[Federal Register Volume 80, Number 61 (Tuesday, March 31, 2015)]
[Notices]
[Pages 17056-17057]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-07300]
-----------------------------------------------------------------------
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; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of meeting of the Ear, Nose, and Throat Devices
Panel of the Medical Devices Advisory Committee. This meeting was
announced in the Federal Register of March 13, 2015. The amendment is
being made to reflect a change in the April 30th Agenda portion of the
document. There are no other changes.
FOR FURTHER INFORMATION CONTACT: 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), code EN. Please call the Information Line for up-to-date
information on this meeting.
SUPPLEMENTARY INFORMATION: In the Federal Register of March 13, 2015
(80 FR 13392), FDA announced that a meeting of the Ear, Nose, and
Throat Devices Panel of the Medical Devices Advisory Committee would be
held on April 30 and May 1, 2015. On page 13393, in the first and
second columns, the Agenda portion of the document is changed to read
as follows:
On April 30, 2015, the Agency is adding three Agenda items to the
original five agenda items posted in the March 13, 2015, Federal
Register document. The three additional items are: Speech Training Aids
for the Hearing Impaired (Battery Powered or Non-Patient), Speech
Training Aids for the Hearing Impaired (AC-powered and Patient-
Contact), and Nasal Septal Button Devices. The committee will discuss
and make recommendations regarding the classification of Hearing
Protectors, Circumaural Hearing Protectors, Tactile Hearing Aids,
Speech Training Aids for the Hearing Impaired (Battery Powered or Non-
Patient), Speech Training Aids for the Hearing Impaired (AC-powered and
Patient-Contact), Vestibular Analysis, Middle Ear Inflation Devices,
and Nasal Septal Button Devices. 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. 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. Speech Training Aids for the Hearing Impaired
(Battery Powered or Non-Patient) are currently regulated under the
heading, ``Aids, Speech Training For The Hearing Impaired (Battery-
Operated or Non-Patient),'' Product Code LFA, as unclassified under the
510(k) premarket notification authority. Speech Training Aids for the
Hearing Impaired (AC-Powered and Patient-Contact) are currently
regulated under the heading, ``Aids, Speech Training For The Hearing
Impaired (AC-Powered and Patient-Contact),'' Product Code LEZ, 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. 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. Nasal Septal Button
Devices are currently regulated under the heading, ``Button, Nasal
Septal,'' Product Code LFB, 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, Tactile Hearing Aids,
Speech Training Aids for the Hearing Impaired (Battery Powered or Non-
Patient), Speech Training Aids for the Hearing Impaired (AC-Powered and
Patient-Contact), Vestibular Analysis, Middle Ear Inflation Devices,
and Nasal Septal Button Devices.
[[Page 17057]]
On May 1, 2015, the committee will discuss key issues related to a
potential pre- to postmarket 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
postmarket shift in clinical data requirements.
2. Appropriate premarket clinical data requirements to support pre-
to postmarket 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 postmarket 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.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Dated: March 24, 2015.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2015-07300 Filed 3-30-15; 8:45 am]
BILLING CODE 4164-01-P