General Considerations for Animal Studies Intended To Evaluate Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

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Published

March 28, 2023

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "General Considerations for Animal Studies Intended to Evaluate Medical Devices." FDA developed this guidance document to assist medical device sponsors, testing facilities, and other persons involved in designing, conducting, and reporting the results of animal studies intended to assess the safety of medical devices to support premarket submissions. These animal studies typically provide initial evidence of device safety, which may include device performance and handling, and the biological effects when used in a living system.

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<title>Federal Register, Volume 88 Issue 59 (Tuesday, March 28, 2023)</title>
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[Federal Register Volume 88, Number 59 (Tuesday, March 28, 2023)]
[Notices]
[Pages 18321-18322]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-06254]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-3419]

General Considerations for Animal Studies Intended To Evaluate
Medical Devices; 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 ``General Considerations
for Animal Studies Intended to Evaluate Medical Devices.'' FDA
developed this guidance document to assist medical device sponsors,
testing facilities, and other persons involved in designing,
conducting, and reporting the results of animal studies intended to
assess the safety of medical devices to support premarket submissions.
These animal studies typically provide initial evidence of device
safety, which may include device performance and handling, and the
biological effects when used in a living system.

DATES: The announcement of the guidance is published in the Federal
Register on March 28, 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: <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-2015-D-3419 for ``General Considerations for Animal Studies
Intended to Evaluate Medical Devices.'' 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 guidance document entitled
``General Considerations for Animal Studies Intended to Evaluate
Medical Devices'' 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: Judith A. Davis, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2220, Silver Spring, MD 20993-0002, 301-
796-6636.

SUPPLEMENTARY INFORMATION:

I. Background

FDA developed this guidance document to assist medical device
sponsors, testing facilities, and other persons involved in designing,
conducting, and reporting the results of animal studies intended to
support the safety of medical devices for premarket submissions. These
animal studies typically provide initial evidence of device safety,
which may include their performance and handling, and the biological
effects when used in a living system. This guidance outlines general
considerations for certain animal studies used to support device
premarket submissions, when a suitable alternative to an animal study
is not available. This guidance provides recommendations on study
planning,

[[Page 18322]]

including selecting an appropriate animal model; study monitoring; and
study evaluation. The document also provides recommendations on test
facility selection, animal housing, and records and reports, including
animal study reports for premarket submissions. This guidance
supersedes the final guidance ``General Considerations for Animal
Studies for Cardiovascular Devices,'' issued on July 28, 2010.
A notice of availability of the draft guidance appeared in the
Federal Register of October 14, 2015 (80 FR 61820). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including increased emphasis of the 3Rs to reduce,
refine, and replace animal use in testing when feasible, reorganization
of the guidance to better represent the study design, conduct, and
reporting process, clarification of important terminology, and
technical edits.
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 general considerations for animal Studies
intended to evaluate medical devices. 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 <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 guidance document is also
available at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or https://<a href="http://www.fda.gov/regulatory-information/search-fda-guidance-documents">www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. Persons unable to
download an electronic copy of ``General Considerations for Animal
Studies Intended to Evaluate Medical Devices'' may send an email
request to <a href="/cdn-cgi/l/email-protection#743730263c5933011d10151a1711341210155a1c1c075a131b02"><span class="__cf_email__" data-cfemail="b3f0f7e1fb9ef4c6dad7d2ddd0d6f3d5d7d29ddbdbc09dd4dcc5">[email&#160;protected]</span></a> to receive an electronic copy of
the document. Please use the document number GUI00001802 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, guidance, and forms
have been approved by OMB as listed in the following table:

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OMB control
21 CFR part; guidance; or FDA form 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 on Medical Q-submissions....... 0910-0756
Device Submissions: The Pre-
Submission Program and Meetings
with Food and Drug Administration
Staff''.
820............................... Current Good 0910-0073
Manufacturing
Practice (CGMP);
Quality System (QS)
Regulation.
58................................ Good Laboratory 0910-0119
Practice (GLP)
Regulations for
Nonclinical
Laboratory Studies.
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Dated: March 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06254 Filed 3-27-23; 8:45 am]
BILLING CODE 4164-01-P

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