[Federal Register Volume 86, Number 77 (Friday, April 23, 2021)]
[Notices]
[Pages 21749-21753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08467]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1584]


Authorization of Emergency Use of Certain Medical Devices During 
COVID-19; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance of Emergency Use Authorizations (EUAs) (the Authorizations) 
for certain medical devices related to the Coronavirus Disease 2019 
(COVID-19) public health emergency. FDA has issued the Authorizations 
listed in this document under the Federal Food, Drug, and Cosmetic Act 
(FD&C Act). These Authorizations contain, among other things, 
conditions on the emergency use of the authorized products. The 
Authorizations follow the February 4, 2020, determination by the 
Secretary of Health and Human Services (HHS) that there is a public 
health emergency that has a significant potential to affect national 
security or the health and security of U.S. citizens living abroad, and 
that involves the virus that causes COVID-19, and the subsequent 
declarations on February 4, 2020, March 2, 2020, and March 24, 2020, 
that circumstances exist justifying the authorization of emergency use 
of in vitro diagnostics for detection and/or diagnosis of the virus 
that causes COVID-19, personal respiratory protective devices, and 
medical devices, including alternative products used as medical 
devices, respectively, subject to the terms of any authorization issued 
under the FD&C Act. These Authorizations, which include an explanation 
of the reasons for issuance, are listed in this document, and are 
available on FDA's website at the links indicated.

DATES: These Authorizations are effective on their date of issuance.

ADDRESSES: Submit written requests for single copies of an EUA 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 Authorization may be sent. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the Authorization.

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, 301-796-8510 (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. With this EUA authority, FDA can help ensure that 
medical countermeasures may be used in emergencies to diagnose, treat, 
or prevent serious or life-threatening diseases or conditions caused by 
a biological, chemical, radiological, or nuclear agent or agents when 
there are no adequate, approved, and available alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may 
be issued, the Secretary of HHS must declare that circumstances exist 
justifying the authorization based on one of the following grounds: (1) 
A determination by the Secretary of Homeland Security that there is a 
domestic emergency, or a significant potential for a domestic 
emergency, involving a heightened risk of attack with a biological, 
chemical, radiological, or nuclear agent or agents; (2) a determination 
by the Secretary of Defense that there is a military emergency, or a 
significant potential for a military emergency, involving a heightened 
risk to U.S. military forces, including personnel operating under the 
authority of title 10 or title 50 of the U.S. Code, of attack with (A) 
a biological, chemical, radiological, or nuclear agent or agents; or 
(B) an agent or agents that may cause, or are otherwise associated 
with, an imminently life-threatening and specific risk to U.S. military 
forces; \1\ (3) a determination by the Secretary of HHS that there is a 
public health emergency, or a significant potential for a public health 
emergency, that affects, or has a significant potential to affect, 
national security or the health and security of U.S. citizens living 
abroad, and that involves a biological, chemical, radiological, or 
nuclear agent or agents, or a disease or condition that may be 
attributable to such agent or agents; or (4) the identification of a 
material threat by the Secretary of Homeland Security pursuant to 
section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-
6b) sufficient to affect national security or the health and security 
of U.S. citizens living abroad.
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    \1\ In the case of a determination by the Secretary of Defense, 
the Secretary of HHS shall determine within 45 calendar days of such 
determination, whether to make a declaration under section 564(b)(1) 
of the FD&C Act, and, if appropriate, shall promptly make such a 
declaration.
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    Once the Secretary of HHS has declared that circumstances exist 
justifying an authorization under section 564 of the FD&C Act, FDA may 
authorize the emergency use of a drug, device, or biological product if 
the Agency concludes that the statutory criteria are satisfied. Under 
section 564(h)(1) of the FD&C Act, FDA is required to publish in the 
Federal Register a notice of each authorization, and each termination 
or revocation of an authorization, and an explanation of the reasons 
for the action. Under section 564(h)(1) of the FD&C Act, revisions to 
an authorization shall be made available on the internet website of 
FDA.
    Section 564 of the FD&C Act permits FDA to authorize the 
introduction into interstate commerce of a drug, device, or biological 
product intended for use when the Secretary of HHS has declared that 
circumstances exist justifying the authorization of emergency use. 
Products appropriate for emergency use may include products and uses 
that are not approved, cleared, or licensed under section 505, 510(k), 
512, or 515 of the FD&C Act (21 U.S.C. 355, 360(k), 360b, or 360e) or 
section 351 of the PHS Act (42 U.S.C. 262), or conditionally approved 
under section 571 of the FD&C Act (21 U.S.C. 360ccc). FDA may issue an 
EUA only if, after consultation with the HHS Assistant Secretary for 
Preparedness and Response, the Director of the National Institutes of 
Health, and the Director of the Centers for Disease Control and 
Prevention (CDC) (to the extent feasible and appropriate given the 
applicable

