Document ID: FDA-2022-N-0049-0002
Agency: fda
Document Type: Notice
Title: Revocation of Five Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID–19; Availability
Posted Date: 2022-04-18T04:00Z

[Federal Register Volume 87, Number 74 (Monday, April 18, 2022)]
[Notices]
[Pages 22900-22906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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 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.
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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]
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