[Federal Register Volume 89, Number 56 (Thursday, March 21, 2024)]
[Notices]
[Pages 20211-20218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05980]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-1091]


Revocation of Six 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 Life Technologies Corp. (a legal entity of 
Thermo Fisher Scientific, Inc.), for the TaqPath COVID-19 Pooling Kit; 
Bio-Rad Laboratories, Inc., for the Reliance SARS-CoV-2 RT-PCR Assay 
Kit; Revvity, Inc., (on behalf of Revvity Omics (a Revvity, Inc. 
company that was a rebranding of PerkinElmer Genomics)), for the 
PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit; bioM[eacute]rieux SA for 
the VIDAS SARS-CoV-2 IgM kit; bioM[eacute]rieux SA for the VIDAS SARS-
CoV-2 IgG kit; and Luminex Corp. for the xMAP SARS-CoV-2 Multi-Antigen 
IgG Assay. 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 Authorization for the Life Technologies Corp.'s (a legal 
entity of Thermo Fisher Scientific, Inc.) TaqPath COVID-19 Pooling Kit 
is revoked as of January 16, 2024. The Authorization for the Bio-Rad 
Laboratories, Inc.'s Reliance SARS-CoV-2 RT-PCR Assay Kit is revoked as 
of January 16, 2024. The Authorization for the Revvity, Inc.'s (on 
behalf of Revvity Omics (a Revvity, Inc. company that was a rebranding 
of PerkinElmer Genomics)) PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit is 
revoked as of January 30, 2024. The Authorization for the 
bioM[eacute]rieux SA's VIDAS SARS-CoV-2 IgM kit is revoked as of 
January 31, 2024. The Authorization for the bioM[eacute]rieux SA's 
VIDAS SARS-CoV-2 IgG kit is revoked as of January 31, 2024. The 
Authorization for the Luminex Corp.'s xMAP SARS-CoV-2 Multi-Antigen IgG 
Assay is revoked as of February 22, 2024.

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 May 25, 2021, FDA 
issued the Authorization to Life Technologies Corp. (a legal entity of 
Thermo Fisher Scientific, Inc.), for the TaqPath COVID-19 Pooling Kit, 
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 at 39043), as required by section 564(h)(1) of the 
FD&C Act.
    On January 15, 2021, FDA issued the Authorization to Bio-Rad 
Laboratories, Inc., for the Reliance SARS-CoV-2 RT-PCR Assay Kit, 
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 21549 at 21751), as required by section 564(h)(1) of the 
FD&C Act.
    On April 12, 2021, FDA issued the Authorization to PerkinElmer 
Genomics, (Revvity, Inc. (Revvity Omics, a Revvity, Inc. company that 
was a rebranding of PerkinElmer Genomics)) for the PerkinElmer SARS-
CoV-2 RT-qPCR Reagent Kit, 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 at 39042), as required 
by section 564(h)(1) of the FD&C Act.
    On August 6, 2020, FDA issued the Authorization to 
bioM[eacute]rieux SA for the VIDAS SARS-CoV-2 IgM 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 at 74350), as required by section 564(h)(1) of the 
FD&C Act.
    On August 6, 2020, FDA issued the Authorization to 
bioM[eacute]rieux SA for the

