82 FR 45853 - Display Devices for Diagnostic Radiology; Guidance for Industry and Food and Drug Administration Staff; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 189 (October 2, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 189 (October 2, 2017)
| Page Range | 45853-45854 | |
| FR Document | 2017-21078 |
[Federal Register Volume 82, Number 189 (Monday, October 2, 2017)] [Notices] [Pages 45853-45854] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21078] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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: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. 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: 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. 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. 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.thefederalregister.org/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 [email protected] 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
![Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices 45853
pursuant to Executive Order 13708, and DEPARTMENT OF HEALTH AND manner detailed (see ‘‘Written/Paper
will expire on September 30, 2017. HUMAN SERVICES Submissions’’ and ‘‘Instructions’’).
Purpose: The Advisory Board is Written/Paper Submissions
Food and Drug Administration
charged with (a) providing advice to the Submit written/paper submissions as
Secretary, HHS, on the development of [Docket No. FDA–2017–D–5140]
follows:
guidelines under Executive Order
Display Devices for Diagnostic • Mail/Hand delivery/Courier (for
13179; (b) providing advice to the written/paper submissions): Dockets
Radiology; Guidance for Industry and
Secretary, HHS, on the scientific Management Staff (HFA–305), Food and
Food and Drug Administration Staff;
validity and quality of dose Drug Administration, 5630 Fishers
Availability
reconstruction efforts performed for this Lane, Rm. 1061, Rockville, MD 20852.
program; and (c) upon request by the AGENCY: Food and Drug Administration, • For written/paper comments
Secretary, HHS, advise the Secretary on HHS. submitted to the Dockets Management
whether there is a class of employees at ACTION: Notice of availability. Staff, FDA will post your comment, as
any Department of Energy facility who well as any attachments, except for
SUMMARY: The Food and Drug information submitted, marked and
were exposed to radiation but for whom
Administration (FDA or Agency) is identified, as confidential, if submitted
it is not feasible to estimate their announcing the availability of the
radiation dose, and on whether there is as detailed in ‘‘Instructions.’’
guidance entitled ‘‘Display Devices for Instructions: All submissions received
reasonable likelihood that such Diagnostic Radiology.’’ This guidance must include the Docket No. FDA–
radiation doses may have endangered document provides recommendations 2017–D–5140 for ‘‘Display Devices for
the health of members of this class. SPR for the types of information you should Diagnostic Radiology’’ comments will
was established to aid the Advisory provide in your premarket notification be placed in the docket and, except for
Board in carrying out its duty to advise submission (510(k)) for display devices those submitted as ‘‘Confidential
the Secretary, HHS, on dose intended for diagnostic radiology with Submissions,’’ publicly viewable at
reconstruction. SPR is responsible for the assigned product code PGY. This https://www.regulations.gov or at the
overseeing, tracking, and participating guidance replaces a previously issued Dockets Management Staff between 9
in the reviews of all procedures used in final guidance entitled ‘‘Display a.m. and 4 p.m., Monday through
the dose reconstruction process by the Accessories for Full-Field Digital Friday.
