Notice2025-04710
Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices 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
March 20, 2025
Effective
January 8, 2025
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 Authorizations (EUAs) (the Authorizations) issued to Beckman Coulter, Inc., for the Access SARS- CoV-2 IgG, Access SARS-CoV-2 IgM, and Access SARS-CoV-2 IgG II tests. 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 90 Issue 53 (Thursday, March 20, 2025)</title>
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[Federal Register Volume 90, Number 53 (Thursday, March 20, 2025)]
[Notices]
[Pages 13164-13167]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-04710]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0150]
Revocation of Three Authorizations of Emergency Use of In Vitro
Diagnostic Devices 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 Authorizations (EUAs) (the
Authorizations) issued to Beckman Coulter, Inc., for the Access SARS-
CoV-2 IgG, Access SARS-CoV-2 IgM, and Access SARS-CoV-2 IgG II tests.
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 Beckman Coulter,
Inc.'s Access SARS-CoV-2 IgG, Access SARS-CoV-2 IgM, and Access SARS-
CoV-2 IgG II tests are effective as of January 8, 2025.
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 June 26, 2020, FDA issued the Authorization to Beckman Coulter,
Inc., for the Access SARS-CoV-2 IgG test, subject to the terms of the
Authorization. Notice of the issuance of this Authorization was
published in the Federal Register on November 20, 2020 (85 FR 74346),
as required by section 564(h)(1) of the FD&C Act.
On October 8, 2020, FDA issued the Authorization to Beckman
Coulter, Inc., for the Access SARS-CoV-2 IgM test, subject to the terms
of the Authorization. Notice of the issuance of this Authorization was
published in the Federal Register on April 23, 2021 (86 FR 21749), as
required by section 564(h)(1) of the FD&C Act.
On March 22, 2021, FDA issued the Authorization to Beckman Coulter,
Inc., for the Access SARS-CoV-2 IgG II test, 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.
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 November 22, 2024, Beckman Coulter,
Inc., requested the revocation of, and on January 8, 2025, FDA revoked,
the Authorization for the Beckman Coulter, Inc.'s Access SARS-CoV-2 IgG
test. Beckman Coulter, Inc., notified FDA of their intent to
discontinue distribution of the Beckman Coulter, Inc.'s Access SARS-
CoV-2 IgG test as of January 1, 2025, and requested FDA revoke the
Beckman Coulter, Inc.'s Access SARS-CoV-2 IgG test. 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 November 22, 2024, Beckman Coulter,
Inc., requested the revocation of, and on January 8, 2025, FDA revoked,
the Authorization for the Beckman Coulter, Inc.'s Access SARS-CoV-2 IgM
test. Beckman Coulter, Inc., notified FDA of their intent to
discontinue distribution of the Beckman Coulter, Inc.'s Access SARS-
CoV-2 IgM test as of January 1, 2025, and requested FDA revoke the
Beckman Coulter, Inc.'s Access SARS-CoV-2 IgM test. FDA has determined
that it is appropriate to protect the public health or safety to revoke
this Authorization.
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In a request received by FDA on November 22, 2024, Beckman Coulter,
Inc., requested the revocation of, and on January 8, 2025, FDA revoked,
the Authorization for the Beckman Coulter, Inc.'s Access SARS-CoV-2 IgG
II test. Beckman Coulter, Inc., notified FDA of their intent to
discontinue distribution of the Beckman Coulter, Inc.'s Access SARS-
CoV-2 IgG II test as of January 1, 2025, and requested FDA revoke the
Beckman Coulter, Inc.'s Access SARS-CoV-2 IgG II test. 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 EUAs of Beckman Coulter, Inc.'s Access SARS-CoV-2 IgG,
Access SARS-CoV-2 IgM, and Access SARS-CoV-2 IgG II tests. The
revocations in their entirety follow and provide an explanation of the
reasons for revocation, as required by section 564(h)(1) of the FD&C
Act.
BILLING CODE 4164-01-P
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Dated: March 13, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025-04710 Filed 3-19-25; 8:45 am]
BILLING CODE 4164-01-C
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