Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 1161 

of the applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

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 

section 910(c)(1)(A)(i) of the FD&C Act 

have been approved under OMB control 

number 0910–0768; the collections of 

information in section 905(j) of the 

FD&C Act (21 U.S.C. 387e(j)) have been 

approved under OMB control number 

0910–0673; the collections of 

information in 21 CFR part 1107 have 

been approved under OMB control 

number 0910–0684; the collections of 

information in section 904(a)(3) of the 

FD&C Act have been approved under 

OMB control number 0910–0732, and 

the collections of information in 21 CFR 

part 1114 have been approved under 

OMB control number 0910–0879. 

III. Electronic Access 

Persons with access to the internet 

may obtain an electronic version of the 

guidance at https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, https://

www.fda.gov/tobacco-products/rulesregulations-and-guidance-relatedtobacco-products/guidance-relatedtobacco-products, or https:// 

www.regulations.gov. 

Dated: December 26, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–31541 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–2023–D–5591] 

Evaluation of Sex-Specific and GenderSpecific Data in Medical Device 

Clinical Studies; Draft Guidance for 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 ‘‘Evaluation of SexSpecific and Gender-Specific Data in 

Medical Device Clinical Studies.’’ This 

document provides guidance on the 

study and evaluation of sex- and/or 

gender-specific data in clinical 

investigations or research involving one 

or more subjects to determine the safety 

or effectiveness of a device. The purpose 

of this guidance is to encourage sciencedriven consideration of sex and/or 

gender, as appropriate for both the 

scientific question being addressed and 

the intended use of the device, when 

designing medical device clinical 

studies and reporting data from such 

studies in accordance with legal 

requirements. 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– 

2023–D–5591 for ‘‘Evaluation of SexSpecific and Gender-Specific Data in 

Medical Device Clinical Studies.’’ 

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)). 


ddrumheller on DSK120RN23PROD with NOTICES1
1162 Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 

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 ‘‘Evaluation of SexSpecific and Gender-Specific Data in 

Medical Device Clinical Studies’’ 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: 

Terri Cornelison, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5516, Silver Spring, 

MD 20993–0002, 301–796–5682; 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. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Recognition of the importance of sexand gender-specific considerations has 

been steadily growing in areas such as 

medical technology design and 

development, including clinical study 

design, and assessing product 

performance throughout the total 

product life cycle and other medical 

device-related matters. Sex and gender 

are key considerations in the 

development and performance of 

medical devices. Although there has 

been steady growth in the recognition of 

sex- and gender-considerations in 

medical technology design and 

development, it is important to 

understand that this was not always the 

case. Historically, females and/or 

women have been under-represented in 

or excluded from many clinical studies. 

This has led to a lack of information 

available for females and/or women and 

their health care providers regarding the 

benefits and risks of many medical 

devices. Further, individuals with 

intersex traits and those with 

differences in sex development may 

have not been properly included within 

clinical studies. In addition, 

historically, as gender was often 

conflated with sex or otherwise not 

properly reported in clinical studies, 

there is a lack of data regarding the 

underrepresentation of nonbinary, 

transgender, fluid gender identities and 

other gender identities. 

Given these historical concerns and 

the growing recognition of the 

importance of sex- and gender-specific 

considerations in medical technology 

design and development, it is important 

that a medical device be developed and 

evaluated with study participants that 

represent the demographic, clinical, and 

disease characteristics of the intended 

population. The purpose of this draft 

guidance is to encourage science-driven 

consideration of sex and/or gender. 

Upon finalization, this document will 

update the policy reflected in the 

existing guidance entitled ‘‘Evaluation 

of Sex-Specific Data in Medical Device 

Clinical Studies’’ by addressing both 

sex- and gender-specific data and will 

replace the existing guidance. As such, 

the recommendations within the 

guidance have been updated to help 

sponsors consider sex- and/or genderspecific data, as appropriate for the 

scientific questions being addressed and 

the intended use of the device, when 

designing medical device clinical 

studies and reporting data from such 

studies in accordance with legal 

requirements. The guidance provides 

recommendations for sponsors to 

consider sex- and/or gender-specific 

data throughout the clinical study 

process. This includes updated 

recommendations for clinical study 

design, study participant enrollment, 

data collection and analysis, and 

reporting of study information for sexspecific data, gender-specific data, or 

both, according to the scientific 

question at hand. 

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 ‘‘Evaluation of Sex-Specific and 

Gender-Specific Data in Medical Device 

Clinical Studies.’’ 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 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 ‘‘Evaluation of SexSpecific and Gender-Specific Data in 

Medical Device Clinical Studies’’ may 

send an email request to CDRHGuidance@fda.hhs.gov to receive an 

electronic copy of the document. Please 

use the document number GUI00001727 

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 or guidance Topic OMB control No. 

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

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

814, subpart H ............................................................................................................ Humanitarian Device Exemption 0910–0332 

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

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

‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission 

Program and Meetings with Food and Drug Administration Staff’’.

Q-submissions ............................ 0910–0756 

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

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


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices 1163 

21 CFR Part or guidance Topic OMB control No. 

50, 56 .......................................................................................................................... Protection of Human Subjects 

and Institutional Review 

Boards.

0910–0130 

Dated: December 26, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–31526 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–2021–N–0553] 

Evaluating the Public Health 

Importance of Food Allergens Other 

Than the Major Food Allergens Listed 

in the Federal Food, Drug, and 

Cosmetic Act; Guidance for FDA Staff 

and Interested Parties; 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 FDA staff and interested 

parties entitled ‘‘Evaluating the Public 

Health Importance of Food Allergens 

Other Than the Major Food Allergens 

Listed in the Federal Food, Drug, and 

Cosmetic Act.’’ This guidance document 

provides our current thinking on the 

approach we generally intend to take 

when we evaluate the public health 

importance of a food allergen other than 

one of the major food allergens (i.e., 

milk, eggs, fish, Crustacean shellfish, 

tree nuts, wheat, peanuts, soybean, and 

sesame) listed in the Federal Food, 

Drug, and Cosmetic Act (FD&C Act). 

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 FDA 

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– 

2021–N–0553 for ‘‘Evaluating the Public 

Health Importance of Food Allergens 

Other Than the Major Food Allergens 

Listed in the Federal Food, Drug, and 

Cosmetic Act.’’ 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 

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 Division of 

Chemical Contaminants, Office of PostMarket Assessment, Human Foods 

Program, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740. Send two selfaddressed adhesive labels to assist that 

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Stefano Luccioli, Office of Post-Market 

Assessment, Human Foods Program, 

Food and Drug Administration, 5001 

Campus Dr., College Park, MD 20740, 

240–402–1283; or Alexandra Beliveau, 

Office of Policy, Regulations, and 

Information, Human Foods Program, 

Food and Drug Administration, 5001 

Campus Dr., College Park, MD 20740, 

240–402–2378. 

SUPPLEMENTARY INFORMATION: 


ddrumheller on DSK120RN23PROD with NOTICES1