Document ID: FDA-2015-N-2781-0604
Agency: fda
Document Type: Notice
Title: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting
Posted Date: 2014-06-09T04:00Z

[Federal Register Volume 79, Number 110 (Monday, June 9, 2014)]
[Notices]
[Pages 32964-32965]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-13290]

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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 July 10 and 11, 2014, 
from 8 a.m. to 6 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Building 
31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 
20993-0002. Information regarding special accommodations due to a 
disability, visitor parking, and transportation may be accessed at: 
http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading 
``Resources for You,'' click on ``Public Meetings at the FDA White Oak 
Campus.'' Please note that visitors to the White Oak Campus must enter 
through Building 1.
    Contact Person: Shanika Craig, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver 
Spring, MD 20993, 301-796-6639, 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 July 10 and 11, 2014, the committee will discuss the 
safety of laparoscopic power morcellator devices as it pertains to 
their potential to disseminate and upstage a confined, but undetected 
(occult) uterine malignancy during laparoscopic hysterectomy or 
myomectomy. FDA is convening this committee to seek expert scientific 
and clinical opinion on the risks and benefits of these types of 
devices when used for these procedures, based on available scientific 
data. The committee will make recommendations regarding the appropriate 
use, premarket testing, labeling, and other risk mitigations

[[Page 32965]]

(including the use of containment bags) for these devices.
    On July 11, 2014, during the afternoon session, the committee will 
also be asked to discuss the regulatory classification of laparoscopic 
power morcellator devices when used to cut and extract tissue during 
gynecologic laparoscopic procedures and to assist FDA in determining 
the appropriate level of regulatory control necessary for this device 
type, including discussion of class II (special controls) or 
reclassification to class III (subject to premarket approval 
application (PMA)).
    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.
    The Center for Devices and Radiological Health (CDRH) plans to 
provide a live webcast of the July 10 and 11, 2014, meeting of the 
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory 
Committee. 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 reestablish the transmission as soon as 
possible. The link for the webcast is available at: https://colaboration.fda.gov/obgyd/, or 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: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/ObstetricsandGynecologyDevices/default.htm. Select the link for 2014 Meeting Materials.
    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 June 
24, 2014. Oral presentations from the public will be scheduled between 
approximately 9 a.m. and 10 a.m. for both days of this meeting. 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 June 
16, 2014. 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 June 19, 2014.
    FDA will work with the manufacturers of laparoscopic morcellators 
and containment bags who wish to make presentations to ensure that 
adequate time, separate from the approximate time slots for the general 
open public hearing session, is provided. Manufacturers interested in 
making formal presentations to the committee should notify the contact 
person on or before June 18, 2014. Manufacturers with common interests 
are urged to coordinate their oral presentations.
    FDA is opening a docket for public comment on this document. The 
docket number is FDA-2014-N-0736. The docket will close on August 11, 
2014. Interested persons are encouraged to use the docket to submit 
electronic or written comments regarding this meeting. Submit 
electronic comments to http://www.regulations.gov. Comments received on 
or before July 1, 2014, will be provided to the committee for their 
consideration. Comments received after July 1, 2014, will be taken into 
consideration by the Agency.
    Submit written comments to the Division of Dockets Management, Food 
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 
20852. It is only necessary to send one set of 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.
    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, 
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: June 3, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-13290 Filed 6-6-14; 8:45 am]
BILLING CODE 4160-01-P