[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39040-39044]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-15680]


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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

[[Page 39041]]

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 can be accessed on FDA's website from 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 the 
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 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 aavailable on the internet and can be accessed from 
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

[[Page 39042]]

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, can be accessed 
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 February 16, 
2021, through May 31, 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 multianalyte 
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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     University of Illinois Office of the Vice President for 
Economic Development and Innovation's covidSHIELD, issued February 24, 
2021;
     Viracor Eurofins Clinical Diagnostics's Viracor SARS-CoV-2 
Assay DTC, issued February 26, 2021;
     Quidel Corporation's QuickVue At-Home COVID-19 Test, 
issued March 1, 2021;
     Clinical Research Sequencing Platform (CRSP), LLC at the 
Broad Institute of the Massachusetts Institute of Technology and 
Harvard's CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR 
Diagnostic Assay (Version 3), issued March 5, 2021;
     Cue Health Inc.'s Cue COVID-19 Test for Home and Over The 
Counter (OTC) Use, issued March 5, 2021;
     Color Health, Inc.'s Color SARS-CoV-2 RT-LAMP Diagnostic 
Assay DTC, issued March 19, 2021;
     Twist Bioscience Corporation's SARS-CoV-2 NGS Assay, 
issued March 23, 2021;
     STS Lab Holdco's (a subsidiary of Amazon.com Services 
LLC), Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2, issued 
March 25, 2021;
     DiaSorin, Inc.'s LIAISON SARS-CoV-2 Ag, issued March 26, 
2021;
     Abbott Diagnostics Scarborough, Inc.'s BinaxNOW COVID-19 
Ag 2 Card, issued March 31, 2021;
     Quidel Corporation's QuickVue At-Home OTC COVID-19 Test, 
issued March 31, 2021;
     Abbott Diagnostics Scarborough, Inc.'s BinaxNOW COVID-19 
Antigen Self Test, issued March 31, 2021;
     Abbott Diagnostics Scarborough, Inc.'s BinaxNOW COVID-19 
Ag Card 2 Home Test, issued March 31, 2021;
     Thermo Fisher Scientific's Amplitude Solution with the 
TaqPath COVID-19 High-Throughput Combo Kit, issued April 9, 2021;
     Lucira Health, Inc.'s Lucira CHECK[radic]IT COVID-19 Test 
Kit, issued April 9, 2021;
     PerkinElmer Genomics's PerkinElmer SARS-CoV-2 RT-qPCR 
Reagent Kit, issued April 12, 2021;
     Qorvo Biotechnologies, LLC.'s Omnia SARS-CoV-2 Antigen 
Test, issued April 13, 2021;
     Clinical Enterprise, Inc.'s Clinical Enterprise SARS-CoV-2 
RT-PCR Assay DTC, issued April 13, 2021;
     Clinical Enterprise, Inc.'s Clinical Enterprise SARS-CoV-2 
RT-PCR Assay, issued April 13, 2021;
     LGC, Biosearch Technologies' Biosearch Technologies SARS-
CoV-2 Real-Time and End-Point RT-PCR Test, issued April 15, 2021;
     Synergy Diagnostic Laboratory, Inc.'s (DBA SynergyDx), 
SynergyDx SARS-CoV-2 RNA Test, issued April 16, 2021;
     Synergy Diagnostic Laboratory, Inc.'s (DBA SynergyDx), 
SynergyDx SARS-CoV-2 RNA Test DTC, issued April 16, 2021;
     Celltrion USA, Inc.'s Celltrion DiaTrust COVID-19 Ag Rapid 
Test, issued April 16, 2021;
     Southern California Permanente Medical Group's Kaiser 
Permanente High Throughput SARS-CoV-2 Assay, issued April 19, 2021;
     PathogenDx, Inc.'s DetectX-Rv, issued April 20, 2021;
     InBios International, Inc.'s SCoV-2 Ag Detect Rapid Test, 
issued May 6, 2021;
     Phosphorus Diagnostics LLC's Phosphorous COVID19 RT-qPCR 
Test DTC, issued May 17, 2021;
     Salofa Oy's Sienna-Clarity COVID-19 Antigen Rapid Test 
Cassette, issued May 20, 2021;
     Harvard University Clinical Laboratory's Quaeris SARS-CoV-
2 Assay, issued May 21, 2021;
     Thermo Fisher Scientific Inc.'s TaqPath COVID-19 Pooling 
Kit, issued May 25, 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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     Abbott Laboratories Inc.'s AdviseDx SARS-CoV-2 IgG II, 
issued March 1, 2021;
     Beckman Coulter, Inc.'s Access SARS-CoV-2 IgG II, issued 
March 22, 2021;
     Siemens Healthcare Diagnostics Inc.'s Atellica IM SARS-
CoV-2 IgG (sCOVG), issued March 23, 2021;
     Symbiotica, Inc.'s COVID-19 Self-Collected Antibody Test 
System, issued April 5, 2021;
     Inova Diagnostics, Inc.'s QUANTA Flash SARS-CoV-2 IgG, 
issued April 19, 2021;
     QIAGEN, GmbH's QIAreach Anti-SARS-CoV-2 Total Test, issued 
May 11, 2021;
     ZEUS Scientific, Inc.'s ZEUS ELISA SARS-CoV-2 Total 
Antibody Test System, issued May 11, 2021;
     DiaSorin, Inc.'s LIAISON SARS-CoV-2 TrimericS IgG, issued 
May 19, 2021;
     NOWDiagnostics, Inc.'s ADEXUSDx COVID-19 Test, issued May 
24, 2021.
    FDA is hereby announcing the following Authorization for a T-cell 
immune response test:
     Adaptive Biotechnologies Corporation's T-Detect COVID 
Test, issued March 5, 2021.\5\
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    \5\ As set forth in the EUA, 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 T-Detect COVID Test may be 
effective in diagnosing recent or prior infection with SARS-CoV-2 by 
identifying individuals with a T-cell immune response to the virus 
that causes COVID-19, and that the known and potential benefits of 
your product when used for such use, outweigh the known and 
potential risks of the T-Detect COVID Test; and (3) there is no 
adequate, approved, and available alternative to the emergency use 
of the T-Detect COVID Test.

