Draft Meeting Agenda

GENERAL AND PLASTIC SURGERY DEVICES PANEL

of the

MEDICAL DEVICES ADVISORY COMMITTEE

 

Salons A, B & C Hilton Washington, DC North

620 Perry Parkway

Gaithersburg, Maryland

August 25 & 26, 2005

 

Acting Panel Chair:                                                              Executive Secretary:

Joseph LoCicero, III, M.D.                                                                    David Krause, Ph.D.

 

 

August 25, 2005 Schedule:

 

8:00 am                 Call to Order, Conflict of Interest, Temporary Voting Member Deputization and Opening Remarks
David Krause

Panel Introductions
Joseph LoCicero, III

Panel Update
CDR Stephen P. Rhodes, USPHS, Division of General, Restorative, and Neurological Devices (DGRND), Office of Device Evaluation (ODE)

 

8:15 am                Critical Path Initiative in Medical Devices
Sousan S. Altaie, Ph.D., Scientific Policy Advisor, Office of In Vitro Diagnostic Device Evaluation and Safety

 

8:30 am                Condition of Approval Studies: Recent Changes in CDRH
Susan N. Gardner, Ph.D., Director, Office of Surveillance and Biometrics

 

8:45 am                 Introduction to Device Classification
Ms. Marjorie G. Shulman, ODE

 

9:00 am                 Classification of Bone Wax

Industry Presentation

FDA Presentation
David Krause, PRSB, DGRND, ODE

Panel Discussion and Address FDA Questions

 

10:15 am               Break

 

10:30 am               Open Public Comment

11:00 am               Classification Questionnaire and Vote
Ms. Marjorie G. Shulman, ODE

11:45 am               Lunch

 

12:30 pm                Classification of Medical Maggots

Industry Presentation

FDA Presentation

Charles N. Durfor, Ph.D., PRSB, DGRND, ODE

Panel Discussion and Address FDA Questions

1:45 pm                 Open Public Comment

 

2:15 pm                 Classification Questionnaire and Vote
Marjorie G. Shulman

 

3:00 pm                 Break

 

3:15 pm                 Classification of Medicinal Leeches

Industry Presentation

FDA Presentation
Charles N. Durfor

 

4:30 pm                 Open Public Comment

 

5:00 pm                 Classification Questionnaire and Vote
Marjorie G. Shulman

 

6:00 pm                 Adjournment Day 1 Activities

August 26, 2005 Schedule:

 

8:00 am                Call to Order, Conflict of Interest, Temporary Voting Member Deputization and Opening Remarks
David Krause

Panel Introductions
Joseph LoCicero, III

 

8:30 am                Classification of Inflatable Tissue Expanders

Industry Presentation

FDA Presentation
Nada O. Hanafi, MSE, PRSB, DGRND, ODE

 

9:45 am                Open Public Comment

 

10:15 am                Break

 

10:30 am                Classification Questionnaire and Vote
Marjorie G. Shulman

 

11:30 am                Lunch

 

12:30 pm                Classification of Wound Dressing with Drugs

Industry Presentation

FDA Presentation
Sam Arepalli, Ph.D., PRSB, DGRND, ODE

 

1:45 pm                Open Public Comment

 

2:15 pm                Classification Questionnaire and Vote
Marjorie G. Shulman

 

3:15 pm                Meeting Adjournment and Final Remarks
Joseph LoCicero, III