[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