[[Page 21750]]

circumstances), FDA \2\ concludes: (1) That an agent referred to in a 
declaration of emergency or threat can cause a serious or life-
threatening disease or condition; (2) that, based on the totality of 
scientific evidence available to FDA, including data from adequate and 
well-controlled clinical trials, if available, it is reasonable to 
believe that (A) the product may be effective in diagnosing, treating, 
or preventing (i) such disease or condition; or (ii) a serious or life-
threatening disease or condition caused by a product authorized under 
section 564, approved or cleared under the FD&C Act, or licensed under 
section 351 of the PHS Act, for diagnosing, treating, or preventing 
such a disease or condition caused by such an agent; and (B) 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, taking into consideration the material threat 
posed by the agent or agents identified in a declaration under section 
564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no 
adequate, approved, and available alternative to the product for 
diagnosing, preventing, or treating such disease or condition; (4) in 
the case of a determination described in section 564(b)(1)(B)(ii), that 
the request for emergency use is made by the Secretary of Defense; and 
(5) that such other criteria as may be prescribed by regulation are 
satisfied. No other criteria for issuance have been prescribed by 
regulation under section 564(c)(4) of the FD&C Act.
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    \2\ The Secretary of HHS has delegated the authority to issue an 
EUA under section 564 of the FD&C Act to the Commissioner of Food 
and Drugs.
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II. Electronic Access

    An electronic version of this document and the full text of the 
Authorizations are available on the internet at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

