Notice2025-18402
Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency; Guidance for Industry and Food and Drug Administration Staff; Availability
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Published
September 23, 2025
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 "Consideration of Enforcement Policies for In Vitro Diagnostic Tests During a Section 564 Declared Emergency." This guidance describes the factors FDA intends to assess in deciding whether to issue an enforcement policy regarding in vitro diagnostic test manufacturers' offering of certain unapproved in vitro diagnostic tests and unapproved uses of approved in vitro diagnostic tests during a declared emergency.
Full Text
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<title>Federal Register, Volume 90 Issue 182 (Tuesday, September 23, 2025)</title>
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[Federal Register Volume 90, Number 182 (Tuesday, September 23, 2025)]
[Notices]
[Pages 45771-45772]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18402]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-5365]
Consideration of Enforcement Policies for In Vitro Diagnostic
Tests 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 entitled ``Consideration of
Enforcement Policies for In Vitro Diagnostic Tests During a Section 564
Declared Emergency.'' This guidance describes the factors FDA intends
to assess in deciding whether to issue an enforcement policy regarding
in vitro diagnostic test manufacturers' offering of certain unapproved
in vitro diagnostic tests and unapproved uses of approved in vitro
diagnostic tests during a declared emergency.
DATES: The announcement of the guidance is published in the Federal
Register on September 23, 2025.
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-2023-D-5365 for ``Consideration of Enforcement Policies for In
Vitro Diagnostic Tests 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
[[Page 45772]]
single hard copy of the guidance document entitled ``Consideration of
Enforcement Policies for In Vitro Diagnostic Tests 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. 5431, 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, 10903 New Hampshire
Ave., Bldg. 66, Rm. 3416, Silver Spring, MD 20993-0002, 301-796-6512.
SUPPLEMENTARY INFORMATION:
I. Background
During an emergency, appropriately safe and effective in vitro
diagnostic tests are critical to the diagnosis, treatment, tracking,
and interruption of transmission of infectious diseases during
outbreaks, as well as for diagnosing and treating diseases or
conditions caused by chemical, biological, radiological, and nuclear
threat agents. FDA is issuing this guidance to describe the factors FDA
plans to assess in deciding whether to issue an enforcement policy
regarding in vitro diagnostic test manufacturers' offering of certain
unapproved in vitro diagnostic tests and unapproved uses of approved in
vitro diagnostic tests for the diagnosis of a disease or other
condition to help quickly increase in vitro diagnostic test
availability when appropriate during a relevant declared emergency
under section 564 of the Federal Food, Drug, and Cosmetic Act.
This guidance describes the factors FDA intends to assess in
deciding whether to issue an enforcement policy, including: (1) the
need for accelerated availability of in vitro diagnostic tests; (2) the
known or potential risks of such in vitro diagnostic tests; (3) the
availability of appropriate alternative in vitro diagnostic tests that
are authorized or approved; and (4) the availability of sufficient
mitigations to address risks of false results. When issuing an
enforcement policy, FDA generally intends to describe the circumstances
in which the Agency intends to exercise enforcement discretion,
including, for example, when the in vitro diagnostic test has been
validated. FDA may also identify the initial duration in which an
enforcement policy is intended to be in effect.
This guidance finalizes the draft guidance entitled ``Consideration
of Enforcement Policies for Tests During a Section 564 Declared
Emergency.'' FDA considered the applicability of Executive Order 14192,
per OMB guidance in M-25-20, and finds this action to be deregulatory
in nature.
A notice of availability of the draft guidance appeared in the
Federal Register of May 6, 2024 (89 FR 37232). FDA considered comments
received and revised the guidance as appropriate in response to the
comments, including clarifying that the scope of the guidance is in
vitro diagnostic tests.
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 ``Consideration of Enforcement Policies for
In Vitro Diagnostic Tests 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.
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> and <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 ``Consideration of Enforcement Policies
for In Vitro Diagnostic Tests During a Section 564 Declared Emergency''
may send an email request to <a href="/cdn-cgi/l/email-protection#763532243e5b31031f121718151336101217581e1e0558111900"><span class="__cf_email__" data-cfemail="377473657f1a70425e535659545277515356195f5f4419505841">[email protected]</span></a> to receive an
electronic copy of the document. Please use the document number
GUI00007009 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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21 CFR part; guidance; or FDA OMB
form Topic control No.
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``Emergency Use Authorization of Emergency Use 0910-0595
Medical Products and Related Authorization.
Authorities''.
807, subpart E................... Premarket notification.. 0910-0120
814, subparts A through E........ Premarket approval...... 0910-0231
814, subpart H................... Humanitarian Use 0910-0332
Devices; Humanitarian
Device Exemption.
812.............................. Investigational Device 0910-0078
Exemption.
860, subpart D................... De Novo classification 0910-0844
process.
803.............................. Medical Device Reporting 0910-0437
820.............................. Current Good 0910-0073
Manufacturing Practice
(CGMP); Quality System
(QS) Regulation.
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Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18402 Filed 9-22-25; 8:45 am]
BILLING CODE 4164-01-P
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