[Federal Register Volume 88, Number 221 (Friday, November 17, 2023)]
[Notices]
[Pages 80314-80315]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-25470]


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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.

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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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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

[[Page 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 risk-informed 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-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also 
available at https://www.regulations.gov and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. 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 <a href="/cdn-cgi/l/email-protection#93d0d7c1dbbed4e6faf7f2fdf0f6d3f5f7f2bdfbfbe0bdf4fce5"><span class="__cf_email__" data-cfemail="aeedeafce683e9dbc7cacfc0cdcbeec8cacf80c6c6dd80c9c1d8">[email protected]</span></a> 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:

------------------------------------------------------------------------
                                                            OMB control
     21 CFR part; or guidance               Topic               No.
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807, subpart E....................  Premarket                  0910-0120
                                     notification.
814, subparts A through E.........  Premarket approval..       0910-0231
814, subpart H....................  Humanitarian Device        0910-0332
                                     Exemption.
812...............................  Investigational            0910-0078
                                     Device Exemption.
860, subpart D....................  De Novo                    0910-0844
                                     classification
                                     process.
``Requests for Feedback and         Q-Submissions and          0910-0756
 Meetings for Medical Device         Early Payor
 Submissions: The Q-Submission       Feedback Request
 Program''.                          Programs for
                                     Medical Devices.
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    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


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