Document ID: FDA-2022-N-0049-0001
Agency: fda
Document Type: Notice
Title: Revocation of Five Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID–19; Availability
Posted Date: 2022-01-21T05:00Z

[Federal Register Volume 87, Number 14 (Friday, January 21, 2022)]
[Notices]
[Pages 3306-3313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01139]

-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
revocation of the Emergency Use Authorizations (EUAs) (the

[[Page 3307]]

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 https://www.regulations.gov/.

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

[[Page 3308]]

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
[GRAPHIC] [TIFF OMITTED] TN21JA22.005

[[Page 3309]]

[GRAPHIC] [TIFF OMITTED] TN21JA22.006

[[Page 3310]]

[GRAPHIC] [TIFF OMITTED] TN21JA22.007

[[Page 3311]]

[GRAPHIC] [TIFF OMITTED] TN21JA22.008

[[Page 3312]]

[GRAPHIC] [TIFF OMITTED] TN21JA22.009

[[Page 3313]]

    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