Notice2023-22188
Revocation of Eleven Authorizations of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
Primary source
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Published
October 5, 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 Authorizations (EUAs) (the Authorizations) issued to Luminostics, Inc., for the Clip COVID Rapid Antigen Test; NeuMoDx Molecular, Inc., a QIAGEN Company, for the NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay; LGC, Biosearch Technologies for the SARS-CoV-2 Real-Time and End-Point RT-PCR Test; LGC, Biosearch Technologies, for the Biosearch Technologies SARS-CoV-2 ultra-high-throughput End-Point RT-PCR Test; Becton, Dickinson and Co. for the BD Veritor At-Home COVID-19 Test; Verily Life Sciences for the Verily COVID-19 RT-PCR Test; Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard for the CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3); Xtrava Health for the SPERA COVID-19 Ag Test; Exact Sciences Laboratories for the COVID-Flu Multiplex Assay; Exact Sciences Laboratories for the SARS-CoV-2 (N gene detection) Test; and dba SpectronRx for the Hymon SARS-CoV-2 Test Kit. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by the Authorization holders. The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.
Full Text
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<title>Federal Register, Volume 88 Issue 192 (Thursday, October 5, 2023)</title>
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[Federal Register Volume 88, Number 192 (Thursday, October 5, 2023)]
[Notices]
[Pages 69192-69205]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-22188]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-4182]
Revocation of Eleven 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 Authorizations (EUAs) (the
Authorizations) issued to Luminostics, Inc., for the Clip COVID Rapid
Antigen Test; NeuMoDx Molecular, Inc., a QIAGEN Company, for the
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay; LGC, Biosearch
Technologies for the SARS-CoV-2 Real-Time and End-Point RT-PCR Test;
LGC, Biosearch Technologies, for the Biosearch Technologies SARS-CoV-2
ultra-high-throughput End-Point RT-PCR Test; Becton, Dickinson and Co.
for the BD Veritor At-Home COVID-19 Test; Verily Life Sciences for the
Verily COVID-19 RT-PCR Test; Clinical Research Sequencing Platform
(CRSP), LLC at the Broad Institute of MIT and Harvard for the CRSP
SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay
(Version 3); Xtrava Health for the SPERA COVID-19 Ag Test; Exact
Sciences Laboratories for the COVID-Flu Multiplex Assay; Exact Sciences
Laboratories for the SARS-CoV-2 (N gene detection) Test; and dba
SpectronRx for the Hymon SARS-CoV-2 Test Kit. FDA revoked these
Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C
Act) as requested by the Authorization holders. The revocations, which
include an explanation of the reasons for each revocation, are
reprinted in this document.
DATES: The Authorization for the Luminostics, Inc.'s, Clip COVID Rapid
Antigen Test is revoked as of May 5, 2023. The Authorization for the
NeuMoDx Molecular, Inc., a QIAGEN Company, for the NeuMoDx Flu A-B/RSV/
SARS-CoV-2 Vantage Assay is revoked as of May 24, 2023. The
Authorization for the LGC, Biosearch Technologies for the SARS-CoV-2
Real-
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Time and End-Point RT-PCR Test is revoked as of June 1, 2023. The
Authorization for the LGC, Biosearch Technologies, for the Biosearch
Technologies SARS-CoV-2 ultra-high-throughput End-Point RT-PCR Test is
revoked as of June 1, 2023. The Authorization for the Becton, Dickinson
and Co.'s BD Veritor At-Home COVID-19 Test is revoked as of June 15,
2023. The Authorization for the Verily Life Sciences' Verily COVID-19
RT-PCR Test is revoked as of June 21, 2023. The Authorization for the
Clinical Research Sequencing Platform (CRSP), LLC at the Broad
Institute of MIT and Harvard for the CRSP SARS-CoV-2 Real-time Reverse
Transcriptase (RT)-PCR Diagnostic Assay (Version 3) is revoked as of
July 3, 2023. The Authorization for the Xtrava Health's SPERA COVID-19
Ag Test is revoked as of August 3, 2023. The Authorization for the
Exact Sciences Laboratories' COVID-Flu Multiplex Assay is revoked as of
August 18, 2023. The Authorization for the Exact Sciences Laboratories'
SARS-CoV-2 (N gene detection) Test is revoked as of August 18, 2023.
The Authorization for the dba SpectronRx's Hymon SARS-CoV-2 Test Kit is
revoked as of August 23, 2023.
