[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)]
[Notices]
[Pages 45853-45854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21078]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5140]


Display Devices for Diagnostic Radiology; Guidance for Industry 
and Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the guidance entitled ``Display Devices for 
Diagnostic Radiology.'' This guidance document provides recommendations 
for the types of information you should provide in your premarket 
notification submission (510(k)) for display devices intended for 
diagnostic radiology with the assigned product code PGY. This guidance 
replaces a previously issued final guidance entitled ``Display 
Accessories for Full-Field Digital Mammography Systems-Premarket 
Notification (510(k)) Submissions'' issued on May 30, 2008.

DATES: The announcement of the guidance is published in the Federal 
Register on October 2, 2017.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2017-D-5140 for ``Display Devices for Diagnostic Radiology'' 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://

[[Page 45854]]

www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    An electronic copy of the guidance document is available for 
download from the internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Display Devices for Diagnostic Radiology'' to the Office of the 
Center Director, Guidance and Policy Development, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your request.

FOR FURTHER INFORMATION CONTACT: Robert Ochs, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4308, Silver Spring, MD 20993-0002, 301-796-6661.

SUPPLEMENTARY INFORMATION: 

I. Background

    This guidance applies to display devices intended for diagnostic 
radiology as identified in Section III of the guidance and currently 
classified under 21 CFR 892.2050 as class II devices according to 
section 513(a)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) (21 U.S.C. 360c(a)(1)) with the assigned product code PGY. This 
guidance is intended to assist industry in preparing a 510(k) for 
display devices intended for use in diagnostic radiology. This guidance 
provides recommendations for the types of information you should 
provide in your 510(k) submission for display devices intended for 
diagnostic radiology. This information supplements the requirements for 
a 510(k) submission found in 21 CFR 807 Subpart E, as well as 
recommendations provided in other FDA guidance documents concerning the 
specific content of a 510(k) submission.
    FDA considered comments on the draft guidance that appeared in the 
Federal Register of February 9, 2016 (81 FR 6869). FDA revised the 
guidance as appropriate in response to the comments.
    This guidance applies to workstation medical image displays for 
diagnostic radiology. These devices are classified as class II devices 
that are intended to be used in controlled viewing conditions to 
display and view digital images for primary image interpretation. 
Display devices for diagnostic radiology may also be referred to as 
soft-copy displays or medical grade monitors.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance represents the 
current thinking of FDA on Display Devices for Diagnostic Radiology. It 
does not establish any rights for any person and is not binding on FDA 
or the public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations. This guidance 
is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at https://www.regulations.gov. Persons 
unable to download an electronic copy of ``Display Devices for 
Diagnostic Radiology'' may send an email request to <a href="/cdn-cgi/l/email-protection#a0e3e4f2e88de7d5c9c4c1cec3c5e0c6c4c18ec8c8d38ec7cfd6"><span class="__cf_email__" data-cfemail="3c7f786e74117b4955585d525f597c5a585d1254544f125b534a">[email protected]</span></a> to receive an electronic copy of the document. 
Please use the document number 1500022 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously 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 807, subpart E have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 801 have been approved under OMB control 
number 0910-0485; and the collections of information in the guidance 
entitled ``Requests for Feedback on Medical Device Submissions: The 
Pre-Submission Program and Meetings with Food and Drug Administration 
Staff'' have been approved under OMB control number 0910-0756.

    Dated: September 25, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-21078 Filed 9-29-17; 8:45 am]
 BILLING CODE 4164-01-P


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