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[[Page 39043]]

    FDA is hereby announcing the following Authorizations for 
multianalyte in vitro diagnostics: \6\
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    \6\ There are FDA-approved/cleared tests for Influenza A virus 
(with subtype differentiation), and other organisms, such as 
Influenza B virus, Respiratory Syncytial virus (RSV) A and RSV B, 
Coronaviruses 229E, OC43, NL63 and HKU1, Human Metapneumovirus, 
Rhinovirus/Enterovirus, Adenovirus, Parainfluenza virus Types 1, 2, 
3, and 4, Human Bocavirus, Chlamydophila pneumoniae, and Mycoplasma 
pneumoniae but there are no FDA approved/cleared multiplexed tests 
for simultaneous qualitative detection and differentiation of SARS-
CoV-2, and these additional pathogens targeted by the products (see 
individual EUAs for specific other pathogens). Respiratory 
infections caused by the aforementioned pathogens and SARS-CoV-2 can 
have similar clinical presentation and diagnostic considerations. 
Thus, to differentially detect SARS-CoV-2, information from a test 
that detects and differentiates the virus that causes COVID-19 and 
other respiratory pathogens is needed. For example, the common 
influenza viruses that cause seasonal epidemics of flu, influenza A 
and B, is needed during the flu season that coincides with the 
COVID-19 pandemic.
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     Luminex Molecular Diagnostics, Inc.'s NxTAG Respiratory 
Pathogen Panel + SARS-CoV-2, issued March 3, 2021; \7\
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    \7\ As set forth in the EUA, 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 product may be effective 
in diagnosing COVID-19, through the simultaneous detection and 
differentiation of nucleic acids from SARS-CoV-2 and other 
respiratory viral and bacterial organisms 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. The NxTAG Respiratory Pathogen Panel + SARS-CoV-
2 is intended for the simultaneous detection and differentiation of 
nucleic acid from SARS- CoV-2 and the following organism types and 
subtypes: Influenza A, Influenza A H1, Influenza A H3, Influenza B, 
Respiratory Syncytial Virus A, Respiratory Syncytial Virus B, 
Coronavirus 229E, Coronavirus OC43, Coronavirus NL63, Coronavirus 
HKU1, Human Metapneumovirus, Rhinovirus/Enterovirus, Adenovirus, 
Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, 
Parainfluenza virus 4, Human Bocavirus, Chlamydophila pneumoniae, 
and/or Mycoplasma pneumoniae.
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     Abbott Molecular Inc.'s Alinity m Resp-4-Plex, issued 
March 4, 2021; \8\
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    \8\ As set forth in the EUA, 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 product may be effective 
in diagnosing COVID-19 through the simultaneous detection and 
differentiation of SARS-CoV-2, influenza A virus, influenza B virus 
and/or RSV nucleic acids 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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     Becton, Dickinson and Company's (BD's) BD Veritor System 
for Rapid Detection of SARS-CoV-2 & Flu A+B, issued March 24, 2021; \9\
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    \9\ As set forth in the EUA, 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 product may be effective 
in diagnosing COVID-19 through the simultaneous detection and 
differentiation of SARS-CoV-2, and/or influenza A virus and 
influenza B virus protein antigens and that the known and potential 
benefits of the product when used for such a 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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     NeuMoDx Molecular, Inc.'s NeuMoDx Flu A-B/RSV/SARS-CoV-2 
Vantage Assay, issued March 25, 2021.\10\
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    \10\ As set forth in the EUA, 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 product may be effective 
in diagnosing COVID-19 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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    FDA is hereby announcing the following Authorizations for other 
medical devices:
