Document ID: FDA-2009-N-0664-0104
Agency: fda
Document Type: Notice
Title: Radiological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
Posted Date: 2009-10-22T04:00Z

[Federal Register: October 22, 2009 (Volume 74, Number 203)]
[Notices]               
[Page 54583]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22oc09-62]                         

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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.

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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: 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of the draft guidance document entitled ``Class II Special Controls 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/DeviceRegulationandGuidance/
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.
[FR Doc. E9-25406 Filed 10-21-09; 8:45 am]

BILLING CODE 4160-01-S