Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability, 21749-21753 [2021-08467]
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Federal Register / Vol. 86, No. 77 / Friday, April 23, 2021 / Notices
records, e.g., the formulation or recipe,
that a manufacturer has and maintains
as a normal course of its doing business.
Thus, the burden to the food
manufacturer is limited to assembling
and retaining the records.
Dated: April 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–08480 Filed 4–22–21; 8:45 am]
BILLING CODE 4164–01–P
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.
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 are
available on FDA’s website at the links
indicated.
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SUMMARY:
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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:
DATES:
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 lifethreatening 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
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21749
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.
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
(CDC) (to the extent feasible and
appropriate given the applicable
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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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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II. Electronic Access
An electronic version of this
document and the full text of the
Authorizations are available on the
internet at https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/emergency-useauthorization.
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,
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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are available on the internet from the
FDA web page entitled ‘‘Emergency Use
Authorization,’’ available at https://
www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatoryand-policy-framework/emergency-useauthorization. The lists that follow
include Authorizations issued from
September 15, 2020, through February
15, 2021, and we have included
explanations of the reasons for their
issuance, as required by section
564(h)(1) of the FD&C Act. In addition,
the EUAs that have been reissued can be
accessed from FDA’s web page: https://
www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatoryand-policy-framework/emergency-useauthorization. FDA is hereby
announcing the following
Authorizations for molecular diagnostic
and antigen tests for COVID–19,
excluding multi-analyte tests: 3
• Visby Medical, Inc.’s Visby Medical
COVID–19, issued September 16, 2020;
• GK Pharmaceuticals Contract
Manufacturing Operations’ GK ACCU–
RIGHT SARS–CoV–2 RT–PCR KIT,
issued September 18, 2020;
• KimForest Enterprise Co., Ltd.’s
KimForest SARS–CoV–2 Detection Kit
v1, issued September 21, 2020;
• Vela Operations Singapore Pte.
Ltd.’s ViroKey SARS–CoV–2 RT–PCR
Test v2.0, issued September 22, 2020;
• Quadrant Biosciences Inc.’s Clarifi
COVID–19 Test Kit, issued September
22, 2020;
• Clear Labs, Inc.’s Clear Dx SARS–
CoV–2 Test, issued September 23, 2020;
• Genetrack Biolabs, Inc.’s Genetrack
SARS–CoV–2 Molecular Assay, issued
September 25, 2020;
• National Jewish Health’s SARS–
CoV–2 MassArray Test, issued
September 29, 2020;
• Akron Children’s Hospital’s Akron
Children’s Hospital SARS–CoV–2