     GetMyDNA's GetMyDNA COVID-19 Test Home Collection Kit, 
issued March 9, 2021; \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 GetMyDNA COVID-19 Test Home Collection Kit 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 GetMyDNA 
COVID-19 Test Home Collection Kit when used for diagnosing COVID-19, 
outweigh the known and potential risks of the GetMyDNA COVID-19 Test 
Home Collection Kit; and (3) there is no adequate, approved, and 
available alternative to the emergency use of the GetMyDNA COVID-19 
Test Home Collection Kit.
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     Color Health, Inc.'s Color COVID-19 Self-Swab Collection 
Kit DTC, issued March 19, 2021; \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 Color COVID-19 Self-Swab Collection Kit DTC 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 Color 
COVID-19 Self-Swab Collection Kit DTC when used for diagnosing 
COVID-19, outweigh the known and potential risks of the Color COVID-
19 Self-Swab Collection Kit DTC; and (3) there is no adequate, 
approved, and available alternative to the emergency use of the 
Color COVID-19 Self-Swab Collection Kit DTC.
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     Tiger Tech Solutions, Inc.'s Tiger Tech COVID Plus 
Monitor, issued March 19, 2021.\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 Tiger Tech COVID Plus Monitor, when used by trained 
personnel, may be effective at preventing exposure to and spread of 
SARS-CoV-2 by identifying certain biomarkers in asymptomatic 
individuals over the age of 5, when performed following a 
temperature reading that does not meet the criteria for fever in 
settings where temperature check is being conducted in accordance 
with CDC and local institutional infection prevention and control 
guidelines, and that the known and potential benefits of such 
product, when used as described in the Scope of Authorization of the 
authorization letter, outweigh the known and potential risks; and 
(3) there are no adequate, approved, and available alternatives to 
the emergency use of the Tiger Tech COVID Plus Monitor.
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     Inspire Rx, LLC's Inspire Rx, LLC Portable Negative 
Pressure Isolation & Procedural Tent System, (referred to as the 
``AerosolVE Device''), issued March 29, 2021; \14\
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    \14\ As set forth in the EUA, 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 AerosolVE Device may be 
effective in preventing healthcare provider 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, or when performing airway-
related medical procedures, or during certain transport (when end-
tidal CO2 monitoring is not available) 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 the AerosolVE Device for such use outweigh its known and 
potential risks; and (3) there is no adequate, approved, and 
available alternative to the emergency use of the AerosolVE Device. 
During the public health emergency, it would not be feasible to 
require healthcare providers to limit use of the AerosolVE Device to 
patients with suspected or confirmed COVID-19; therefore, the 
authorization does not restrict use to such patients.
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     J. Peter Rubin, MD, MBA, FACS at the University of 
Pittsburgh's Individual Biocontainment Unit (``IBU''), issued April 1, 
2021; \15\
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    \15\ As set forth in the EUA, 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 IBU may be effective in 
preventing healthcare provider 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, or when performing medical 
procedures, or during transport of patients with suspected or 
confirmed diagnosis of COVID-19 and that the known and potential 
benefits of the IBU for such use outweigh its known and potential 
risks; and (3) there are no adequate, approved, and available 
alternatives to the emergency use of the IBU. During the public 
health emergency, it would not be feasible to require healthcare 
providers to limit the IBU use for patients with suspected or 
confirmed COVID-19; therefore, the authorization does not restrict 
use to such patients.

