2020-21952. 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.

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 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.

Dated: September 29, 2020.

Lauren K. Roth,

Associate Commissioner for Policy.