Notice2022-13639
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
June 27, 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 Quanterix Corp. for the Simoa Semi- Quantitative SARS-CoV-2 IgG Antibody Test and for the Simoa SARS-CoV-2 N Protein Antigen Test. 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 122 (Monday, June 27, 2022)</title>
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[Federal Register Volume 87, Number 122 (Monday, June 27, 2022)]
[Notices]
[Pages 38163-38165]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-13639]
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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 Quanterix Corp. for the Simoa Semi-
Quantitative SARS-CoV-2 IgG Antibody Test and for the Simoa SARS-CoV-2
N Protein Antigen Test. 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 for the Simoa Semi-Quantitative SARS-CoV-2
IgG Antibody Test and for the Simoa SARS-CoV-2 N Protein Antigen Test
are revoked as of May 10, 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 December 23, 2020, FDA issued
an EUA to Quanterix Corp. for the Simoa Semi-Quantitative SARS-CoV-2
IgG Antibody Test, 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 January 5, 2021, FDA issued an EUA to
Quanterix Corp. for the Simoa SARS-CoV-2 N Protein Antigen Test,
subject to the terms of the Authorization. Notice of the issuance of
this Authorization was published in the Federal Register on April 23,
2021, 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 requests received by FDA on May 5, 2022, and May 9, 2022,
Quanterix Corp. requested withdrawal of, and on May 10, 2022, FDA
revoked, the Authorization for the Simoa Semi-Quantitative SARS-CoV-2
IgG Antibody Test. Because Quanterix Corp. notified FDA that Quanterix
Corp. did not distribute the authorized product in the United States
and requested FDA to withdraw the authorization of the Simoa Semi-
Quantitative SARS-CoV-2 IgG Antibody Test, FDA determined that it is
appropriate to protect the public health or safety to revoke this
Authorization.
In requests received by FDA on May 5, 2022, and May 9, 2022,
Quanterix Corp. requested withdrawal of, and on May 10, 2022, FDA
revoked, the Authorization for the Simoa SARS-CoV-2 N Protein Antigen
Test. Because Quanterix Corp. notified FDA that Quanterix Corp. has
discontinued distribution of the authorized product and requested FDA
withdraw the authorization of the Simoa SARS-CoV-2 N Protein Antigen
Test, FDA 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 of Quanterix Corp. for the Simoa Semi-Quantitative
SARS-CoV-2 IgG Antibody Test and for the Simoa SARS-CoV-2 N Protein
Antigen Test. 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: June 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-13639 Filed 6-24-22; 8:45 am]
BILLING CODE 4164-01-P
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