Federal Register / Vol. 89, No. 233 / Wednesday, December 4, 2024 / Notices 96259 

IV. Continuation of Policy. Except as 

inconsistent with this reorganization, all 

statements of policy and interpretations 

with respect to organizational 

components affected by this notice 

within ACF, heretofore issued and in 

effect on this date of this reorganization, 

are continued in full force and effect. 

V. Delegation of Authority. All 

delegations and redelegations of 

authority made to officials and 

employees of affected organizational 

components will continue in them or 

their successors pending further 

redelegations, provided they are 

consistent with this reorganization. 

VI. Funds, Personnel, and Equipment. 

Transfer of organizations and functions 

affected by this reorganization shall be 

accompanied in each instance by direct 

and support funds, positions, personnel, 

records, equipment, supplies, and other 

resources. 

Xavier Becerra, 

Secretary, Health and Human Services. 

[FR Doc. 2024–28428 Filed 12–3–24; 8:45 am] 

BILLING CODE 4184–79–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–2628] 

Marketing Submission 

Recommendations for a Predetermined 

Change Control Plan for Artificial 

Intelligence-Enabled Device Software 

Functions; 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, Agency, or we) is 

announcing the availability of a final 

guidance entitled ‘‘Marketing 

Submission Recommendations for a 

Predetermined Change Control Plan for 

Artificial Intelligence-Enabled Device 

Software Functions.’’ This guidance 

demonstrates FDA’s commitment to 

developing innovative approaches to the 

regulation of artificial intelligence (AI)- 

enabled devices. More specifically, this 

guidance provides recommendations on 

the information to include in a 

Predetermined Change Control Plan 

(PCCP) in a marketing submission for a 

device that includes one or more AIenabled device software functions (AI– 

DSFs). This guidance recommends that 

a PCCP describe the planned AI–DSF 

modifications, the associated 

methodology to develop, validate, and 

implement those modifications, and an 

assessment of the impact of those 

modifications. FDA reviews the PCCP as 

part of a marketing submission for a 

device to ensure the continued safety 

and effectiveness of the device without 

necessitating additional marketing 

submissions for implementing each 

modification described in the PCCP. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 4, 2024. 

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– 

2022–D–2628 for ‘‘Marketing 

Submission Recommendations for a 

Predetermined Change Control Plan for 

Artificial Intelligence-Enabled Device 

Software Functions.’’ 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 ‘‘Marketing 


ddrumheller on DSK120RN23PROD with NOTICES1
96260 Federal Register / Vol. 89, No. 233 / Wednesday, December 4, 2024 / Notices 

1Available at https://www.fda.gov/media/ 

122535/download?attachment, and also at FDA’s 

website on ‘‘Artificial Intelligence and Machine 

Learning in Software as a Medical Device,’’ 

available at https://www.fda.gov/medical-devices/ 

software-medical-device-samd/artificialintelligence-and-machine-learning-softwaremedical-device. 

2E.O. 14110 of October 30, 2023, Safe, Secure, 

and Trustworthy Development and Use of Artificial 

Intelligence, available at https://

www.federalregister.gov/d/2023-24283. 

Submission Recommendations for a 

Predetermined Change Control Plan for 

Artificial Intelligence-Enabled Device 

Software Functions’’ to the Office of 

Policy, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5441, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your request. 

FOR FURTHER INFORMATION CONTACT: 

Sonja Fulmer, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5530, Silver Spring, 

MD 20993–0002, 240–402–5979; James 

Myers, Center for Biologics Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 71, Rm. 7301, Silver Spring, 

MD 20993–0002, 240–402–7911; Tala 

Fakhouri, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6330, Silver Spring, 

MD 20993–0002, 301–837–7407; or 

Stephanie Shapley, Office of 

Combination Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5118, Silver Spring, 

MD 20993–0002, 301–796–4836. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA has a longstanding commitment 

to develop and apply innovative 

approaches to the regulation of medical 

device software and other digital health 

technologies to ensure their safety and 

effectiveness. As technology continues 

to advance all facets of healthcare, 

medical software incorporating AI, 

including the subset of AI known as 

machine learning (ML), has become an 

important part of many medical devices. 

In April 2019, FDA published the 

‘‘Proposed Regulatory Framework for 

Modifications to Artificial Intelligence/ 

Machine Learning (AI/ML)-Based 

Software as a Medical Device (SaMD)— 

Discussion Paper and Request for 

Feedback.’’ 1 The 2019 discussion paper 

received a substantial amount of 

feedback from a wide array of interested 

parties that contributed to the 

development of the draft of this 

guidance. 

On December 29, 2022, section 3308 

of the Food and Drug Omnibus Reform 

Act of 2022, Title III of Division FF of 

the Consolidated Appropriations Act, 

2023 (FDORA) (Pub. L. 117–328), added 

section 515C ‘‘Predetermined Change 

Control Plans for Devices’’ to the 

Federal Food, Drug, and Cosmetic 

(FD&C) Act (21 U.S.C. 360e–4). Section 

515C of the FD&C Act has provisions 

regarding PCCPs for devices requiring 

premarket approval (PMA) or premarket 

notification (510(k)). While under the 

FD&C Act FDA may approve or clear a 

PCCP for a variety of devices, this 

guidance provides recommendations 

specifically for PCCPs for AI–DSFs. 

