|CDRH||September 21, 2012||8:00 a.m. - 6:00 p.m.|| |
Hilton Washington DC North/Gaithersburg
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0001]
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public.
Name of Committee: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee.
General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.
Contact Person: Sara J. Anderson, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg 66, rm. 1611, Silver Spring, MD 20993-0002, 301 796-7047, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), to find out further information regarding FDA advisory committee information. A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.
Agenda: On September 21, 2012, the committee will discuss and make recommendations regarding the classification of posterior cervical screws, including pedicle and lateral mass screws. Cervical pedicle and lateral mass screws are components of rigid, posterior spinal screw and rod systems generally intended as an adjunct to fusion for the treatment of degenerative disc disease (as defined by neck pain confirmed by radiographic studies), trauma, deformity, failed previous fusion, tumor, infection, and inflammatory disorders in the cervical spine.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/default.htm. Scroll down to the appropriate advisory committee meeting link.
Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before September 14, 2012. Oral presentations from the public will be scheduled between approximately 12:15 p.m. and 1:15 p.m. on September 21, 2012. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 6, 2012. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by September 7, 2012.
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact James Clark at James.Clark@fda.hhs.gov or 301-796-5293 at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Dated: June 12, 2012.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
September 21, 2012: Meeting Materials FDA Generated
Agenda.(PDF - 35KB) [ARCHIVED] Panel Roster(PDF - 28KB) [ARCHIVED] Panel Questions(PDF - 82KB) [ARCHIVED] FDA Executive Summary.(PDF - 484KB) [ARCHIVED] Articles.(PDF - 7KB) [ARCHIVED] OSMA Petition Cover Letter(PDF - 685KB) [ARCHIVED] OSMA Petition(PDF - 1.5MB) [ARCHIVED] Appendix B - Pediatric Data Abstraction Tables(PDF - 85KB) [ARCHIVED] 24-Hour Summary(PDF - 83KB) [ARCHIVED] Presentation: FDA(PDF - 1.7MB) [ARCHIVED] Transcript: Sept. 21. 2012(PDF - 958KB) [ARCHIVED]
September 21, 2012: Meeting Materials Non-FDA Generated
OSMA Executive Summary Cover Letter(PDF - 94KB) [ARCHIVED] OSMA Executive Summary(PDF - 551KB) [ARCHIVED] Abstracts Design-Effectiveness(PDF - 335KB) [ARCHIVED] Abstracts Safety(PDF - 217KB) [ARCHIVED] Close‐up of Hooks and Screws(PDF - 46KB) [ARCHIVED] Close‐up of Hooks and Screws: Larger photo(PDF - 280KB) [ARCHIVED] OCT Construct X-rays(PDF - 268KB) [ARCHIVED] Journals and Articles(PDF - 7KB) [ARCHIVED]
- C2 Pedicle Screw Insertion
Lateral Mass Screw Insertion OSMA Presentation(PDF - 7MB) [ARCHIVED] Scoliosis Research Society Presentation(PDF - 2.8MB) [ARCHIVED] Presentation: American Academy of Orthopadic(PDF - 953KB) [ARCHIVED] Presentation: North American Spine Society(PDF - 665KB) [ARCHIVED] Presentation: Cervical Spine Research Society(PDF - 189KB) [ARCHIVED]