[Federal Register Volume 74, Number 202 (Wednesday, October 21, 2009)]
[Notices]
[Pages 54053-54055]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-25233]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0503]


Draft 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 (PMA) 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availability of two related draft guidance documents. One is a draft 
guidance entitled, ``Computer-Assisted Detection Devices Applied to 
Radiology Images and Radiology Device Data--Premarket Notification 
[510(k)] Submissions'' (``CADe 510(k) draft guidance''). This draft 
guidance provides recommendations regarding premarket notification 
(510(k)) submissions of certain computer-assisted detection (CADe) 
devices applied to radiology images and radiology device data. The 
second draft guidance is entitled, ``Clinical Performance Assessment: 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performance assessment draft guidance''). This draft guidance provides 
recommendations on how to design and conduct clinical performance 
studies for CADe devices applied to radiology images and radiology 
device data. These studies may be part of a premarket submission to 
FDA, whether it is a 510(k) submission, an application for premarket 
approval (PMA), an application for a humanitarian device exemption 
(HDE), or an application for an investigational device exemption (IDE). 
These draft guidances are not final nor are they in effect at this 
time.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115(g)(5)), to ensure that the agency considers your comment on 
these draft guidances before it begins work on the final versions of 
these guidances, submit written or electronic comments on the draft 
guidances by January 19, 2010.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance document entitled ``Computer-Assisted Detection Devices 
Applied to Radiology Images and Radiology Device Data--Premarket 
Notification [510(k)] Submissions'' or the draft 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., WO66-4613, Silver Spring, MD 20993. 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 draft 
guidances.
    Submit written comments concerning either of these draft guidances 
and the questions found in the supplementary information to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://www.regulations.gov. Identify comments with the 
docket number found in brackets in the heading of this document. Please 
include your rationale and/or scientific justification with your 
comments.

FOR FURTHER INFORMATION CONTACT: Nicholas Petrick, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., White Oak Bldg. 62, rm. 4116, Silver Spring, MD 20993, 
301-796-2563, and Joyce Whang, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., White 
Oak Bldg. 66, rm. G318, Silver Spring, MD 20993.

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

[[Page 54054]]

patient radiology images or patient radiology device data by the 
intended user (i.e., a physician or other health care professional). In 
drafting these documents, we considered the recommendations made during 
the Radiological Devices Panel on March 4 through 5, 2008. Further 
information on this public advisory committee meeting, including panel 
transcripts, can be found at: http://www.fda.gov/ohrms/dockets/ac/cdrh08.html#radiology.
    The CADe 510(k) draft 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 draft guidance 
provides recommendations regarding clinical performance studies for 
both Class II and Class III CADe devices applied to radiology images 
and radiology device data.

