AGENDA

GENERAL AND PLASTIC SURGERY DEVICES PANEL

of the

MEDICAL DEVICES ADVISORY COMMITTEE

 

Grand Ballroom, Gaithersburg Marriott Hotel

9751 Washingtonian Blvd., Gaithersburg, Maryland

October 14 and 15, 2003

 

Panel Acting Chair:                                                                            Executive Secretary:

Thomas V. Whalen, MD                                                                                                         David Krause, PhD

 

October 14, 2003

 

8:00 am                 Call to Order

 

Conflict of Interest and Opening Remarks

David Krause, PhD, Executive Secretary

 

Panel Introductions

Thomas V. Whalen, MD, Acting Chairman

 

Welcome Remarks

CDR Stephen P. Rhodes, USPHS, Branch Chief, Plastic and Reconstructive Surgery Devices Branch, Division of General, Restorative & Neurological Devices (DGRND), Office of Device Evaluation (ODE)

 

8:15 am                 Open Public Comment

10:15 am               Break

 

10:30 am               Open Public Comment Continued

 

12:30 pm               Lunch

 

1:25 pm                 Regulatory Overview of Silicone Gel-Filled Breast Implants

Celia M. Witten, Ph.D., M.D., Director, DGRND, ODE

 

1:30 pm                 Applicant Presentation, Inamed Corporation, McGhan Silicone-Filled Breast Implants

 

Introduction

Ronald J. Ehmsen, Sc.D., Senior Vice President, Clinical and Regulatory Affairs

 

Preclinical Studies Review

Thomas E. Powell, Director, Technologies

 

Clinical Studies

JoAnn M. Kuhne, M.S.N., R.A.C., Senior Director, Regulatory and Clinical Affairs

 

3:00 pm                 Break

 

 

3:15 pm                 FDA Presentation

ODE and Office of Surveillance and Biometrics (OSB)

 

Introduction and Mechanical Testing

CDR Samie Allen, DGRND, ODE

 

Chemical Testing

Sam Arepalli, Ph.D., DGRND, ODE

 

Toxicology Testing

David B. Berkowitz, Ph.D, V.M.D., DGRND, ODE

 

Clinical Data Overview

Sahar M. Dawisha, M.D., DGRND, ODE

 

Statistical Review

Telba Z. Irony, Ph.D., Division of Biostatistics, OSB

 

Medical Device Surveillance and Literature Review

S. Lori Brown, Ph.D., M.P.H., Division of Postmarket Surveillance, OSB

Postapproval Study and Labeling
CDR Samie Allen, DGRND, ODE

 

4:45 pm                 Open Panel Discussion

 

6:00 pm                 Dinner

 

7:00 pm                 Open Panel Discussion and FDA Questions

 

 10:00 pm              Day 1Adjournment

October 15, 2003

 

7:30 am                 Call to Order

 

Panel Introductions

Thomas V. Whalen, MD, Acting Chairman

 

7:45 am                 Open Public Comment

 

9:45 am                 Break

 

10:00 am               Open Public Comment Continued

 

12:00 am               Lunch

 

12:45 pm               FDA Summation

 

Sponsor Summation

 

Concluding Panel Deliberations and Vote

 

5:00 pm                 Concluding Remarks and Adjournment