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[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Pathogens During a Section 564 Declared Emergency; Draft Guidance for 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the availability of the draft guidance entitled ``Validation of Certain 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 The draft guidance describes general 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 This draft guidance is not final nor is it for 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DATES: Submit either electronic or written comments on the draft 
guidance by March 10, 2025 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:

------------------------------------------------------------------------
                                                            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]
BILLING CODE 4164-01-P
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