[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:
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
[[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 [email protected] 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:
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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]
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