[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)]
[Notices]
[Pages 13392-13393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-05675]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-0001]
Ear, Nose, and Throat Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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[[Page 13393]]
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: Ear, Nose, and Throat 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 April 30 and May 1, 2015
from 8 a.m. to 6 p.m.
Location: Hilton Washington DC North/Gaithersburg, Salons A, B, C,
and D, 620 Perry Pkwy., Gaithersburg, MD 20877. The hotel's telephone
number is 301-977-8900.
Contact Person: Patricio Garcia, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1535, Silver Spring MD 20993-0002,
[email protected], 301-796-6875, 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 April 30, 2015, the committee will discuss and make
recommendations regarding the classification of Hearing Protectors,
Circumaural Hearing Protectors, Middle Ear Inflation Devices, Tactile
Hearing Aid Devices, and Vestibular Analysis Apparatuses. These devices
are considered preamendments devices since they were in commercial
distribution prior to May 28, 1976, when the Medical Devices Amendments
became effective. Hearing Protectors are currently regulated under the
heading, ``Protector, Hearing (Insert),'' Product Code EWD, as
unclassified under the 510(k) premarket notification authority.
Circumaural Hearing Protectors are currently regulated under the
heading, ``Protector, Hearing (Circumaural),'' Product Code EWE, as
unclassified under the 510(k) premarket notification authority. Middle
Ear Inflation Devices are currently regulated under the heading,
``Device, Inflation, Middle Ear,'' Product Code MJV, as unclassified
under the 510(k) premarket notification authority. Tactile Hearing Aid
Devices are currently regulated under the heading, ``Hearing Aid,
Tactile,'' Product Code LRA, as unclassified under the 510(k) premarket
notification authority. Vestibular Analysis Apparatuses are currently
regulated under the heading, ``Apparatus, Vestibular Analysis,''
Product Code LXV, as unclassified under the 510(k) premarket
notification authority. FDA is seeking committee input on the risks,
safety and effectiveness and the regulatory classification of Hearing
Protectors, Circumaural Hearing Protectors, Middle Ear Inflation
Devices, Tactile Hearing Aid Devices, and Vestibular Analysis
Apparatuses.
On May 1, 2015 the committee will discuss key issues related to a
potential pre- to post-market shift in clinical data requirements for
modifications to cochlear implants in pediatric patients. These issues
are categorized into three broad areas for discussion:
1. Cochlear implant changes (e.g. sound processing features,
patient characteristics) that may be suitable for this pre- to post-
market shift in clinical data requirements.
2. Appropriate premarket clinical data requirements to support pre-
to post-market shift (e.g. leveraging clinical data from adults and/or
older children).
3. Clinical study design considerations (e.g. study endpoints and
test metrics, subject characteristics) for post market studies to
confirm safety and effectiveness and inform future labeling.
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.
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
April 22, 2015. Oral presentations from the public will be scheduled
between approximately 8:45 a.m. and 9:45 a.m. on April 30, 2015 and
between approximately 1 p.m. and 2 p.m. on May 1, 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
April 14, 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 April 16, 2015.
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 at James Clark at
[email protected], or 301-796-5293 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: March 9, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05675 Filed 3-12-15; 8:45 am]
BILLING CODE 4164-01-P