III. The Authorizations

    Having concluded that the criteria for the issuance of the 
following Authorizations under section 564(c) of the FD&C Act are met, 
FDA has authorized the emergency use of the following products for 
diagnosing, treating, or preventing COVID-19 subject to the terms of 
each Authorization. The Authorizations in their entirety, including any 
authorized fact sheets and other written materials, are available on 
the internet from the FDA web page entitled ``Emergency Use 
Authorization,'' available at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. The lists that follow include 
Authorizations issued from September 15, 2020, through February 15, 
2021, and we have included explanations of the reasons for their 
issuance, as required by section 564(h)(1) of the FD&C Act. In 
addition, the EUAs that have been reissued can be accessed from FDA's 
web page: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. FDA 
is hereby announcing the following Authorizations for molecular 
diagnostic and antigen tests for COVID-19, excluding multi-analyte 
tests: \3\
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    \3\ As set forth in the EUAs for these products, FDA has 
concluded that: (1) SARS-CoV-2, the virus that causes COVID-19, can 
cause a serious or life-threatening disease or condition, including 
severe respiratory illness, to humans infected by this virus; (2) 
based on the totality of scientific evidence available to FDA, it is 
reasonable to believe that the products may be effective in 
diagnosing COVID-19, and that the known and potential benefits of 
the products, when used for diagnosing COVID-19, outweigh the known 
and potential risks of such products; and (3) there is no adequate, 
approved, and available alternative to the emergency use of the 
products.
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     Visby Medical, Inc.'s Visby Medical COVID-19, issued 
September 16, 2020;
     GK Pharmaceuticals Contract Manufacturing Operations' GK 
ACCU-RIGHT SARS-CoV-2 RT-PCR KIT, issued September 18, 2020;
     KimForest Enterprise Co., Ltd.'s KimForest SARS-CoV-2 
Detection Kit v1, issued September 21, 2020;
     Vela Operations Singapore Pte. Ltd.'s ViroKey SARS-CoV-2 
RT-PCR Test v2.0, issued September 22, 2020;
     Quadrant Biosciences Inc.'s Clarifi COVID-19 Test Kit, 
issued September 22, 2020;
     Clear Labs, Inc.'s Clear Dx SARS-CoV-2 Test, issued 
September 23, 2020;
     Genetrack Biolabs, Inc.'s Genetrack SARS-CoV-2 Molecular 
Assay, issued September 25, 2020;
     National Jewish Health's SARS-CoV-2 MassArray Test, issued 
September 29, 2020;
     Akron Children's Hospital's Akron Children's Hospital 
SARS-CoV-2 Assay, issued September 29, 2020;
     CENTOGENE US, LLC's CentoSure SARS-CoV-2 RT-PCR Assay, 
issued September 29, 2020;
     Aeon Global Health's Aeon Global Health SARS-CoV-2 Assay, 
issued September 30, 2020;
     Alimetrix, Inc.'s Alimetrix SARS-CoV-2 RT-PCR Assay, 
issued September 30, 2020;
     Tempus Labs, Inc.'s iC SARS-CoV2 Test, issued October 1, 
2020;
     UMass Memorial Medical Center's UMass Molecular Virology 
Laboratory 2019-nCoV rRT-PCR Dx Panel, issued October 1, 2020;
     SEASUN BIOMATERIALS, Inc.'s AQ-TOP COVID-19 Rapid 
Detection Kit PLUS, issued October 5, 2020;
     University of California, Los Angeles's (UCLA's) UCLA 
SwabSeq COVID-19 Diagnostic Platform, issued October 6, 2020;
     Access Bio, Inc.'s CareStart COVID-19 Antigen, issued 
October 8, 2020;
     LumiraDx UK Ltd.'s LumiraDx SARS-CoV-2 RNA STAR Complete, 
issued October 14, 2020;
     Celltrion USA, Inc.'s Sampinute COVID-19 Antigen MIA, 
issued October 23, 2020;
     Agena Bioscience, Inc.'s MassARRAY SARS-CoV-2 Panel, 
issued October 26, 2020;
     Lucira Health, Inc.'s Lucira COVID-19 All-In-One Test Kit, 
issued November 17, 2020;
     Gravity Diagnostics, LLC's Gravity Diagnostics SARS-CoV-2 
RT-PCR Assay, issued November 23, 2020;
     Cepheid's Xpert Omni SARS-CoV-2, issued November 27, 202;
     Luminostics, Inc.'s Clip COVID Rapid Antigen Test, issued 
December 7, 2020;
     Laboratory Corporation of America's Pixel by LabCorp 
COVID-19 Test Home Collection Kit, issued December 9, 2020;
     ResearchDx, Inc., DBA Pacific Diagnostics' PacificDx 
Covid-19 Test, issued December 11, 2020;
     RCA Laboratory Services LLC dba GENETWORx's GENETWORx 
Covid-19 Nasal Swab Test, issued December 15, 2020;
     Ellume Limited's Ellume COVID-19 Home Test, issued 
December 15, 2020;
     Abbott Diagnostics Scarborough, Inc.'s BinaxNOW COVID-19 
Ag Card Home Test, issued December 16, 2020;
     Materials and Machines Corporation of America's (DBA 
MatmaCorp, Inc.) MatMaCorp COVID-19 2SF Test, issued December 17, 2020;
     Quidel Corporation's QuickVue SARS Antigen Test, issued 
December 18, 2020;
     Quidel Corporation's Solana SARS-CoV-2 Assay, issued 
December 23, 2020;
     Cepheid's Xpert Xpress SARS-CoV-2 DoD, issued December 23, 
2020;
     Quanterix Corporation's Simoa SARS-CoV-2 N Protein Antigen 
Test, issued January 5, 2021;

