
[Federal Register Volume 78, Number 68 (Tuesday, April 9, 2013)]
[Notices]
[Pages 21129-21130]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08218]


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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 May 21, 2013, from 8 
a.m. to 5 p.m. and on May 22, 2013, from 8 a.m. to 4 p.m.
    Location: Holiday Inn, Ballroom, Two Montgomery Village Ave., 
Gaithersburg, MD 20879. The hotel phone number is 301-948-8900.
    Contact Person: Jamie Waterhouse, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1611, Silver Spring, MD 20993-0002, 
Jamie.Waterhouse@fda.hhs.gov, 301-796-3063, 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 May 21, 2013, the committee will discuss and make 
recommendations regarding the classification of one of the remaining 
preamendments class III devices, shortwave diathermy for all other uses 
except for the treatment of malignancies. The class III shortwave 
diathermy is a device that applies electromagnetic energy to the body 
in a radiofrequency band ranging between 13 megahertz to 27.12 
megahertz and is intended for the treatment of medical conditions by 
means other than the generation of deep heat within body tissues.
    On July 6, 2012 (77 FR 39953), FDA issued a proposed rule which, if 
made final, would make shortwave diathermy devices for all other uses 
class III requiring premarket approval (PMA) applications. In response 
to the proposed rule calling for PMAs, FDA received petitions under 
section 515(b)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 360e(b)(2)(B)) requesting a change in 
classification. The reclassification petitions are available for public 
review and comment at www.regulations.gov under docket number FDA-2012-
N-0378. The prior regulatory history of shortwave diathermy for all 
other uses has been discussed as part of the proposed rule (77 FR 
39953).
    The discussion at the panel meeting will involve making 
recommendations regarding regulatory classification to either reconfirm 
to class III (subject to PMA), or reclassify to class I or class II 
(subject to premarket notification (510(k))), as directed by section 
515(i) of the FD&C Act.
    On May 22, 2013, the committee will discuss and make 
recommendations regarding the 515(i) order issued by FDA on April 9, 
2009 (Docket No. FDA-2009-M-0101), for one of the remaining 
preamendments class III devices, pedicle screw spinal systems, intended 
to treat degenerative disc disease and spondylolisthesis other than 
either severe spondylolisthesis (grades 3 and 4) at L5-S1, or 
degenerative spondylolisthesis with objective evidence of neurologic 
impairment. Pedicle screw spinal systems are posterior spinal screw and 
rod systems intended as an adjunct to fusion for the treatment of 
degenerative disc disease, trauma, deformity, failed previous fusion, 
tumor, infection, and inflammatory disorders in the thoracolumbar 
spine.
    On July 27, 1998 (63 FR 40025), FDA published a final rule 
classifying certain previously unclassified preamendments pedicle screw 
spinal systems and reclassifying certain postamendments pedicle screw 
spinal systems. On May 22, 2001 (66 FR 28051), FDA published a 
technical amendment to the final rule to include an intended use that 
was inadvertently omitted from the codified language in the rule. As 
described in the summary of revisions in the technical amendment, FDA 
changed the intended uses for which pedicle screw spinal systems are 
class III from ``all other uses,'' to ``when intended to provide 
immobilization and stabilization of spinal segments in the thoracic, 
lumbar, and sacral spine as an adjunct to fusion in the treatment of 
degenerative disc disease and spondylolisthesis other than either 
severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative 
spondylolisthesis with objective evidence of neurologic impairment.'' 
Since the technical amendment, FDA has not established an effective 
date for the submission of PMAs for pedicle screw spinal systems with 
these class III indications for use; consequently, these systems have 
been subject to 510(k).
    The discussion at the panel meeting will involve making 
recommendations regarding regulatory classification to either reconfirm 
to class III (subject to PMA), or reclassify to class I or class II 
(subject to 510(k)), as directed by section 515(i) of the FD&C Act.
    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.

[[Page 21130]]

    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 May 
13, 2013. Oral presentations from the public will be scheduled between 
approximately 12 p.m. and 1 p.m. on May 21, 2013, and between 
approximately 10:45 a.m. and 11:45 a.m. on May 22, 2013. 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 May 
3, 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 May 6, 2013.
    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 
(Annmarie.williams@fda.hhs.gov, 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: April 4, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-08218 Filed 4-8-13; 8:45 am]
BILLING CODE 4160-01-P


