Document ID: FDA-2020-N-1602-0002
Agency: fda
Document Type: Notice
Title: 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)
Posted Date: 2020-10-05T04:00Z

[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

[[Page 62740]]

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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