[Federal Register Volume 77, Number 39 (Tuesday, February 28, 2012)]
[Page 12064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4670]

[[Page 12064]]



Food and Drug Administration

[Docket No. FDA-2012-N-0001]

Radiological 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: Radiological 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 April 11 and 12, 2012, 
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: Shanika Craig, Shanika.Craig@fda.hhs.gov, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, rm. 1613, 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), and follow the prompts 
to the desired center or product area. Please call the Information Line 
for up-to-date information on this meeting. 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 and call the appropriate advisory committee hot line/
phone line to learn about possible modifications before coming to the 
    Agenda: On April 11, 2012, the committee will discuss, make 
recommendations, and vote on information related to a premarket 
approval application for the Automated Breast Ultrasound (ABUS) 
scanning device, sponsored by U-Systems, Inc. The ABUS scanning device 
is intended to increase breast cancer detection in asymptomatic dense-
breasted women following a negative screening mammogram.
    On April 12, 2012, during session I, the committee will discuss and 
make recommendations regarding the 515(i) order issued by FDA on April 
9, 2009 (74 FR 16214), for breast transilluminators, one of the 
remaining preamendments class III devices. On July 18, 1995 (60 FR 
36639), FDA published a Final Rule that misbranded breast 
transilluminators and effectively placed them in class III based on the 
recommendation of the Obstetrics and Gynecology Devices Panel, which 
concluded there were no published studies or clinical data 
demonstrating the safety and effectiveness of this device. The 
committee discussion will include a review of the present literature to 
assess the current knowledge of breast transilluminators and determine 
if sufficient safety and effectiveness data are available to support 
reclassification of breast transilluminators.
    During session II on April 12, 2012, the committee will discuss and 
make recommendations regarding the classification of blood irradiators. 
Blood irradiators have been found to be substantially equivalent to 
predicate devices marketed in interstate commerce prior to May 28, 
1976, and are subject to the general controls provisions of the Federal 
Food, Drug and Cosmetic Act. These devices have never been formally 
classified. There is an agreement between the Center for Devices and 
Radiological Health (CDRH) and the Center for Biologics Evaluation and 
Research (CBER) that outlines which FDA center will regulate these 
devices. CDRH regulates irradiators intended for use in the 
immunologically active cells in blood and other tissues and CBER 
regulates irradiators intended for use in the in-process inactivation 
of HIV viruses or other pathogens. The committee discussion will focus 
on whether these devices should be classified in class I, II, or III.
    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 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 
April 3, 2012. On April 11, 2012, oral presentations from the public 
will be scheduled between approximately 1 p.m. and 2 p.m.; on April 12, 
2012, oral presentations will be scheduled between approximately 9 a.m. 
and 10 a.m. for session I and between 1:30 p.m. and 2:30 p.m. for 
session II. 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 appropriate meeting topic, the names and addresses of 
proposed participants, and an indication of the approximate time 
requested to make their presentation on or before March 26, 2012. 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 March 27, 2012.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
    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, 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).

    Dated: February 23, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-4670 Filed 2-27-12; 8:45 am]