[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

    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