87 FR 14 pgs. 3306-3313 - Revocation of Five Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
Type: NOTICEVolume: 87Number: 14Pages: 3306 - 3313
Pages: 3306, 3307, 3308, 3309, 3310, 3311, 3312, 3313Docket number: [Docket No. FDA-2022-N-0049]
FR document: [FR Doc. 2022-01139 Filed 1-20-22; 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-0049]
Revocation of Five 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:
[top] The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the
DATES:
The Authorization for the Cellex q-SARS-CoV-2 IgG/IgM Rapid Test is revoked as of December 10, 2021. The Authorizations for the SARS-COV-2 R-GENE, Atellica IM SARS-CoV-2 IgG (COV2G), and ADVIA Centaur SARS-CoV-2 IgG (COV2G) are revoked as of December 17, 2021. The Authorization for the Xpert Omni SARS-CoV-2 is revoked as of December 20, 2021.
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 April 1, 2020, FDA issued an EUA to Cellex Inc. for the Cellex q-SARS-CoV-2 IgG/IgM Rapid Test, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on June 5, 2020 (85 FR 34638), as required by section 564(h)(1) of the FD&C Act. On May 6, 2020, FDA issued an EUA to BioMérieux SA for the SARS-COV-2 R-GENE, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on July 14, 2020 (85 FR 42407), as required by section 564(h)(1) of the FD&C Act. On July 31, 2020, FDA issued an EUA to Siemens Healthcare Diagnostics Inc. for the Atellica IM SARS-CoV-2 IgG (COV2G), subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on November 20, 2020 (85 FR 74346), as required by section 564(h)(1) of the FD&C Act. On July 31, 2020, FDA issued an EUA to Siemens Healthcare Diagnostics Inc. for the ADVIA Centaur SARS-CoV-2 IgG (COV2G), subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the Federal Register on November 20, 2020 (85 FR 74346), as required by section 564(h)(1) of the FD&C Act. On November 27, 2020, FDA issued an EUA to Cepheid for the Xpert Omni SARS-CoV-2, 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
On December 7, 2021, Cellex requested withdrawal of, and on December 10, 2021, FDA revoked, the Authorization for the Cellex q-SARS-CoV-2 IgG/IgM Rapid Test. Because Cellex requested that FDA withdraw the Authorization and FDA understands the product is no longer being distributed, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. On December 10, 2021, FDA received a request from BioMérieux SA for the revocation of, and on December 17, 2021, FDA revoked, the Authorization for the SARS-COV-2 R-GENE. Because BioMérieux SA notified FDA that BioMérieux SA has decided to no longer commercially support the authorized product and requested FDA revoke the Authorization, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. On December 9, 2021, FDA received a request from Siemens Healthcare Diagnostics Inc. for the voluntary removal of, and on December 17, 2021, FDA revoked, the Authorization for the Atellica IM SARS-CoV-2 IgG (COV2G). Because Siemens Healthcare Diagnostics Inc. notified FDA that Siemens Healthcare Diagnostics Inc. has decided to no longer market the authorized product and requested FDA voluntarily remove the Atellica IM SARS-CoV-2 IgG (COV2G) from FDA's list of authorized devices, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. On December 9, 2021, FDA received a request from Siemens Healthcare Diagnostics Inc. for the voluntary removal of, and on December 17, 2021, FDA revoked, the Authorization for the ADVIA Centaur SARS-CoV-2 IgG (COV2G). Because Siemens Healthcare Diagnostics Inc. notified FDA that Siemens Healthcare Diagnostics Inc. has decided to no longer market the authorized product and requested FDA voluntarily remove the ADVIA Centaur SARS-CoV-2 IgG (COV2G) from FDA's list of authorized devices, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. On December 17, 2021, FDA received a request from Cepheid for the revocation of, and on December 20, 2021, FDA revoked, the Authorization for the Xpert Omni SARS-CoV-2. Because Cepheid has notified FDA that Cepheid has not commercially distributed any of the Xpert Omni SARS-CoV-2 product due to the current public clinical needs being met by Cepheid's other EUA tests that are available and requested FDA revoke the EUA for the Xpert Omni SARS-CoV-2, 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
[top] 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 for
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Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01139 Filed 1-20-22; 8:45 am]
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