GENERAL HOSPITAL AND PERSONAL USE DEVICES PANEL

of the

MEDICAL DEVICES ADVISORY COMMITTEE

Thirty Sixth Meeting

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

September 27, 2005

DRAFT

Panel Chairperson Executive Secretary

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

              Panel Introductions

              Conflict of Interest Statement

8:15 a.m. The Challenges and Opportunities on the Critical Path to New Medical Devices

              Sousan S. Altaie, PhD

8:30 a.m. Division/Branch Update - Chiu Lin, Director, PhD DAGID Director

8:45 a.m. Presentations by FDA

              Sheila Murphey, MD

              Elaine Mayhall Ph.D.

              Estelle Russek-Cohen, Ph.D.

              Ronald Brown MS, DABT

10:15 a.m. BREAK

10:30 a.m. FDA Guest Speaker - Allan Hidderly

Medicines & Healthcare Products Regulatory Agency (Devices),

Device Technology & Safety-Biologics & Implants, United Kingdom

11:00 a.m. Open Public Session*

12:00 a.m. LUNCH BREAK

1:00 p.m. Presentations by Industry

2:30 p.m. BREAK

2:45 p.m. Open Public Session**

3:15 p.m. Panel Deliberations

4:45 p.m. Panel Final Remarks

5:00 p.m. MEETING ADJOURNED