[[Page 21751]]

     Ortho Clinical Diagnostics, Inc.'s VITROS Immunodiagnostic 
Products SARS-CoV-2 Antigen Reagent Pack used in combination with the 
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator, issued 
January 11, 2021;
     SML GENETREE Co., Ltd.'s Ezplex SARS-CoV-2 G Kit, issued 
January 13, 2021;
     Bio-Rad Laboratories, Inc.'s Bio-Rad Reliance SARS-CoV-2 
RT-PCR Assay Kit, issued January 15, 2021;
     Ambry Genetics Laboratory's Ambry COVID-19 RT-PCR Test, 
issued January 22, 2021;
     Clinomics USA Inc.'s Clinomics TrioDx RT-PCR COVID-19 
Test, issued February 4, 2021;
     Visby Medical, Inc.'s Visby Medical COVID-19 Point of Care 
Test, issued February 8, 2021;
     Grifols Diagnostic Solutions Inc.'s Procleix SARS-CoV-2 
Assay, issued February 10, 2021;
     Assurance Scientific Laboratories' Assurance SARS-CoV-2 
Panel DTC, issued February 13, 2021; and
     Gravity Diagnostics, LLC's Gravity Diagnostics SARS-CoV-2 
RT-PCR for use with DTC kits, issued February 13, 2021.
    FDA is hereby announcing the following Authorizations for serology 
tests: \4\
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    \4\ As set forth in the EUAs for these products, FDA has 
concluded that: (1) SARS-CoV-2 can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that the products may be effective in diagnosing recent or prior 
infection with SARS-CoV-2 by identifying individuals with an 
adaptive immune response to the virus that causes COVID-19, and that 
the known and potential benefits of the products when used for such 
use, outweigh the known and potential risks of the products; and (3) 
there is no adequate, approved, and available alternative to the 
emergency use of the products.
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     Jiangsu Well Biotech Co., Ltd.'s Orawell IgM/IgG Rapid 
Test, issued September 23, 2020;
     Quotient Suisse SA's MosaiQ COVID-19 Antibody Magazine, 
issued September 25, 2020;
     Nirmidas Biotech, Inc.'s Nirmidas COVID-19 (SARS-CoV-2) 
IgM/IgG Antibody Detection Kit, issued September 29, 2020;
     NanoEntek America, Inc.'s FREND COVID-19 total Ab, issued 
September 29, 2020;
     DiaSorin, Inc.'s DiaSorin LIAISON SARS-CoV-2 IgM Assay, 
issued September 29, 2020;
     Thermo Fisher Scientific's OmniPATH COVID-19 Total 
Antibody ELISA Test, issued October 2, 2020;
     ZEUS Scientific, Inc.'s ZEUS ELISA SARS-CoV-2 IgG Test 
System Company, issued October 6, 2020;
     Genalyte, Inc.'s Maverick SARS-CoV-2 Multi-Antigen 
Serology Panel v2, issued October 8, 2020;
     Beckman Coulter, Inc.'s Access SARS-CoV-2 IgM, issued 
October 8, 2020;
     Abbott Laboratories Inc.'s AdviseDx SARS-CoV-2 IgM, issued 
October 9, 2020;
     Quansys Biosciences, Inc.'s Q-Plex SARS-CoV-2 Human IgG (4 
Plex), issued October 28, 2020;
     GenScript USA Inc.'s cPass SARS-CoV-2 Neutralization 
Antibody Detection Kit, issued November 6, 2020;
     Innovita (Tangshan) Biological Technology Co., Ltd.'s 
Innovita 2019-nCoV Ab Test (Colloidal Gold), issued November 23, 2020;
     Kantaro Biosciences, LLC's COVID-SeroKlir, Kantaro Semi-
Quantitative SARS-CoV-2 IgG Antibody Kit, issued November 24, 2020;
     Roche Diagnostics, Inc.'s Elecsys Anti-SARS-CoV-2 S, 
issued November 25, 2020;
     ACON Laboratories, Inc.'s ACON SARS-CoV-2 IgG/IgM Rapid 
Test, issued December 15, 2020;
     Quanterix Corporation's Simoa Semi-Quantitative SARS-CoV-2 
IgG Antibody Test, issued December 23, 2020;
     Nirmidas Biotech, Inc.'s MidaSpot COVID-19 Antibody Combo 
Detection Kit, issued December 31, 2020;
     Siemens Healthcare Diagnostics Inc.'s Dimension Vista 
SARS-CoV-2 IgG (COV2G), issued January 8, 2021;
     Siemens Healthcare Diagnostics Inc.'s Dimension EXL SARS-
CoV-2 IgG (CV2G), issued January 8, 2021;
     ADVAITE, Inc.'s RapCov Rapid COVID-19 Test, issued January 
11, 2021;
     Phadia AB's EliA SARS-CoV-2-Sp1 IgG Test, issued January 
11, 2021;
     United Biomedical, Inc.'s UBI SARS-CoV-2 ELISA, issued 
January 15, 2021; and