NIOSH Division of Compensation Mammography Systems-Premarket • Confidential Submissions—To
Analysis and Support (DCAS) and its Notification (510(k)) Submissions’’ submit a comment with confidential
dose reconstruction contractor (Oak issued on May 30, 2008. information that you do not wish to be
Ridge Associated Universities—ORAU). DATES: The announcement of the made publicly available, submit your
guidance is published in the Federal comments only as a written/paper
Matters to be Considered: The agenda
Register on October 2, 2017. submission. You should submit two
will include discussions on the copies total. One copy will include the
following dose reconstruction ADDRESSES: You may submit either
electronic or written comments on information you claim to be confidential
procedures: DCAS Program Evaluation with a heading or cover note that states
Report 59 (addressing dose Agency guidances at any time as
follows: ‘‘THIS DOCUMENT CONTAINS
reconstructions at the Norton Company, CONFIDENTIAL INFORMATION.’’ The
Worcester MA); DCAS Report 5: Electronic Submissions Agency will review this copy, including
Alternative Dissolution Models for Submit electronic comments in the the claimed confidential information, in
Insoluble Plutonium 238; Outstanding following way: its consideration of comments. The
Findings of Prior Subcommittee • Federal eRulemaking Portal: second copy, which will have the
Reviews; and DCAS Procedures Not Yet https://www.regulations.gov. Follow the claimed confidential information
Reviewed. Agenda items are subject to instructions for submitting comments. redacted/blacked out, will be available
change as priorities dictate. Comments submitted electronically, for public viewing and posted on
The Director, Management Analysis including attachments, to https:// https://www.regulations.gov. Submit
and Services Office, has been delegated www.regulations.gov will be posted to both copies to the Dockets Management
the authority to sign Federal Register the docket unchanged. Because your Staff. If you do not wish your name and
notices pertaining to announcements of comment will be made public, you are contact information to be made publicly
solely responsible for ensuring that your available, you can provide this
meetings and other committee
comment does not include any information on the cover sheet and not
management activities, for both the
confidential information that you or a in the body of your comments and you
Centers for Disease Control and third party may not wish to be posted, must identify this information as
Prevention and the Agency for Toxic such as medical information, your or ‘‘confidential.’’ Any information marked
Substances and Disease Registry. anyone else’s Social Security number, or as ‘‘confidential’’ will not be disclosed
Elaine L. Baker, confidential business information, such except in accordance with 21 CFR 10.20
Director, Management Analysis and Services
as a manufacturing process. Please note and other applicable disclosure law. For
Office, Centers for Disease Control and that if you include your name, contact more information about FDA’s posting
Prevention. information, or other information that of comments to public dockets, see 80
sradovich on DSK3GMQ082PROD with NOTICES
[FR Doc. 2017–21046 Filed 9–29–17; 8:45 am]
identifies you in the body of your FR 56469, September 18, 2015, or access
comments, that information will be the information at: https://www.gpo.gov/
BILLING CODE 4163–19–P
posted on https://www.regulations.gov. fdsys/pkg/FR-2015-09-18/pdf/2015-
• If you want to submit a comment 23389.pdf.
with confidential information that you Docket: For access to the docket to
do not wish to be made available to the read background documents or the
public, submit the comment as a electronic and written/paper comments
written/paper submission and in the received, go to https://
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![45854 Federal Register / Vol. 82, No. 189 / Monday, October 2, 2017 / Notices
www.regulations.gov and insert the radiology. These devices are classified Dated: September 25, 2017.
docket number, found in brackets in the as class II devices that are intended to Leslie Kux,
heading of this document, into the be used in controlled viewing Associate Commissioner for Policy.
‘‘Search’’ box and follow the prompts conditions to display and view digital [FR Doc. 2017–21078 Filed 9–29–17; 8:45 am]
and/or go to the Dockets Management images for primary image interpretation. BILLING CODE 4164–01–P
Staff, 5630 Fishers Lane, Rm. 1061, Display devices for diagnostic radiology
Rockville, MD 20852. may also be referred to as soft-copy
You may submit comments on any displays or medical grade monitors. DEPARTMENT OF HEALTH AND
guidance at any time (see 21 CFR HUMAN SERVICES
10.115(g)(5)). II. Significance of Guidance
An electronic copy of the guidance This guidance is being issued Food and Drug Administration
document is available for download consistent with FDA’s good guidance
from the internet. See the [Docket No. FDA–2017–D–5372]
practices regulation (21 CFR 10.115).
SUPPLEMENTARY INFORMATION section for
This guidance represents the current Marketing Clearance of Diagnostic
information on electronic access to the thinking of FDA on Display Devices for Ultrasound Systems and Transducers;
guidance. Submit written requests for a Draft Guidance for Industry and Food
Diagnostic Radiology. It does not
single hard copy of the guidance and Drug Administration Staff;
establish any rights for any person and
document entitled ‘‘Display Devices for Availability
is not binding on FDA or the public.