A notice of availability of the draft 

guidance, under the title ‘‘Marketing 

Submission Recommendations for a 

Predetermined Change Control Plan for 

Artificial Intelligence/Machine Learning 

(AI/ML)-Enabled Device Software 

Functions,’’ appeared in the Federal 

Register of April 3, 2023 (88 FR 19648). 

FDA considered comments received and 

revised the guidance as appropriate in 

response to the comments, including the 

title. In this final guidance, FDA 

provides additional clarification 

throughout, including related to the 

scope of the guidance, information 

related to the PCCP to include in 

labeling and publicly available decision 

summaries, implementation of a 

modification to a device consistent with 

an authorized PCCP, and postmarket 

surveillance recommendations. We 

revised the definitions of the terms 

‘‘artificial intelligence’’ and ‘‘machine 

learning’’ to align with definitions in 

Executive Order 14110 of October 30, 

2023.2 In response to comments 

received, we also clarified other 

terminology used in the guidance, 

including clarifications for training, 

tuning, and test data. 

This final guidance represents the 

Agency’s next step in working to 

develop innovative approaches tailored 

to AI-enabled devices. These 

recommendations are based on the 

statutory authorities provided in the 

FD&C Act, including the provisions 

added by FDORA, as well as feedback 

obtained through our various 

interactions with interested parties and 

through public comment on the draft of 

this guidance. The recommendations in 

this guidance are intended to provide a 

forward-thinking approach to promote 

the development of safe and effective 

AI-enabled devices. 

This guidance provides 

recommendations on the information to 

include in a PCCP in a marketing 

submission for a device that includes 

one or more AI–DSFs. The guidance 

recommends that a PCCP describe the 

planned AI–DSF modifications, the 

associated methodology to develop, 

validate, and implement those 

modifications, and an assessment of the 

impact of those modifications. FDA 

reviews the PCCP as part of a marketing 

submission for a device to ensure the 

continued safety and effectiveness of the 

device without necessitating additional 

marketing submissions for 

implementing each modification 

described in the PCCP. 

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 ‘‘Marketing 

Submission Recommendations for a 

Predetermined Change Control Plan for 

Artificial Intelligence-Enabled Device 

Software Functions.’’ 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, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, 

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

biologics-guidances, or https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs. Persons unable to 

download an electronic copy of 

‘‘Marketing Submission 

Recommendations for a Predetermined 

Change Control Plan for Artificial 

Intelligence-Enabled Device Software 

Functions’’ may send an email request 

to CDRH-Guidance@fda.hhs.gov to 

receive an electronic copy of the 

document. Please use the document 

number GUI00020049 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 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 233 / Wednesday, December 4, 2024 / Notices 96261 

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; guidance; or FDA form Topic OMB control No. 

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

814, subparts A through E ...................................................... Premarket approval ................................................................. 0910–0231 

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

‘‘Requests for Feedback and Meetings for Medical Device 

Submissions: The Q-Submission Program’’.

Q-submissions and Early Payor Feedback Request Programs for Medical Devices.0910–0756 

800, 801, 809, and 830 ........................................................... Medical Device Labeling Regulations; Unique Device Identification.0910–0485 

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

822 ........................................................................................... Postmarket Surveillance of Medical Devices .......................... 0910–0449 

50, 56 ....................................................................................... Protection of Human Subjects and Institutional Review 

Boards.

0910–0130 

58 ............................................................................................. Good Laboratory Practice (GLP) Regulations for Nonclinical 

Laboratory Studies.

0910–0119 

Dated: November 25, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–28361 Filed 12–3–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–D–1334] 

Notifying the Food and Drug 

Administration of a Permanent 

Discontinuance in the Manufacture or 

an Interruption of the Manufacture of 

an Infant Formula; Draft Guidance for 

Industry; Availability; Agency 

Information Collection Activities; 

Proposed Collection; Comment 

Request 

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 draft 

guidance for industry entitled 

‘‘Notifying FDA of a Permanent 

Discontinuance in the Manufacture or 

an Interruption of the Manufacture of an 

Infant Formula.’’ Under the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act), a manufacturer of a critical food 

(which includes infant formula) must 

notify FDA of a permanent 

discontinuance or an interruption of the 

manufacture of a critical food that is 

likely to lead to a meaningful disruption 

in the supply of the food in the United 

States. The draft guidance, when 

finalized, is intended to help the infant 

formula industry comply with this 

notification requirement as it pertains to 

infant formula. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by February 18, 2025 to ensure that we 

consider your comment on this draft 

guidance before we begin work on the 

final version of the guidance. Submit 

electronic or written comments on the 

proposed collection of information in 

the draft guidance by February 3, 2025. 

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– 

2024–D–1334 for ‘‘Notifying FDA of a 

Permanent Discontinuance in the 

Manufacture or an Interruption of the 

Manufacture of an Infant Formula.’’ 

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.’’ We 

will review this copy, including the 

claimed confidential information, in our 

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 


ddrumheller on DSK120RN23PROD with NOTICES1