ORTHOPAEDIC AND REHABILITATION DEVICES PANEL
Hilton Washington, DC North
620 Perry Parkway
September 9, 2005
Panel Chairperson Executive Secretary
John S. Kirkpatrick, M.D. Janet L. Scudiero, M.S.
8:00 a.m. Call to Order
Design of Clinical Studies for
Spinal Devices to Treat Mild to Moderate Low Back Pain
8:30 a.m. Open Public Hearing*
Orthopaedic Surgical Manufacturers’ Association
Sally Maher, Esq., President
Hal Matthews, M.D., title, affiliation
Spine Wave, Inc.
Ronald K. Smith, Director of Quality Systems & Regulatory Affairs
John Pafford, Chief Technical Officer
Reginald Davis, M.D., Greater Baltimore Medical Center
Abbott Spine, Emerging Technologies Research & Development
Paul McAfee, M.D., Towson Orthopedics Association, Baltimore
Brent Blumenthal, Ph.D., TriArc Consulting, Seattle
Stryker Spine, Inc.
American Association of Neurological Surgeons
North American Spine Society
Marjorie Eskay-Auerbach, M.D., J.D.
St. Francis Medical Technologies, Inc.
Paul Anderson, M.D., University of Wisconsin
Spine Arthroplasty Society
* Open Public Hearings: During the open public hearings, 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, the Chair may ask them to remain if the panel wishes to question them. Then the Chair will recognize unscheduled speakers as time allows. Only the panel may question speakers during the open public hearing.
9:45 a.m. Break
10:00 a.m. FDA Presentation
Jonathan H. Peck, Orthopedic Devices Branch
10:30 a.m. Panel Deliberation
Lead Discussant, Michael J.Yaszemski, M.D., Ph.D.
1:00 p.m. Adjournment