[Federal Register Volume 87, Number 49 (Monday, March 14, 2022)]
[Notices]
[Pages 14273-14275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-05310]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0150]
Revocation of Two 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 LifeHope Labs for the LifeHope 2019-nCoV
Real-Time RT-PCR Diagnostic Panel, and Omnipathology Solutions Medical
Corporation for the Omni COVID-19 Assay by RT-PCR. FDA revoked these
Authorizations 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: The Authorization for the LifeHope 2019-nCoV Real-Time RT-PCR
Diagnostic Panel is revoked as of February 7, 2022. The Authorization
for the Omni COVID-19 Assay by RT-PCR is revoked as of February 14,
2022.
ADDRESSES: Submit written requests for a single copy 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) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
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 29, 2020, FDA issued an
EUA to LifeHope Labs for the LifeHope 2019-nCoV Real-Time RT-PCR
Diagnostic Panel, subject to the terms of the Authorization. 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 June 17, 2020, FDA issued an EUA to
Omnipathology Solutions Medical Corporation for the Omni COVID-19 Assay
by RT-PCR, subject to the terms of the Authorization. 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. Subsequent updates to the Authorizations were made
available on FDA's website. 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
In a request received by FDA on January 6, 2022, LifeHope Labs
requested discontinuation of, and on February 7, 2022, FDA revoked, the
Authorization for the LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic
Panel. Because LifeHope Labs notified FDA that it is no longer using
the LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic Panel and requested
FDA discontinue the LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic
Panel, FDA has determined that it is appropriate to protect the public
health or safety to revoke this Authorization.
In requests received by FDA on February 7, 2022, and February 9,
2022, Omnipathology Solutions Medical Corporation requested revocation
of, and on February 14, 2022, FDA revoked, the Authorization for the
Omni COVID-19 Assay by RT-PCR. Because Omnipathology Solutions Medical
Corporation notified FDA that it is no longer using the Omni COVID-19
Assay by RT-PCR and requested FDA revoke the EUA for the Omni COVID-19
Assay by RT-PCR, FDA has determined that it
[[Page 14274]]
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/.
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 EUA of LifeHope Labs for the LifeHope 2019-nCoV Real-
Time RT-PCR Diagnostic Panel and of Omnipathology Solutions Medical
Corporation for the Omni COVID-19 Assay by RT-PCR. 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: March 3, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-05310 Filed 3-11-22; 8:45 am]
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