http://www.fda.gov/advisorycommittees/calendar/ucm400221.htm
July 10-11, 2014: Obstetrics and
Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting
Announcement
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Center
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Date
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Time
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Location
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CDRH
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July 10-11, 2014
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8:00 a.m. - 6:00 p.m.
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FDA White Oak Campus
10903 New Hampshire Ave.
Building 31 Conference Center, the Great Room (rm. 1503)
Silver Spring, MD 20993-0002
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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.
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, Shanika.Craig@fda.hhs.gov, 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 (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/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/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.
