November 17-18, 2009: Radiological Devices Advisory Committee Meeting Announcement

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
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 November 17 and 18, 2009,
from 8 a.m. to 5:30 p.m.
Location: Holiday Inn, Ballroom, Two Montgomery Village Ave.,
Gaithersburg, MD.

Contact Person: Toby Lowe, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD
20993, 301–796–6512, or FDA Advisory Committee Information Line, 1–800–
741–8138 (301–443–0572 in the Washington, DC area), code 3014512526.
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 meeting.

Agenda: On November 17, 2009, the committee will discuss and make
recommendations regarding the agency’s regulatory strategy for Full Field
Digital Mammography (FFDM) Devices. The committee will discuss the public
comments received in response to the publication of the draft guidance
document entitled ‘‘Class II Special Controls Guidance Document: Full Field
Digital Mammography System.’’ This guidance document can be found on the
FDA Web site at http://www.fda.gov/MedicalDevices/DeviceRegulation
andGuidance/GuidanceDocuments/ucm107552.htm.

On November 18, 2009, the committee will discuss and make
recommendations regarding the agency’s regulatory strategy for computer assisted
detection (CADe) devices for radiological devices. CADe devices are
devices intended to identify, mark, highlight or in any other manner direct
attention to potential abnormalities revealed in radiological data of the human
body or imaging device data during interpretation of patient images or patient
imaging data by a physician or other health care professional. The committee
will discuss two draft guidance documents entitled ‘‘Computer-Assisted
Detection Devices Applied to Radiology Images and Radiology Device Data—
Premarket Notification [510(k)] Submissions’’ and ‘‘Clinical Performance
Assessment: Considerations for Computer-Assisted Detection Devices Applied
to Radiology Images and Radiology Device Data—Premarket Approval (PMA)
and Premarket Notification [510(k)] Submissions.’’ These guidance documents
can be found on the FDA Web site at http://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/GuidanceDocuments. Type in the title of the
guidance document included in this notice. The guidance documents will also
be available as background materials.

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 November 12,
2009. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. on both days. Those desiring to make 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
November 6, 2009. 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 November 9, 2009.

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, Conference Management Staff,
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: October 16, 2009.
David Horowitz,
Assistant Commissioner for Policy.