Document ID: FDA-2011-N-0002-0071
Agency: fda
Document Type: Notice
Title: Obstetrics and Gynecology Devices Panel of Medical Devices Advisory Committee: Notice of Meeting
Posted Date: 2011-07-14T04:00Z

[Federal Register Volume 76, Number 135 (Thursday, July 14, 2011)]
[Notices]
[Pages 41507-41508]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-17695]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Obstetrics and Gynecology Devices Panel of the Medical Devices 
Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

    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: Obstetrics and Gynecology 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.
    Date and Time: The meeting will be held on September 8 and 9, 2011, 
from 8 a.m. to 6 p.m.
    Location: Holiday Inn, Ballroom, 2 Montgomery Village Ave., 
Gaithersburg, MD 20879.
    Contact Person: Shanika Craig, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, rm. 1613, 301-796-6639, or 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 
and call the appropriate advisory committee hot line/phone line to 
learn about possible modifications before coming to the meeting.
    Agenda: On September 8 and 9, 2011, the committee will discuss and 
make recommendations regarding the safety and effectiveness of 
transvaginal surgical mesh used for repair of pelvic organ prolapse. 
FDA is convening this meeting to seek expert opinion on the risks and 
benefits of these devices in light of adverse events, e.g., vaginal 
erosion leading to pelvic pain and dyspareunia, and available 
information on clinical benefit. The committee will be asked to provide 
scientific and clinical input on the Agency's proposed premarket and 
postmarket regulatory strategies for these devices, including

[[Page 41508]]

reclassification into Class III (premarket approval), labeling 
improvements and postmarket surveillance studies. The committee will 
also consider surgical mesh used to treat stress urinary incontinence.
    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/Calendar/default.htm. Scroll down to the appropriate advisory committee 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 
August 30, 2011. Oral presentations from the public will be scheduled 
between approximately 10 a.m. and 11 a.m. on September 8 and 9, 2011. 
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 
August 22, 2011. 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 August 23, 2011.
    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 AnnMarie Williams, 
Committee Management Staff, 301-796-5966 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 30, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2011-17695 Filed 7-13-11; 8:45 am]
BILLING CODE 4160-01-P