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.

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.