Notice2024-05980
Revocation of Six Authorizations of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 21, 2024
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 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.
Full Text
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<title>Federal Register, Volume 89 Issue 56 (Thursday, March 21, 2024)</title>
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[Federal Register Volume 89, Number 56 (Thursday, March 21, 2024)]
[Notices]
[Pages 20211-20218]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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 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.
BILLING CODE 4164-01-P
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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]
BILLING CODE 4164-01-C
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