80314 Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm111462.htm for 

procedures on public conduct during 

advisory committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. 1001 et seq.). This meeting notice 

also serves as notice that, pursuant to 21 

CFR 10.19, the requirements in 21 CFR 

14.22(b), (f), and (g) relating to the 

location of advisory committee meetings 

are hereby waived to allow for this 

meeting to take place using an online 

meeting platform. This waiver is in the 

interest of allowing greater transparency 

and opportunities for public 

participation, in addition to 

convenience for advisory committee 

members, speakers, and guest speakers. 

No participant will be prejudiced by 

this waiver, and the ends of justice will 

be served by allowing for this 

modification to FDA’s advisory 

committee meeting procedures. 

Dated: November 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–25475 Filed 11–16–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–D–0980] 

Assessing the Credibility of 

Computational Modeling and 

Simulation in Medical Device 

Submissions; 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 ‘‘Assessing the 

Credibility of Computational Modeling 

and Simulation in Medical Device 

Submissions; Guidance for Industry and 

Food and Drug Administration Staff.’’ 

Computational modeling and simulation 

(CM&S) can be used in a variety of ways 

in medical device applications, 

including to perform ‘‘in silico’’ device 

testing or as part of software embedded 

in a device. This guidance provides a 

risk-informed framework for credibility 

assessment of CM&S used in medical 

device regulatory submissions. The 

guidance is intended to promote 

consistency and facilitate efficient 

review of medical device submissions, 

to increase confidence in the use of 

CM&S in regulatory submissions, and to 

facilitate improved interpretation of 

CM&S credibility evidence submitted in 

regulatory submissions. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on November 17, 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– 

2021–D–0980 for ‘‘Assessing the 

Credibility of Computational Modeling 

and Simulation in Medical Device 

Submissions.’’ 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 ‘‘Assessing the 

Credibility of Computational Modeling 

and Simulation in Medical Device 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 88, No. 221 / Friday, November 17, 2023 / Notices 80315 

Submissions’’ 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 self-addressed adhesive 

label to assist that office in processing 

your request. 

FOR FURTHER INFORMATION CONTACT: Pras 

Pathmanathan, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 62, Rm 1133, Silver Spring, 

MD 20993–0002, at 301–796–3490. 

SUPPLEMENTARY INFORMATION: 

I. Background 

CM&S can be used in a variety of 

ways in medical device applications, 

including to perform ‘‘in silico’’ (virtual) 

device testing or to influence algorithms 

within software embedded in a device. 

This guidance provides a general riskinformed framework that can be used in 

the credibility assessment of CM&S used 

in medical device regulatory 

submissions. For the purposes of this 

guidance, CM&S refers to first 

principles-based (e.g., physics-based or 

mechanistic) computational models, 

and not statistical or data-driven (e.g., 

machine learning or artificial 

intelligence-based) models. This 

guidance is intended to help improve 

the consistency and transparency of the 

review of CM&S, to increase confidence 

in the use of CM&S in regulatory 

submissions, and to facilitate improved 

interpretation of CM&S credibility 

evidence submitted in regulatory 

submissions 

A notice of availability of the draft 

guidance appeared in the Federal 

Register of December 23, 2021 (86 FR 

72969). FDA considered comments 

received and revised the guidance as 

appropriate in response to the 

comments, including revising the 

categorization of credibility evidence 

defined in the guidance, clarifying the 

scope of the guidance, and clarifying 

how the recommendations in the 

guidance relate to the framework 

described in the FDA-recognized 

standard American Society of 

Mechanical Engineers V&V 40, 

‘‘Assessing Credibility of Computational 

Modeling through Verification and 

Validation: Application to Medical 

Devices.’’ 

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 ‘‘Assessing the 

Credibility of Computational Modeling 

and Simulation in Medical Device 

Submissions.’’ 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 at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments. Persons unable to download 

an electronic copy of ‘‘Assessing the 

Credibility of Computational Modeling 

and Simulation in Medical Device 

Submissions’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number GUI01500056 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 and Meetings for Medical Device Submissions: The Q-Submission Program’’.Q-Submissions and Early Payor Feedback Request Programs for 

Medical Devices.

0910–0756 

Dated: November 14, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–25470 Filed 11–16–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0369] 

Product-Specific Guidances; Draft and 

Revised Draft Guidances 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 

additional draft and revised draft 

product-specific guidances. The 

guidances provide product-specific 

recommendations on, among other 

things, the design of bioequivalence 

(BE) studies to support abbreviated new 

drug applications (ANDAs). In the 

Federal Register of June 11, 2010, FDA 

announced the availability of a guidance 

for industry entitled ‘‘Bioequivalence 

Recommendations for Specific 

Products’’ that explained the process 

that would be used to make productspecific guidances available to the 

public on FDA’s website. The guidances 

identified in this notice were developed 

using the process described in that 

guidance. 


khammond on DSKJM1Z7X2PROD with NOTICES