Notice2024-19724
Revocation of Authorization of Emergency Use of In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 3, 2024
Effective
July 3, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 170 (Tuesday, September 3, 2024)</title>
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[Federal Register Volume 89, Number 170 (Tuesday, September 3, 2024)]
[Notices]
[Pages 71372-71374]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>.
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.
BILLING CODE 4164-01-P
[GRAPHIC] [TIFF OMITTED] TN03SE24.085
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[GRAPHIC] [TIFF OMITTED] TN03SE24.086
Dated: August 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-19724 Filed 8-30-24; 8:45 am]
BILLING CODE 4164-01-C
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