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[[Page 39044]]

     Yale School of Public Health, Department of Epidemiology 
of Microbial Diseases' SalivaDirect At-Home Collection Kit, issued 
April 9, 2021; \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 SalivaDirect At-Home Collection Kit 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 SalivaDirect At-Home 
Collection Kit when used for diagnosing COVID-19, outweigh the known 
and potential risks of the SalivaDirect At-Home Collection Kit; and 
(3) there is no adequate, approved, and available alternative to the 
emergency use of the SalivaDirect At-Home Collection Kit.
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     Color Health, Inc.'s Color COVID-19 Self-Swab Collection 
Kit with Saline, issued April 14, 2021; \17\
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    \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 Color COVID-19 Self-Swab Collection Kit with Saline 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 Color 
COVID-19 Self-Swab Collection Kit with Saline when used for 
diagnosing COVID-19, outweigh the known and potential risks of the 
Color COVID-19 Self-Swab Collection Kit with Saline; and (3) there 
is no adequate, approved, and available alternative to the emergency 
use of the Color COVID-19 Self-Swab Collection Kit with Saline.
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     Prep Tech, LLC's ISOCUBE SS and ISOCUBE ONE (``ISOCUBE''), 
issued May 4, 2021; \18\
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    \18\ As set forth in the EUA, FDA has concluded: (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 ISOCUBE may be effective in 
preventing healthcare provider 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, or 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 ISOCUBE for such use outweigh its known and 
potential risks; and (3) there are no adequate, approved, and 
available alternatives to the emergency use of the ISOCUBE. During 
the public health emergency, it would not be feasible to require 
healthcare providers to limit the ISOCUBE use for patients with 
suspected or confirmed COVID-19; therefore, the authorization does 
not restrict use to such patients.
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     Breegi Scientific, Inc.'s Negative Pressure SteriDome 
(NPS), issued May 6, 2021; \19\
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    \19\ As set forth in the EUA, FDA has concluded: (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 NPS may be effective in 
preventing healthcare provider 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 1 hour, of patients with suspected or confirmed 
diagnosis of COVID-19 and that the known and potential benefits of 
the NPS for such use outweigh its known and potential risks; and (3) 
there are no adequate, approved, and available alternatives to the 
emergency use of the NPS. During the public health emergency, it 
would not be feasible to require healthcare providers to limit use 
of the NPS to patients with suspected or confirmed COVID-19; 
therefore, the authorization does not restrict use to such patients.
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     Phosphorus Diagnostics LLC's Pinpoint by Phosphorus COVID-
19 Test Home Collection Kit DTC, issued May 17, 2021.\20\
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    \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 Pinpoint by Phosphorus COVID-19 Test Home Collection Kit 
DTC 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 Pinpoint by Phosphorus COVID-19 Test Home Collection Kit DTC 
when used for diagnosing COVID-19, outweigh the known and potential 
risks of the Pinpoint by Phosphorus COVID-19 Test Home Collection 
Kit DTC; and (3) there is no adequate, approved, and available 
alternative to the emergency use of the Pinpoint by Phosphorus 
COVID-19 Test Home Collection Kit DTC.
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    Finally, FDA is hereby announcing an amendment to certain EUAs to 
allow certain authorized molecular diagnostic SARS-CoV-2 tests to be 
distributed and used to pool anterior nasal respiratory specimens from 
asymptomatic individuals as part of a serial testing program after 
developers submit a complete notification, including meeting required 
validation data, as set forth in the amendment letter. The amendment 
``Amending Certain EUAs for RT-PCR Molecular-Based Diagnostic Tests to 
Authorize the Detection of Nucleic Acid from SARS-CoV-2 from Pooled 
Anterior Nasal Respiratory Specimens for Screening When Used as Part of 
a Serial Testing Program,'' was issued to ``Developers of Molecular-
Based Diagnostic Tests Authorized for Emergency Use for Coronavirus 
Disease 2019 (COVID-19) as of Today's Date'' on April 20, 2021.\21\
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    \21\ As set forth in the amendment, FDA has concluded (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 authorized tests may be 
effective in diagnosing COVID-19 for the indications set forth in 
the appendices of the amendment letter, and that the known and 
potential benefits of the authorized tests when used for such use, 
outweigh the known and potential risks of the authorized tests 
included in the amendment; and (3) there are no adequate, approved, 
and available alternatives to the emergency use of the authorized 
tests included in the amendment.

    Dated: July 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-15680 Filed 7-22-21; 8:45 am]
BILLING CODE 4164-01-P


