Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability, 12459-12461 [2022-04635]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 87, Number 43 (Friday, March 4, 2022)]
[Notices]
[Pages 12459-12461]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04635]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0150]


Revocation of Two 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 Bio-Rad Laboratories for the BioPlex 2200 
SARS-CoV-2 IgG, and Quotient Suisse SA for the MosaiQ COVID-19 Antibody 
Magazine. 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 Authorizations are revoked as of January 11, 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 July 1, 2021, FDA issued an 
EUA to Bio-Rad Laboratories for the BioPlex 2200 SARS-CoV-2 IgG, 
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 59738), as required by section 564(h)(1) of the FD&C Act. 
On September 25, 2020, FDA issued an EUA to Quotient Suisse SA for the 
MosaiQ COVID-19 Antibody Magazine, 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 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. EUA Revocation Requests

    In a request received by FDA on December 20, 2021, Bio-Rad 
Laboratories requested revocation of, and on January 11, 2022, FDA 
revoked, the Authorization for the BioPlex 2200 SARS-CoV-2 IgG. Because 
Bio-Rad Laboratories notified FDA that Bio-Rad Laboratories has not 
commercialized the authorized product in the United States and 
requested FDA revoke the BioPlex 2200 SARS-CoV-2 IgG, 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 December 22, 2021, Quotient Suisse 
SA requested termination of, and on January 11, 2022, FDA revoked, the 
Authorization for the MosaiQ COVID-19 Antibody Magazine. Because 
Quotient Suisse SA notified FDA that Quotient Suisse SA has decided not 
to continue to commercially support the product and requested FDA 
terminate the MosaiQ COVID-19 Antibody Magazine, 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 Bio-Rad Laboratories for the BioPlex 2200 SARS-
CoV-2 IgG and of Quotient Suisse SA for the MosaiQ COVID-19 Antibody 
Magazine. 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: February 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04635 Filed 3-3-22; 8:45 am]
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