:

Food and Drug Administration White Oak Campus
10903 New Hampshire Avenue
Bldg. 31, Room 1503 (Salons B & C)
Silver Spring, MD 20993

The meeting will be available via webcast, at:
http://fda.yorkcast.com/webcast/Viewer/?peid=fae7c7ac49174d159e49e8d83aaf3b9d

Agenda

7:00 - 8:00Registration 
8:00 - 8:05Welcome - Opening RemarksJeff Shuren
8:05 - 8:15Objectives - Innovation and CDRHJonathan Sackner-Bernstein
 I. The Innovation Pathway 
8:15 - 8:30Innovator PresentationTom Fogarty, Fogarty Institute for Innovation
8:30 - 8:45Goals & QuestionsMegan Moynahan
8:45 - 10:00Panel DiscussionModerator - Megan Moynahan
 DiscussantsTom Fogarty, Fogarty Institute for Innovation
Tim Wright, Hospital for Special Surgery
Belinda Seto, National Institute of Biomedical Imaging and Bioengineering
George Tolomiczenko, University of Southern California
Ida Cahill, Sam Schmidt Paralysis Foundation
Tom Fitzsimons, University of Pennsylvania
Carolyn Pekar, Abiomed
Michael Tracey, Johnson & Johnson
Rick Kuntz, Medtronic
Jack Lasersohn, The Vertical Group
Jonathan Leff, Warburg Pincus
10:00 - 10:15Break 
10:15 - 11:00Public Comment 
 II. Core Curriculum 
11:00 - 11:10Regulatory Science & Device DevelopmentMichelle McMurry-Heath
11:10 - 12:15Panel DiscussionModerator Jonathan Sackner-Bernstein
 DiscussantsSherry Keramidas, Regulatory Affairs Professional Society
Terry Sanger, University of Southern California
David Chen, University of Virginia
Aaron Kaplan, Dartmouth College
Barry Myers, Duke University
Sergio Gadaleta, Becton Dickinson
Susan Alpert, Medtronic
Shamiram Feinglass, Zimmer
12:15- 1:30Lunch  
 III. Strengthening Clinical Trial Infrastructure 
1:30 - 1:40Goals & QuestionsJonathan Sackner-Bernstein
1:40 - 2:45Panel DiscussionModerator - Jonathan Sackner-Bernstein
 DiscussantsGary Zammit, Clinilabs
Robert Jaeger, U.S. Dept. Veterans Affairs
Laurence Clarke, National Cancer Institute
MaryAnn Guerra, BioAccel
Barry Myers, Duke University
George Tolomiczenko, University of Southern California
Elisabeth George, Philips
Mark Deem, The Foundry
Aaron Kaplan, Dartmouth College
Rick Kuntz, Medtronic
Ross Jaffe, Versant Ventures
Jack Lasersohn, The Vertical Group
 IV. Leveraging International Data 
2:45 - 2:55Goals & QuestionsJonathan Sackner-Bernstein
2:55 - 4:00Panel DiscussionModerator - Jonathan Sackner-Bernstein
 DiscussantsGary Zammit, Clinilabs
Bob Jaeger, Veterans Affairs
Laurence Clarke, National Cancer Institute
MaryAnn Guerra, BioAccel
Tamima Itani, Boston Scientific
Jing Xie, Biomet
Elisabeth George, Philips
Mark Deem, The Foundry
Ross Jaffe, Versant Ventures
Lou Bock, Scale Venture Partners
Carolyn Pekar, Abiomed
4:00 - 4:45Public Comment 
4:45 - 5:00Adjourn 

*Note: Times for Open Public Sessions may be reallocated depending on the number of Registered Speakers per session.

Registration

Registration is now closed.

If you need special accommodations due to a disability, please contact Susan Monahan at 301-796-5661, at susan.monahan@fda.hhs.gov at least 7 days in advance of the meeting.

Contact Us

For information regarding logistics, registration and special accommodations, contact:

Susan Monahan
Office of Communication, Education, and Radiation Programs
Center for Devices and Radiological Health
Food and Drug Administration
10903 New Hampshire Avenue, Bldg. 66
Silver Spring, MD 20993
phone: 301-796-5661
email: Susan.Monahan@fda.hhs.gov

For information regarding the program, contact:

Jonathan Sackner-Bernstein, M.D.
Center for Devices and Radiological Health
Food and Drug Administration
phone: 301-796-6313
email: jonathan.sackner-bernstein@fda.hhs.gov

Additional Information