Medical Devices
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
- Agenda
- Registration
- Contact Us
- Additional Information (White Paper, etc.)
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 - 8:00 | Registration | |
| 8:00 - 8:05 | Welcome - Opening Remarks | Jeff Shuren |
| 8:05 - 8:15 | Objectives - Innovation and CDRH | Jonathan Sackner-Bernstein |
| I. The Innovation Pathway | ||
| 8:15 - 8:30 | Innovator Presentation | Tom Fogarty, Fogarty Institute for Innovation |
| 8:30 - 8:45 | Goals & Questions | Megan Moynahan |
| 8:45 - 10:00 | Panel Discussion | Moderator - Megan Moynahan |
| Discussants | Tom 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 - 10:15 | Break | |
| 10:15 - 11:00 | Public Comment | |
| II. Core Curriculum | ||
| 11:00 - 11:10 | Regulatory Science & Device Development | Michelle McMurry-Heath |
| 11:10 - 12:15 | Panel Discussion | Moderator Jonathan Sackner-Bernstein |
| Discussants | Sherry 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- 1:30 | Lunch | |
| III. Strengthening Clinical Trial Infrastructure | ||
| 1:30 - 1:40 | Goals & Questions | Jonathan Sackner-Bernstein |
| 1:40 - 2:45 | Panel Discussion | Moderator - Jonathan Sackner-Bernstein |
| Discussants | Gary 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 - 2:55 | Goals & Questions | Jonathan Sackner-Bernstein |
| 2:55 - 4:00 | Panel Discussion | Moderator - Jonathan Sackner-Bernstein |
| Discussants | Gary 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 - 4:45 | Public Comment | |
| 4:45 - 5:00 | Adjourn |
*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
