Document ID: FDA-2022-N-0150-0005
Agency: fda
Document Type: Notice
Title: Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID–19; Availability
Posted Date: 2022-06-27T04:00Z

[Federal Register Volume 87, Number 122 (Monday, June 27, 2022)]
[Notices]
[Pages 38163-38165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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 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