Notice2021-18789
Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
Primary source
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Published
August 31, 2021
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 Curative Inc. for the Curative SARS-Cov-2 Assay. FDA revoked the Authorization on July 15, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as requested by Curative Inc. on June 16, 2021. The revocation, which includes an explanation of the reasons for the revocation, is reprinted in this document.
Full Text
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<title>Federal Register, Volume 86 Issue 166 (Tuesday, August 31, 2021)</title>
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[Federal Register Volume 86, Number 166 (Tuesday, August 31, 2021)]
[Notices]
[Pages 48736-48737]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-18789]
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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 Curative Inc. for the Curative SARS-Cov-2 Assay. FDA revoked
the Authorization on July 15, 2021, under the Federal Food, Drug, and
Cosmetic Act (FD&C Act), as requested by Curative Inc. on June 16,
2021. The revocation, which includes an explanation of the reasons for
the revocation, is reprinted in this document.
DATES: The Authorization for the Curative SARS-Cov-2 Assay is revoked
as of July 15, 2021.
ADDRESSES: Submit written requests 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, 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) 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 16, 2020, FDA issued the Authorization to Curative
Inc. (original issuance to KorvaLabs, Inc. under the name Curative-
Korva SARS-Cov-2 Assay). Notice of the issuance of the 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. The authorization of
a device for emergency use under section 564 of the FD&C Act may,
pursuant to section 564(g)(2)(C) of the FD&C Act, be revoked when
circumstances make such revocation appropriate to protect the public
health or safety.
II. EUA Revocation Request of an In Vitro Diagnostic Device
On June 16, 2021, Curative Inc. requested the revocation of, and on
July 15, 2021, FDA revoked, the Authorization for the Curative SARS-
Cov-2 Assay. Because Curative Inc. notified FDA that it will no longer
be using the Curative SARS-Cov-2 Assay as of July 15, 2021, and
requested FDA revoke the authorization effective that day, 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 <a href="https://www.regulations.gov/">https://www.regulations.gov/</a> and <a href="https://www.fda.gov/media/150773/download">https://www.fda.gov/media/150773/download</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 for the Curative 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 48737]]
[GRAPHIC] [TIFF OMITTED] TN31AU21.042
Dated: August 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-18789 Filed 8-30-21; 8:45 am]
BILLING CODE 4164-01-C
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