Federal Register / Vol. 88, No. 173 / Friday, September 8, 2023 / Notices 62091 

Developing Drugs for Treatment.’’ 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. 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 21 CFR part 312 relating 

to the submissions of investigational 

new drug applications have been 

approved under OMB control number 

0910–0014. The collections of 

information in 21 CFR part 314 relating 

to the submissions of new drug 

applications and abbreviated new drug 

applications have been approved under 

OMB control number 0910–0001. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

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

guidances-drugs, https://www.fda.gov/ 

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

www.regulations.gov. 

Dated: September 5, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19419 Filed 9–7–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–0350] 

Use of International Standard ISO 

10993–1, ‘‘Biological Evaluation of 

Medical Devices—Part 1: Evaluation 

and Testing Within a Risk Management 

Process’’; 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 a final 

guidance entitled ‘‘Use of International 

Standard ISO 10993–1, ‘Biological 

evaluation of medical devices—Part 1: 

Evaluation and testing within a risk 

management process’.’’ This guidance 

was revised to incorporate updates to 

FDA’s current thinking regarding the 

type of biocompatibility information 

that should be provided in a premarket 

submission for certain devices made 

from common polymers and fabrics that 

are in contact with intact skin. The 

purpose of this guidance is to provide 

further clarification and updated 

information on the use of International 

Standard ISO 10993–1, ‘‘Biological 

evaluation of medical devices—Part 1: 

Evaluation and testing within a risk 

management process’’ to support 

premarket approval applications 

(PMAs), humanitarian device 

exemptions (HDEs), investigational 

device exemption (IDE) applications, 

premarket notifications (510(k)s), and 

De Novo requests. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 8, 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– 

2013–D–0350 for ‘‘Use of International 

Standard ISO 10993–1, ‘Biological 

evaluation of medical devices—Part 1: 

Evaluation and testing within a risk 

management 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 


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62092 Federal Register / Vol. 88, No. 173 / Friday, September 8, 2023 / Notices 

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 ‘‘Use of International 

Standard ISO 10993–1, ‘Biological 

evaluation of medical devices—Part 1: 

Evaluation and testing within a risk 

management process’ ’’ 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; or to the Office of 

Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

request. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer Goode, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 1656, Silver Spring, 

MD 20993–0002, 301–796–5701; 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 

On September 4, 2020, FDA issued a 

guidance entitled ‘‘Use of International 

Standard ISO 10993–1, ‘Biological 

evaluation of medical devices—Part 1: 

Evaluation and testing within a risk 

management process’ ’’ (‘‘2020 

Biocompatibility Guidance’’). The 2020 

Biocompatibility Guidance was 

developed to assist industry with PMAs, 

HDEs, IDEs, 510(k)s, and De Novo 

requests for medical devices that come 

into direct contact or indirect contact 

with the human body to determine the 

potential for an unacceptable adverse 

biological response resulting from 

contact of the component materials of 

the device with the body. 

On October 15, 2020, FDA issued a 

draft guidance entitled ‘‘Select Updates 

for Biocompatibility of Certain Devices 

in Contact with Intact Skin’’ (the Select 

Updates Guidance) which proposed 

updates to the 2020 Biocompatibility 

Guidance regarding the type of 

biocompatibility information that 

should be provided in a premarket 

submission for certain devices made 

from common synthetic polymers and 

natural fabrics that are in contact with 

intact skin. A notice of availability of 

the draft guidance appeared in the 

Federal Register of October 15, 2020 (85 

FR 65410). 

FDA is issuing this guidance to 

incorporate content from the Select 

Updates Guidance. FDA considered 

comments received to the Select 

Updates Guidance, and we revised the 

guidance as appropriate in response to 

the comments, including addition of 

materials to the list of those included in 

the policy and clarification of the 

following: applicability of the policy to 

device components, devices or 

components made from multiple 

materials, and materials including 

processing chemicals; situations where 

additional discussion on applicability of 

the policy is recommended; and 

clarification on characteristics of 

devices or materials to which this policy 

does not apply. In addition, FDA made 

minor updates to the guidance to align 

with the current recognized versions of 

consensus standards. This guidance 

supersedes the 2020 Biocompatibility 

Guidance. 

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 Use of International 

Standard ISO 10993–1, ‘‘Biological 

evaluation of medical devices—Part 1: 

Evaluation and testing within a risk 

management process.’’ 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, or 

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

Persons unable to download an 

electronic copy of ‘‘Use of International 

Standard ISO 10993–1, ‘Biological 

evaluation of medical devices—Part 1: 

Evaluation and testing within a risk 

management process’ ’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number GUI00001811 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 OMB under the PRA. 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 

Q-Submission Program and Meetings with Food and Drug 

Administration Staff’’.

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 


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Federal Register / Vol. 88, No. 173 / Friday, September 8, 2023 / Notices 62093 

21 CFR part or guidance Topic OMB control 

No. 

803 .............................................................................................. Medical Devices; Medical Device Reporting; Manufacturer reporting, importer reporting, user facility reporting, distributor 

reporting.

0910–0437 

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

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

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

Laboratory Studies.

0910–0119 

Dated: September 5, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–19402 Filed 9–7–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–4848] 

Application of Human Factors 

Engineering Principles for 

Combination Products: Questions and 

Answers; Guidance for Industry and 

FDA 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 a final 

guidance for industry and FDA staff 

entitled ‘‘Application of Human Factors 

Engineering Principles for Combination 

Products: Questions and Answers.’’ This 

document provides questions and 

answers for industry and FDA staff on 

the application of human factors 

engineering (HFE) principles to the 

development of combination products 

as defined under the regulations. The 

guidance clarifies how the unique 

aspects of a combination product 

influence the considerations within the 

HFE process. This guidance is intended 

to facilitate the development of 

combination products. This guidance 

finalizes the draft guidance entitled 

‘‘Human Factors Studies and Related 

Clinical Study Considerations in 

Combination Product Design and 

Development’’ issued on February 3, 

2016. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on September 8, 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– 

2015–D–4848 for ‘‘Application of 

Human Factors Engineering Principles 

for Combination Products: Questions 

and Answers.’’ 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 this guidance to the Office of 


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