Assay, issued September 29, 2020;
• CENTOGENE US, LLC’s CentoSure
SARS–CoV–2 RT–PCR Assay, issued
September 29, 2020;
• Aeon Global Health’s Aeon Global
Health SARS–CoV–2 Assay, issued
September 30, 2020;
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 lifethreatening 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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• Alimetrix, Inc.’s Alimetrix SARS–
CoV–2 RT–PCR Assay, issued
September 30, 2020;
• Tempus Labs, Inc.’s iC SARS–CoV2
Test, issued October 1, 2020;
• UMass Memorial Medical Center’s
UMass Molecular Virology Laboratory
2019–nCoV rRT–PCR Dx Panel, issued
October 1, 2020;
• SEASUN BIOMATERIALS, Inc.’s
AQ–TOP COVID–19 Rapid Detection Kit
PLUS, issued October 5, 2020;
• University of California, Los
Angeles’s (UCLA’s) UCLA SwabSeq
COVID–19 Diagnostic Platform, issued
October 6, 2020;
• Access Bio, Inc.’s CareStart COVID–
19 Antigen, issued October 8, 2020;
• LumiraDx UK Ltd.’s LumiraDx
SARS–CoV–2 RNA STAR Complete,
issued October 14, 2020;
• Celltrion USA, Inc.’s Sampinute
COVID–19 Antigen MIA, issued October
23, 2020;
• Agena Bioscience, Inc.’s
MassARRAY SARS–CoV–2 Panel,
issued October 26, 2020;
• Lucira Health, Inc.’s Lucira COVID–
19 All-In-One Test Kit, issued
November 17, 2020;
• Gravity Diagnostics, LLC’s Gravity
Diagnostics SARS–CoV–2 RT–PCR
Assay, issued November 23, 2020;
• Cepheid’s Xpert Omni SARS–CoV–
2, issued November 27, 202;
• Luminostics, Inc.’s Clip COVID
Rapid Antigen Test, issued December 7,
2020;
• Laboratory Corporation of
America’s Pixel by LabCorp COVID–19
Test Home Collection Kit, issued
December 9, 2020;
• ResearchDx, Inc., DBA Pacific
Diagnostics’ PacificDx Covid–19 Test,
issued December 11, 2020;
• RCA Laboratory Services LLC dba
GENETWORx’s GENETWORx Covid–19
Nasal Swab Test, issued December 15,
2020;
• Ellume Limited’s Ellume COVID–19
Home Test, issued December 15, 2020;
• Abbott Diagnostics Scarborough,
Inc.’s BinaxNOW COVID–19 Ag Card
Home Test, issued December 16, 2020;
• Materials and Machines
Corporation of America’s (DBA
MatmaCorp, Inc.) MatMaCorp COVID–
19 2SF Test, issued December 17, 2020;
• Quidel Corporation’s QuickVue
SARS Antigen Test, issued December
18, 2020;
• Quidel Corporation’s Solana SARS–
CoV–2 Assay, issued December 23,
2020;
• Cepheid’s Xpert Xpress SARS–
CoV–2 DoD, issued December 23, 2020;
• Quanterix Corporation’s Simoa
SARS–CoV–2 N Protein Antigen Test,
issued January 5, 2021;
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• Ortho Clinical Diagnostics, Inc.’s
VITROS Immunodiagnostic Products
SARS–CoV–2 Antigen Reagent Pack
used in combination with the VITROS
Immunodiagnostic Products SARS–
CoV–2 Antigen Calibrator, issued
January 11, 2021;
• SML GENETREE Co., Ltd.’s Ezplex
SARS–CoV–2 G Kit, issued January 13,
2021;
• Bio-Rad Laboratories, Inc.’s Bio-Rad
Reliance SARS–CoV–2 RT–PCR Assay
Kit, issued January 15, 2021;
• Ambry Genetics Laboratory’s
Ambry COVID–19 RT–PCR Test, issued
January 22, 2021;
• Clinomics USA Inc.’s Clinomics
TrioDx RT–PCR COVID–19 Test, issued
February 4, 2021;
• Visby Medical, Inc.’s Visby Medical
COVID–19 Point of Care Test, issued
February 8, 2021;
• Grifols Diagnostic Solutions Inc.’s
Procleix SARS–CoV–2 Assay, issued
February 10, 2021;
• Assurance Scientific Laboratories’
Assurance SARS–CoV–2 Panel DTC,
issued February 13, 2021; and
• Gravity Diagnostics, LLC’s Gravity
Diagnostics SARS–CoV–2 RT–PCR for
use with DTC kits, issued February 13,
2021.
