Notice2021-20754
Revocation of Three Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID-19; Availability
Primary source
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Published
September 24, 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 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.
Full Text
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<title>Federal Register, Volume 86 Issue 183 (Friday, September 24, 2021)</title>
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[Federal Register Volume 86, Number 183 (Friday, September 24, 2021)]
[Notices]
[Pages 53064-53067]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>, <a href="https://www.fda.gov/media/151030/download">https://www.fda.gov/media/151030/download</a>,
<a href="https://www.fda.gov/media/151349/download">https://www.fda.gov/media/151349/download</a>, and <a href="https://www.fda.gov/media/151378/download">https://www.fda.gov/media/151378/download</a>.
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.
BILLING CODE 4164-01-P
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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]
BILLING CODE 4164-01-C
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