ADDRESSES: Submit a written request 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 December 7, 2020,
FDA issued the Authorization to Luminostics, Inc., for the for the Clip
COVID Rapid Antigen 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 25, 2021, FDA issued the
Authorization to NeuMoDx Molecular, Inc., a QIAGEN Company, for the
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay, 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 15, 2021, FDA
issued the Authorization to LGC, Biosearch Technologies for the SARS-
CoV-2 Real-Time and End-Point RT-PCR Test. Notice of the issuance of
this Authorization was published in the Federal Register on July 23,
2021 (86 FR 39040), subject to the terms of the Authorization. On
August 24, 2021, FDA issued the Authorization to Becton, Dickinson and
Co. for the BD Veritor At-Home COVID-19 Test, subject to the terms of
the Authorization. Notice of the issuance of this Authorization was
published in the Federal Register on October 28, 2021 (86 FR 59740), as
required by section 564(h)(1) of the FD&C Act. On April 26, 2022, FDA
issued the Authorization to LGC, Biosearch Technologies, for the
Biosearch Technologies SARS-CoV-2 ultra-high-throughput End-Point RT-
PCR Test, subject to the terms of the Authorization. Notice of the
issuance of this Authorization was published in the Federal Register on
July 22, 2022 (87 FR 43877), as required by section 564(h)(1) of the
FD&C Act. On September 8, 2020, FDA issued the Authorization to Verily
Life Sciences for the Verily COVID-19 RT-PCR 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 March 5, 2021, FDA
issued the Authorization to Clinical Research Sequencing Platform
(CRSP), LLC at the Broad Institute of MIT and Harvard for the CRSP
SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay
(Version 3), 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 October 12, 2021, FDA issued the Authorization to Xtrava
Health for the SPERA COVID-19 Ag Test, subject to the terms of the
Authorization. Notice of the issuance of this Authorization was
published in the Federal Register on March 22, 2022 (87 FR 16198), as
required by section 564(h)(1) of the FD&C Act. On July 1, 2021, FDA
issued the Authorization to Exact Sciences Laboratories for the COVID-
Flu Multiplex Assay, subject to the terms of the Authorization. Notice
of the issuance of this Authorization was published in the Federal
Register on October 28, 2021 (86 FR 59740), as required by section
564(h)(1) of the FD&C Act. On March 31, 2020, FDA issued the
Authorization to Exact Sciences Laboratories for the SARS-CoV-2 (N gene
detection) 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 May 22, 2020, FDA issued the
Authorization to dba SpectronRx for the Hymon SARS-CoV-2 Test Kit,
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.
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. Authorization Revocation Requests
In a request received by FDA on May 2, 2023, Luminostics, Inc.
requested the withdrawal of, and on May 5, 2023, FDA revoked, the
Authorization for the Luminostics, Inc.'s Clip COVID Rapid Antigen
Test. Because Luminostics, Inc. notified FDA that there are no viable
Clip COVID Rapid Antigen Test reagents remaining in distribution in the
United States and requested FDA withdraw the Luminostics, Inc.'s Clip
COVID Rapid Antigen 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 May 11, 2023, NeuMoDx Molecular,
Inc., a QIAGEN Company requested revocation
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of, and on May 24, 2023, FDA revoked, the Authorization for the NeuMoDx
Molecular, Inc., a QIAGEN Company's, NeuMoDx Flu A-B/RSV/SARS-CoV-2
Vantage Assay. Because NeuMoDx Molecular, Inc., a QIAGEN Company,
notified FDA that it has decided to discontinue distribution of the
NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay in the United States and
requested FDA voluntary revocation of the EUA for the NeuMoDx Flu A-B/
RSV/SARS-CoV-2 Vantage Assay, 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 May 1, 2023, LGC, Biosearch
Technologies requested revocation of, and on June 1, 2023, FDA revoked,
the Authorization for the LGC Biosearch Technologies' SARS-CoV-2 Real-
Time and End-Point RT-PCR Test. Because LGC, Biosearch Technologies
notified FDA that it is no longer marketing the SARS-CoV-2 Real-Time
and End-Point RT-PCR Test and requested FDA revoke the EUA for the LGC
Biosearch Technologies SARS-CoV-2 Real-Time and End-Point RT-PCR 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 May 1, 2023, LGC, Biosearch
Technologies requested revocation of, and on June 1, 2023, FDA revoked,
the Authorization for the LGC Biosearch Technologies' SARS-CoV-2 ultra-
high-throughput End-Point RT-PCR Test. Because LGC, Biosearch
Technologies notified FDA that it is no longer marketing the SARS-CoV-2
ultra-high-throughput End-Point RT-PCR Test and requested FDA revoke
the EUA for the LGC Biosearch Technologies SARS-CoV-2 ultra-high-
