Notice2022-15160
Revocation of Authorization of Emergency Use of an In Vitro Diagnostic Device for Detection and/or Diagnosis of COVID-19; Availability
Primary source
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Published
July 15, 2022
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 Authorization (EUA) (the Authorization) issued to ScienCell Research Laboratories (ScienCell) for the ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit. FDA revoked this Authorization under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The revocation, which includes an explanation of the reasons for revocation, is reprinted in this document.
Full Text
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<title>Federal Register, Volume 87 Issue 135 (Friday, July 15, 2022)</title>
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[Federal Register Volume 87, Number 135 (Friday, July 15, 2022)]
[Notices]
[Pages 42488-42490]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-15160]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0412]
Revocation of Authorization of Emergency Use of an In Vitro
Diagnostic Device for Detection and/or Diagnosis of COVID-19;
Availability
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorization (EUA) (the Authorization)
issued to ScienCell Research Laboratories (ScienCell) for the ScienCell
SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection
[[Page 42489]]
Kit. FDA revoked this Authorization under the Federal Food, Drug, and
Cosmetic Act (FD&C Act). The revocation, which includes an explanation
of the reasons for revocation, is reprinted in this document.
DATES: The Authorization for the ScienCell SARS-CoV-2 Coronavirus Real-
time RT-PCR (RT-qPCR) Detection Kit is revoked as of June 7, 2022.
ADDRESSES: Submit a written request for a single copy of the revocation
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 revocation may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the revocation.
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 April 3, 2020, FDA issued an
EUA to ScienCell for the ScienCell SARS-CoV-2 Coronavirus Real-time RT-
PCR (RT-qPCR) Detection Kit, subject to the terms of the Authorization.
Notice of the issuance of this Authorization was published in the
Federal Register on June 5, 2020 (85 FR 34638), as required by section
564(h)(1) of the FD&C Act. Subsequent updates to the Authorization 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 Request
In a request received by FDA on June 2, 2022, ScienCell requested
revocation of, and on June 7, 2022, FDA revoked, the Authorization for
the ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR)
Detection Kit. Because ScienCell notified FDA that ScienCell decided to
discontinue distribution of the ScienCell SARS-CoV-2 Coronavirus Real-
time RT-PCR (RTqPCR) Detection Kit and requested FDA revoke the EUA for
the ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR)
Detection Kit, 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
revocation is available on the internet at <a href="https://www.regulations.gov/">https://www.regulations.gov/</a>.
IV. The Revocation
Having concluded that the criteria for revocation of the
Authorization under section 564(g)(2)(C) of the FD&C Act are met, FDA
has revoked the EUA of ScienCell for the ScienCell SARS-CoV-2
Coronavirus Real-time RT-PCR (RTqPCR) Detection Kit. The revocation in
its entirety follows and provides an explanation of the reasons for
revocation, as required by section 564(h)(1) of the FD&C Act.
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[GRAPHIC] [TIFF OMITTED] TN15JY22.008
Dated: July 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15160 Filed 7-14-22; 8:45 am]
BILLING CODE 4164-01-P
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