1154 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 

Dated: December 26, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–31547 Filed 1–6–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–D–4488] 

Artificial Intelligence-Enabled Device 

Software Functions: Lifecycle 

Management and Marketing 

Submission Recommendations; 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 ‘‘Artificial Intelligence 

Enabled Device Software Functions: 

Lifecycle Management and Marketing 

Submission Recommendations.’’ This 

draft guidance, when finalized, will 

provide recommendations regarding the 

contents of marketing submissions for 

devices that include artificial 

intelligence (AI)-enabled device 

software functions including 

documentation and information that 

will support FDA’s evaluation of safety 

and effectiveness. To support the 

development of appropriate 

documentation for FDA’s assessment of 

the device, this draft guidance also 

proposes recommendations for the 

design, development, and 

implementation of AI-enabled devices 

that sponsors may wish to consider 

using throughout the total product 

lifecycle (TPLC). This draft guidance is 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written comments on the draft guidance 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 April 7, 2025 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draft guidance before it begins work on 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– 

2024–D–4488 for ‘‘Artificial 

Intelligence-Enabled Device Software 

Functions: Lifecycle Management and 

Marketing Submission 

Recommendations.’’ 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 ‘‘Artificial 

Intelligence-Enabled Device Software 

Functions: Lifecycle Management and 

Marketing Submission 

Recommendations’’ 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: 

Sonja Fulmer, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5536, Silver Spring, 

MD 20993–0002, 240–402–5979; or 

James Myers, 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; or Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 1155 

Ave., Hillandale Bldg., 4th Floor, Silver 

Spring, MD 20993–0002, 301–796–3400. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA has long promoted a TPLC 

approach to oversight of medical 

devices, including AI-enabled devices, 

and has committed to developing 

guidances and resources for such an 

approach. Some recent efforts include 

developing guiding principles for good 

machine learning practice (GMLP) and 

transparency for machine learningenabled devices to help promote safe, 

effective, and high-quality machine 

learning models; and a public workshop 

on fostering a patient-centered approach 

to AI-enabled devices, including 

discussion of device transparency for 

users. This draft guidance intends to 

continue these efforts, by proposing 

recommendations tailored to a TPLC 

approach for AI-enabled devices. This 

draft guidance, when finalized, will 

provide recommendations regarding the 

contents of marketing submissions for 

devices that include AI-enabled device 

software functions including 

documentation and information that 

will support FDA’s evaluation of safety 

and effectiveness. The 

recommendations reflect a 

comprehensive approach to the 

management of risk throughout the 

device TPLC. To support the 

development of appropriate 

documentation for FDA’s assessment of 

the device, this draft guidance also 

proposes recommendations for the 

design, development, and 

implementation of AI-enabled devices 

that manufacturers may wish to 

consider using throughout the TPLC. 

This draft guidance, when finalized, 

also will include FDA’s current thinking 

on strategies to address transparency 

and bias throughout the TPLC of AIenabled devices, including by collecting 

evidence to evaluate whether a device 

benefits all relevant demographic 

groups (e.g., race, ethnicity, sex, and 

age) similarly, to help ensure that these 

devices remain safe and effective for 

their intended use. These 

interconnected considerations are 

important throughout the TPLC and 

should be incorporated from the earliest 

stages of device development through 

decommission to help design 

transparency into the device. Finally, 

this draft guidance proposes 

recommendations that address the 

performance of AI-enabled devices in 

the postmarket setting. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Artificial Intelligence Enabled 

Device Software Functions: Lifecycle 

Management and Marketing Submission 

Recommendations.’’ 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. Other Considerations 

The recommendations discussed 

within the document are based upon 

FDA’s experience with reviewing a 

diversity of AI-enabled devices and 

current regulatory science research. 

However, FDA understands that the 

development of AI is an evolving field, 

with experts from many different sectors 

that can contribute to the development 

of AI-enabled devices. FDA requests 

public comment from all interested 

stakeholders on the following items: 

• How well the proposed 

recommendations align with the AI 

lifecycle. 

• The adequacy of the recommended 

documentation to be included in a 

marketing submission to address 

concerns that may be raised with AIenabled devices that use emerging 

technology, such as generative AI. 

• The proposed approach to 

performance monitoring, including use 

of a performance monitoring plan as a 

means of risk mitigation for AI-enabled 

devices. 

• The proposed approach to the type 

of information that should be conveyed 

to users about AI-enabled devices, 

including the example model card. 

III. 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 ‘‘Artificial 

Intelligence Enabled Device Software 

Functions: Lifecycle Management and 

Premarket Submission 

Recommendations’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number GUI00007028 and complete 

title to identify the guidance you are 

requesting. 

IV. 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 (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 

814, subpart H ............................................................................ Humanitarian Use Devices; Humanitarian Device Exemption .. 0910–0332 

812 .............................................................................................. Investigational Device Exemption .............................................. 0910–0078 

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 

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

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


ddrumheller on DSK120RN23PROD with NOTICES1
1156 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 

Dated: December 27, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–31543 Filed 1–6–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2019–D–2648] 

Heritable Intentional Genomic 

Alterations in Animals: The Approval 

Process; Guidance for Industry; 

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 a final 

guidance for industry #187B entitled 

‘‘Heritable Intentional Genomic 

Alterations in Animals: The Approval 

Process.’’ This guidance clarifies FDA’s 

requirements and recommendations for 

developers of intentional genomic 

alterations (IGAs) in animals. The 

guidance is one of two companion 

documents. ‘‘Heritable Intentional 

Genomic Alterations in Animals: The 

Approval Process’’ describes how the 

FDA approval process applies to 

heritable IGAs in animals. The 

companion final guidance, GFI #187A 

entitled ‘‘Heritable Intentional Genomic 

Alterations in Animals: Risk-Based 

Approach,’’ describes FDA’s risk-based 

regulatory approach to the oversight of 

heritable IGAs in animals. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on January 7, 2025. 

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– 

2019–D–2648 for ‘‘Heritable Intentional 

Genomic Alterations in Animals: The 

Approval Process.’’ 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)). 

Submit written requests for single 

copies of the guidance to the Policy and 

Regulations Staff, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Adam Moyer, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–796–2319, 

Adam.Moyer@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On May 2, 2024, FDA announced in 

the Federal Register the availability of 

two companion guidances to describe 

FDA’s approach to regulating IGAs in 

animals. The notice of availability of the 

first of these two guidances, final GFI 

#187A, entitled ‘‘Heritable Intentional 

Genomic Alterations in Animals: RiskBased Approach’’ (89 FR 35832), 

describes FDA’s risk-based approach to 

the oversight of IGAs in animals. 

The second companion IGA guidance, 

draft GFI #187B entitled ‘‘Heritable 

Intentional Genomic Alterations in 

Animals: The Approval Process’’ (89 FR 

35834), describes how the FDA approval 

process applies to heritable IGAs in 

animals. Interested parties had until 

July 31, 2024, to comment on the draft 

guidance. 

FDA received approximately 5,000 

comments on draft GFI #187B, with 

4,982 of them resulting from two writein campaigns. Those campaigns 


ddrumheller on DSK120RN23PROD with NOTICES1