[Federal Register Volume 84, Number 76 (Friday, April 19, 2019)]
[Notices]
[Pages 16517-16519]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07936]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-1470]


Technical Performance Assessment of Quantitative Imaging in 
Premarket Device Submissions; Draft Guidance for Industry and Food and 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the availability of the draft guidance entitled ``Technical Performance 
Assessment of Quantitative Imaging in Premarket Device Submissions.'' 
This draft guidance document provides recommendations on the 
information that should be included in premarket submissions for 
devices that include quantitative imaging functions. This draft 
guidance is not final nor is it in effect at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by June 18, 2019 to ensure that the

[[Page 16518]]

Agency considers your comment on this draft guidance before it begins 
work on the final version of the guidance.

ADDRESSES: You may submit comments on any guidance 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-2019-D-1470 for ``Technical Performance Assessment of Quantitative 
Imaging in Premarket Device Submissions.'' Received 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.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://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 draft guidance document entitled 
``Technical Performance Assessment of Quantitative Imaging in Premarket 
Device Submissions'' to the Office of Policy, 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: Dina Jerebitski, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002, 301-
796-2411.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance document provides recommendations on the 
information that should be included in premarket submissions for 
devices that include quantitative imaging functions. Medical imaging is 
used routinely in hospitals and clinics to assist with the diagnosis 
and management of patients with a variety of diseases and conditions, 
by providing visual representations of the internal structures of the 
body. Most medical images are acquired with the intention of 
qualitative interpretation by a trained physician to identify the 
presence or absence of a structure or feature. Quantitative imaging 
extracts additional information from medical images in the form of 
numerical values.
    This draft guidance document is applicable to all devices that 
generate quantitative imaging values across a wide range of imaging 
modalities, intended uses, levels of automation, and complexity of 
algorithm. For the purpose of this document, FDA considers quantitative 
imaging values to be objective characteristics measured on a ratio or 
interval scale; that is, measured parameters derived from medical 
images that have physical meaning.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Technical 
Performance Assessment of Quantitative Imaging in Premarket Device 
Submissions.'' 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 draft 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. This 
guidance document is also available at https://www.regulations.gov. 
Persons

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unable to download an electronic copy of ``Technical Performance 
Assessment of Quantitative Imaging in Premarket Device Submissions'' 
may send an email request to [email protected] to receive an 
electronic copy of the document. Please use the document number 18017 
to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information. 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 
the following FDA regulations and guidances have been approved by OMB 
as listed in the following table:

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  21 CFR Part; guidance; or FDA                             OMB Control
              form                         Topic                No.
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807, subpart E..................  Premarket notification       0910-0120
814, subparts A through E.......  Premarket approval....       0910-0231
814, subpart H..................  Humanitarian Device          0910-0332
                                   Exemption.
812.............................  Investigational Device       0910-0078
                                   Exemption.
``De Novo Classification Process  De Novo classification       0910-0844
 (Evaluation of Automatic Class    process.
 III Designation)''.
``Requests for Feedback on        Q-submissions.........       0910-0756
 Medical Device Submissions: The
 Pre-Submission Program and
 Meetings with Food and Drug
 Administration Staff''.
800, 801, and 809...............  Medical Device               0910-0485
                                   Labeling Regulations.
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    Dated: April 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07936 Filed 4-18-19; 8:45 am]
BILLING CODE 4164-01-P