87 FR 43 pgs. 12459-12461 - Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
Type: NOTICEVolume: 87Number: 43Pages: 12459 - 12461
Pages: 12459, 12460, 12461Docket number: [Docket No. FDA-2022-N-0150]
FR document: [FR Doc. 2022-04635 Filed 3-3-22; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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.
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.
BILLING CODE 4164-01-P
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[Federal Register graphic "EN04MR22.003" is not available. Please view the graphic in the PDF version of this document.]
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[Federal Register graphic "EN04MR22.004" is not available. Please view the graphic in the PDF version of this document.]
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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