Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices 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 Authorizations (EUAs) (the Authorizations) issued to Gravity Diagnostics, LLC (Gravity) for the Gravity Diagnostics COVID-19 Assay, Materials and Machines Corporation of America (DBA MatmaCorp, Inc.) (Matmacorp) for the MatMaCorp COVID-19 2SF Test, and Guardant Health Inc. (Guardant) for the Guardant-19. FDA revoked Gravity's Authorization on July 21, 2021, Matmacorp's Authorization on August 3, 2021, and Guardant's Authorization on August 6, 2021, under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocations, which include an explanation of the reasons for each revocation, are reprinted in this document.

DATES:

Gravity's Authorization is revoked as of July 21, 2021. Matmacorp's Authorization is revoked as of August 3, 2021. Guardant's Authorization is revoked as of August 6, 2021.

ADDRESSES:

Submit written requests for single copies of the revocations 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 revocations may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the revocations.

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 June 1, 2020, FDA issued an EUA to Gravity for the Gravity Diagnostics COVID-19 Assay. 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. On August 21, 2020, FDA issued an EUA to Guardant for the Guardant-19. 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. On December 17, 2020, FDA issued an EUA to Matmacorp, for the MatMaCorp COVID-19 2SF Test. Notice of the issuance of this Authorization was published in the Federal Register on April 23, 2021 (86 FR 21749), 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) 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 Requests

On March 11, 2021, and reconfirmed July 12, 2021, Gravity requested the revocation of, and on July 21, 2021, FDA revoked, the Authorization for the Gravity Diagnostics COVID-19 Assay. Because Gravity notified FDA that it is no longer using the Gravity Diagnostics COVID-19 Assay and requested FDA revoke the Authorization, FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization. On July 29, 2021, Matmacorp requested the revocation of, and on August 3, 2021, FDA revoked, the Authorization for the MatMaCorp COVID-19 2SF Test. Because Matmacorp notified FDA that it will no longer be distributing the MatMaCorp COVID-19 2SF Test as of July 31, 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. On August 2, 2021, Guardant requested the revocation of, and on August 6, 2021, FDA revoked, the Authorization for the Guardant-19. Because Guardant requested that FDA revoke the Authorization, 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/,, https://www.fda.gov/media/151030/download,, https://www.fda.gov/media/151349/download,, and https://www.fda.gov/media/151378/download.

IV. The Revocations

Having concluded that the criteria for revocation of the Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA has revoked the EUAs for Gravity's Gravity Diagnostics COVID-19 Assay, Matmacorp's MatMaCorp COVID-19 2SF Test, and Guardant's Guardant-19. The revocations in their entirety follow and provide an explanation of the reasons for each revocation, as required by section 564(h)(1) of the FD&C Act.