[Federal Register Volume 78, Number 85 (Thursday, May 2, 2013)]
[Notices]
[Pages 25747-25749]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10394]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-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.

[[Page 25748]]

    Date and Time: The meeting will be held on June 27, 2013, from 8 
a.m. to 6 p.m.
    Location: Holiday Inn, Ballroom, 2 Montgomery Village Ave., 
Gaithersburg, MD 20879. The hotel's phone number is 301-948-8900.
    Contact Person: Shanika Craig, Shanika.Craig@fda.hhs.gov, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-6639, 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 June 27, 2013, during session I, the committee will 
discuss and make recommendations regarding the proposed classification 
of sorbent hemoperfusion systems, one of the remaining preamendments 
class III devices. The class III sorbent hemoperfusion system is a 
device intended for the treatment of poisoning, drug overdose, hepatic 
coma, and metabolic disturbances. It consists of an extracorporeal 
blood system and a container filled with adsorbent material that 
removes a wide range of substances, both toxic and normal, from blood 
flowing through it. The adsorbent materials are usually activated 
carbon or resins, which may be coated or immobilized to prevent fine 
particles from entering the patient's blood. The generic type of device 
may include lines and filters specifically designed to connect the 
device to the extracorporeal blood system. Sorbent hemoperfusion 
systems may also include the machine or instrument used to drive and 
manage blood and fluid flow within the extracorporeal circuit, as well 
as any accompanying controllers, monitors, or sensors.
    On April 4, 2013 (78 FR 20268), FDA issued a proposed order which, 
if made final, would reclassify sorbent hemoperfusion systems labeled 
for the treatment of poisoning and drug overdose class II subject to 
premarket notification [510(k)] and special controls, while sorbent 
hemoperfusion systems labeled for the treatment of hepatic coma and 
metabolic disturbances would remain class III requiring premarket 
approval (PMA) applications. The committee's discussion will involve 
making 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 sorbent hemoperfusion devices labeled for the treatment of poisoning 
and drug overdose. The regulatory history of sorbent hemoperfusion has 
been discussed as part of a previously published proposed rule (77 FR 
9610).
    During session II on June 27, 2013, the committee will discuss and 
make recommendations regarding the proposed classification of implanted 
blood access devices for hemodialysis from class III to class II. The 
class III implanted blood access devices for hemodialysis include 
various flexible or rigid tubes, such as catheters, cannulae or hollow 
needles. Chronic hemodialysis catheters are soft, blunt-tipped plastic 
catheters that have a subcutaneous ``cuff''' for tissue ingrowth. They 
are placed in a central vein to allow blood access. Chronic 
hemodialysis catheters serve as conduits for the removal of blood from 
the patient, delivery to a hemodialysis machine for filtering, and 
return of filtered blood to the patient. They have no moving parts, 
consisting, essentially, of flexible tubing terminating in rigid Luer 
lock connectors for attachment to a dialysis machine. Subcutaneous 
catheters are totally implanted below the skin surface with no external 
communication. Arteriovenous shunts and vessel tips are tubing with 
tapered tips that are inserted into the artery and vein. The tubing is 
attached to the roughened or etched outer surface of the tip. The 
tubing is external to the skin and can be accessed with needles. They 
are similar to subcutaneous catheters.
    On June 20, 2012 (77 FR 36951), FDA issued a proposed rule which, 
if made final, would make the class III implanted blood access devices 
class II subject to premarket notification [510(k)] and special 
controls. The regulatory history of implanted blood access devices has 
been discussed as part of the proposed rule (77 FR 36951).
    The committee's discussion will involve making recommendations 
regarding regulatory classification to either reaffirm class III or 
reclassify these devices into class II and comment on whether special 
controls are adequate to reasonably ensure the safety and effectiveness 
of this device.
    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 
11, 2013. Oral presentations from the public will be scheduled between 
approximately 9 a.m. and 10 a.m. for session I and session II will 
start immediately after lunch between approximately 1:30 p.m. and 2:30 
p.m. 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 
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 June 4, 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 James Clark, 
Committee Management Staff, at james.clark@fda.hhs.gov, 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/

[[Page 25749]]

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 26, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-10394 Filed 5-1-13; 8:45 am]
BILLING CODE 4160-01-P