[Federal Register Volume 78, Number 247 (Tuesday, December 24, 2013)]
[Notices]
[Pages 77689-77690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-30580]


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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 February 21, 2014, from 
8 a.m. to 3 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 20993-0002, [email protected], 
301-796-7047, 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 February 21, 2014, 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], relating to the regulatory 
classification of iontophoresis devices, one of the remaining 
preamendments class III devices. Iontophoresis is a method of non-
invasive transdermal delivery in which a substance bearing a charge is 
propelled through the skin by an electric current. Iontophoresis 
devices generally consist of a controller, active and return 
electrode(s), and power supply used to deliver currents to transport 
drugs, soluble salts, or ionic solutions across the skin.
    The regulation for iontophoresis devices (21 CFR 890.5525) 
currently has two parts. Part (a) of the regulation classifies 
iontophoresis devices as class II when indicated to introduce drugs or 
soluble salts to induce sweating for use in the diagnosis of cystic 
fibrosis or for other uses if the drug intended for use with the device 
bears adequate directions for the device's use with that drug. Devices 
identified in part (a) of the regulation will not be considered in the 
scope of the committee meeting. Part (b) of the regulation classifies 
iontophoresis devices as class III when intended to use direct current 
to introduce soluble salts or other drugs into the body for purposes 
other than those specified in part (a). Devices identified in part (b) 
of the regulation are the subject of the committee meeting.
    On August 28, 1979, FDA published a proposed rule (44 FR 50520) for 
classification of iontophoresis devices for specialized uses (for the 
diagnosis of cystic fibrosis, fluoride uptake acceleration in 
dentistry, and for local anesthesia of the intact tympanic membrane) 
into class II and for all other uses into class III. FDA recommended 
class III for iontophoresis devices when used for purposes other than 
those specifically considered because such use presents ``a potential 
unreasonable risk of injury without benefit to the patient because 
substantial data and clinical investigations do not exist to support 
the claims made for the devices.'' In addition, the Agency noted that 
insufficient information exists to determine that general controls 
would provide reasonable assurance of the safety and effectiveness of 
the device and that insufficient information exists to establish a 
performance standard to provide this assurance.
    Subsequent to the proposed rule, FDA published a final rule (48 FR 
53047) on November 23, 1983, classifying iontophoresis devices for use 
in the diagnosis of cystic fibrosis or other uses if the labeling of 
the drug intended for use with the device bears adequate directions for 
the device's use with that drug as class II (performance standards)

[[Page 77690]]

and iontophoresis devices intended for any other purposes as class III 
(premarket approval). The final rule was issued after consideration of 
three comments submitted in response to the 1979 proposed rule that 
disagreed with the proposal classifying into class III iontophoresis 
devices for uses other than diagnosing cystic fibrosis, application of 
fluoride in dentistry, or anesthetizing the tympanic membrane. Based on 
FDA's analysis of the available literature and input from the Physical 
Medicine; Ear, Nose and Throat; and Dental Device Classification Panels 
(see the preamble to the proposed rule 44 FR 50520), FDA disagreed with 
the comments and concluded that insufficient data exist to support uses 
of the device other than those specifically considered. In addition, 
the final rule removed the dental application of fluoride and local 
anesthesia of the intact tympanic membrane uses from the class II 
definition because it was determined that there were no marketed drugs 
with adequate instructions for use with an iontophoresis device for 
these uses. The effect of this change in the identification was to 
classify into class III iontophoresis devices for these two uses.
    In 1987, FDA published a clarification by inserting language in the 
codified language stating that no effective date had been established 
for the requirement for premarket approval for iontophoresis devices 
intended for any other purposes (52 FR 17742, May 11, 1987).
    On August 22, 2000, FDA published a proposed rule (65 FR 50949) to 
amend the iontophoresis device regulation to remove the class III 
(premarket approval) identification because FDA believed there were no 
preamendments iontophoresis devices marketed for uses other than those 
described in the class II identification. The proposed rule stated that 
manufacturers of iontophoresis devices that had been cleared as class 
III 510(k)s could revise the labeling of their devices to meet the 
class II identification.
    On November 4, 2004, FDA withdrew the proposed rule issued on 
August 22, 2000 (65 FR 50949), in response to comments received (69 FR 
64266). FDA simultaneously issued a Notice of Intent to reclassify 
iontophoresis devices currently in class III into class II (special 
controls) and provided an opportunity for interested persons to submit 
any new information concerning the safety and effectiveness of 
iontophoresis devices (69 FR 64313). FDA did not take further 
regulatory action regarding iontophoresis devices prior to issuing the 
2009 515(i) order on April 9, 2009 [Docket No. FDA-2009-M-0101], 
relating to their regulatory classification.
    The discussion at the committee 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)). The committee will further be asked to comment on 
whether general and/or special controls are adequate to reasonably 
ensure the safety and effectiveness of the device and whether, if 
reclassified to Class II, these devices should be exempt from premarket 
notification 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 
January 31, 2014. Oral presentations from the public will be scheduled 
between approximately 10:45 a.m. and 11:45 a.m. on February 21, 2014. 
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 
January 23, 2014. 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 January 24, 
2014.
    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 at 
[email protected], 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: December 17, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-30580 Filed 12-23-13; 8:45 am]
BILLING CODE 4160-01-P