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VIDAS SARS-CoV-2 IgG 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 at 74350), as 
required by section 564(h)(1) of the FD&C Act.
    On July 16, 2020, FDA issued the Authorization to Luminex Corp. for 
the xMAP SARS-CoV-2 Multi-Antigen IgG Assay, 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 at 
74350), 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 13, 2023, Life 
Technologies Corp. (a legal entity of Thermo Fisher Scientific, Inc.), 
requested the revocation of, and on January 16, 2024, FDA revoked, the 
Authorization for the Life Technologies Corp.'s (a legal entity of 
Thermo Fisher Scientific, Inc.) TaqPath COVID-19 Pooling Kit. Because 
Life Technologies Corp. notified FDA that they are no longer 
commercially supporting the TaqPath COVID-19 Pooling Kit and requested 
FDA revoke the Authorization for Life Technologies Corp.'s TaqPath 
COVID-19 Pooling Kit, 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 January 7, 2024, Bio-Rad 
Laboratories, Inc., requested the revocation of, and on January 16, 
2024, FDA revoked, the Authorization for Bio-Rad Laboratories, Inc.'s 
Reliance SARS-CoV-2 RT-PCR Assay Kit. Because Bio-Rad Laboratories, 
Inc. notified FDA that they have ceased U.S. distribution of the Bio-
Rad Reliance SARS-CoV-2 RT-PCR Assay Kit and requested FDA revoke the 
Authorization for Bio-Rad Laboratories, Inc.'s Reliance SARS-CoV-2 RT-
PCR Assay Kit, 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 January 19, 2024, Revvity, Inc. (on 
behalf of Revvity Omics (a Revvity, Inc. company that was a rebranding 
of PerkinElmer Genomics)), requested the revocation of, and on January 
30, 2024, FDA revoked, the Authorization for the Revvity, Inc.'s 
PerkinElmer SARS-CoV-2 RT-qPCR Reagent Kit. Because Revvity, Inc. 
notified FDA that they have discontinued use of the PerkinElmer SARS-
CoV-2 RT-qPCR Reagent Kit at the Revvity Omics laboratory, and 
requested FDA revoke the Authorization for Revvity, Inc.'s PerkinElmer 
SARS-CoV-2 RT-qPCR Reagent Kit, 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 January 22, 2024, bioM[eacute]rieux 
SA, requested the revocation of, and on January 31, 2024, FDA revoked, 
the Authorization for the bioM[eacute]rieux SA's VIDAS SARS-CoV-2 IgM 
kit. Because bioM[eacute]rieux SA notified FDA that they will no longer 
commercially support the authorized product, and requested FDA revoke 
the Authorization for bioM[eacute]rieux SA's VIDAS SARS-CoV-2 IgM kit, 
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 January 22, 2024, bioM[eacute]rieux 
SA, requested the revocation of, and on January 31, 2024, FDA revoked, 
the Authorization for the bioM[eacute]rieux SA's VIDAS SARS-CoV-2 IgG 
kit. Because bioM[eacute]rieux SA notified FDA that they will no longer 
commercially support the authorized product, and requested FDA revoke 
the Authorization for bioM[eacute]rieux SA's VIDAS SARS-CoV-2 IgG kit, 
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 February 19, 2024, Luminex Corp., 
requested the withdrawal of, and on February 22, 2024, FDA revoked, the 
Authorization for the Luminex Corp.'s xMAP SARS-CoV-2 Multi-Antigen IgG 
Assay. Because Luminex Corp. notified FDA that they have discontinued 
the manufacture of the authorized product, and requested FDA revoke the 
Authorization for Luminex Corp.'s xMAP SARS-CoV-2 Multi-Antigen IgG 
Assay, 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 Life Technologies Corp.'s (a legal entity of 
Thermo Fisher Scientific, Inc.) TaqPath COVID-19 Pooling Kit, Bio-Rad 
Laboratories, Inc.'s Reliance SARS-CoV-2 RT-PCR Assay Kit, Revvity, 
Inc.'s (on behalf of Revvity Omics (a Revvity, Inc. company that was a 
rebranding of PerkinElmer Genomics)) PerkinElmer SARS-CoV-2 RT-qPCR 
Reagent Kit, bioM[eacute]rieux SA's VIDAS SARS-CoV-2 IgM kit, 
bioM[eacute]rieux SA's VIDAS SARS-CoV-2 IgG kit, and Luminex Corp.'s 
xMAP SARS-CoV-2 Multi-Antigen IgG Assay. 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.
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    Dated: March 15, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05980 Filed 3-20-24; 8:45 am]
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