2020-15138. 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)  

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    AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    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.

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    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).

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    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.

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    BILLING CODE 4164-01-P

    [FR Doc. 2020-15138 Filed 7-13-20; 8:45 am]

    BILLING CODE 4164-01-C

Document Information

Published:
07/14/2020
Department:
Food and Drug Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
2020-15138
Dates:
Chembio's Authorization is revoked as of June 16, 2020.
Pages:
42414-42417 (4 pages)
Docket Numbers:
Docket No. FDA-2020-N-1602
PDF File:
2020-15138.Pdf
Supporting Documents:
» 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)
» 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)