[Federal Register Volume 85, Number 193 (Monday, October 5, 2020)]
[Notices]
[Pages 62739-62746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21952]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1602]
Revocation of Authorizations of Emergency Use of In Vitro
Diagnostic Devices for Detection of Antibodies Against SARS-CoV-2, the
Virus That Causes Coronavirus Disease 2019 (COVID-19)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocations of the Emergency Use Authorizations (EUAs) (the
Authorizations) issued to Autobio Diagnostics Co. Ltd. (``Autobio'')
for the Anti-SARS-CoV-2 Rapid Test (``Autobio's Test'') and to
Manufacturers and Other Stakeholders (``Stakeholders'') for certain in
vitro diagnostic SARS-CoV-2 Antibody Tests. FDA revoked Autobio's
Authorization on August 6, 2020, and the Stakeholders' Authorization on
July 21, 2020, 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: Autobio's Authorization is revoked as of August 6, 2020. The
Stakeholders' Authorization is revoked as of July 21, 2020.
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 April 24, 2020, FDA issued an EUA for Autobio's Anti-
SARS-CoV-2 Rapid Test, subject to the terms of the Authorization. On
April 28, 2020, FDA issued an EUA to Stakeholders, for certain in vitro
diagnostic SARS-CoV-2 Antibody Tests (lateral flow or enzyme-linked
immunosorbent assay tests to detect IgG only, IgG and IgM, or total
antibodies in human plasma and/or serum) for use at laboratories
certified under the Clinical Laboratory Improvement Amendments of 1988,
42 U.S.C. 263a, to perform moderate or high complexity tests. Notice of
the issuance of the Authorizations was published in the Federal
Register on July 14, 2020 (85 FR 42407), as required by section
564(h)(1) of the FD&C Act. Subsequent to the issuance of the
Authorization for Autobio's Test, FDA considered new information,
including from an independent evaluation of Autobio's Test from the
National Institute of Health's Frederick National Laboratory for Cancer
Research, part of the National Cancer Institute (the ``NCI study''),
demonstrating performance below the performance information submitted
in Autobio's original EUA request and reflected in the authorized
labeling for Autobio's Test. Subsequent to the Stakeholders'
Authorization, FDA considered that no device had been listed under the
EUA and that FDA may issue individual EUAs instead.
II. EUA Criteria for Issuance No Longer Met and Other Circumstances
Make Revocation Appropriate To Protect the Public Health or Safety
Under section 564(g)(2)(B) and (C) of the FD&C Act, the Secretary
of HHS may revoke an EUA if, among other things, the criteria for
issuance are no longer met or other circumstances make such revocation
appropriate to protect the public health or safety. On August 6, 2020,
FDA revoked the EUA for Autobio's Test because the criteria for
issuance were no longer met and other circumstances make such
revocation appropriate to protect the public health or safety. Under
section 564(c)(2) of the FD&C Act, an EUA may be issued only if FDA
concludes that, based on the totality of scientific evidence available,
including data from adequate and well-controlled clinical trials, if
available, it is reasonable to believe that the product may be
effective in diagnosing, treating, or preventing such disease or
condition and that the known and potential benefits of the product,
when used to diagnose, prevent, or treat such disease or condition,
outweigh the known and potential risks of the product.
Given the poor device performance observed in the NCI study since
the issuance of the Authorization for Autobio's Test, FDA has concluded
it is not reasonable to believe the product may be effective in
detecting antibodies against SARS-CoV-2 or that the known and potential
benefits of the device outweigh its known and potential risks. In
addition, based on the same information and the risks to public health
from false test results, FDA has concluded under section 564(g)(2)(C)
of the FD&C Act that other circumstances make revocation appropriate to
protect the public health or safety. Accordingly, FDA has revoked
EUA200349 for Autobio's Anti-SARS-CoV-2 Rapid Test, pursuant to section
564(g)(2)(B) and (C) of the FD&C Act. On July 21, 2020, FDA revoked the
EUA for Stakeholders' certain in vitro diagnostic SARS-CoV-2 Antibody
Tests because other circumstances make such revocation appropriate to
protect the public health or safety (section 564(g)(2)(C) of the FD&C
Act), considering that no device has been listed under the EUA, and FDA
can issue individual EUAs instead.
III. Electronic Access
An electronic version of this document and the full text of the
revocations are available on the internet
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at https://www.regulations.gov/, https://www.fda.gov/media/140351/download and https://www.fda.gov/media/140908/download.
IV. The Revocations
Having concluded that the criteria for revocation of the
Authorizations under section 564(g) of the FD&C Act are met, FDA has
revoked the EUAs for Autobio's Anti-SARS-CoV-2 Rapid Test and
Stakeholders' certain in vitro diagnostic SARS-CoV-2 Antibody Tests.
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 29, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-21952 Filed 10-2-20; 8:45 am]
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