Notice2022-04635
Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
Primary source
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Published
March 4, 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 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.
Full Text
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<title>Federal Register, Volume 87 Issue 43 (Friday, March 4, 2022)</title>
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[Federal Register Volume 87, Number 43 (Friday, March 4, 2022)]
[Notices]
[Pages 12459-12461]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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 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.
BILLING CODE 4164-01-P
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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]
BILLING CODE 4164-01-C
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