Proposed Rule2024-08934
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In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration Under Section 564; Draft Guidance for Laboratory Manufacturers and Food and Drug Administration Staff; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 6, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564."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 This draft guidance is not final nor is it for implementation at this time.
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 88 (Monday, May 6, 2024)</title>
</head>
<body><pre>
[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-08934]
[[Page 37158]]
=======================================================================
-----------------------------------------------------------------------
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Section 564; Draft Guidance for Laboratory Manufacturers and Food and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.
-----------------------------------------------------------------------
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:
<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-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 <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 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 <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> or <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 ``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 <a href="/cdn-cgi/l/email-protection#d39097819bfe94a6bab7b2bdb0b693b5b7b2fdbbbba0fdb4bca5"><span class="__cf_email__" data-cfemail="6e2d2a3c2643291b070a0f000d0b2e080a0f4006061d40090118">[email protected]</span></a> 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:
------------------------------------------------------------------------
OMB control
21 CFR part or guidance Topic No.
------------------------------------------------------------------------
``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
------------------------------------------------------------------------
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on May 6, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.