Guidances for Industry and Food and Drug Administration Staff: 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 and Premarket Notification (510(k)) Submissions; Availability, 39498-39499 [2012-16227]
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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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16:27 Jul 02, 2012
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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
03JYN1
Federal Register / Vol. 77, No. 128 / Tuesday, July 3, 2012 / Notices
for both class II and class III CADe
devices applied to radiology images and
radiology device data. These clinical
performance studies may be part of a
premarket submission to FDA, whether
it is a 510(k) submission, an application
for PMA, an application for a
humanitarian device exemption, or an
application for an investigational device
exemption.
In the Federal Register of October 21,
2009 (74 FR 54053), FDA announced the
availability of the draft guidance
documents. Interested persons were
invited to comment by January 19, 2010.
Six comments were received with
multiple recommendations about
changes to the content of the
documents. FDA also received
comments during the public meetings of
the Radiology Devices Panel, an FDA
advisory committee, on March 4–5,
2008, and November 17–18, 2009. In
response to all of these comments, FDA
revised both guidance documents to
clarify the level of detail the Agency
would like to see regarding the
description and operation of the CADe
device and about test data reuse. In
response to the comments, the new
guidance documents also clarify that
digitized film is within the scope of
radiological data and that FDA intends
to create new product codes as
necessary to identify and track new
types of CADe products.
FDA’s revisions, based on comments
on the CADe 510(k) guidance, also
include updated recommendations on
the scoring process and when a clinical
performance assessment may be
necessary. The Generalizability Testing
subsection was extensively modified,
including removing recommendations
on algorithm stability testing. In
response to comments on the CADe
clinical performance assessment
guidance, FDA limited the postmarket
section to outlining the basic
postapproval study process.
srobinson on DSK4SPTVN1PROD with NOTICES
II. Significance of Guidance
These guidances are being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidances represent the Agency’s
current thinking on premarket
notification (510(k)) submissions of
certain CADe devices applied to
radiology images and radiology device
data and on clinical performance
studies for CADe devices applied to
radiology images and radiology device
data. The guidance documents do not
create or confer any rights for or on any
person and do not operate to bind FDA
or the public. An alternative approach
may be used if such approach satisfies
VerDate Mar<15>2010
16:27 Jul 02, 2012
Jkt 226001
the requirements of the applicable
statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of either guidance may do so by using
the Internet. A search capability for all
CDRH guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm.
Guidance documents are also available
at https://www.regulations.gov. To
receive ‘‘Computer-Assisted Detection
Devices Applied to Radiology Images
and Radiology Device Data—Premarket
Notification (510(k)) Submissions,’’ or
‘‘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,’’ you may either send an
email request to dsmica@fda.hhs.gov to
receive an electronic copy of the
document or send a fax request to 301–
847–8149 to receive a hard copy. Please
use the document number (1697) to
identify the CADe 510(k) guidance or
the document number (1698) to identify
the CADe clinical performance
assessment guidance.
IV. Paperwork Reduction Act of 1995
These guidance documents refer to
currently approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 801 have
been approved under OMB control
number 0910–0485; the collections of
information in 21 CFR part 807, subpart
E, have been approved under OMB
control number 0910–0120; the
collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078; and
the collections of information in 21 CFR
part 814 have been approved under
OMB control numbers 0910–0231 and
0910–0332.
V. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES), either electronic or written
comments regarding this document. It is
only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
PO 00000
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39499
Dated: June 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–16227 Filed 7–2–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center For Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel Revisions on
the Protections for Human Subjects Study
Section.
Date: July 30, 2012.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Lorien Hotel and Spa, 1600 King
Street, Alexandria, VA 22314.
Contact Person: Karin F. Helmers, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3166,
MSC 7770, Bethesda, MD 20892, 301–254–
9975, helmersk@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel, Member
Conflict: Motor Function, Speech and
Rehabilitation.
Date: July 30, 2012.
Time: 1:00 p.m. to 2:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Weijia Ni, Ph.D., Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 3184, MSC 7848, Bethesda, MD
20892, (301) 237–9918, niw@csr.nih.gov.
Name of Committee: Biology of
Development and Aging Integrated Review
Group, International and Cooperative
Projects—1 Study Section.
Date: August 2, 2012.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
E:\FR\FM\03JYN1.SGM
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Agencies
[Federal Register Volume 77, Number 128 (Tuesday, July 3, 2012)]
[Notices]
[Pages 39498-39499]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-16227]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-D-0503]
Guidances for Industry and Food and Drug Administration Staff:
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 and Premarket Notification (510(k))
Submissions; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: 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.
---------------------------------------------------------------------------
\1\ The use of the acronym CADe for computer-assisted 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.
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 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
[[Page 39499]]
for both class II and class III CADe devices applied to radiology
images and radiology device data. These clinical performance studies
may be part of a premarket submission to FDA, whether it is a 510(k)
submission, an application for PMA, an application for a humanitarian
device exemption, or an application for an investigational device
exemption.
In the Federal Register of October 21, 2009 (74 FR 54053), FDA
announced the availability of the draft guidance documents. Interested
persons were invited to comment by January 19, 2010. Six comments were
received with multiple recommendations about changes to the content of
the documents. FDA also received comments during the public meetings of
the Radiology Devices Panel, an FDA advisory committee, on March 4-5,
2008, and November 17-18, 2009. In response to all of these comments,
FDA revised both guidance documents to clarify the level of detail the
Agency would like to see regarding the description and operation of the
CADe device and about test data reuse. In response to the comments, the
new guidance documents also clarify that digitized film is within the
scope of radiological data and that FDA intends to create new product
codes as necessary to identify and track new types of CADe products.
FDA's revisions, based on comments on the CADe 510(k) guidance,
also include updated recommendations on the scoring process and when a
clinical performance assessment may be necessary. The Generalizability
Testing subsection was extensively modified, including removing
recommendations on algorithm stability testing. In response to comments
on the CADe clinical performance assessment guidance, FDA limited the
postmarket section to outlining the basic postapproval study process.
II. Significance of Guidance
These guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The guidances represent
the Agency's current thinking on premarket notification (510(k))
submissions of certain CADe devices applied to radiology images and
radiology device data and on clinical performance studies for CADe
devices applied to radiology images and radiology device data. The
guidance documents do not create or confer any rights for or on any
person and do not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of either guidance may do so
by using the Internet. A search capability for all CDRH guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at https://www.regulations.gov. To receive
``Computer-Assisted Detection Devices Applied to Radiology Images and
Radiology Device Data--Premarket Notification (510(k)) Submissions,''
or ``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,'' you may either send an email request to
dsmica@fda.hhs.gov to receive an electronic copy of the document or
send a fax request to 301-847-8149 to receive a hard copy. Please use
the document number (1697) to identify the CADe 510(k) guidance or the
document number (1698) to identify the CADe clinical performance
assessment guidance.
IV. Paperwork Reduction Act of 1995
These guidance documents refer to currently approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 801 have been approved under
OMB control number 0910-0485; the collections of information in 21 CFR
part 807, subpart E, have been approved under OMB control number 0910-
0120; the collections of information in 21 CFR part 812 have been
approved under OMB control number 0910-0078; and the collections of
information in 21 CFR part 814 have been approved under OMB control
numbers 0910-0231 and 0910-0332.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Dated: June 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-16227 Filed 7-2-12; 8:45 am]
BILLING CODE 4160-01-P