     Immunodiagnostic Systems Ltd's IDS SARS-CoV-2 IgG, issued 
February 10, 2021.
    FDA is hereby announcing the following Authorizations for multi-
analyte in vitro diagnostics: \5\
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    \5\ As set forth in the EUAs, FDA has concluded that: (1) SARS-
CoV-2 can cause a serious or life-threatening disease or condition, 
including severe respiratory illness, to humans infected by this 
virus; (2) based on the totality of scientific evidence available to 
FDA, it is reasonable to believe that the products may be effective 
in diagnosing COVID-19 (through the simultaneous detection and 
differentiation of SARS-CoV-2 and various other pathogens (see 
individual EUAs for specific other pathogens)) and that the known 
and potential benefits of the products when used for such a use, 
outweigh the known and potential risks of the products; and (3) 
there is no adequate, approved, and available alternative to the 
emergency use of the products.
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     Cepheid's Xpert Xpress SARS-CoV-2/Flu/RSV, issued 
September 24, 2020;
     BioFire Diagnostics, LLC's BioFire Respiratory Panel 2.1-
EZ (RP2.1-EZ), issued October 2, 2020;
     Quidel Corporation's Sofia 2 Flu + SARS Antigen FIA, 
issued October 2, 2020;
     GenMark Diagnostics, Inc.'s ePlex Respiratory Pathogen 
Panel 2 (ePlex RP2 Panel), issued October 7, 2020;
     Quest Diagnostics Infectious Disease, Inc.'s Quest 
Diagnostics RC COVID-19 +Flu RT-PCR, issued December 4, 2020;
     Hologic, Inc.'s Aptima SARS-CoV-2/Flu assay, issued 
December 16, 2020;
     Princeton BioMeditech Corp.'s Status COVID-19/Flu, issued 
February 4, 2021;
     Becton, Dickinson and Company's BD SARS-CoV-2/Flu for BD 
MAX System, issued February 10, 2021;
     Thermo Fisher Scientific's TaqPath COVID-19, FluA, FluB 
Combo Kit, issued February 10, 2021; and
     Bio-Rad Laboratories, Inc.'s Bio-Rad Reliance SARS-CoV-2/
FluA/FluB RT-PCR Assay Kit, issued February 11, 2021.
    FDA is hereby announcing the following Authorizations for other 
medical devices:
     Duke University's COVIAGE, issued September 24, 2020; \6\
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    \6\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that COVIAGE may be effective in preventing healthcare providers' 
exposure to pathogenic biological airborne particulates by providing 
an extra layer of barrier protection in addition to personal 
protective equipment, at the time of definitive airway management, 
when performing airway-related medical procedures, or during certain 
transport of patients with suspected or confirmed diagnosis of 
COVID-19 and that the known and potential benefits of COVIAGE for 
such use outweigh its known and potential risks; and (3) there is no 
adequate, approved, and available alternative to the emergency use 
of COVIAGE.
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     Dascena, Inc.'s COViage Hemodynamic Instability and 
Respiratory Decompensation Prediction System (COViage), issued 
September 24, 2020; \7\
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    \7\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that COViage may be effective when used by healthcare providers as a 
diagnostic aid to assist with the early identification of adult 
COVID-19 patients (18 years of age or older who are admitted to the 
hospital) who are likely to be diagnosed with hemodynamic 
instability or respiratory decompensation, which are common 
complications associated with COVID-19, and that the known and 
potential benefits of COViage, for such use, outweigh the known and 
potential risks; and (3) there is no adequate, approved, and 
available alternative to the emergency use of COViage when used by 
healthcare providers as a diagnostic aid to assist with the early 
identification of adult COVID-19 patients who are likely to be 
diagnosed with hemodynamic instability or respiratory 
decompensation, which are common complications associated with 
COVID-19.

