Notice2024-02356
Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; 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
February 6, 2024
Effective
September 29, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorization (EUAs) (the Authorizations) issued to Southern California Permanente Medical Group, for the Kaiser Permanente High Throughput SARS-CoV-2 Assay, that includes the Kaiser Permanente Saliva Home Collection Kit, and Drexel University College of Medicine, for the SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay. FDA revoked the Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.
Full Text
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<title>Federal Register, Volume 89 Issue 25 (Tuesday, February 6, 2024)</title>
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[Federal Register Volume 89, Number 25 (Tuesday, February 6, 2024)]
[Notices]
[Pages 8205-8208]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-02356]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0150]
Revocation of Two Authorizations of Emergency Use of In Vitro
Diagnostic Device for Detection and/or Diagnosis of COVID-19;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorization (EUAs) (the
Authorizations) issued to Southern California Permanente Medical Group,
for the Kaiser Permanente High Throughput SARS-CoV-2 Assay, that
[[Page 8206]]
includes the Kaiser Permanente Saliva Home Collection Kit, and Drexel
University College of Medicine, for the SARS-CoV-2 DUCoM-PDL Modified
Tetracore Assay. FDA revoked the Authorizations under the Federal Food,
Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization
holder. The revocations, which include an explanation of the reasons
for each revocation, are reprinted at the end of this document.
DATES: The revocation of the Authorization for the Southern California
Permanente Medical Group's Kaiser Permanente High Throughput SARS-CoV-2
Assay, that includes the Kaiser Permanente Saliva Home Collection Kit,
is effective as of September 29, 2023. The revocation of the
Authorization for the Drexel University College of Medicine for the
SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay is effective as of
October 5, 2023.
ADDRESSES: Submit written requests for a single copy of the revocations
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 or include a fax
number to which the revocations may be sent. See the SUPPLEMENTARY
INFORMATION section for electronic access to the revocations.
FOR FURTHER INFORMATION CONTACT: Kim Sapsford-Medintz, Office of
Product Evaluation and Quality, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 3216, Silver Spring, MD 20993-0002, 301-796-0311 (this is not a
toll-free number).
SUPPLEMENTARY INFORMATION:
I. Background
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, radiological, or nuclear agent or agents. Among
other things, section 564 of the FD&C Act allows FDA to authorize the
use of an unapproved medical product or an unapproved use of an
approved medical product in certain situations. On April 19, 2021, FDA
issued the Authorization to Southern California Permanente Medical
Group, for the Kaiser Permanente High Throughput SARS-CoV-2 Assay, that
includes the Kaiser Permanente Saliva Home Collection Kit, subject to
the terms of the Authorization. Notice of the issuance of this
Authorization was published in the Federal Register on July 23, 2021
(86 FR 39040), as required by section 564(h)(1) of the FD&C Act.
On April 28, 2023, FDA issued the Authorization to Drexel
University College of Medicine, for the SARS-CoV-2 DUCoM-PDL Modified
Tetracore Assay, subject to the terms of the Authorization. Notice of
the issuance of this Authorization was published in the Federal
Register on January 25, 2024 (89 FR 4952), as required by section
564(h)(1) of the FD&C Act.
Subsequent updates to the Authorizations were made available on
FDA's website. The authorization of a device for emergency use under
section 564 of the FD&C Act may, pursuant to section 564(g)(2) of the
FD&C Act, be revoked when the criteria under section 564(c) of the FD&C
Act for issuance of such authorization are no longer met (section
564(g)(2)(B) of the FD&C Act), or other circumstances make such
revocation appropriate to protect the public health or safety (section
564(g)(2)(C) of the FD&C Act).
II. Authorizations Revocation Requests
In a request received by FDA on May 11, 2023, Southern California
Permanente Medical Group requested the withdrawal of, and on September
29, 2023, FDA revoked, the Authorization for the Southern California
Permanente Medical Group's Kaiser Permanente High Throughput SARS-CoV-2
Assay, that includes the Kaiser Permanente Saliva Home Collection Kit.
Because Southern California Permanente Medical Group notified FDA that
they have stopped distributing the Kaiser Permanente Saliva Home
Collection Kit at the end of May 2023 and have also stopped receiving
and processing the kits and requested FDA withdraw the Southern
California Permanente Medical Group's Kaiser Permanente High Throughput
SARS-CoV-2 Assay, that includes the Kaiser Permanente Saliva Home
Collection Kit, FDA has determined that it is appropriate to protect
the public health or safety to revoke this Authorization.
In a request received by FDA on September 29, 2023, Drexel
University College of Medicine requested the withdrawal of, and on
October 5, 2023, FDA revoked, the Authorization for the Drexel
University College of Medicine's SARS-CoV-2 DUCoM-PDL Modified
Tetracore Assay. Because Drexel University College of Medicine notified
FDA that they have discontinued the use of SARS-CoV-2 DUCoM-PDL
Modified Tetracore Assay at Drexel University, Drexel Medicine
Diagnostics and requested FDA withdraw the Drexel University College of
Medicine's SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay, FDA has
determined that it is appropriate to protect the public health or
safety to revoke this Authorization.
III. Electronic Access
An electronic version of this document and the full text of the
revocations are available on the internet at <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>.
IV. The Revocations
Having concluded that the criteria for revocation of the
Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA
has revoked the EUA of Southern California Permanente Medical Group's
Kaiser Permanente High Throughput SARS-CoV-2 Assay, that includes the
Kaiser Permanente Saliva Home Collection Kit, and Drexel University
College of Medicine's SARS-CoV-2 DUCoM-PDL Modified Tetracore Assay.
The revocation in its entirety follows and provide an explanation of
the reasons for revocation, as required by section 564(h)(1) of the
FD&C Act.
BILLING CODE 4161-01-P
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[GRAPHIC] [TIFF OMITTED] TN06FE24.022
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[GRAPHIC] [TIFF OMITTED] TN06FE24.023
Date: February 1, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-02356 Filed 2-5-24; 8:45 am]
BILLING CODE 4161-01-C
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</html>Indexed from Federal Register on February 6, 2024.
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