[Federal Register Volume 79, Number 113 (Thursday, June 12, 2014)]
[Notices]
[Pages 33760-33761]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-13650]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]


Gastroenterology and Urology 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: Gastroenterology and Urology 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 July 30 and 31, 2014, 
from 8 a.m. to 6 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 July 30, 2014, the committee will discuss, make 
recommendations, and vote on information regarding the premarket 
approval application (PMA) for the Ablatherm Integrated Imaging device 
sponsored by EDAP Technomed, Inc. The proposed Indication for Use for 
the Ablatherm Integrated Imaging device, as stated in the PMA, is as 
follows:
    The Ablatherm Integrated Imaging device is intended for the primary 
treatment of prostate cancer in subjects with low risk, localized 
prostate cancer.
    On July 31, 2014, the committee will discuss and make 
recommendations regarding the classification of Penile Tumescence 
Monitors, Nephrostomy Catheters, Stimulators for Electrical Sperm 
Collection, Erectile Dysfunction Devices, and Alloplastic 
Spermatoceles. These devices are considered preamendments devices since 
they were in commercial distribution prior to May 28, 1976, when the 
Medical Devices Amendments became effective. Penile Tumescence Monitors 
are currently regulated under the heading, ``Monitor, Penile 
Tumescence,'' Product Code LIL, as unclassified under the 510(k) 
premarket notification authority. Nephrostomy Catheters are currently 
regulated under the heading, ``Catheter, Nephrostomy,'' Product Code 
LJE, as unclassified under the 510(k) premarket notification authority. 
Stimulators for Electrical Sperm Collection are currently regulated 
under the heading, ``Stimulator, Electrical for Sperm Collection,'' 
Product Code LNL, as unclassified under the 510(k) premarket 
notification authority. Erectile Dysfunction Devices are currently 
regulated under the heading, ``Device, Erectile Dysfunction,'' Product 
Code LST, as unclassified under the 510(k) premarket notification 
authority. Alloplastic Spermatoceles are currently regulated under the 
heading, ``Spermatocele, Alloplastic,'' Product Code LQS, as 
unclassified under the 510(k) premarket notification authority. FDA is 
seeking committee input on the safety and effectiveness and the 
regulatory classification of Penile Tumescence Monitors, Nephrostomy 
Catheters, Stimulators for Electrical Sperm Collection, Erectile 
Dysfunction Devices, and Alloplastic Spermatoceles.
    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 June 
24, 2014. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on July 30, 2014, and between 
approximately 8:50 a.m. and 9:50 a.m. on July 31, 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 June 
16, 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 June 17, 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 James Clark at 
[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 33761]]


    Dated: June 6, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-13650 Filed 6-11-14; 8:45 am]
BILLING CODE 4164-01-P