Notice2023-21407
Antimicrobial Susceptibility Test System Devices-Updating Breakpoints in Device Labeling; Guidance for Industry; Availability
Primary source
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Published
September 29, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry and FDA staff entitled "Antimicrobial Susceptibility Test (AST) System Devices--Updating Breakpoints in Device Labeling." This guidance is intended to provide industry and FDA staff with information regarding updating susceptibility test interpretative criteria (STIC)/breakpoints and associated performance data in device labeling for antimicrobial susceptibility test (AST) system devices in response to breakpoint changes posted on the FDA-Recognized Antimicrobial Susceptibility Test Interpretative Criteria website (STIC website). This guidance is expected to facilitate the timely adoption of updated breakpoints in AST system devices, which helps to ensure device safety and effectiveness.
Full Text
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<title>Federal Register, Volume 88 Issue 188 (Friday, September 29, 2023)</title>
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[Federal Register Volume 88, Number 188 (Friday, September 29, 2023)]
[Notices]
[Pages 67308-67309]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-21407]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-4045]
Antimicrobial Susceptibility Test System Devices--Updating
Breakpoints in Device Labeling; Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
availability of a final guidance for industry and FDA staff entitled
``Antimicrobial Susceptibility Test (AST) System Devices--Updating
Breakpoints in Device Labeling.'' This guidance is intended to provide
industry and FDA staff with information regarding updating
susceptibility test interpretative criteria (STIC)/breakpoints and
associated performance data in device labeling for antimicrobial
susceptibility test (AST) system devices in response to breakpoint
changes posted on the FDA-Recognized Antimicrobial Susceptibility Test
Interpretative Criteria website (STIC website). This guidance is
expected to facilitate the timely adoption of updated breakpoints in
AST system devices, which helps to ensure device safety and
effectiveness.
DATES: The announcement of the guidance is published in the Federal
Register on September 29, 2023.
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.''
Instructions: All submissions received must include the Docket No.
FDA-2023-D-4045 for ``Antimicrobial Susceptibility Test (AST) System
Devices--Updating Breakpoints in Device Labeling.'' 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
``Antimicrobial Susceptibility Test (AST) System Devices--Updating
Breakpoints in Device Labeling'' to the Office of Policy, Center of
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 requests.
FOR FURTHER INFORMATION CONTACT: Ribhi Shawar, Center for Devices and
Radiological Health, 10903 New Hampshire Ave., Bldg. 66, Rm. 3218,
Silver Spring, MD 20993-0002, 301-796-6698.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry and
FDA staff entitled ``Antimicrobial Susceptibility Test (AST) System
Devices--Updating Breakpoints in Device Labeling.'' We are issuing this
guidance consistent with our good guidance practices (GGP) regulation
(21 CFR 10.115). We are implementing this guidance without prior public
comment because we have determined that prior public participation is
not feasible or appropriate (see 21 CFR 10.115(g)(2) and section
701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
371(h)(1)(C)(i))). Specifically, we are not seeking prior comment
because the guidance presents a less burdensome policy consistent with
the public health and the urgent public health need for sponsors to
update breakpoints for legacy AST system devices. Although
[[Page 67309]]
this guidance document is immediately in effect, it remains subject to
comment in accordance with FDA's GGP regulation.
AST system devices are intended to determine the in vitro
susceptibility of bacterial or fungal pathogens to different
antimicrobial agents. Accurate results are essential for guiding the
treatment of infections by clinicians and for monitoring the spread of
antimicrobial resistant microorganisms. Generally, healthcare
professionals rely on AST system devices to help choose an appropriate
treatment, as STIC (also referred to as breakpoints) are the criteria
used to interpret AST results.
Section 3044 of the 21st Century Cures Act, signed into law on
December 13, 2016, added section 511A (21 U.S.C. 360a-2),
``Susceptibility Test Interpretive Criteria for Microorganisms,'' to
the Federal Food, Drug, and Cosmetic Act and authorizes FDA to
recognize, in whole or in part, a consensus standard that provides
antimicrobial STIC or establish alternative STIC, and requires FDA to
establish and maintain a dedicated website that contains a list of any
appropriate new or updated STIC and standards.
This guidance describes approaches for AST system device sponsors
to adopt updated breakpoints recognized on the STIC website (FDA-
Recognized Antimicrobial Susceptibility Test Interpretative Criteria)
and associated performance data in device labeling to facilitate the
timely availability of devices with the most up-to-date STIC for
patient care and public health. FDA believes that this guidance
presents less burdensome approaches for AST system device sponsors to
utilize predetermined change control plans (PCCPs) and breakpoint
change protocols to update their device labeling to include adoption of
updated breakpoints recognized on FDA's STIC website in a timely manner
while helping to ensure device safety and effectiveness. This guidance
provides recommendations on the marketing submission content for PCCPs
for new AST system devices, describes an enforcement policy regarding
applying such updates to ``legacy'' AST system devices (AST system
devices that were reviewed and cleared by FDA and did not include a
breakpoint change protocol), and clarifies the process for
incorporating by reference a cleared PCCP or breakpoint change protocol
into a new 510(k) submission for an AST system device.
This guidance supersedes Sections II.A and V of Updating Labeling
for Susceptibility Test Information in Systemic Antibacterial Drug
Products and Antimicrobial Susceptibility Testing Devices (June 2009).
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 ``Antimicrobial Susceptibility Test (AST)
System Devices--Updating Breakpoints in Device Labeling.'' 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> and <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 ``Antimicrobial Susceptibility Test
(AST) System Devices--Updating Breakpoints in Device Labeling'' may
send an email request to <a href="/cdn-cgi/l/email-protection#71323523395c36041815101f1214311715105f1919025f161e07"><span class="__cf_email__" data-cfemail="145750465c3953617d70757a7771547270753a7c7c673a737b62">[email protected]</span></a> to receive an
electronic copy of the document. Please use the document number
GUI00007019 and complete title to identify the guidance you are
requesting.
III. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in the following table have been approved by OMB:
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OMB control
21 CFR part or guidance Topic No.
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800, 801, and 809.............. Medical Device Labeling 0910-0485
Regulations.
807, subpart E................. Premarket notification. 0910-0120
820............................ Current Good 0910-0073
Manufacturing Practice
(CGMP); Quality System
(QS) Regulation.
``Requests for Feedback and Q-submissions; Pre- 0910-0756
Meetings for Medical Device submissions.
Submissions: The Q-Submission
Program''.
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Dated: September 25, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-21407 Filed 9-28-23; 8:45 am]
BILLING CODE 4164-01-P
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