Notice2021-15680
Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 23, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 139 (Friday, July 23, 2021)</title>
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[Federal Register Volume 86, Number 139 (Friday, July 23, 2021)]
[Notices]
[Pages 39040-39044]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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
<a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization</a>.
[[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 <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization</a>.
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: <a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization">https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization</a>.
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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<bullet> University of Illinois Office of the Vice President for
Economic Development and Innovation's covidSHIELD, issued February 24,
2021;
<bullet> Viracor Eurofins Clinical Diagnostics's Viracor SARS-CoV-2
Assay DTC, issued February 26, 2021;
<bullet> Quidel Corporation's QuickVue At-Home COVID-19 Test,
issued March 1, 2021;
<bullet> 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;
<bullet> Cue Health Inc.'s Cue COVID-19 Test for Home and Over The
Counter (OTC) Use, issued March 5, 2021;
<bullet> Color Health, Inc.'s Color SARS-CoV-2 RT-LAMP Diagnostic
Assay DTC, issued March 19, 2021;
<bullet> Twist Bioscience Corporation's SARS-CoV-2 NGS Assay,
issued March 23, 2021;
<bullet> STS Lab Holdco's (a subsidiary of <a href="http://Amazon.com">Amazon.com</a> Services
LLC), Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2, issued
March 25, 2021;
<bullet> DiaSorin, Inc.'s LIAISON SARS-CoV-2 Ag, issued March 26,
2021;
<bullet> Abbott Diagnostics Scarborough, Inc.'s BinaxNOW COVID-19
Ag 2 Card, issued March 31, 2021;
<bullet> Quidel Corporation's QuickVue At-Home OTC COVID-19 Test,
issued March 31, 2021;
<bullet> Abbott Diagnostics Scarborough, Inc.'s BinaxNOW COVID-19
Antigen Self Test, issued March 31, 2021;
<bullet> Abbott Diagnostics Scarborough, Inc.'s BinaxNOW COVID-19
Ag Card 2 Home Test, issued March 31, 2021;
<bullet> Thermo Fisher Scientific's Amplitude Solution with the
TaqPath COVID-19 High-Throughput Combo Kit, issued April 9, 2021;
<bullet> Lucira Health, Inc.'s Lucira CHECK[radic]IT COVID-19 Test
Kit, issued April 9, 2021;
<bullet> PerkinElmer Genomics's PerkinElmer SARS-CoV-2 RT-qPCR
Reagent Kit, issued April 12, 2021;
<bullet> Qorvo Biotechnologies, LLC.'s Omnia SARS-CoV-2 Antigen
Test, issued April 13, 2021;
<bullet> Clinical Enterprise, Inc.'s Clinical Enterprise SARS-CoV-2
RT-PCR Assay DTC, issued April 13, 2021;
<bullet> Clinical Enterprise, Inc.'s Clinical Enterprise SARS-CoV-2
RT-PCR Assay, issued April 13, 2021;
<bullet> LGC, Biosearch Technologies' Biosearch Technologies SARS-
CoV-2 Real-Time and End-Point RT-PCR Test, issued April 15, 2021;
<bullet> Synergy Diagnostic Laboratory, Inc.'s (DBA SynergyDx),
SynergyDx SARS-CoV-2 RNA Test, issued April 16, 2021;
<bullet> Synergy Diagnostic Laboratory, Inc.'s (DBA SynergyDx),
SynergyDx SARS-CoV-2 RNA Test DTC, issued April 16, 2021;
<bullet> Celltrion USA, Inc.'s Celltrion DiaTrust COVID-19 Ag Rapid
Test, issued April 16, 2021;
<bullet> Southern California Permanente Medical Group's Kaiser
Permanente High Throughput SARS-CoV-2 Assay, issued April 19, 2021;
<bullet> PathogenDx, Inc.'s DetectX-Rv, issued April 20, 2021;
<bullet> InBios International, Inc.'s SCoV-2 Ag Detect Rapid Test,
issued May 6, 2021;
<bullet> Phosphorus Diagnostics LLC's Phosphorous COVID19 RT-qPCR
Test DTC, issued May 17, 2021;
<bullet> Salofa Oy's Sienna-Clarity COVID-19 Antigen Rapid Test
Cassette, issued May 20, 2021;
<bullet> Harvard University Clinical Laboratory's Quaeris SARS-CoV-
2 Assay, issued May 21, 2021;
<bullet> 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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<bullet> Abbott Laboratories Inc.'s AdviseDx SARS-CoV-2 IgG II,
issued March 1, 2021;
<bullet> Beckman Coulter, Inc.'s Access SARS-CoV-2 IgG II, issued
March 22, 2021;
<bullet> Siemens Healthcare Diagnostics Inc.'s Atellica IM SARS-
CoV-2 IgG (sCOVG), issued March 23, 2021;
<bullet> Symbiotica, Inc.'s COVID-19 Self-Collected Antibody Test
System, issued April 5, 2021;
<bullet> Inova Diagnostics, Inc.'s QUANTA Flash SARS-CoV-2 IgG,
issued April 19, 2021;
<bullet> QIAGEN, GmbH's QIAreach Anti-SARS-CoV-2 Total Test, issued
May 11, 2021;
<bullet> ZEUS Scientific, Inc.'s ZEUS ELISA SARS-CoV-2 Total
Antibody Test System, issued May 11, 2021;
<bullet> DiaSorin, Inc.'s LIAISON SARS-CoV-2 TrimericS IgG, issued
May 19, 2021;
<bullet> 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:
<bullet> 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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<bullet> 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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<bullet> 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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<bullet> 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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<bullet> 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:
<bullet> 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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<bullet> 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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<bullet> 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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<bullet> 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 CO<INF>2</INF> 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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<bullet> 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]]
<bullet> 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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<bullet> 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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<bullet> 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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<bullet> 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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<bullet> 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
</pre></body>
</html>Indexed from Federal Register on July 23, 2021.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.