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[[Page 21752]]

     Beckman Coulter, Inc's Access IL-6, issued October 1, 
2020; \8\
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    \8\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that the product may be effective in treating COVID-19, by assisting 
in identifying severe inflammatory response in patients with 
confirmed COVID-19 illness to aid in determining the risk of 
intubation with mechanical ventilation, and that the known and 
potential benefits of the product when used for such use, outweigh 
the known and potential risks of the product; and (3) there is no 
adequate, approved, and available alternative to the emergency use 
of the product.
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     Spectrum Solutions LLC's SDNA-1000 Saliva Collection 
Device, issued October 8, 2020; \9\
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    \9\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that the product may be effective in diagnosing COVID-19 by serving 
as an appropriate means to collect, stabilize, and maintain during 
transport, unprocessed saliva specimens suspected of containing 
SARS-CoV-2 RNA, and that the known and potential benefits of the 
products when used for such use, outweigh the known and potential 
risks of the product; and (3) there is no adequate, approved, and 
available alternative to the emergency use of the product.
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     Roxby Development, LLC's Zoe-Ann Decontamination System, 
issued October 20, 2020; \10\
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    \10\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that the Zoe-Ann Decontamination System may be effective at 
decontaminating compatible N95 respirators for single-user reuse by 
healthcare providers to prevent exposure to SARS-CoV-2 and other 
pathogenic biological airborne particulates, and that the known and 
potential benefits of this product, when used for such use, outweigh 
the known and potential risks of the use of such product; and (3) 
there is no adequate, approved, and available alternative to the 
emergency use of the Zoe-Ann Decontamination System for 
decontaminating compatible N95 respirators for single-user reuse by 
healthcare providers to prevent exposure to SARS-CoV-2 and other 
pathogenic biological airborne particulates during filtering 
facepiece respirator shortages during the COVID-19 pandemic.
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     DNA Genotek Inc.'s OMNIgene[middot]ORAL OM-505 and OME-505 
(OMNIgene[middot]ORAL) saliva collection devices, issued October 14, 
2020; \11\
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    \11\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that the product may be effective in diagnosing COVID-19 by serving 
as an appropriate means to collect, stabilize, and maintain during 
transport, saliva specimens suspected of containing SARS-CoV-2 RNA, 
and that the known and potential benefits of the product when used 
for such use, outweigh the known and potential risks of the product; 
and (3) there is no adequate, approved, and available alternative to 
the emergency use of the product.
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     Clinical Enterprise, Inc.'s EmpowerDX At-Home COVID-19 PCR 
Test Kit, issued on October 15, 2020; \12\
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    \12\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that the product may be effective in diagnosing COVID-19 by serving 
as an appropriate means to collect and transport human specimens so 
that an authorized laboratory can detect SARS-CoV-2 RNA from the 
self-collected human specimen, and that the known and potential 
benefits of the product when used for such use, outweigh the known 
and potential risks of the product; and (3) there is no adequate, 
approved, and available alternative to the emergency use of the 
product.
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     binx health, Inc.'s binx health At-Home Nasal Swab COVID-
19 Sample Collection Kit, issued October 20, 2020; \13\
