[Federal Register Volume 79, Number 110 (Monday, June 9, 2014)]
[Notices]
[Pages 32964-32965]
From the Federal Register Online via the Government Publishing 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 [email protected], 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