Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency; Guidance for Industry and Food and Drug Administration Staff; Availability

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Published

November 10, 2026

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 titled "Validation of Certain In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564 Declared Emergency." The guidance describes general recommendations for the validation of in vitro diagnostic devices (IVDs) for emerging pathogens during an applicable declaration of public health emergency (PHE). This guidance and the associated template include the recommendations that apply to test data and information submitted in a pre-Emergency Use Authorization (EUA), an EUA request, or to a test offered as described in an applicable enforcement discretion policy.

Full Text

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<title>Federal Register, Volume 91 Issue 216 (Tuesday, November 10, 2026)</title>
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[Federal Register Volume 91, Number 216 (Tuesday, November 10, 2026)]
[Notices]
[Pages 72541-72543]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-22883]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-D-2707]

Validation of Certain In Vitro Diagnostic Devices for Emerging
Pathogens During a Section 564 Declared Emergency; 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 titled ``Validation of Certain In
Vitro Diagnostic Devices for Emerging Pathogens During a Section 564
Declared Emergency.'' The guidance describes general recommendations
for the validation of in vitro diagnostic devices (IVDs) for emerging
pathogens during an applicable declaration of public health emergency
(PHE). This guidance and the associated template include the
recommendations that apply to test data and information submitted in a
pre-Emergency Use Authorization (EUA), an EUA request, or to a test
offered as described in an applicable enforcement discretion policy.

DATES: The announcement of the guidance is published in the Federal
Register on November 10, 2026.

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'').

[[Page 72542]]

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-2024-D-2707 for ``Validation of Certain In Vitro Diagnostic Devices
for Emerging Pathogens During a Section 564 Declared Emergency.''
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 titled
``Validation of Certain In Vitro Diagnostic Devices for Emerging
Pathogens During a Section 564 Declared Emergency'' to the Office of
Policy, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5441, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Toby Lowe, Center for Devices and
Radiological Health, Food and Drug Administration, 301-796-6512.

SUPPLEMENTARY INFORMATION:

I. Background

The guidance describes general recommendations for the validation
of IVDs for emerging pathogens to help test manufacturers better
prepare for future outbreaks by clarifying FDA's recommendations for
test validation during an applicable declaration under section 564 of
the Federal Food, Drug, and Cosmetic Act (FD&C Act). Accurate and
reliable IVDs are critical to the diagnosis, tracking, treatment, and
interruption of transmission of infectious diseases during outbreaks,
as well as for diagnosing and treating diseases or conditions caused by
chemical, biological, radiological, or nuclear threats. These
recommendations apply to test data and information submitted in a pre-
EUA, an EUA request, or to a test offered as described in an applicable
enforcement discretion policy. This guidance and the associated
template address recommendations from two independent assessments of
FDA's response to COVID-19. Specifically, FDA selected Booz Allen
Hamilton to do such an independent assessment, which culminated in an
October 2021 report, ``Emergency Use Authorization Assessment--Final
Report,'' that recommended FDA ``Develop a framework for how to conduct
validation of diagnostic tests for emerging pathogens in the setting of
a declared PHE.'' Similarly, the Health and Human Services Office of
the Inspector General's September 2022 report, ``FDA Repeatedly Adapted
Emergency Use Authorization Policies To Address the Need for COVID-19
Testing,'' recommended that FDA ``Develop a suite of EUA templates for
future emergencies involving novel pathogens'' and ``Expand and improve
resources'' on the EUA process among other actions FDA has taken or is
taking.
A notice of availability of the draft guidance appeared in the
Federal Register of January 7, 2025 (90 FR 1168). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including providing consolidated and streamlined test
validation recommendations applicable across diagnostic test types,
adding language emphasizing flexibility in the validation
recommendations and addressing challenges at different stages of an
outbreak, and clarifying FDA's focus on the most important and least
burdensome information to collect and/or submit during a section 564
declared emergency.
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 Validation of Certain In Vitro Diagnostic
Devices for Emerging Pathogens During a Section 564 Declared Emergency.
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.
FDA considered the applicability of Executive Order 14192, per OMB
guidance in M-25-20, and finds this action to be neither an E.O.
regulatory action nor an E.O. deregulatory action.

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>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>. Persons unable to
download an electronic copy of ``Validation of Certain In Vitro
Diagnostic Devices for Emerging

[[Page 72543]]

Pathogens During a Section 564 Declared Emergency'' may send an email
request to <a href="/cdn-cgi/l/email-protection#a3e0e7f1eb8ee4d6cac7c2cdc0c6e3c5c7c28dcbcbd08dc4ccd5"><span class="__cf_email__" data-cfemail="783b3c2a30553f0d111c19161b1d381e1c195610100b561f170e">[email&#160;protected]</span></a> to receive an electronic copy of
the document. Please use the document number GUI00007020 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; guidance; or FDA form Topic No.
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``Emergency Use Authorization of Emergency use 0910-0595
Medical Products and Related authorization.
Authorities; Guidance for Industry
and Other Stakeholders''.
807, subpart E..................... Premarket 0910-0120
notification.
814, subparts A through E.......... Premarket approval... 0910-0231
814, subpart H..................... Humanitarian Use 0910-0332
Devices;
Humanitarian Device
Exemption.
812................................ Investigational 0910-0078
Device Exemption.
860, subpart D..................... De Novo 0910-0844
classification
process.
``Administrative Procedures for CLIA Administrative 0910-0607
CLIA Categorization'' and Procedures; CLIA
``Recommendations: Clinical Waivers.
Laboratory Improvement Amendments
of 1988 (CLIA) Waiver Applications
for Manufacturers of In Vitro
Diagnostic Devices''.
800, 801, 809, and 830............. Medical Device 0910-0485
Labeling
Regulations; Unique
Device
Identification.
820................................ Current Good 0910-0073
Manufacturing
Practice (CGMP);
Quality System (QS)
Regulation.
50, 56............................. Protection of Human 0910-0130
Subjects and
Institutional Review
Boards.
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Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-22883 Filed 11-9-26; 8:45 am]
BILLING CODE 4164-01-P

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