DRAFT

ORTHOPAEDIC AND REHABILITATION DEVICES PANEL

of the

MEDICAL DEVICES ADVISORY COMMITTEE

Gaithersburg Marriott 

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

Conflict of Interest and Deputization to Voting Member Status Statements

                                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