FDA is hereby announcing the
following Authorizations for serology
tests: 4
• Jiangsu Well Biotech Co., Ltd.’s
Orawell IgM/IgG Rapid Test, issued
September 23, 2020;
• Quotient Suisse SA’s MosaiQ
COVID–19 Antibody Magazine, issued
September 25, 2020;
• Nirmidas Biotech, Inc.’s Nirmidas
COVID–19 (SARS–CoV–2) IgM/IgG
Antibody Detection Kit, issued
September 29, 2020;
• NanoEntek America, Inc.’s FREND
COVID–19 total Ab, issued September
29, 2020;
• DiaSorin, Inc.’s DiaSorin LIAISON
SARS–CoV–2 IgM Assay, issued
September 29, 2020;
• Thermo Fisher Scientific’s
OmniPATH COVID–19 Total Antibody
ELISA Test, issued October 2, 2020;
• ZEUS Scientific, Inc.’s ZEUS ELISA
SARS–CoV–2 IgG Test System
Company, issued October 6, 2020;
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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• Genalyte, Inc.’s Maverick SARS–
CoV–2 Multi-Antigen Serology Panel v2,
issued October 8, 2020;
• Beckman Coulter, Inc.’s Access
SARS–CoV–2 IgM, issued October 8,
2020;
• Abbott Laboratories Inc.’s AdviseDx
SARS–CoV–2 IgM, issued October 9,
2020;
• Quansys Biosciences, Inc.’s Q-Plex
SARS–CoV–2 Human IgG (4 Plex),
issued October 28, 2020;
• GenScript USA Inc.’s cPass SARS–
CoV–2 Neutralization Antibody
Detection Kit, issued November 6, 2020;
• Innovita (Tangshan) Biological
Technology Co., Ltd.’s Innovita 2019–
nCoV Ab Test (Colloidal Gold), issued
November 23, 2020;
• Kantaro Biosciences, LLC’s COVID–
SeroKlir, Kantaro Semi-Quantitative
SARS–CoV–2 IgG Antibody Kit, issued
November 24, 2020;
• Roche Diagnostics, Inc.’s Elecsys
Anti-SARS–CoV–2 S, issued November
25, 2020;
• ACON Laboratories, Inc.’s ACON
SARS–CoV–2 IgG/IgM Rapid Test,
issued December 15, 2020;
• Quanterix Corporation’s Simoa
Semi-Quantitative SARS–CoV–2 IgG
Antibody Test, issued December 23,
2020;
• Nirmidas Biotech, Inc.’s MidaSpot
COVID–19 Antibody Combo Detection
Kit, issued December 31, 2020;
• Siemens Healthcare Diagnostics
Inc.’s Dimension Vista SARS–CoV–2
IgG (COV2G), issued January 8, 2021;
• Siemens Healthcare Diagnostics
Inc.’s Dimension EXL SARS–CoV–2 IgG
(CV2G), issued January 8, 2021;
• ADVAITE, Inc.’s RapCov Rapid
COVID–19 Test, issued January 11,
2021;
• Phadia AB’s EliA SARS–CoV–2–
Sp1 IgG Test, issued January 11, 2021;
• United Biomedical, Inc.’s UBI
SARS–CoV–2 ELISA, issued January 15,
2021; and
• Immunodiagnostic Systems Ltd’s
IDS SARS–CoV–2 IgG, issued February
10, 2021.
FDA is hereby announcing the
following Authorizations for multianalyte in vitro diagnostics: 5
5 As set forth in the EUAs, FDA has concluded
that: (1) SARS–CoV–2 can cause a serious or lifethreatening 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
(through the simultaneous detection and
differentiation of SARS–CoV–2 and various other
pathogens (see individual EUAs for specific other
pathogens)) and that the known and potential
benefits of the products when used for such a use,
outweigh the known and potential risks of the
products; and (3) there is no adequate, approved,
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• Cepheid’s Xpert Xpress SARS–
CoV–2/Flu/RSV, issued September 24,
2020;
• BioFire Diagnostics, LLC’s BioFire
Respiratory Panel 2.1–EZ (RP2.1–EZ),
issued October 2, 2020;
• Quidel Corporation’s Sofia 2 Flu +
SARS Antigen FIA, issued October 2,
2020;
• GenMark Diagnostics, Inc.’s ePlex
Respiratory Pathogen Panel 2 (ePlex RP2
Panel), issued October 7, 2020;
• Quest Diagnostics Infectious
Disease, Inc.’s Quest Diagnostics RC
COVID–19 +Flu RT–PCR, issued
December 4, 2020;
• Hologic, Inc.’s Aptima SARS–CoV–
2/Flu assay, issued December 16, 2020;
• Princeton BioMeditech Corp.’s
Status COVID–19/Flu, issued February
4, 2021;
• Becton, Dickinson and Company’s
BD SARS–CoV–2/Flu for BD MAX
System, issued February 10, 2021;
• Thermo Fisher Scientific’s TaqPath
COVID–19, FluA, FluB Combo Kit,
issued February 10, 2021; and
• Bio-Rad Laboratories, Inc.’s Bio-Rad
Reliance SARS–CoV–2/FluA/FluB RT–
PCR Assay Kit, issued February 11,
2021.
