Document ID: FDA-2022-N-0150-0002
Agency: fda
Document Type: Notice
Title: Revocation of Two Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID–19; Availability
Posted Date: 2022-03-14T04:00Z

[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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