[Federal Register Volume 86, Number 206 (Thursday, October 28, 2021)]
[Notices]
[Pages 59738-59741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-23501]


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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 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.

[[Page 59739]]

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 (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 available 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.

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 June 1, 2021, 
through September 10, 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

[[Page 59740]]

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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     OraSure Technologies, Inc.'s InteliSwab COVID-19 Rapid 
Test Pro, issued June 4, 2021;
     OraSure Technologies, Inc's InteliSwab COVID-19 Rapid 
Test, issued June 4, 2021;
     OraSure Technologies, Inc's InteliSwab COVID-19 Rapid Test 
Rx, issued June 4, 2021;
     Roche Molecular Systems' cobas SARS-CoV-2 Nucleic acid 
test for use on the cobas LIAT System (cobas SARS-CoV-2), issued June 
17, 2021;
     WREN Laboratories LLC's WREN Laboratories COVID-19 PCR 
Test DTC, issued June 17, 2021;
     BioGX, Inc.'s BioGX Xfree COVID-19 Direct RT-PCR, issued 
June 29, 2021;
     Ellume Limited's Ellume.lab COVID Antigen Test, issued 
July 8, 2021;
     Thermo Fisher Scientific Inc's TaqPath COVID-19 RNase P 
Combo Kit 2.0, issued July 8, 2021;
     GenBody Inc.'s GenBody COVID-19 Ag, issued July 13, 2021;
     PHASE Scientific International, Ltd.'s INDICAID COVID-19 
Rapid Antigen Test, issued July 28, 2021;
     Life Technologies Corporation's (a part of Thermo Fisher 
Scientific, Inc.) TaqPath COVID-19 Fast PCR Combo Kit 2.0, issued July 
30, 2021;
     Access Bio, Inc.'s CareStart COVID-19 Antigen Home Test, 
issued August 2, 2021;
     Life Technologies Corporation's (a part of Thermo Fisher 
Scientific, Inc.) TaqPath COVID-19 MS2 Combo Kit 2.0, issued August 2, 
2021;
     QIAGEN GmbH's QIAreach SARS-CoV-2 Antigen Test, issued 
August 5, 2021;
     Cleveland Clinic Robert J. Tomsich Pathology and 
Laboratory Medicine Institute's SelfCheck COVID-19 TaqPath Multiplex 
PCR, issued August 9, 2021;
     STS Lab Holdco's Amazon Multi-Target SARS-CoV-2 Real-Time 
RT-PCR DTC Test (``Amazon Multi-Target DTC Test''), issued August 11, 
2021;
     STS Lab Holdco's Amazon Multi-Target SARS-CoV-2 Real-Time 
RT-PCR Test (``Amazon Multi-Target Test''), issued August 11, 2021;
     The Mount Sinai Hospital, Center for Clinical 
Laboratories' Mount Sinai SARS-CoV-2 Assay, issued August 23, 2021;
     Becton, Dickinson and Company's BD Veritor At-Home COVID-
19 Test, issued August 24, 2021;
     Empire City Laboratories' ECL COVID TEST SYSTEM, issued 
August 25, 2021;
     Empire City Laboratories' ECL COVID TEST SYSTEM-1, issued 
August 25, 2021; and
     Yale School of Public Health, Department of Epidemiology 
of Microbial Diseases' SalivaDirect for use with DTC Kits, issued 
August 27, 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, unless 
otherwise noted in this document, 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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     Diabetomics, Inc.'s CovAb SARS-CoV-2 Ab Test, issued June 
4, 2021;
     Siemens Healthcare Diagnostics Inc.'s ADVIA Centaur SARS-
CoV-2 IgG (sCOVG), issued June 17, 2021;
     Access Bio, Inc.'s CareStart EZ COVID-19 IgM/IgG, issued 
June 24, 2021;
     Bio-Rad Laboratories' BioPlex 2200 SARS-CoV-2 IgG, issued 
July 1, 2021;
     Ortho-Clinical Diagnostics, Inc.'s VITROS Immunodiagnostic 
Products Anti-SARS-CoV-2 IgG Quantitative Reagent Pack used in 
combination with the VITROS Immunodiagnostic Products Anti- SARS-CoV-2 
IgG Quantitative Calibrator, issued July 9, 2021; \5\
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    \5\ As set forth in this 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 recent or prior infection with SARS-CoV-2 by aiding in 
identifying individuals with an adaptive immune response to the 
virus that causes COVID-19, 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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     Ortho-Clinical Diagnostics, Inc.'s VITROS Immunodiagnostic 
Products Anti-SARS-CoV-2 Total N Reagent Pack used in combination with 
the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total N Antibody 
Calibrators, issued July 22, 2021; \6\
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    \6\ As set forth in this 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 recent or prior infection with SARS-CoV-2 by aiding in 
identifying individuals with an adaptive immune response to the 
virus that causes COVID-19, 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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     LumiraDx UK Ltd.'s LumiraDx SARS-CoV-2 Ab Test, issued 
August 2, 2021; and
     InBios International, Inc.'s SCoV-2 Detect IgG Rapid Test, 
issued August 24, 2021.
    FDA is hereby announcing the following Authorizations for 
multianalyte in vitro diagnostics:
     Exact Sciences Laboratories' COVID-Flu Multiplex Assay, 
issued July 1, 2021 \7\ and
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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 COVID-Flu Multiplex Assay 
may be effective in diagnosing COVID-19 through the simultaneous 
detection and differentiation of SARS-CoV-2, influenza A virus, and/
or influenza B virus nucleic acids and that the known and potential 
benefits of the COVID-Flu Multiplex Assay when used for diagnosing 
COVID-19, outweigh the known and potential risks of the COVID-Flu 
Multiplex Assay; and (3) there is no adequate, approved, and 
available alternative to the emergency use of the COVID-Flu 
Multiplex Assay.
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     Cepheid's Xpert Xpress CoV-2/Flu/RSV plus, issued 
September 10, 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 Xpert Xpress CoV-2/Flu/RSV 
plus may be effective in diagnosing COVID-19 through the 
simultaneous detection and differentiation of nucleic acid from 
SARS-CoV-2 virus, influenza A, influenza B and respiratory syncytial 
virus (RSV) and that the known and potential benefits of the Xpert 
Xpress CoV-2/Flu/RSV plus when used for diagnosing COVID-19, 
outweigh the known and potential risks of the Xpert Xpress CoV-2/
Flu/RSV plus; and (3) there is no adequate, approved, and available 
alternative to the emergency use of the Xpert Xpress CoV-2/Flu/RSV 
plus.
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    FDA is hereby announcing the following Authorizations for other 
medical devices:

[[Page 59741]]

     WREN Laboratories LLC's WREN Laboratories COVID-19 Saliva 
Test Collection Kit DTC, issued June 17, 2021; \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 WREN Laboratories COVID-19 Saliva Test 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 WREN 
Laboratories COVID-19 Saliva Test Collection Kit DTC when used for 
such use, outweigh the known and potential risks of the WREN 
Laboratories COVID-19 Saliva Test Collection Kit DTC; and (3) there 
is no adequate, approved, and available alternative to the emergency 
use of the WREN Laboratories COVID-19 Saliva Test Collection Kit 
DTC.
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     Tidal Medical Technologies LLC's InSee incentive 
spirometer accessory, issued June 30, 2021; \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 InSee COVID-19 may be effective in treating respiratory 
conditions in patients with COVID-19 in hospital settings by 
quantitatively tracking patient usage of Vyaire Medical's AirLife 
incentive spirometer, and that the known and potential benefits of 
the InSee when used for treating COVID-19, outweigh the known and 
potential risks of InSee; and (3) there is no adequate, approved, 
and available alternative to the emergency use of the InSee for 
treating COVID-19 for such use.
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     Everlywell, Inc.'s Everlywell COVID-19 & Flu Test Home 
Collection Kit, issued July 1, 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 Everlywell COVID-19 & Flu 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 influenza A and/or influenza B 
nucleic acids from the home collected human specimen and that the 
known and potential benefits of the Everlywell COVID-19 & Flu Test 
Home Collection Kit when used for diagnosing COVID-19, outweigh the 
known and potential risks of the Everlywell COVID-19 & Flu Test Home 
Collection Kit; and (3) there is no adequate, approved, and 
available alternative to the emergency use of the Everlywell COVID-
19 & Flu Test Home Collection Kit.
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     Becton, Dickinson and Company's BD Vacutainer Plus Citrate 
Plasma Tubes (UK Manufacturing Site), issued July 22, 2021; \12\
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    \12\ FDA is using the term ``UK Manufacturing Site'' to 
differentiate the authorized version from the FDA-cleared version of 
these products that are also manufactured by Becton, Dickinson and 
Company. 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 BD Vacutainer Plus Citrate Plasma Tubes (UK Manufacturing 
Site) may be effective in aiding in the identification and treatment 
of coagulopathy in patients, including patients with known or 
suspected COVID-19, by collecting, transporting, and storing blood 
specimens for coagulation testing, and that the known and potential 
benefits of the BD Vacutainer Plus Citrate Plasma Tubes (UK 
Manufacturing Site) when used for such use, outweigh the known and 
potential risks of the BD Vacutainer Plus Citrate Plasma Tubes (UK 
Manufacturing Site); and (3) there is no adequate, approved, and 
available alternative to the emergency use of the BD Vacutainer Plus 
Citrate Plasma Tubes (UK Manufacturing Site).
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     Kwokman Diagnostics, LLC's Kwokman Diagnostics COVID-19 
Home Collection Kit, issued August 13, 2021; \13\ and
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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 Kwokman Diagnostics COVID-19 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 Kwokman 
Diagnostics COVID-19 Home Collection Kit when used for such use, 
outweigh the known and potential risks of the Kwokman Diagnostics 
COVID-19 Home Collection Kit; and (3) there is no adequate, 
approved, and available alternative to the emergency use of the 
Kwokman Diagnostics COVID-19 Home Collection Kit.
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     Yale School of Public Health, Department of Epidemiology 
of Microbial Diseases' SalivaDirect DTC Saliva Collection Kit, issued 
August 27, 2021.\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 SalivaDirect DTC Saliva 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 DTC Saliva 
Collection Kit when used for such use, outweigh the known and 
potential risks of the SalivaDirect DTC Saliva Collection Kit; and 
(3) there is no adequate, approved, and available alternative to the 
emergency use of the SalivaDirect DTC Saliva Collection Kit.

    Dated: October 22, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-23501 Filed 10-27-21; 8:45 am]
BILLING CODE 4164-01-P