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    \13\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that the product may be effective in diagnosing COVID-19, by serving 
as an appropriate means to collect and transport human nasal swab 
specimens so that an authorized laboratory can detect SARS-CoV-2 RNA 
from the self-collected specimen, and that the known and potential 
benefits of the product when used for diagnosing COVID-19, outweigh 
the known and potential risks of the product; and (3) there is no 
adequate, approved, and available alternative to the emergency use 
of the product.
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     DNA Genotek Inc.'s ORAcollectRNA OR-100 and 
ORAcollectRNA ORE-100 saliva collection devices, issued October 
28, 2020; \14\
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    \14\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that the product may be effective in diagnosing COVID-19 by serving 
as an appropriate means to collect, stabilize, and maintain during 
transport, saliva specimens suspected of containing SARS-CoV-2 RNA, 
and that the known and potential benefits of the product when used 
for such use, outweigh the known and potential risks of the product; 
and (3) there is no adequate, approved, and available alternative to 
the emergency use of the product.
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     Terumo Cardiovascular's CAPIOX Emergency Bypass System 
(CAPIOX EBS), issued November 21, 2020; \15\
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    \15\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that the CAPIOX EBS may be effective in treating COVID-19 by 
providing long-term (> 6 hours) respiratory or cardiopulmonary 
support to treat patients 18 years or older with COVID-19 who have 
acute respiratory failure or acute cardiopulmonary failure where 
other available treatment options have failed, and continued 
clinical deterioration is expected or the risk of death is imminent, 
and that the known and potential benefits of the CAPIOX EBS for such 
use, outweigh the known and potential risks; and (3) there is no 
adequate, approved, and available alternative to the emergency use 
of the CAPIOX EBS when there are shortages of FDA-cleared 
alternatives during the COVID-19 pandemic.
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     RapidRona, Inc.'s RapidRona Self-Collection Kit, issued 
November 23, 2020; \16\
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    \16\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that the product may be effective in diagnosing COVID-19, by serving 
as an appropriate means to collect and transport human nasal swab 
specimens so that an authorized laboratory can detect SARS-CoV-2 RNA 
from the self-collected specimen, and that the known and potential 
benefits of the product when used for diagnosing COVID-19, outweigh 
the known and potential risks of the product; and (3) there is no 
adequate, approved, and available alternative to the emergency use 
of the product.
---------------------------------------------------------------------------

     3B Medical, Inc.'s Lumin LM3000 Bioburden Reduction UV 
System (``Lumin LM3000''), issued December 3, 2020; \17\
---------------------------------------------------------------------------

    \17\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that the Lumin LM3000 may be effective at bioburden reduction of 
compatible N95 respirators for single-user reuse by healthcare 
providers to supplement CDC reuse recommendations to prevent 
exposure to SARS-CoV-2 and other pathogenic biological airborne 
particulates, and that the known and potential benefits of this 
product, when used for such use, outweigh the known and potential 
risks of the use of such product; and (3) there is no adequate, 
approved, and available alternative to the emergency use of the 
Lumin LM3000 for bioburden reduction of compatible N95 respirators 
for single-user reuse by healthcare providers to supplement CDC 
reuse recommendations to prevent exposure to SARS-CoV-2 and other 
pathogenic biological airborne particulates during filtering 
facepiece respirator shortages during the COVID-19 pandemic.
---------------------------------------------------------------------------