FDA is hereby announcing the
following Authorizations for other
medical devices:
• Duke University’s COVIAGE, issued
September 24, 2020; 6
• Dascena, Inc.’s COViage
Hemodynamic Instability and
Respiratory Decompensation Prediction
System (COViage), issued September 24,
2020; 7
and available alternative to the emergency use of
the products.
6 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 COVIAGE may
be effective in preventing healthcare providers’
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 of
patients with suspected or confirmed diagnosis of
COVID–19 and that the known and potential
benefits of COVIAGE for such use outweigh its
known and potential risks; and (3) there is no
adequate, approved, and available alternative to the
emergency use of COVIAGE.
7 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 COViage may
be effective when used by healthcare providers as
a diagnostic aid to assist with the early
identification of adult COVID–19 patients (18 years
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• Beckman Coulter, Inc’s Access IL–
6, issued October 1, 2020; 8
• Spectrum Solutions LLC’s SDNA–
1000 Saliva Collection Device, issued
October 8, 2020; 9
• Roxby Development, LLC’s ZoeAnn Decontamination System, issued
October 20, 2020; 10
• DNA Genotek Inc.’s
OMNIgene·ORAL OM–505 and OME–
of age or older who are admitted to the hospital)
who are likely to be diagnosed with hemodynamic
instability or respiratory decompensation, which
are common complications associated with COVID–
19, and that the known and potential benefits of
COViage, for such use, outweigh the known and
potential risks; and (3) there is no adequate,
approved, and available alternative to the
emergency use of COViage when used by healthcare
providers as a diagnostic aid to assist with the early
identification of adult COVID–19 patients who are
likely to be diagnosed with hemodynamic
instability or respiratory decompensation, which
are common complications associated with COVID–
19.
8 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 product
may be effective in treating COVID–19, by assisting
in identifying severe inflammatory response in
patients with confirmed COVID–19 illness to aid in
determining the risk of intubation with mechanical
ventilation, 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.
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 product
may be effective in diagnosing COVID–19 by
serving as an appropriate means to collect, stabilize,
and maintain during transport, unprocessed saliva
specimens suspected of containing SARS–CoV–2
RNA, and that the known and potential benefits of
the products 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.
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 Zoe-Ann
Decontamination System may be effective at
decontaminating compatible N95 respirators for
single-user reuse by healthcare providers to prevent
exposure to SARS–CoV–2 and other pathogenic
biological airborne particulates, and that the known
and potential benefits of this product, when used
for such use, outweigh the known and potential
risks of the use of such product; and (3) there is no
adequate, approved, and available alternative to the
emergency use of the Zoe-Ann Decontamination
System for decontaminating compatible N95
respirators for single-user reuse by healthcare
providers to prevent exposure to SARS–CoV–2 and
other pathogenic biological airborne particulates
during filtering facepiece respirator shortages
during the COVID–19 pandemic.
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505 (OMNIgene·ORAL) saliva collection
devices, issued October 14, 2020; 11
• Clinical Enterprise, Inc.’s
EmpowerDX At-Home COVID–19 PCR
Test Kit, issued on October 15, 2020; 12
• binx health, Inc.’s binx health AtHome Nasal Swab COVID–19 Sample
Collection Kit, issued October 20,
2020; 13
• DNA Genotek Inc.’s
ORAcollect•RNA OR–100 and
ORAcollect•RNA ORE–100 saliva
collection devices, issued October 28,
2020; 14
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 product
may be effective in diagnosing COVID–19 by
serving as an appropriate means to collect, stabilize,
and maintain during transport, saliva specimens
suspected of containing SARS–CoV–2 RNA, 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.