Diagnostic Radiology’’ to the Office of
You can use an alternative approach if
the Center Director, Guidance and AGENCY: Food and Drug Administration,
it satisfies the requirements of the
Policy Development, Center for Devices HHS.
applicable statutes and regulations. This
and Radiological Health, Food and Drug ACTION: Notice of availability.
guidance is not subject to Executive
Administration, 10903 New Hampshire
Order 12866. SUMMARY: The Food and Drug
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one self- III. Electronic Access Administration (FDA or Agency) is
addressed adhesive label to assist that announcing the availability of the draft
office in processing your request. Persons interested in obtaining a copy guidance entitled ‘‘Marketing Clearance
FOR FURTHER INFORMATION CONTACT: of the guidance may do so by of Diagnostic Ultrasound Systems and
Robert Ochs, Center for Devices and downloading an electronic copy from Transducers; Draft Guidance for
Radiological Health, Food and Drug the Internet. A search capability for all Industry and Food and Drug
Administration, 10903 New Hampshire Center for Devices and Radiological Administration Staff.’’ This draft
Ave., Bldg. 66, Rm. 4308, Silver Spring, Health guidance documents is available guidance provides detailed information
MD 20993–0002, 301–796–6661. at https://www.fda.gov/MedicalDevices/ recommended for manufacturers
DeviceRegulationandGuidance/ seeking marketing clearance of
SUPPLEMENTARY INFORMATION:
GuidanceDocuments/default.htm. diagnostic ultrasound systems and
I. Background Guidance documents are also available transducers. This draft guidance is not
This guidance applies to display at https://www.regulations.gov. Persons final nor is it in effect at this time.
devices intended for diagnostic unable to download an electronic copy DATES: Submit either electronic or
radiology as identified in Section III of of ‘‘Display Devices for Diagnostic written comments on the draft guidance
the guidance and currently classified Radiology’’ may send an email request by January 2, 2018 to ensure that the
under 21 CFR 892.2050 as class II to CDRH-Guidance@fda.hhs.gov to Agency considers your comment on this
devices according to section 513(a)(1) of receive an electronic copy of the draft guidance before it begins work on
the Federal Food, Drug, and Cosmetic document. Please use the document the final version of the guidance.
Act (the FD&C Act) (21 U.S.C. number 1500022 to identify the ADDRESSES: You may submit comments
360c(a)(1)) with the assigned product guidance you are requesting. on any guidance at any time as follows:
code PGY. This guidance is intended to IV. Paperwork Reduction Act of 1995
assist industry in preparing a 510(k) for Electronic Submissions
display devices intended for use in This guidance refers to previously Submit electronic comments in the
diagnostic radiology. This guidance approved collections of information following way:
provides recommendations for the types found in FDA regulations. These • Federal eRulemaking Portal:
of information you should provide in collections of information are subject to https://www.regulations.gov. Follow the
your 510(k) submission for display review by the Office of Management and instructions for submitting comments.
devices intended for diagnostic Budget (OMB) under the Paperwork Comments submitted electronically,
radiology. This information Reduction Act of 1995 (44 U.S.C. 3501– including attachments, to https://
supplements the requirements for a 3520). The collections of information in www.regulations.gov will be posted to
510(k) submission found in 21 CFR 807 21 CFR part 807, subpart E have been the docket unchanged. Because your
Subpart E, as well as recommendations approved under OMB control number comment will be made public, you are
provided in other FDA guidance 0910–0120; the collections of solely responsible for ensuring that your
documents concerning the specific information in 21 CFR part 801 have comment does not include any
content of a 510(k) submission. been approved under OMB control confidential information that you or a
FDA considered comments on the number 0910–0485; and the collections third party may not wish to be posted,
sradovich on DSK3GMQ082PROD with NOTICES
draft guidance that appeared in the of information in the guidance entitled such as medical information, your or
Federal Register of February 9, 2016 (81 ‘‘Requests for Feedback on Medical anyone else’s Social Security number, or
FR 6869). FDA revised the guidance as Device Submissions: The Pre- confidential business information, such
appropriate in response to the Submission Program and Meetings with as a manufacturing process. Please note
comments. Food and Drug Administration Staff’’ that if you include your name, contact
This guidance applies to workstation have been approved under OMB control information, or other information that
medical image displays for diagnostic number 0910–0756. identifies you in the body of your
VerDate Sep<11>2014 19:01 Sep 29, 2017 Jkt 244001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\02OCN1.SGM 02OCN1](https://thefederalregister.org/doc/82_FR_46042/page/2.svg)
Document Created: 2017-09-30 04:41:41
Document Modified: 2017-09-30 04:41:41
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | The announcement of the guidance is published in the Federal Register on October 2, 2017. | |
| 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. | |
| FR Citation | 82 FR 45853 |
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