[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1168-1170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31522]
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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Pathogens During a Section 564 Declared Emergency; Draft Guidance for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the availability of the draft guidance entitled ``Validation of Certain
In Vitro Diagnostic Devices for Emerging Pathogens During a Section 564
Declared Emergency.'' The draft guidance describes general
recommendations for the validation of in vitro diagnostic devices
(IVDs) for emerging pathogens during an applicable declaration of
public health emergency. 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. This draft guidance is not final nor is it for
implementation at this time.
DATES: Submit either electronic or written comments on the draft
guidance by March 10, 2025 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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:
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-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 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
[[Page 1169]]
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 draft guidance document entitled
``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. 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
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 expectations for test
validation during an applicable declaration under section 564 of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360bbb-3).
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 draft
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'' (https://www.fda.gov/media/152992/download), 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 Office of the Inspector
General's September 2022 report, ``FDA Repeatedly Adapted Emergency Use
Authorization Policies To Address the Need for COVID-19 Testing''
(https://oig.hhs.gov/oei/reports/OEI-01-20-00380.pdf), 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.
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 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.
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 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 or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``Validation of Certain In Vitro
Diagnostic Devices for Emerging Pathogens During a Section 564 Declared
Emergency'' may send an email request to [email protected] 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:
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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.
[[Page 1170]]
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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Dated: December 26, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31522 Filed 1-6-25; 8:45 am]
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