Document ID: FDA-2021-N-0973-0001
Agency: fda
Document Type: Notice
Title: Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID–19; Availability
Posted Date: 2021-09-24T04:00Z

[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Pages 53064-53067]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20754]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0973]

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.

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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

[[Page 53065]]

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.
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    Dated: September 17, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-20754 Filed 9-23-21; 8:45 am]
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