Notice2022-12930
Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff; Availability
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Published
June 16, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 116 (Thursday, June 16, 2022)</title>
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[Federal Register Volume 87, Number 116 (Thursday, June 16, 2022)]
[Notices]
[Pages 36332-36334]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This guidance document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. 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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