     Ecolab Inc.'s Bioquell Technology System, issued December 
4, 2020; \18\
---------------------------------------------------------------------------

    \18\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that the Bioquell Technology System may be effective at 
decontaminating compatible N95 respirators for single-user reuse by 
healthcare providers to prevent exposure to SARS-CoV-2 and other 
pathogenic biological airborne particulates, and that the known and 
potential benefits of this product, when used for such use, outweigh 
the known and potential risks of the use of such product; and (3) 
there is no adequate, approved, and available alternative to the 
emergency use of the Bioquell Technology System for decontaminating 
compatible N95 respirators for single-user reuse by healthcare 
providers to prevent exposure to SARS-CoV-2 and other pathogenic 
biological airborne particulates during filtering facepiece 
respirator shortages during the COVID-19 pandemic.

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[[Page 21753]]

     SCONE Medical Solutions Inc.'s SCONE, issued December 18, 
2020; \19\
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    \19\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that SCONE may be effective in preventing healthcare providers 
exposure to pathogenic biological airborne particulates by providing 
an extra layer of barrier protection in addition to personal 
protective equipment, at the time of definitive airway management, 
when performing airway-related medical procedures, or during certain 
transport for a maximum duration of use of 30 minutes, of patients 
with suspected or confirmed diagnosis of COVID-19 and that the known 
and potential benefits of SCONE for such use outweigh its known and 
potential risks; and (3) there is no adequate, approved, and 
available alternative to the emergency use of SCONE.
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     Siemens Healthcare Diagnostics Inc.'s ADVIA Centaur IL6 
assay, issued December 18, 2020; \20\
---------------------------------------------------------------------------

    \20\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that the product may be effective in treating COVID-19, by assisting 
in identifying severe inflammatory response in patients with 
confirmed COVID-19 illness to aid in determining the risk of 
intubation with mechanical ventilation, and that the known and 
potential benefits of the product when used for such use, outweigh 
the known and potential risks of the product; and (3) there is no 
adequate, approved, and available alternative to the emergency use 
of the product.
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     Yale New Haven Health System's Yale New Haven Health 
FILTERING FACEPIECE RESPIRATOR Decontamination System, issued January 
15, 2021; \21\ and
---------------------------------------------------------------------------

    \21\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that the Yale New Haven Health filtering facepiece respirator 
decontamination system may be effective at decontaminating 
compatible N95 respirators for multiple-user reuse by healthcare 
providers to prevent exposure to SARS-CoV-2 and other pathogenic 
biological airborne particulates, and that the known and potential 
benefits of this product, when used for such use, outweigh the known 
and potential risks of the use of such product; and (3) there is no 
adequate, approved, and available alternative to the emergency use 
of the Yale New Haven Health filtering facepiece respirator 
Decontamination System for decontaminating compatible N95 
respirators for multiple-user reuse by healthcare providers to 
prevent exposure to SARS-CoV-2 and other pathogenic biological 
airborne particulates during filtering facepiece respirator 
shortages during the COVID-19 pandemic.
---------------------------------------------------------------------------

     Everlywell, Inc.'s Everlywell COVID-19 Test Home 
Collection Kit DTC, issued February 13, 2021.\22\
---------------------------------------------------------------------------

    \22\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that the product may be effective in diagnosing COVID-19, by serving 
as an appropriate means to collect and transport human specimens so 
that an authorized laboratory can detect SARS-CoV-2 RNA from the 
home-collected human specimen, and that the known and potential 
benefits of the product when used for diagnosing COVID-19, outweigh 
the known and potential risks of the product and (3) there is no 
adequate, approved, and available alternative to the emergency use 
of the product.

    Dated: April 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08467 Filed 4-22-21; 8:45 am]
BILLING CODE 4164-01-P