
[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]


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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.

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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.
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    \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 
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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 http://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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://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


