[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availability of two related draft guidance documents. One is a draft
guidance entitled, ``Computer-Assisted Detection Devices Applied to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[510(k)] Submissions'' (``CADe 510(k) draft guidance''). This draft
guidance provides recommendations regarding premarket notification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second draft guidance is entitled, ``Clinical Performance Assessment: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performance assessment draft guidance''). This draft guidance provides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
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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