[Federal Register Volume 78, Number 216 (Thursday, November 7, 2013)]
[Notices]
[Pages 66942-66944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26722]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0001]
Orthopaedic and Rehabilitation 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: Orthopaedic and Rehabilitation 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 December 12, 2013, from
8 a.m. to 6:30 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: Sara Anderson, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 1643, Silver Spring, MD 20993, [email protected], 301
796-7047; or FDA Advisory Committee Information Line, 1-800-741-8138
(301-443-0572 in the Washington, DC
[[Page 66943]]
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 December 12, 2013, during Session I, the committee will
discuss and make recommendations regarding the classification of spinal
sphere devices. These devices are spheres manufactured from metallic
(e.g., cobalt chromium molybdenum) or polymeric (e.g.,
polyetheretherketone) materials. They are intended to be inserted
between the vertebral bodies into the disc space from L3-S1 to help
provide stabilization and to help promote intervertebral body fusion.
During the arthrodesis procedure, they are to be used with bone graft.
These devices are not intended for use in motion-sparing, non-fusion
procedures.
Spinal sphere devices are considered preamendment devices because
they were in commercial distribution prior to May 28, 1976, when the
Medical Device Amendments became effective. Spinal sphere devices are
currently regulated under the heading of ``Intervertebral Fusion Device
with Bone Graft, Solid-Sphere, Lumbar'', Product Code NVR, as
unclassified devices and reviewed under the 510(k) premarket
notification authority. FDA is seeking committee input on the safety
and effectiveness of spinal sphere devices and the regulatory
classification for spinal sphere devices.
On December 12, 2013, during Session II, the committee will discuss
and make recommendations regarding the reclassification petition
received on November 20, 2012, from DEKA Research & Development Corp.
requesting that FDA reclassify stair climbing wheelchairs (21 CFR
890.3890) from Class III to Class II. A stair-climbing wheelchair is a
device with wheels that is intended for medical purposes to provide
mobility to persons restricted to a sitting position. The device is
intended to climb stairs. On June 12, 2013 (78 FR 35173), FDA issued a
proposed order which, if made final, would reclassify stair-climbing
wheelchairs as Class II subject to premarket notification (510(k)) and
special controls. The petitioner has one stair-climbing wheelchair
approved, the iBot (P020033), and it is indicated for the following: to
provide indoor and outdoor mobility in confined spaces, at an elevated
height, climb curbs, ascend/descend stairs, traverse obstacles, travel
over a wider variety of terrain, and negotiate uneven/inclined
surfaces.
Stair-climbing wheelchairs are preamendment devices because they
were in commercial distribution prior to May 28, 1976, when the Medical
Device Amendments became effective. Stair-climbing wheelchairs are
currently regulated as Class III devices. A call for premarket approval
(PMA) applications was issued on April 13, 2000 (effective July 12,
2000) (65 FR 19834).
The committee's discussion will include recommendations regarding
the regulatory classifications noted above. The committee will also
discuss whether the proposed special controls are adequate to
reasonably ensure the safety and effectiveness of stair-climbing
wheelchairs.
On December 12, 2013, during Session III, the committee will
discuss and make recommendations regarding the possible
reclassification of mechanical wheelchairs (21 CFR 890.3850) from Class
I, currently subject to premarket notification (510(k)), to Class II,
subject to special controls. The mechanical wheelchairs are being
considered for exemption from premarket notification (510(k))
requirements. A mechanical wheelchair is a manually operated device
with wheels that is intended for medical purposes to provide mobility
to persons restricted to a sitting position. No proposed order has been
issued for this proposed change in classification.
Mechanical wheelchairs are preamendment devices because they were
in commercial distribution prior to May 28, 1976, when the Medical
Device Amendments became effective. Mechanical wheelchairs are
currently regulated as Class I devices that are subject to premarket
notification (510(k)) requirements (48 FR 53041).
The committee will discuss whether general and/or special controls
are appropriate to demonstrate a reasonable assurance of safety and
effectiveness of mechanical wheelchairs and whether, if reclassified to
Class II, these devices should be exempt from premarket notification
(510(k)) requirements.
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
November 21, 2013. Oral presentations will be scheduled between
approximately 9:15 a.m. and 9:35 a.m. for Session I and between
approximately 2:40 p.m. and 3:20 p.m. for Session II and Session III.
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 the proposed participants, and an indication of the
approximate time requested to make their presentation on or before
November 13, 2013. 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 November 14,
2013.
Persons attending FDAs 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 James Clark,
[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).
[[Page 66944]]
Dated: November 4, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-26722 Filed 11-6-13; 8:45 am]
BILLING CODE 4160-01-P