GENERAL HOSPITAL AND PERSONAL USE DEVICES PANEL

of the

MEDICAL DEVICES ADVISORY COMMITTEE

Thirty Fifth Meeting

Hilton Washington, DC North, 620 Perry Parkway, Gaithersburg, MD

August 9, 2005

 

 

Panel Chairperson                                                                                                      Executive Secretary

Charles E. Edmiston Jr., Ph.D.                                                     Scott A. Colburn BSN, RN, LT, USPHS

 

 

8:00 a.m.          CALL TO ORDER*

8:00 a.m.            Welcome and Introductory Remarks

·        Charles E. Edmiston Jr., Ph.D., Chairman

·        Scott A. Colburn, BSN, RN, LT, USPHS, Executive Secretary

·        Panel Member Introductions

·        Conflict of Interest Statement

8:15 a.m.            Condition of Approval Studies: Recent Changes in CDRH

·        Susan Gardner, PhD

8:30 a.m.            Division/Branch Update 

·        Chiu Lin, PhD– DAGID Division Director

·        Sheila Murphey, MD – Chief, Infection Control Devices Branch

·        Anthony D. Watson, MS, MBA – Chief, General Hospital Devices Branch

8:45 a.m.          Open Public Session**

9:15 p.m.            Presentations by FDA

·        Introduction and Welcome,

      Anthony D. Watson, MS, MBA

·        Jason F. Lipman

·        Shewit Bezabeh, MD, MPH

·        Dayawansa “Daya” G. Ranamukha-arachchi, PhD.

10:15 a.m.            BREAK

10:30 a.m.            Presentations by CDC and WHO

·        CDC - Bruce Weniger, MD, MPH, CAPT, USPHS

·        WHO – Martin Freide, PhD

11:30 a.m.            LUNCH BREAK

12:30 p.m.            Presentations by the Industry

1:30 p.m.          Panel Deliberations

3:00 p.m.            BREAK

3:15 p.m.          Open Public Session **

3:45 p.m.          Panel Recommendations

4:00 p.m.             MEETING ADJOURNED