Table 4.

Summary list of revoked EUAs during the COVID-19 pandemic in the USA [4]

Date of first issuance	Medical product	Authorized use	Reason for revocation
28-Mar-20	Chloroquine phosphate and hydroxychloroquine sulfate for treatment of COVID-19	To only treat adults and adolescents who weigh 50 kg or more and are hospitalized with COVID-19 for whom a clinical trial is not available, or participation is not feasible	New information including clinical trial data results that have concluded this drug may not be effective to treat COVID-19. In addition, the drug's potential benefits for such use do not outweigh its known and potential risks
24-Apr-20	DPP COVID-19 IgM/IgG System (Chembio Diagnostic System, Inc.)	Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in serum, plasma (EDTA or lithium heparin), venous whole blood, or fingerstick whole blood from individuals suspected of COVID-19 by their healthcare provider	Poor device performance and may not be effective in detecting antibodies against SARS-CoV-2
28-Apr-20	Umbrella EUA for independently validated serology tests for SARS-CoV-2	Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, by detecting antibodies (IgG, or IgG and IgM, or total), as specified in each authorized device’s instructions for use, to SARS-CoV-2 in human plasma and/or serum	FDA has determined that circumstances support revocation of the umbrella EUA to protect the public health or safety
24-Apr-20	Anti-SARS-CoV-2 Rapid Test (Autobio Diagnostics Co. Ltd.)	Anti-SARS-CoV-2 rapid test for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human plasma from anticoagulated blood (heparin/ EDTA/ sodium citrate) or serum	Anti-SARS-CoV-2 rapid test does not meet current clinical performance estimates for serology tests that are generally necessary to satisfy the effectiveness and risk/benefit standards for issuance of an EUA
01-May-20	Protective barrier enclosures	Protective barrier enclosures by HCP when caring for or performing medical procedures on patients who are known or suspected to have COVID-19 in healthcare settings to prevent HCP exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection in addition to PPE	FDA believes it is no longer reasonable to believe that the authorized protective barrier enclosures may be effective at preventing HCP exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection in addition to PPE when caring for or performing medical procedures on patients who are known or suspected to have COVID-19 in healthcare settings
13-May-20	Infusion pumps and infusion pump accessories	To treat conditions caused by the COVID-19 with the controlled infusion of medications, TPN, and/or other fluids	FDA has determined that circumstances support revocation of the umbrella EUA to protect the public health or safety
12-Feb-21	Nova2200 for Decontaminating Compatible N95 Respirators (NovaSterillis, Inc.)	For use in decontaminating compatible N95 respirators that are contaminated or potentially contaminated with SARS-CoV-2 or other pathogenic microorganisms, for a maximum of one decontamination cycle per respirator, for single-user reuse by HCP to prevent exposure to pathogenic biological airborne particulates during the COVID-19 pandemic	FDA has become aware of new data and evidence suggesting that 3M Model 1860 and Halyard FLUIDSHIELD N95 respirators, the only compatible N95 respirators identified in this EUA, may not maintain adequate fit and filtration efficiency following one decontamination cycle using the Nova2200
17-Mar-21	BioFire Respiratory Panel 2.1 (RP2.1) (BioFire Diagnostics, LLC)	Device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test	FDA has determined that the criteria for issuance of such authorization under section 564(c) of the Act are no longer met. Under section 564(c)(3) of the Act, an EUA may be issued only if FDA concludes there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition
16-Apr-21	Bamlanivimab	For the treatment of mild-to-moderate COVID-19 in adult and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg (about 88 pounds), and who are at high risk for progressing to severe COVID-19 and/or hospitalization	The known and potential benefits of bamlanivimab alone no longer outweigh the known and potential risks for the product
30-Apr-21	Battelle Decontamination System	For use in decontaminating compatible N95 respirators for multiple-user reuse by HCP to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of FFRs resulting from the COVID-19 pandemic	Battelle has notified FDA that it has ceased operations and associated activities and requests withdrawal of the authorization, FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization

COVID-19 Coronavirus Disease 2019, Ig immunoglobulin, EDTA ethylenediaminetetraacetic acid, EUA Emergency Use Authorization, FDA US Food and Drug Administration, FFRs filtering facepiece respirators, HCP healthcare providers, PPE personal protective equipment, TPN total parenteral nutrition