Document ID: FDA-2014-N-0736-0015
Agency: fda
Document Type: Notice
Title: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting
Posted Date: 2015-07-22T04:00Z

[Federal Register Volume 80, Number 140 (Wednesday, July 22, 2015)]
[Notices]
[Pages 43440-43441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17985]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0736]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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 24, 2015, from 
8 a.m. to 6 p.m.

ADDRESSES: FDA is opening a docket for interested persons to submit 
electronic or written comments regarding this meeting. The docket 
number is FDA-2014-N-0736. Please see the Procedure section of the 
notice for further information.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information 
regarding special accommodations due to a disability, visitor parking, 
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    Contact Person: Shanika Craig, Center for Devices and Radiological 
Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., 
Silver Spring, MD 20993, 301-796-6639, Shanika.Craig@fda.hhs.gov, or 
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 
in the Washington, DC area). 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 24, 2015, the committee will discuss the risks 
and benefits of Bayer HealthCare's Essure System for permanent female 
sterilization. The system, originally approved in November 2002, under 
P020014, consists of a delivery system and nickel-containing permanent 
implants. The implants are placed without a skin incision, through the 
vagina, within each fallopian tube; they elicit tissue ingrowth, which 
over time results in tubal occlusion.
    FDA is convening this committee to seek expert scientific and 
clinical opinion on the risks and benefits of the Essure System. The 
committee will be asked to evaluate currently available scientific data 
pertaining to the safety and effectiveness of the Essure System, such 
as events related to implant perforation/migration, device removal, 
chronic pain, allergic reactions, and unintended pregnancy. The 
committee will be asked to provide recommendations regarding 
appropriate device use, product labeling, and potential need for 
additional postmarket clinical studies.
    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 meeting 
link.
    CDRH plans to provide a live Webcast of the September 24, 2015, 
meeting of the Obstetrics and Gynecology Devices Panel. While CDRH is 
working to make Webcasts available to the public for all advisory 
committee meetings held at the White Oak campus, there are instances 
where the Webcast transmission is not successful; staff will work to 
re-establish the transmission as soon as possible. The link for the 
Webcast is available at: https://collaboration.fda.gov/gudpm052015/. 
Further information regarding the Webcast, including the Web address 
for the Webcast, will be made available at least 2 days in advance of 
the meeting at the following Web site: https://collaboration.fda.gov/ogdp2015/.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending

[[Page 43441]]

before the committee. Written submissions may be made to the contact 
person on or before September 4, 2015. Oral presentations from the 
public will be scheduled between approximately 9 a.m. and 10 a.m. on 
September 24, 2015. 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 24, 2015. 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 
28, 2015.
    FDA is opening a docket for public comment on this document. The 
docket will close on October 24, 2015. Interested persons are 
encouraged to use the docket to submit electronic or written comments 
regarding this meeting. Comments received on or before August 31, 2015, 
will be provided to the committee. Comments received after that date 
will be taken into consideration by the Agency.
    Submit electronic comments to http://www.regulations.gov. Submit 
written comments to the Division of Dockets Management, Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments. Comments are to be identified with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Divisions of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
    For press inquiries, please contact the Office of Media Affairs at 
fdaoma@fda.hhs.gov or 301-796-4540.
    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 Ann Marie Williams, 
at AnnMarie.Williams@fda.hhs.gov or 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: July 17, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-17985 Filed 7-21-15; 8:45 am]
BILLING CODE 4164-01-P