Document ID: FDA-2021-N-0412-0002
Agency: fda
Document Type: Notice
Title: Revocation of Authorization of 
Emergency Use of an In Vitro 
Diagnostic Device for Detection and/or 
Diagnosis of COVID–19; Availability
Posted Date: 2021-08-31T04:00Z

[Federal Register Volume 86, Number 166 (Tuesday, August 31, 2021)]
[Notices]
[Pages 48736-48737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov/ and https://www.fda.gov/media/150773/download.

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.
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[[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]
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