Document ID: FDA-2023-N-4182-0001
Agency: fda
Document Type: Notice
Title: Revocation of Eleven Authorizations of Emergency Use of In Vitro Diagnostic
Device for Detection and/or Diagnosis of COVID–19; Availability
Posted Date: 2023-10-05T04:00Z

[Federal Register Volume 88, Number 192 (Thursday, October 5, 2023)]
[Notices]
[Pages 69192-69205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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

[[Page 69194]]

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 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 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

[[Page 69195]]

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.
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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