Notice2022-08230
Revocation of Five Authorizations of Emergency Use of In Vitro Diagnostic Devices 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
April 18, 2022
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 BillionToOne, Inc. for the qSanger-COVID-19 Assay, RTA Laboratories Biological Products Pharmaceutical and Machinery Industry (RTA) for the Diagnovital SARS-CoV-2 Real-Time PCR Kit, DiaSorin Inc. for the DiaSorin LIAISON SARS-CoV-2 IgM Assay, and CENTOGENE US, LLC for both the CentoFast-SARS-CoV-2 RT-PCR Assay and CentoSure SARS-CoV-2 RT-PCR Assay. 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.
Full Text
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<title>Federal Register, Volume 87 Issue 74 (Monday, April 18, 2022)</title>
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[Federal Register Volume 87, Number 74 (Monday, April 18, 2022)]
[Notices]
[Pages 22900-22906]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08230]
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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.
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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 BillionToOne, Inc. for the qSanger-COVID-19
Assay, RTA Laboratories Biological Products Pharmaceutical and
Machinery Industry (RTA) for the Diagnovital SARS-CoV-2 Real-Time PCR
Kit, DiaSorin Inc. for the DiaSorin LIAISON SARS-CoV-2 IgM Assay, and
CENTOGENE US, LLC for both the CentoFast-SARS-CoV-2 RT-PCR Assay and
CentoSure SARS-CoV-2 RT-PCR Assay. 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 qSanger-COVID-19 Assay is revoked as
of March 10, 2022. The Authorization for the Diagnovital SARS-CoV-2
Real-Time PCR Kit is revoked as of March 14, 2022. The Authorization
for the DiaSorin LIAISON SARS-CoV-2 IgM Assay is revoked as of March
15, 2022. The Authorizations for the CentoFast-SARS-CoV-2 RT-PCR Assay
and CentoSure SARS-CoV-2 RT-PCR Assay are revoked as of March 17, 2022.
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 September 4, 2020, FDA issued
an EUA to BillionToOne, Inc. for the qSanger-COVID-19 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), as required by section 564(h)(1) of the FD&C Act.
On June 12, 2020, FDA issued an EUA to RTA for the Diagnovital SARS-
CoV-2 Real-Time PCR 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. On September 29, 2020, FDA issued an
EUA to DiaSorin Inc. for the DiaSorin LIAISON SARS-CoV-2 IgM Assay,
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 July 1, 2020, FDA issued an EUA to CENTOGENE US, LLC for the
CentoFast-SARS-CoV-2 RT-PCR 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),
as required by section 564(h)(1) of the FD&C Act. On September 29,
2020, FDA issued an EUA to CENTOGENE US, LLC for the CentoSure SARS-
CoV-2 RT-PCR Assay, 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 changes 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
[[Page 22901]]
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 February 25, 2022, BillionToOne, Inc. requested revocation of,
and on March 10, 2022, FDA revoked, the Authorization for the qSanger-
COVID-19 Assay. Because BillionToOne, Inc. notified FDA that it has
decided to discontinue distribution of the qSanger-COVID-19 Assay and
requested FDA revoke the EUA for the qSanger-COVID-19 Assay, FDA has
determined that it is appropriate to protect the public health or
safety to revoke this Authorization. FDA received a request dated
February 15, 2022, from RTA for the revocation of, and on March 14,
2022, FDA revoked, the Authorization for the Diagnovital SARS-CoV-2
Real-Time PCR Kit. Because RTA notified FDA that the EUA for the
Diagnovital SARS-CoV-2 Real-Time PCR Kit is no longer required and
requested that FDA revoke the EUA for the Diagnovital SARS-CoV-2 Real-
Time PCR Kit, FDA has determined that it is appropriate to protect the
public health or safety to revoke this Authorization. On March 10,
2022, FDA received a request from DiaSorin Inc. for the revocation of,
and on March 15, 2022, FDA revoked, the Authorization for the DiaSorin
LIAISON SARS-CoV-2 IgM Assay. Because DiaSorin Inc. notified FDA that
DiaSorin Inc. has decided to discontinue commercial distribution and
support of the DiaSorin LIAISON SARS-CoV-2 IgM Assay and requested FDA
revoke the EUA for the DiaSorin LIAISON SARS-CoV-2 IgM Assay, FDA has
determined that it is appropriate to protect the public health or
safety to revoke this Authorization. On March 14, 2022, FDA received a
request from CENTOGENE US, LLC. for the revocation of, and on March 17,
2022, FDA revoked, the Authorization for the CentoFast-SARS-CoV-2 RT-
PCR Assay. Because CENTOGENE US, LLC. notified FDA that it does not
offer the CentoFast-SARS-CoV-2 RT-PCR Assay anymore and requested FDA
revoke the EUA for the CentoFast-SARS-CoV-2 RT-PCR Assay, FDA has
determined that it is appropriate to protect the public health or
safety to revoke this Authorization. On March 14, 2022, FDA received a
request from CENTOGENE US, LLC. for the revocation of, and on March 17,
2022, FDA revoked, the Authorization for the CentoSure SARS-CoV-2 RT-
PCR Assay. Because CENTOGENE US, LLC. notified FDA that it does not
offer the CentoSure SARS-CoV-2 RT-PCR Assay anymore and requested FDA
revoke the EUA for the CentoSure SARS-CoV-2 RT-PCR 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 EUAs for BillionToOne, Inc.'s qSanger-COVID-19 Assay,
RTA's Diagnovital SARS-CoV-2 Real-Time PCR Kit, DiaSorin Inc.'s
DiaSorin LIAISON SARS-CoV-2 IgM Assay, and CENTOGENE US, LLC's
CentoFast-SARS-CoV-2 RT-PCR Assay and CentoSure SARS-CoV-2 RT-PCR
Assay. 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
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Dated: April 12, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08230 Filed 4-15-22; 8:45 am]
BILLING CODE 4164-01-C
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</html>Indexed from Federal Register on April 18, 2022.
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