[Federal Register Volume 89, Number 170 (Tuesday, September 3, 2024)]
[Notices]
[Pages 71372-71374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19724]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0150]


Revocation of Authorization of Emergency Use of In Vitro 
Diagnostic Device 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 Authorization (EUA) (the Authorization) 
issued to Roche Molecular Systems, Inc, for the cobas SARS-CoV-2 & 
Influenza A/B nucleic acid test for use on the cobas Liat System, that 
includes the cobas SARS-CoV-2 & Influenza A/B Quality Control Kit. FDA 
revoked the Authorization under the Federal Food, Drug, and Cosmetic 
Act (FD&C Act) as requested by the Authorization holder. The 
revocation, which includes an explanation of the reasons for 
revocation, is reprinted at the end of this document.

DATES: The revocation of the Authorization for the Roche Molecular 
Systems, Inc.'s for the cobas SARS-CoV-2 & Influenza A/B nucleic acid 
test for use on the cobas Liat System, that includes the cobas SARS-
CoV-2 & Influenza A/B Quality Control Kit is effective as of July 3, 
2024.

ADDRESSES: Submit written requests for a single copy of the revocation 
to the Office of Policy, Center for Devices and Radiological Health, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 
5431, 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 revocation may be sent. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the revocation.

FOR FURTHER INFORMATION CONTACT: Kim Sapsford-Medintz, Office of 
Product Evaluation and Quality, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 3216, Silver Spring, MD 20993-0002, 301-796-0311 (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, radiological, or nuclear agent or 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 September 14, 2020, FDA issued the Authorization to Roche 
Molecular Systems, Inc, for the cobas SARS-CoV-2 & Influenza A/B 
nucleic acid test for use on the cobas Liat System, 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.
    Subsequent updates to the Authorization 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. Authorization Revocation Request

    In a request received by FDA on June 21, 2024, Roche Molecular 
Systems, Inc., requested the revocation of, and on July 3, 2024, FDA 
revoked, the Authorization for the Roche Molecular Systems, Inc.'s 
cobas SARS-CoV-2 & Influenza A/B nucleic acid test for use on the cobas 
Liat System, that includes the cobas SARS-CoV-2 & Influenza A/B Quality 
Control Kit. Because Roche Molecular Systems, Inc., notified FDA that 
they have ceased the manufacture and distribution of the cobas SARS-
CoV-2 & Influenza A/B nucleic acid test for use on the cobas Liat 
System, that includes the cobas SARS-CoV-2 & Influenza A/B Quality 
Control Kit and requested FDA revoke Roche Molecular Systems, Inc.'s, 
cobas SARS-CoV-2 & Influenza A/B nucleic acid test for use on the cobas 
Liat System, that includes the cobas SARS-CoV-2 & Influenza A/B Quality 
Control Kit, 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

[[Page 71373]]

revocations are available on the internet at https://www.regulations.gov/.

IV. The Revocation

    Having concluded that the criteria for revocation of the 
Authorization under section 564(g)(2)(C) of the FD&C Act are met, FDA 
has revoked the EUA of Roche Molecular Systems, Inc.'s cobas SARS-CoV-2 
& Influenza A/B nucleic acid test for use on the cobas Liat System, 
that includes the cobas SARS-CoV-2 & Influenza A/B Quality Control Kit. 
The revocation in its entirety follows and provides an explanation of 
the reasons for revocation, as required by section 564(h)(1) of the 
FD&C Act.
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    Dated: August 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19724 Filed 8-30-24; 8:45 am]
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