II. Frequently Asked Questions

    The agency anticipates including a section containing frequently 
asked questions (FAQs) in each of the guidances to further clarify the 
agency's recommendations regarding premarket notification (510(k)) 
submissions of certain computer-assisted detection (CADe) devices 
applied to radiology images and radiology, and on how to design and 
conduct clinical performance studies for CADe devices applied to 
radiology images and radiology device data. The agency is requesting 
public comment on the proposed sample questions provided in this 
document. Suggestions for additional questions and answers that are not 
included below but that may be helpful in understanding the guidances 
are also encouraged. The public comments will allow the agency to 
further refine the guidance and develop a FAQ section to communicate 
the recommended level of evidence for different premarket submissions. 
The agency also wants to ensure that these guidances adequately address 
these anticipated questions. The agency may adjust, add or delete 
questions based on received comments.
    The first group of draft sample questions (Q1-Q7) has been 
developed to provide context to the principles discussed in the CADe 
510(k) draft guidance. They may help in preparing a Premarket 
Notification [510(k)] Submission for your CADe device. Please comment 
on the following questions and what you believe would be the 
expectation of the agency based on the issues presented in the CADe 
510(k) draft guidance.
    Q1: Our CT CADe device is intended to be used on a variety of CT 
devices. Should any clinical trials we perform include every unit with 
which the CT CADe device is intended to be used?
    Q2: Our CADe device is designed to detect lung nodules. Should we 
power our standalone performance assessment so that statistically 
significant results can be obtained for the clinically relevant 
subgroups of lesions, for example, nodules near the mediastinum versus 
the peripheral lung fields?
    Q3: We have an already cleared CADe device and have updated one of 
its algorithms. Should we perform another clinical performance 
assessment (i.e., a reader study)?
    Q4: We have a new CADe device and have done standalone testing 
comparing it to an already cleared CADe device. Our new CADe identified 
additional cancers and had fewer false positive marks than the cleared 
device but ours missed some of the cancers detected by the cleared 
device. Should we perform a clinical performance assessment?
    Q5: We have an already cleared CADe device and have changed the 
prompt format (e.g., masses are now marked with a circle rather than an 
arrow). Should we perform another clinical performance assessment?
    Q6: In a 510(k), can I reuse the test dataset that supported 
clearance of the predicate CADe device and if so what are the 
constraints on this reuse?
    Q7: Our colon CADe device can be used for both 2D and 3D 
interpretation. Should we perform clinical tests using both 
interpretation modes?
    The second set of draft sample questions (Q8-Q11) has been 
developed to provide context to the principles discussed in the CADe 
clinical performance assessment draft guidance. They may help in 
developing and conducting a clinical performance assessment of your 
CADe device to support clearance or approval. Again, please comment on 
these questions and what you believe would be the expectation of the 
agency based on the issues presented in the CADe clinical performance 
assessment draft guidance.
    Q8: The guidance calls for the trial readers to be ``representative 
of the intended population of clinical users.'' Can you give some 
examples and should the number of readers in each of the subgroups be 
proportional to the numbers in the population of clinical users?
    Q9: We have a new breast CADe device and would like to market it 
for use with all legally marketed Full Field Digital Mammography 
(FFDM). Should we perform reader studies with each legally marketed 
FFDM?
    Q10: We have a breast CADe device approved for use with a specific 
legally marketed Full Field Digital Mammography (FFDM) based on a 
robust MRMC study. We would like to market it for use with an 
additional legally marketed FFDM. Should we perform a clinical 
performance assessment (i.e., reader study) to assess the CADe for use 
with the new FFDM or is standalone performance data enough to 
demonstrate comparable results based on the specifications of the 
device?
    Q11: We have improved our legally marketed CADe device and will be 
submitting a new 510(k) for the upgraded version. Is image reading 
without CADe a suitable control arm against which to compare the 
upgraded CADe device?
    The agency is seeking input to the previous sample questions and 
suggestions on additional questions so that it can further refine the 
guidance and develop a FAQ section to communicate the recommended level 
of evidence for different premarket submissions. Your input would allow 
us to consider multiple viewpoints of what is the adequacy of evidence 
for these devices.

III. Significance of Guidance

    These draft guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidances, 
when finalized, will represent, respectively, the agency's current 
thinking on `` Computer-Assisted Detection Devices Applied to Radiology 
Images and Radiology Device Data--Premarket Notification [510(k)] 
Submissions'' and on ``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.'' 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. Alternative approaches may be used if such 
approaches satisfy the requirements of the applicable statute and 
regulations.

IV. Electronic Access

    Persons interested in obtaining a copy of either draft guidance may 
do so by using the Internet. To receive ``Computer-Assisted Detection 
Devices Applied to Radiology Images and Radiology Device Data--
Premarket Notification [510(k)] Submissions,'' you may either send an 
e-mail request to [email protected] to receive an electronic copy of 
the document or send

[[Page 54055]]

a fax request to 301-847-8149 to receive a hard copy. Please use the 
document number 1697 to identify the draft guidance you are requesting. 
To receive ``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 e-mail 
request to [email protected] 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 1698 to identify the draft guidance you 
are requesting.
    CDRH maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with Internet access. Updated on a regular 
basis, the CDRH home page includes device safety alerts, Federal 
Register reprints, information on premarket submissions (including 
lists of approved applications and manufacturers' addresses), small 
manufacturer's assistance, information on video conferencing and 
electronic submissions, mammography matters, and other device-oriented 
information. The CDRH web site may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available at http://www.regulations.gov.

V. Paperwork Reduction Act of 1995

    These draft guidances contain information collection provisions 
that are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 USC 3501-3520) (the PRA). 
The collections of information addressed in these draft guidance 
documents have been approved by OMB in accordance with the PRA under 
the regulations governing premarket notification submissions (21 CFR 
part 807, subpart E, OMB No. 0910-0120), premarket approval 
applications (21 CFR part 814, OMB No. 0910-0231), investigational 
device exemptions (21 CFR part 812, OMB No. 0910-0078), and 
humanitarian use devices (21 CFR part 814, OMB No. 0910-0332). The 
labeling provisions addressed in the ``Computer-Assisted Detection 
Devices Applied to Radiology Images and Radiology Device Data--
Premarket Notification [510(k)] Submissions'' draft guidance have been 
approved by OMB under OMB No. 0910-0485.

VI. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified 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: October 15, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-25233 Filed 10-20-09; 8:45 am]
BILLING CODE 4160-01-S