Document ID: FDA-2020-N-1602-0001
Agency: fda
Document Type: Notice
Title: Revocation of Authorization of Emergency Use of an In Vitro
Diagnostic Device for Detection of Antibodies Against SARS–CoV–2, the
Virus That Causes Coronavirus Disease 2019 (COVID–19)
Posted Date: 2020-07-14T04:00Z

[Federal Register Volume 85, Number 135 (Tuesday, July 14, 2020)]
[Notices]
[Pages 42414-42417]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15138]

[[Page 42414]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1602]

Revocation of Authorization of Emergency Use of an In Vitro 
Diagnostic Device 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 
revocation of the Emergency Use Authorization (EUA) (the Authorization) 
issued to Chembio Diagnostic Systems, Inc. (``Chembio'') for the DPP 
COVID-19 IgM/IgG System. FDA revoked this Authorization on June 16, 
2020, under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), in 
consideration of new information from three evaluations performed since 
the Authorization of the device that demonstrate its performance may be 
both inconsistent and lower than that described in the request for 
Authorization. The revocation, which includes an explanation of the 
reasons for revocation, is reprinted in this document.

DATES: Chembio's Authorization is revoked as of June 16, 2020.

ADDRESSES: Submit written requests for single copies 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) allows FDA to 
strengthen the public health protections against biological, chemical, 
radiological, or nuclear agent or 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 14, 2020, FDA issued an EUA to Chembio, 
for the DPP COVID-19 IgM/IgG System, subject to the terms of the 
Authorization. Notice of the issuance of the Authorization is 
publishing elsewhere in the Federal Register with this revocation, as 
required by section 564(h)(1) of the FD&C Act. Subsequent to the 
Authorization, FDA considered new information from three additional 
evaluations, including two conducted by independent entities, 
demonstrating performance below the performance information submitted 
in the original EUA request and reflected in the authorized labeling 
for the device.

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 June 16, 2020, 
FDA revoked the EUA for Chembio's DPP COVID-19 IgM/IgG System 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 to the Secretary, 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 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 multiple 
evaluations since the Authorization, 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 EUA200179 for the 
DPP COVID-19 IgM/IgG System, pursuant to section 564(g)(2)(B) and (C) 
of the FD&C Act.

III. Electronic Access

    An electronic version of this document and the full text of the 
revocation are available on the internet at https://www.regulations.gov/ and https://www.fda.gov/media/139109/download.

IV. The Revocation

    Having concluded that the criteria for revocation of the 
Authorization under section 564(g) of the FD&C Act are met, FDA has 
revoked the EUA for Chembio's DPP COVID-19 IgM/IgG System. 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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    Dated: July 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15138 Filed 7-13-20; 8:45 am]
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