DRAFT
ORTHOPAEDIC AND REHABILITATION DEVICES PANEL
of the
Salons A, B, C, and D
9751 Washingtonian Boulevard
Gaithersburg,
Maryland
June 3, 2004
Panel
Chairperson Executive Secretary
Michael
J. Yaszemski, M.D., Ph.D. Janet
L. Scudiero, M.S., acting
8:00 am Call to Order
Panel
Introductions
Reclassification
of the Total and Unicompartmental Mobile Bearing
Knee
Joint Prostheses
8:15 am Open Public
Hearing*
8:45 pm Industry Presentation
Orthopedic Surgical
Manufacturers Association
9:30 am FDA Presentation
10:00 am Break
10:15 am Panel Deliberation
Reclassification
Questionnaire, Supplemental Data Sheet, and Vote
12:15 am Lunch
Draft
Hip Joint Prostheses Guidance: Performance Criteria
1:15 pm Open
Public Hearing*
1:45 pm Industry
Presentation
Orthopedic Surgical
Manufacturers Association
2:30 pm FDA
Presentation
3:15 pm Break
3:30 pm Panel
Deliberation and Recommendation
5:00 pm Adjournment
Open Public Hearings: During the open public hearing, interested persons may present data, information, or views, orally
or in writing, on the issue pending before the panel. Scheduled speakers who have requested time to address the panel
will speak at this time. After they
have spoken, Dr. Yaszemski may ask them to remain if the panel wishes to
question them. Then Dr. Yaszemski will recognize unscheduled speakers as time
allows. Only the panel may question
speakers during the open public hearing