Notice2022-21998
Revocation of Authorization of Emergency Use of an 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
October 11, 2022
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 Laboratorio Clinico Toledo for the Laboratorio Clinico Toledo SARS-CoV-2 Assay. FDA revoked this Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document.
Full Text
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<title>Federal Register, Volume 87 Issue 195 (Tuesday, October 11, 2022)</title>
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[Federal Register Volume 87, Number 195 (Tuesday, October 11, 2022)]
[Notices]
[Pages 61334-61335]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-21998]
[[Page 61334]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0412]
Revocation of Authorization of Emergency Use of an 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 Laboratorio Clinico Toledo for the Laboratorio Clinico Toledo
SARS-CoV-2 Assay. FDA revoked this Authorization under the Federal
Food, Drug, and Cosmetic Act (FD&C Act). The revocation, which includes
an explanation of the reasons for revocation, is reprinted in this
document.
DATES: The Authorization for the Laboratorio Clinico Toledo SARS-CoV-2
Assay is revoked as of September 21, 2022.
ADDRESSES: Submit a written request for a single copy of the revocation
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 revocation may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the revocation.
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, 301-796-8510 (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 6, 2020, FDA issued an
EUA to Laboratorio Clinico Toledo for the Laboratorio Clinico Toledo
SARS-CoV-2 Assay, 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. EUA Revocation Request
In a request received by FDA on September 8, 2022, Laboratorio
Clinico Toledo requested withdrawal of, and on September 21, 2022, FDA
revoked, the Authorization for the Laboratorio Clinico Toledo SARS-CoV-
2 Assay. Because Laboratorio Clinico Toledo notified FDA that
Laboratorio Clinico Toledo has decided to no longer test using the
Laboratorio Clinico Toledo SARS-CoV-2 Assay and requested FDA withdraw
the EUA for the Laboratorio Clinico Toledo SARS-CoV-2 Assay, 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
revocation is 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 Laboratorio Clinico Toledo for the Laboratorio
Clinico Toledo SARS-CoV-2 Assay. 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
[[Page 61335]]
[GRAPHIC] [TIFF OMITTED] TN11OC22.000
Dated: October 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21998 Filed 10-7-22; 8:45 am]
BILLING CODE 4164-01-C
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