Notice2022-15699
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 22, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) 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 87 Issue 140 (Friday, July 22, 2022)</title>
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[Federal Register Volume 87, Number 140 (Friday, July 22, 2022)]
[Notices]
[Pages 43877-43880]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-15699]
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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 or Agency) 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. See the SUPPLEMENTARY INFORMATION
[[Page 43878]]
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
<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>.
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 January 25,
2022, through June 15, 2022, 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
[[Page 43879]]
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> Fluidigm Corporation's Advanta Dx COVID-19 EASE Assay,
issued February 7, 2022;
<bullet> Uh-Oh Labs Inc.'s UOL COVID-19 Test, issued February 8,
2022;
<bullet> Oceanit Foundry LLC's ASSURE-100 Rapid COVID-19 Test,
issued February 28, 2022;
<bullet> Siemens Healthcare Diagnostics, Inc.'s ADVIA Centaur SARS-
CoV-2 Antigen (CoV2Ag), issued March 11, 2022;
<bullet> Siemens Healthcare Diagnostics, Inc.'s Atellica IM SARS-
CoV-2 Antigen (CoV2Ag), issued March 11, 2022;
<bullet> Minute Molecular Diagnostics, Inc.'s DASH SARS-CoV-2/S
Test, issued March 15, 2022;
<bullet> PHASE Scientific International, Ltd.'s INDICAID COVID-19
Rapid Antigen At-Home Test, issued March 16, 2022;
<bullet> Helix OpCo LLC's (dba Helix) Helix SARS-CoV-2 Test, issued
March 17, 2022;
<bullet> Quest Diagnostics Nichols Institute's Quest RC COVID-19
PCR DTC, issued March 21, 2022;
<bullet> Quest Diagnostics Nichols Institute's Quest PF COVID-19
PCR DTC, issued March 21, 2022;
<bullet> Quest Diagnostics Nichols Institute's Quest COVID-19 PCR
DTC, issued March 21, 2022;
<bullet> DC Department of Health's Test Yourself DC At-Home COVID-
19 Collection Kit, issued April 6, 2022;
<bullet> OSANG LLC's OHC COVID-19 Antigen Self Test, issued April
6, 2022;
<bullet> Xiamen Boson Biotech Co., Ltd.'s Rapid SARS-CoV-2 Antigen
Test Card, issued April 6, 2022;
<bullet> UCSD BCG EXCITE Lab's UCSD EXCITE COVID-19 EL Test, issued
April 7, 2022;
<bullet> MicroGEM U.S., Inc.'s MicroGEM Sal6830 SARS-CoV-2 Saliva
Test, issued April 14, 2022;
<bullet> LGC, Biosearch Technologies's Biosearch Technologies SARS-
CoV-2 ultra-high-throughput End-Point RT-PCR Test, issued April 26,
2022;
<bullet> Abbott Diagnostics Scarborough, Inc.'s ID NOW COVID-19
2.0, issued May 6, 2022;
<bullet> Cepheid's Xpert Xpress CoV-2 plus, issued May 10, 2022;
<bullet> Nexus Medical Labs, LLC.'s Nexus High Throughput SARS-CoV-
2 Assay, issued May 17, 2022;
<bullet> DxLab Inc.'s DxLab COVID-19 Test, issued June 1, 2022;
<bullet> Roche Molecular Systems, Inc.'s cobas SARS-CoV-2 Duo for
use on the cobas 6800/8800 Systems (cobas SARS-CoV-2 Duo), issued June
14, 2022;
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> LG Chem, Ltd.'s AdvanSure SARS-CoV-2 IgG(S1) ELISA, issued
May 19, 2022;
<bullet> LG Chem, Ltd.'s AdvanSure SARS-CoV-2 IgG(RBD) ELISA,
issued May 31, 2022.
FDA is hereby announcing the following Authorizations for
multianalyte in vitro diagnostics:
<bullet> Cleveland Clinic Robert J. Tomsich Pathology and
Laboratory Medicine Institute's SelfCheck cobas SARS-CoV-2 + Flu Assay,
issued April 11, 2022; \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 product may be effective
in diagnosing COVID-19 through the simultaneous qualitative
detection and differentiation of SARS-CoV-2, influenza A virus, and/
or influenza B virus ribonucleic acid (RNA) 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> OPTI Medical Systems, Inc.'s OPTI SARS-CoV-2/Influenza A/B
RT-PCR Test (Version 1 and Version 2), issued April 21, 2022; \6\
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\6\ 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 qualitative
detection and differentiation of SARS-CoV-2, influenza A virus, and/
or influenza B virus RNA 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> Laboratory Corporation of America's (Labcorp's) Labcorp
Seasonal Respiratory Virus RT-PCR DTC Test, issued May 16, 2022; \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 qualitative
detection and differentiation of SARS-CoV-2, influenza A virus,
influenza B virus and/or respiratory syncytial virus (RSV) RNA 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> Laboratory Corporation of America's (Labcorp's) Labcorp
Seasonal Respiratory Virus RT-PCR Test, issued May 17, 2022; \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 qualitative
detection and differentiation of SARS-CoV-2, influenza A virus,
influenza B virus and/or RSV RNA 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 Authorization for a SARS-
CoV-2 genotyping test:
<bullet> Laboratory Corporation of America's (Labcorp's) Labcorp
VirSeq SARS-CoV-2 NGS Test, issued June 10, 2022.\9\
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\9\ As set forth in the EUAs for this product, FDA has concluded
that: (1) SARS-CoV-2, the virus that causes COVID-19, can cause a
serious or life-threatening disease or condition, including severe
respiratory illness, to humans infected by this virus; (2) based on
the totality of scientific evidence available to FDA, it is
reasonable to believe that the product may be effective in
diagnosing COVID-19, through the identification and differentiation
of SARS-CoV-2 Phylogenetic Assignment of Named Global Outbreak
(PANGO) lineages, and that the known and potential benefits of the
product, when used for diagnosing COVID-19, outweigh the known and
potential risks of such 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 Authorization for a SARS-
CoV-2 diagnostic test that analyzes breath samples:
[[Page 43880]]
<bullet> InspectIR Systems LLC's InspectIR COVID-19 Breathalyzer,
issued April 14, 2022; \10\
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\10\ As set forth in the EUAs for this product, FDA has
concluded that: (1) SARS-CoV-2, the virus that causes COVID-19, can
cause a serious or life-threatening disease or condition, including
severe respiratory illness, to humans infected by this virus; (2)
based on the totality of scientific evidence available to FDA, it is
reasonable to believe that the product may be effective in
diagnosing COVID-19, and that the known and potential benefits of
the product, when used for diagnosing COVID-19, outweigh the known
and potential risks of such 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> Quest Diagnostics Nichols Institute's Quest COVID-19 PCR
Test Home Collection Kit, issued March 21, 2022; \11\
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\11\ 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, by serving as an appropriate means to
collect and transport human specimens so that an authorized
laboratory can detect SARS-CoV-2 RNA from the home-collected human
specimen, and that the known and potential benefits of the product
when used for diagnosing COVID-19, outweigh the known and potential
risks of the product; and (3) there is no adequate, approved, and
available alternative to the emergency use of the product.
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<bullet> Audere's HealthPulse@home Fusion, issue April 26,
2022.\12\
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\12\ 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 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 collected human specimen, and that
the known and potential benefits of the product when used for such
use, outweigh the known and potential risks of the product; and (3)
there is no adequate, approved, and available alternative to the
emergency use of the product.
Dated: July 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-15699 Filed 7-21-22; 8:45 am]
BILLING CODE 4164-01-P
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