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 


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67310 Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices 

1See section 513(f)(2) of the FD&C Act (21 U.S.C. 

360c(f)(2)) and 21 CFR part 860, subpart D. 

2See 163 CONG. REC. S4729–S4736 (daily ed. 

August 2, 2017) (Food and Drug Administration 

User Fee Reauthorization), also available at https:// 

www.fda.gov/media/102699/download, and 168 

CONG. REC. S5194–S5203 (daily ed. September 28, 

2022) (Food and Drug Administration User Fee 

Reauthorization), also available at https://

www.fda.gov/media/158308/download and 168 

CONG. REC. S5194–S5203 (daily ed. September 28, 

2022) (Food and Drug Administration User Fee 

Reauthorization), also available at https://

www.fda.gov/media/158308/download. 

3https://www.govinfo.gov/content/pkg/PLAW115publ52/html/PLAW-115publ52.htm. 

to support De Novo electronic 

submissions to FDA. This draft 

guidance, when finalized, is intended to 

represent one of several steps in meeting 

FDA’s commitment to the development 

of electronic submission templates to 

serve as guidance submission 

preparation tools for industry to 

improve submission consistency and 

enhance efficiency in the review 

process. This draft guidance is not final 

nor is it for implementation at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by November 28, 2023 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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–3788 for ‘‘Electronic 

Submission Template for Medical 

Device De Novo Requests.’’ 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 draft guidance 

document entitled ‘‘Electronic 

Submission Template for Medical 

Device De Novo Requests’’ 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 selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Rebecca Nipper, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1540, Silver Spring, 

MD 20993–0002, 301–796–6527 or 

Anne Taylor, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993, 240–402– 

7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is issuing this draft guidance 

document to introduce submitters of De 

Novo requests 1 to CDRH and CBER to 

the current resources and associated 

content developed and made publicly 

available to support De Novo electronic 

submissions to FDA. This draft 

guidance is intended to represent one of 

several steps in meeting FDA’s 

commitment to the development of 

electronic submission templates to serve 

as guided submission preparation tools 

for industry to improve submission 

consistency and enhance efficiency in 

the review process.2 When finalized, 

this guidance will also facilitate the 

implementation of the FDA’s mandate 

under section 745A(b) of the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) (21 U.S.C. 379k–1(b)), amended by 

section 207 of the FDA Reauthorization 

Act of 2017 (FDARA) (Pub. L. 115–52 3) 

to provide further standards for the 

submission by electronic format, a 

timetable for establishment of these 

further standards, and criteria for 

waivers of and exemptions from the 

requirements. 


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Federal Register / Vol. 88, No. 188 / Friday, September 29, 2023 / Notices 67311 

4https://www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/providingregulatory-submissions-medical-devices-electronicformat-submissions-under-section-745ab. 

FDA’s guidance document ‘‘Providing 

Regulatory Submissions for Medical 

Devices in Electronic Format— 

Submissions Under Section 745A(b) of 

the Federal Food, Drug, and Cosmetic 

Act’’ 4 (hereafter referred to as the 

‘‘745A(b) device parent guidance’’) 

provides a process for the development 

of templates to facilitate the preparation, 

submission, and review of regulatory 

submissions for medical devices solely 

in electronic format. As described in the 

745A(b) device parent guidance, FDA 

plans to implement the requirements of 

section 745A(b)(3) of the FD&C Act with 

individual guidances specifying the 

formats for specific submissions and 

corresponding timetables for 

implementation. When finalized, this 

guidance will provide such information 

for De Novo electronic submissions 

solely in electronic format. 

In section 745A(b) of the FD&C Act, 

Congress granted explicit statutory 

authorization to FDA to specify in 

guidance the statutory requirement for 

electronic submissions solely in 

electronic format by providing 

standards, a timetable, and criteria for 

waivers and exemptions. To the extent 

that this draft guidance provides such 

requirements under section 745A(b)(3) 

of the FD&C Act (i.e., standards, 

timetable, criteria for waivers of and 

exemptions), indicated by the use of the 

mandatory words, such as must or 

required, this document is not subject to 

the usual restrictions in FDA’s good 

guidance practice regulations, such as 

the requirement that guidances not 

establish legally enforceable 

responsibilities (see § 10.115(d) (21 CFR 

10.115(d)).) To the extent that this draft 

guidance describes recommendations 

that are not standards, timetable, criteria 

for waivers of, or exemptions under 

section 745A(b)(3) of the FD&C Act, it 

is being issued consistent with FDA’s 

good guidance practices regulation 

(§ 10.115). 

The draft guidance, when finalized, 

will represent the current thinking of 

FDA on this topic. 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. This draft 

guidance, when finalized, will contain 

both binding and nonbinding 

provisions. 

II. Electronic Access 

Persons interested in obtaining a copy 

of the draft 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, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents or 

https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics. 

Persons unable to download an 

electronic copy of ‘‘Electronic 

Submission Template for Medical 

Device De Novo Requests’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number GUI00021027 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. 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 Topic OMB control No. 

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

860, subpart D ......................................................................... De Novo classification process ............................................... 0910–0844 

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

Dated: September 25, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–21405 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–N–2781] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Data To Support 

Drug Product Communications as 

Used by the Food and Drug 

Administration 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on a generic 

clearance to collect information to 

support communications used by FDA 

about drug products. 

DATES: Either electronic or written 

comments on the collection of 

information must be submitted by 

November 28, 2023. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

November 28, 2023. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are received 

on or before that date. 

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 


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