[Federal Register Volume 89, Number 88 (Monday, May 6, 2024)]
[Proposed Rules]
[Pages 37158-37159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08934]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 809

[Docket No. FDA-2024-D-0083]


Enforcement Policy for Certain In Vitro Diagnostic Devices for 
Immediate Public Health Response in the Absence of a Declaration Under 
Section 564; Draft Guidance for Laboratory Manufacturers and Food and 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the availability of the draft guidance entitled ``Enforcement Policy 
for Certain In Vitro Diagnostic Devices for Immediate Public Health 
Response in the Absence of a Declaration under Section 564.'' In the 
context of emergent situations involving chemical, biological, 
radiological, or nuclear (CBRN) threats, there may be a public health 
need for certain in vitro diagnostic devices (IVDs) to be available for 
immediate response purposes. When finalized, this guidance will 
describe the Agency's enforcement policy for certain laboratory 
manufacturers offering certain unauthorized IVDs for immediate response 
to CBRN agents in the absence of a declaration applicable to IVDs under 
the Federal Food, Drug, and Cosmetic Act (FD&C Act). This draft 
guidance is not final nor is it for implementation at this time.

DATES: Submit either electronic or written comments on the draft 
guidance by July 5, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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-0083 for ``Enforcement Policy for Certain In Vitro 
Diagnostic Devices for Immediate Public Health Response in the Absence 
of a Declaration under Section 564.'' 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 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 
``Enforcement Policy for Certain In Vitro Diagnostic Devices for 
Immediate Public Health Response in the Absence of a Declaration under 
Section 564'' 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

    When finalized, this guidance will describe the Agency's 
enforcement policy for certain laboratory manufacturers offering 
certain unauthorized IVDs for immediate response to CBRN agents in the 
absence of a declaration applicable to IVDs under section 564 of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (hereafter referred to 
as an ``applicable 564 declaration'').\1\ In the context of

[[Page 37159]]

emergent situations involving CBRN threats, there may be a public 
health need for certain IVDs to be available for immediate response 
purposes. An emergent situation is, for purposes of this guidance, the 
period of time between detection of the exposure or outbreak and, 
either, resolution of the exposure or outbreak or issuance of an 
applicable 564 declaration. In the past, during this period of time, 
laboratory manufacturers offered laboratory developed tests (LDTs) for 
which FDA has had a general enforcement discretion approach. However, 
as discussed in the preamble to the final rule amending FDA regulations 
to make explicit that IVDs are devices under the FD&C Act including 
when the manufacturer of the IVD is a laboratory (LDT Final Rule),\2\ 
FDA is phasing out this general enforcement discretion approach for 
LDTs. Accordingly, FDA is issuing this guidance with our enforcement 
policy for ``immediate response'' tests.
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    \1\ The Office of the Federal Register has published this 
document under the category ``Proposed Rule'' pursuant to its 
interpretation of 1 CFR 5.9(b). We note that the categorization as 
such for purposes of publication in the Federal Register does not 
affect the content or intent of the document. See 1 CFR 5.1(c).
    \2\ ``Medical Devices: Laboratory Developed Tests'' is issued 
elsewhere in this Federal Register.
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    This guidance, when finalized, will describe the Agency's 
enforcement policy for certain laboratory manufacturers offering 
certain unauthorized IVDs for immediate response to CBRN agents in the 
absence of an applicable 564 declaration. FDA does not intend to object 
to the offering of ``immediate response'' tests, as defined in the 
guidance, when the test is manufactured and offered by certain 
laboratory manufacturers, the test has been appropriately validated, 
FDA is notified, appropriate transparency is provided, the test is 
labeled for prescription use only, and there is no applicable 564 
declaration, as described in the guidance. Prior to an emergent 
situation and after an emergent situation has been resolved, when there 
might not be a critical need for a coordinated and immediate public 
health response and where the implications of false results may not 
have as serious implications for public health decision-making, such 
tests may fall within the enforcement discretion policies described in 
section V.B of the preamble to the LDT Final Rule.
    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 ``Enforcement 
Policy for Certain In Vitro Diagnostic Devices for Immediate Public 
Health Response in the Absence of a Declaration under Section 564.'' 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 ``Enforcement Policy for Certain In 
Vitro Diagnostic Devices for Immediate Public Health Response in the 
Absence of a Declaration under Section 564'' may send an email request 
to [email protected] to receive an electronic copy of the 
document. Please use the document number GUI00007032 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 or guidance               Topic                 No.
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``Emergency Use Authorization    Emergency Use                 0910-0595
 of Medical Products and          Authorization.
 Related 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.
``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 Labeling       0910-0485
                                  Regulations; Unique
                                  Device Identification.
803............................  Medical Device                0910-0437
                                  Reporting.
810............................  Recalls................       0910-0432
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    Dated: April 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-08934 Filed 4-29-24; 8:45 am]
BILLING CODE 4164-01-P