Notice2022-01139
Revocation of Five Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
Primary source
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Published
January 21, 2022
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 Cellex Inc. for the Cellex q-SARS-CoV-2 IgG/ IgM Rapid Test, BioM[eacute]rieux SA for the SARS-COV-2 R-GENE, Siemens Healthcare Diagnostics Inc. for the Atellica IM SARS-CoV-2 IgG (COV2G), Siemens Healthcare Diagnostics Inc. for the ADVIA Centaur SARS-CoV-2 IgG (COV2G), and Cepheid for the Xpert Omni SARS-CoV-2. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.
Full Text
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[Federal Register Volume 87, Number 14 (Friday, January 21, 2022)]
[Notices]
[Pages 3306-3313]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-01139]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0049]
Revocation of Five 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
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Authorizations) issued to Cellex Inc. for the Cellex q-SARS-CoV-2 IgG/
IgM Rapid Test, BioM[eacute]rieux SA for the SARS-COV-2 R-GENE, Siemens
Healthcare Diagnostics Inc. for the Atellica IM SARS-CoV-2 IgG (COV2G),
Siemens Healthcare Diagnostics Inc. for the ADVIA Centaur SARS-CoV-2
IgG (COV2G), and Cepheid for the Xpert Omni SARS-CoV-2. FDA revoked
these Authorizations under the Federal Food, Drug, and Cosmetic Act
(FD&C Act). The revocations, which include an explanation of the
reasons for each revocation, are reprinted in this document.
DATES: The Authorization for the Cellex q-SARS-CoV-2 IgG/IgM Rapid Test
is revoked as of December 10, 2021. The Authorizations for the SARS-
COV-2 R-GENE, Atellica IM SARS-CoV-2 IgG (COV2G), and ADVIA Centaur
SARS-CoV-2 IgG (COV2G) are revoked as of December 17, 2021. The
Authorization for the Xpert Omni SARS-CoV-2 is revoked as of December
20, 2021.
ADDRESSES: Submit written requests for a single copy of the revocations
to the Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, 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: Jennifer J. Ross, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002, 240-402-8155 (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, nuclear, and radiological 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 1, 2020, FDA issued an
EUA to Cellex Inc. for the Cellex q-SARS-CoV-2 IgG/IgM Rapid Test,
subject to the terms of the Authorization. Notice of the issuance of
this Authorization was published in the Federal Register on June 5,
2020 (85 FR 34638), as required by section 564(h)(1) of the FD&C Act.
On May 6, 2020, FDA issued an EUA to BioM[eacute]rieux SA for the SARS-
COV-2 R-GENE, subject to the terms of the Authorization. Notice of the
issuance of this Authorization was published in the Federal Register on
July 14, 2020 (85 FR 42407), as required by section 564(h)(1) of the
FD&C Act. On July 31, 2020, FDA issued an EUA to Siemens Healthcare
Diagnostics Inc. for the Atellica IM SARS-CoV-2 IgG (COV2G), 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 July 31, 2020, FDA issued an EUA to Siemens Healthcare Diagnostics
Inc. for the ADVIA Centaur SARS-CoV-2 IgG (COV2G), 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 November 27, 2020,
FDA issued an EUA to Cepheid for the Xpert Omni SARS-CoV-2, 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.
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. EUA Revocation Requests
On December 7, 2021, Cellex requested withdrawal of, and on
December 10, 2021, FDA revoked, the Authorization for the Cellex q-
SARS-CoV-2 IgG/IgM Rapid Test. Because Cellex requested that FDA
withdraw the Authorization and FDA understands the product is no longer
being distributed, FDA has determined that it is appropriate to protect
the public health or safety to revoke this Authorization. On December
10, 2021, FDA received a request from BioM[eacute]rieux SA for the
revocation of, and on December 17, 2021, FDA revoked, the Authorization
for the SARS-COV-2 R-GENE. Because BioM[eacute]rieux SA notified FDA
that BioM[eacute]rieux SA has decided to no longer commercially support
the authorized product and requested FDA revoke the Authorization, FDA
has determined that it is appropriate to protect the public health or
safety to revoke this Authorization. On December 9, 2021, FDA received
a request from Siemens Healthcare Diagnostics Inc. for the voluntary
removal of, and on December 17, 2021, FDA revoked, the Authorization
for the Atellica IM SARS-CoV-2 IgG (COV2G). Because Siemens Healthcare
Diagnostics Inc. notified FDA that Siemens Healthcare Diagnostics Inc.
has decided to no longer market the authorized product and requested
FDA voluntarily remove the Atellica IM SARS-CoV-2 IgG (COV2G) from
FDA's list of authorized devices, FDA has determined that it is
appropriate to protect the public health or safety to revoke this
Authorization. On December 9, 2021, FDA received a request from Siemens
Healthcare Diagnostics Inc. for the voluntary removal of, and on
December 17, 2021, FDA revoked, the Authorization for the ADVIA Centaur
SARS-CoV-2 IgG (COV2G). Because Siemens Healthcare Diagnostics Inc.
notified FDA that Siemens Healthcare Diagnostics Inc. has decided to no
longer market the authorized product and requested FDA voluntarily
remove the ADVIA Centaur SARS-CoV-2 IgG (COV2G) from FDA's list of
authorized devices, FDA has determined that it is appropriate to
protect the public health or safety to revoke this Authorization. On
December 17, 2021, FDA received a request from Cepheid for the
revocation of, and on December 20, 2021, FDA revoked, the Authorization
for the Xpert Omni SARS-CoV-2. Because Cepheid has notified FDA that
Cepheid has not commercially distributed any of the Xpert Omni SARS-
CoV-2 product due to the current public clinical needs being met by
Cepheid's other EUA tests that are available and requested FDA revoke
the EUA for the Xpert Omni SARS-CoV-2, 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 for
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Cellex Inc.'s Cellex q-SARS-CoV-2 IgG/IgM Rapid Test, BioM[eacute]rieux
SA's SARS-COV-2 R-GENE, Siemens Healthcare Diagnostics Inc.'s Atellica
IM SARS-CoV-2 IgG (COV2G), Siemens Healthcare Diagnostics Inc.'s ADVIA
Centaur SARS-CoV-2 IgG (COV2G), and Cepheid's Xpert Omni SARS-CoV-2.
The revocations in their entirety follow and provide an explanation of
the reasons for each revocation, as required by section 564(h)(1) of
the FD&C Act.
BILLING CODE 4164-01-P
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Dated: January 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01139 Filed 1-20-22; 8:45 am]
BILLING CODE 4164-01-C
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