Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review, 39498 [2012-16346]
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39498
Federal Register / Vol. 77, No. 128 / Tuesday, July 3, 2012 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Food and Drug Administration
Disease, Disability, and Injury
Prevention and Control Special
Emphasis Panel (SEP): Initial Review
Guidances for Industry and Food and
Drug Administration Staff: ComputerAssisted 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 and
Premarket Notification (510(k))
Submissions; Availability
[Docket No. FDA–2009–D–0503]
The meeting announced below
concerns Special Interest Project (SIP):
Assessing the Pregnancy Prevention
Needs of HIV-Infected Young Women of
Reproductive Age and Effects of
Contraception, SIP12–064, Panel G,
initial review.
In accordance with Section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the aforementioned meeting:
Time and Date: 9:00 a.m.–12:30 p.m., July
26, 2012 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the
public in accordance with provisions set
forth in Section 552b(c) (4) and (6), Title 5
U.S.C., and the Determination of the Director,
Management Analysis and Services Office,
CDC, pursuant to Public Law 92–463.
Matters To Be Discussed: The meeting will
include the initial review, discussion, and
evaluation of applications received in
response to ‘‘Assessing the Pregnancy
Prevention Needs of HIV-Infected Young
Women of Reproductive Age and Effects of
Contraception, SIP12–064, Panel G, initial
review.’’
Contact Person for More Information:
M. Chris Langub, Ph.D., Scientific Review
Officer, CDC, 4770 Buford Highway NE.,
Mailstop F–46, Atlanta, Georgia 30341,
Telephone: (770) 488–3583.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: June 22, 2012.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2012–16346 Filed 7–2–12; 8:45 am]
srobinson on DSK4SPTVN1PROD with NOTICES
BILLING CODE 4163–18–P
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of two related guidance
documents. The first guidance, entitled
‘‘Computer-Assisted Detection Devices
Applied to Radiology Images and
Radiology Device Data—Premarket
Notification (510(k)) Submissions’’
(CADe 510(k) guidance), provides
recommendations regarding premarket
notification (510(k)) submissions of
certain computer-assisted detection
(CADe)1 devices applied to radiology
images and radiology device data. The
second guidance, entitled ‘‘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’’ (CADe clinical
performance assessment guidance),
provides recommendations on the
design and conduct of clinical
performance studies for CADe devices
applied to radiology images and
radiology device data.
DATES: Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for
single copies of the guidance document
entitled ‘‘Computer-Assisted Detection
Devices Applied to Radiology Images
and Radiology Device Data—Premarket
Notification (510(k)) Submissions’’ or
SUMMARY:
1 The use of the acronym CADe for computerassisted detection may not be a generally
recognized acronym in the community at large. It
is used here to identify the specific type of devices
discussed in this document.
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the guidance document entitled
‘‘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’’ to the Division of Small
Manufacturers, International, and
Consumer Assistance, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4613,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
request, or fax your request to 301–847–
8149. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to these guidances.
Submit electronic comments on the
guidances to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Nicholas Petrick, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 62, rm. 4118, Silver Spring,
MD 20993, 301–796–2563, and Mary
Pastel, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. G310, Silver Spring,
MD 20993, 301–796–6887.
SUPPLEMENTARY INFORMATION:
I. Background
CADe devices are computerized
systems that incorporate pattern
recognition and data analysis
capabilities (i.e., combine values,
measurements, or features extracted
from the patient radiological data)
intended to identify, mark, highlight, or
in any other manner direct attention to
portions of an image, or aspects of
radiology device data, that may reveal
abnormalities during interpretation of
patient radiology images or patient
radiology device data by the intended
user (i.e., a physician or other health
care professional).
The CADe 510(k) guidance provides
recommendations on documentation
and performance testing to be part of a
510(k) submission for class II CADe
devices applied to radiology images and
radiology device data. The CADe
clinical performance assessment
guidance provides recommendations
regarding clinical performance studies
E:\FR\FM\03JYN1.SGM
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[Federal Register Volume 77, Number 128 (Tuesday, July 3, 2012)]
[Notices]
[Page 39498]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-16346]
[[Page 39498]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Disease, Disability, and Injury Prevention and Control Special
Emphasis Panel (SEP): Initial Review
The meeting announced below concerns Special Interest Project
(SIP): Assessing the Pregnancy Prevention Needs of HIV-Infected Young
Women of Reproductive Age and Effects of Contraception, SIP12-064,
Panel G, initial review.
In accordance with Section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), the Centers for Disease Control and
Prevention (CDC) announces the aforementioned meeting:
Time and Date: 9:00 a.m.-12:30 p.m., July 26, 2012 (Closed).
Place: Teleconference.
Status: The meeting will be closed to the public in accordance
with provisions set forth in Section 552b(c) (4) and (6), Title 5
U.S.C., and the Determination of the Director, Management Analysis
and Services Office, CDC, pursuant to Public Law 92-463.
Matters To Be Discussed: The meeting will include the initial
review, discussion, and evaluation of applications received in
response to ``Assessing the Pregnancy Prevention Needs of HIV-
Infected Young Women of Reproductive Age and Effects of
Contraception, SIP12-064, Panel G, initial review.''
Contact Person for More Information: M. Chris Langub, Ph.D.,
Scientific Review Officer, CDC, 4770 Buford Highway NE., Mailstop F-
46, Atlanta, Georgia 30341, Telephone: (770) 488-3583.
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register notices pertaining
to announcements of meetings and other committee management
activities, for both the Centers for Disease Control and Prevention
and the Agency for Toxic Substances and Disease Registry.
Dated: June 22, 2012.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. 2012-16346 Filed 7-2-12; 8:45 am]
BILLING CODE 4163-18-P
