[Federal Register Volume 87, Number 116 (Thursday, June 16, 2022)]
[Notices]
[Pages 36332-36334]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12930]


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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 
Radiological Device Premarket Submissions; 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 a final guidance entitled ``Technical Performance 
Assessment of Quantitative Imaging in Radiological Device Premarket 
Submissions.'' FDA is issuing this guidance to provide recommendations 
for manufacturers about the information that should be included in 
premarket submissions for radiological devices that include 
quantitative imaging functions. This guidance document is broadly 
applicable to a variety of premarket submission types (i.e., premarket 
approval applications (PMAs), humanitarian device exemption (HDE) 
applications, premarket notification (510(k)) submissions, 
investigational device exemption (IDE) applications, and De Novo 
requests) for these devices and should be used in conjunction with 
existing device- and submission-specific guidance documents.

DATES: The announcement of the guidance is published in the Federal 
Register on June 16, 2022.

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.''

[[Page 36333]]

    Instructions: All submissions received must include the Docket No. 
FDA-2019-D-1470 for ``Technical Performance Assessment of Quantitative 
Imaging in Radiological Device Premarket 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, 240-402-7500.
    <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.govinfo.gov/content/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, 240-402-7500.
    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 
``Technical Performance Assessment of Quantitative Imaging in 
Radiological Device Premarket Submissions'' to the Office of Policy, 
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: Jana Delfino, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 62, Rm. 3116, Silver Spring, MD 20993-0002, 301-796-6503.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is issuing this guidance to provide recommendations for 
manufacturers about the information that should be included in 
premarket submissions for radiological devices that include 
quantitative imaging functions. This guidance document is broadly 
applicable to a variety of premarket submission types (i.e., PMAs, HDE 
applications, 510(k) submissions, IDE applications, and De Novo 
requests) for these devices and should be used in conjunction with 
existing device- and submission-specific guidance documents.
    This guidance document clarifies that, in general, manufacturers 
preparing premarket submissions for radiological devices that include 
quantitative imaging functions should provide performance 
specifications for the quantitative imaging functions, supporting 
performance data to demonstrate that the quantitative imaging functions 
meet those performance specifications, and sufficient information for 
the end user to obtain, understand, and interpret the values provided 
by the quantitative imaging functions.
    A notice of availability of the draft guidance appeared in the 
Federal Register of April 19, 2019 (84 FR 16517). FDA considered 
comments received and revised the guidance as appropriate in response 
to the comments, including clarification in scope that the guidance is 
intended to provide recommendations for radiological devices with 
quantitative imaging functions, and other technical clarifications.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on technical performance assessment of 
quantitative imaging in radiological device premarket 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.

II. 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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to 
download an electronic copy of ``Technical Performance Assessment of 
Quantitative Imaging in Radiological Device Premarket Submissions'' may 
send an email request to <a href="/cdn-cgi/l/email-protection#cd8e899f85e08ab8a4a9aca3aea88daba9ace3a5a5bee3aaa2bb"><span class="__cf_email__" data-cfemail="a6e5e2f4ee8be1d3cfc2c7c8c5c3e6c0c2c788ceced588c1c9d0">[email protected]</span></a> to receive an 
electronic copy of the document. Please use the document number 18017 
and complete title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it 
does refer to previously approved FDA collections of information. 
Therefore, clearance by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in the following FDA regulations and guidance have been 
approved by OMB as listed in the following table:

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                                                            OMB control
      21 CFR part or guidance               Topic               No.
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807, subpart E....................  Premarket                  0910-0120
                                     notification.

[[Page 36334]]

 
814, subparts A through E.........  Premarket approval..       0910-0231
814, subpart H....................  Humanitarian Device        0910-0332
                                     Exemption.
812...............................  Investigational            0910-0078
                                     Device Exemption.
``De Novo Classification Process    De Novo                    0910-0844
 (Evaluation of Automatic Class      classification
 III Designation)''.                 process.
``Requests for Feedback and         Q-submissions; pre-        0910-0756
 Meetings for Medical Device         submissions.
 Submissions: The Q-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: June 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12930 Filed 6-15-22; 8:45 am]
BILLING CODE 4164-01-P


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