Notice2021-27812
Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Primary source
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Published
December 23, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions." 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-based framework that can be used in the credibility assessment of computational modeling and simulation (CM&S) used in medical device regulatory submissions. The draft guidance is intended to improve the consistency and transparency of the review of computational modeling evidence. This draft guidance is not final nor is it in effect at this time.
Full Text
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<title>Federal Register, Volume 86 Issue 244 (Thursday, December 23, 2021)</title>
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[Federal Register Volume 86, Number 244 (Thursday, December 23, 2021)]
[Notices]
[Pages 72969-72971]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-27812]
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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Simulation in Medical Device Submissions; Draft Guidance for Industry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the availability of the draft guidance entitled ``Assessing the
Credibility of Computational Modeling and Simulation in Medical Device
Submissions.'' 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-based framework that can be
used in the credibility assessment of computational modeling and
simulation (CM&S) used in medical device regulatory submissions. The
draft guidance is intended to improve the consistency and transparency
of the review of computational modeling evidence. This draft guidance
is not final nor is it in effect at this time.
DATES: Submit either electronic or written comments on the draft
guidance
[[Page 72970]]
by February 22, 2022 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 draft guidance document entitled
``Assessing the Credibility of Computational Modeling and Simulation in
Medical Device 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. 66, Rm. 1133, Silver Spring, MD 20993-0002, 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 as part of algorithms within software embedded in a device. However,
regulatory submissions involving CM&S often lack clear information for
why model predictions can be considered credible. This draft guidance
provides a risk-based framework that can be used in the credibility
assessment of CM&S used in medical device regulatory submissions. This
draft guidance builds upon the FDA-recognized consensus standard
American Society of Mechanical Engineers V&V 40, ``Assessing
Credibility of Computational Modeling Through Verification and
Validation: Application to Medical Devices,'' by providing a general
framework for demonstrating CM&S credibility that incorporates the
different types of evidence typically generated for regulatory
submissions. The framework is intended to be applicable to any use of
CM&S in a medical device submission. It is not specific to any device
type, modeling discipline or clinical specialty.
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 ``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 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 <a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products">https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products</a>. This draft guidance document
is also available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> and at https://
w<a href="http://ww.fda.gov/regulatory-information/search-fda-guidance-documents">ww.fda.gov/regulatory-information/search-fda-guidance-documents</a>.
Persons unable to download
[[Page 72971]]
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#2c6f687e64016b5945484d424f496c4a484d0244445f024b435a"><span class="__cf_email__" data-cfemail="5b181f0913761c2e323f3a35383e1b3d3f3a75333328753c342d">[email protected]</span></a> to receive an electronic
copy of the document. Please use the document number 1500056 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.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations and guidances have been
approved by OMB as listed in the following table:
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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.
``De Novo Classification Process De Novo 0910-0844
(Evaluation of Automatic Class classification
III Designation)''. process.
``Requests for Feedback and Q-submissions; pre- 0910-0756
Meetings for Medical Device submissions.
Submissions: The Q-Submission
Program''.
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Dated: December 17, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27812 Filed 12-22-21; 8:45 am]
BILLING CODE 4164-01-P
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