throughput End-Point RT-PCR 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 May 30, 2023, Becton, Dickinson and
Co. requested withdrawal of, and on June 15, 2023, FDA revoked, the
Authorization for the Becton, Dickinson and Co.'s BD Veritor At-Home
COVID-19 Test. Because Becton, Dickinson and Co. notified FDA that it
has discontinued the sale of BD Veritor At-Home COVID-19 Test and
requested FDA withdraw the EUA for the Becton, Dickinson and Co.'s BD
Veritor At-Home COVID-19 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 June 13, 2023, Verily Life Sciences
requested withdrawal of, and on June 21, 2023, FDA revoked, the
Authorization for the Verily Life Sciences' Verily COVID-19 RT-PCR
Test. Because Verily Life Sciences notified FDA that it is no longer
distributing the Verily COVID-19 Nasal Swab Kits (authorized as part of
the Verily COVID-19 RT-PCR Test) or offering testing services at the
Verily Life Sciences' laboratory using the Verily COVID-19 RT-PCR Test
and requested FDA withdraw the EUA for the Verily Life Sciences' Verily
COVID-19 RT-PCR 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 June 14, 2023, Clinical Research
Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and
Harvard, requested voluntary revocation of, and on July 3, 2023, FDA
revoked, the Authorization for the CRSP, LLC at the Broad Institute of
MIT and Harvard's CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-
PCR Diagnostic Assay (Version 3). Because CRSP, LLC at the Broad
Institute of MIT and Harvard notified FDA that it is no longer
distributing the CRSP Self-swab Kits (authorized as part of the CRSP
SARS-CoV-2 Real-time RT-PCR Diagnostic Assay (Version 3)) or offering
testing services at the CRSP, LLC at the Broad Institute of MIT and
Harvard laboratory using the CRSP SARS-CoV-2 Real-time RT-PCR
Diagnostic Assay (Version 3), and requested FDA revoke the EUA for the
CRSP, LLC at the Broad Institute of MIT and Harvard's CRSP SARS-CoV-2
Real-time RT-PCR Diagnostic Assay (Version 3), 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 July 18, 2023, Xtrava Health
requested the withdrawal of, and on August 3, 2023, FDA revoked, the
Authorization for the Xtrava Health's SPERA COVID-19 Ag Test. Because
Xtrava Health notified FDA that there are no SPERA COVID-19 Ag Test
reagents in distribution in the United States and requested FDA
withdraw the Xtrava Health's, SPERA COVID-19 Ag 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 August 1, 2023, Exact Sciences
Laboratories requested the withdrawal of, and on August 18, 2023, FDA
revoked, the Authorization for the Exact Sciences Laboratories' COVID-
Flu Multiplex Assay. Because Exact Sciences Laboratories notified FDA
that they have discontinued use of the COVID-Flu Multiplex Assay at
Exact Sciences Laboratories and requested FDA withdraw the Exact
Sciences Laboratories' COVID-Flu Multiplex Assay, 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 August 1, 2023, Exact Sciences
Laboratories requested the withdrawal of, and on August 18, 2023, FDA
revoked, the Authorization for the Exact Sciences Laboratories' SARS-
CoV-2 (N gene detection) Test. Because Exact Sciences Laboratories
notified FDA that they have discontinued use of the SARS-CoV-2 (N gene
detection) Test at Exact Sciences Laboratories and requested FDA
withdraw the Exact Sciences Laboratories' SARS-CoV-2 (N gene detection)
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 March 24, 2023, dba SpectronRx
requested the withdrawal of, and on August 23, 2023, FDA revoked, the
Authorization for the dba SpectronRx's Hymon SARS-CoV-2 Test Kit.
Because dba SpectronRx notified FDA that they are discontinuing the
distribution of the Hymon SARS-CoV-2 Test Kit and requested FDA
withdraw the dba SpectronRx for the Hymon SARS-CoV-2 Test Kit, 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 Luminostics, Inc.'s, Clip COVID Rapid Antigen
Test, NeuMoDx Molecular, Inc., a QIAGEN Company's, NeuMoDx Flu A-B/RSV/
SARS-CoV-2 Vantage Assay, LGC Biosearch Technologies' SARS-CoV-2 Real-
Time and End-Point RT-PCR Test, LGC Biosearch Technologies' SARS-CoV-2
ultra-high-throughput End-Point RT-PCR Test, Becton, Dickinson and
Co.'s BD Veritor At-Home COVID-19 Test, Verily Life Sciences' Verily
COVID-19 RT-PCR Test, Clinical Research Sequencing Platform (CRSP), LLC
at the Broad Institute of MIT and Harvard's CRSP SARS-CoV-2 Real-time
Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3), Xtrava
Health's SPERA COVID-19 Ag Test, Exact Sciences Laboratories' COVID-Flu
Multiplex Assay, Exact Sciences
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Laboratories' SARS-CoV-2 (N gene detection) Test, and dba SpectronRx's
Hymon SARS-CoV-2 Test Kit. These 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: October 2, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22188 Filed 10-4-23; 8:45 am]
BILLING CODE 4164-01-C
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