2021-18789. 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.

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.

Dated: August 26, 2021.

Lauren K. Roth,

Acting Principal Associate Commissioner for Policy.