[Federal Register Volume 88, Number 188 (Friday, September 29, 2023)]
[Notices]
[Pages 67308-67309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-21407]



[[Page 67308]]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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:
     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-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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 
``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 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 and https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 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 [email protected] 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:

------------------------------------------------------------------------
                                                            OMB control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
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''.
------------------------------------------------------------------------


    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