67308 Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices 

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 


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices 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-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-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 CDRH-Guidance@fda.hhs.gov 

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: 

21 CFR part or guidance Topic OMB control 

No. 

800, 801, and 809 ....................................................................... Medical Device Labeling Regulations ........................................ 0910–0485 

807, subpart E ............................................................................ Premarket notification ................................................................ 0910–0120 

820 .............................................................................................. Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation.0910–0073 

‘‘Requests for Feedback and Meetings for Medical Device 

Submissions: The Q-Submission Program’’.

Q-submissions; Pre-submissions ............................................... 0910–0756 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–D–3788] 

Electronic Submission Template for 

Medical Device De Novo Requests; 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the draft 

guidance entitled ‘‘Electronic 

Submission Template for Medical 

Device De Novo Requests.’’ FDA is 

issuing this draft guidance to introduce 

submitters of De Novo requests to the 

Center for Devices and Radiological 

Health (CDRH) and Center for Biologics 

Evaluation and Research (CBER) to the 

current resources and associated content 

developed and made publicly available 


lotter on DSK11XQN23PROD with NOTICES1