|CDRH||June 27-28, 2012||7:30 a.m. - 7:00 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; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. This meeting was announced in the Federal Register of March 30, 2012 (77 FR 19293). The amendment is being made to reflect a change in the DATES and ADDRESSES portion of the document. The amendment also provides a Web address where the meeting webcast can be accessed. There are no other changes.
FOR FURTHER INFORMATION CONTACT:
Center for Devices and Radiological Health,
Food and Drug Administration,
10903 New Hampshire Ave.,
Bldg. 66, Rm. 1535,
Silver Spring, MD 20993-0002,
or please use the FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), and follow the prompts to the desired center or product area. Please call the Information Line for up-to-date information on this meeting. 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.
SUPPLEMENTARY INFORMATION: In the Federal Register of March 30, 2012, FDA announced that a meeting of the Orthopaedic and Rehabilitation Devices Panel would be held on June 27 and 28, 2012. On page 19293, in the first column the DATES portion of the document is changed to read as follows:
The meeting will be held on June 27 and 28, 2012, from 7:30 a.m. to 7 p.m.
On page 19293, in the first column, the ADDRESSES portion of the document is changed to read as follows:
Hilton Washington DC North/Gaithersburg, Salons A, B, C, and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel’s telephone number is 301- 977- 8900.
The meeting will be webcast live and free of charge on both days and can be accessed at the following Web address:
On June 27, Day 1 http://fda.yorkcast.com/webcast/Viewer/?peid=12f84ea095b445d78e9b115f495392731d
The webcast will be broadcast using Windows Media Player.
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Dated: May 24, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
June 27-28, 2012: Meeting Materials FDA Generated
Public Agenda Day 1: June 27, 2012(PDF - 35KB) [ARCHIVED] Public Agenda Day 2: June 28, 2012(PDF - 35KB) [ARCHIVED] Panel Roster Day 1: June 27, 2012(PDF - 26KB) [ARCHIVED] Panel Roster Day 2: June 28, 2012(PDF - 29KB) [ARCHIVED] FDA Executive Summary(PDF - 2.5MB) [ARCHIVED] Draft Panel Questions(PDF - 117KB) [ARCHIVED] Appendix A: Hip Implant Device Utilization in the U.S.(PDF - 165KB) [ARCHIVED] Appendix B: FDA Safety Communication (Website) for MoM Hip Systems(PDF - 553KB) [ARCHIVED] Appendix C(PDF - 43KB) [ARCHIVED] Appendix D: MoM Total Hip Replacement Section 522 Studies(PDF - 43KB) [ARCHIVED] Appendix G: Summary of MoM Hip Resurfacing Post-Approval Studies(PDF - 56KB) [ARCHIVED] Appendix I: Summary of Medical Device Adverse Event Reports(PDF - 630KB) [ARCHIVED] Appendix J: Supporting Documents for FDA Literature Review(PDF - 2MB) [ARCHIVED] Appendix M: Comments Received to FDA Docket through May 9, 2012(PDF - 12KB) [ARCHIVED] June 27, 2012 Meeting Presentations[ARCHIVED] 24-Hour Summary Day 2 - June 28, 2012(PDF - 96KB) [ARCHIVED] Transcript: June 27, 2012(PDF - 1.3MB) [ARCHIVED] Transcript: June 28, 2012(PDF - 1.5MB) [ARCHIVED]