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 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
self-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.
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 product
may be effective in diagnosing COVID–19, by
serving as an appropriate means to collect and
transport human nasal swab specimens so that an
authorized laboratory can detect SARS–CoV–2 RNA
from the self-collected 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.
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 product
may be effective in diagnosing COVID–19 by
serving as an appropriate means to collect, stabilize,
and maintain during transport, saliva specimens
suspected of containing SARS–CoV–2 RNA, 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.
PO 00000
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Fmt 4703
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• Terumo Cardiovascular’s CAPIOX
Emergency Bypass System (CAPIOX
EBS), issued November 21, 2020; 15
• RapidRona, Inc.’s RapidRona SelfCollection Kit, issued November 23,
2020; 16
• 3B Medical, Inc.’s Lumin LM3000
Bioburden Reduction UV System
(‘‘Lumin LM3000’’), issued December 3,
2020; 17
• Ecolab Inc.’s Bioquell Technology
System, issued December 4, 2020; 18
15 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 CAPIOX
EBS may be effective in treating COVID–19 by
providing long-term (≤ 6 hours) respiratory or
cardiopulmonary support to treat patients 18 years
or older with COVID–19 who have acute respiratory
failure or acute cardiopulmonary failure where
other available treatment options have failed, and
continued clinical deterioration is expected or the
risk of death is imminent, and that the known and
potential benefits of the CAPIOX EBS for such use,
outweigh the known and potential risks; and (3)
there is no adequate, approved, and available
alternative to the emergency use of the CAPIOX
EBS when there are shortages of FDA-cleared
alternatives during the COVID–19 pandemic.
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 product
may be effective in diagnosing COVID–19, by
serving as an appropriate means to collect and
transport human nasal swab specimens so that an
authorized laboratory can detect SARS–CoV–2 RNA
from the self-collected 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.
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 Lumin
LM3000 may be effective at bioburden reduction of
compatible N95 respirators for single-user reuse by
healthcare providers to supplement CDC reuse
recommendations to prevent exposure to SARS–
CoV–2 and other pathogenic biological airborne
particulates, and that the known and potential
benefits of this product, when used for such use,
outweigh the known and potential risks of the use
of such product; and (3) there is no adequate,
approved, and available alternative to the
emergency use of the Lumin LM3000 for bioburden
reduction of compatible N95 respirators for singleuser reuse by healthcare providers to supplement
CDC reuse recommendations to prevent exposure to
SARS–CoV–2 and other pathogenic biological
airborne particulates during filtering facepiece
respirator shortages during the COVID–19
pandemic.
18 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
E:\FR\FM\23APN1.SGM
23APN1
Federal Register / Vol. 86, No. 77 / Friday, April 23, 2021 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
• SCONE Medical Solutions Inc.’s
SCONE, issued December 18, 2020; 19
• Siemens Healthcare Diagnostics
Inc.’s ADVIA Centaur IL6 assay, issued
December 18, 2020; 20
• Yale New Haven Health System’s
Yale New Haven Health FILTERING
FACEPIECE RESPIRATOR
Decontamination System, issued
January 15, 2021; 21 and
FDA, it is reasonable to believe that the Bioquell
Technology System may be effective at
decontaminating compatible N95 respirators for
single-user reuse by healthcare providers to prevent
exposure to SARS–CoV–2 and other pathogenic
biological airborne particulates, and that the known
and potential benefits of this product, when used
for such use, outweigh the known and potential
risks of the use of such product; and (3) there is no
adequate, approved, and available alternative to the
emergency use of the Bioquell Technology System
for decontaminating compatible N95 respirators for
single-user reuse by healthcare providers to prevent
exposure to SARS–CoV–2 and other pathogenic
biological airborne particulates during filtering
facepiece respirator shortages during the COVID–19
pandemic.
19 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 SCONE may be
effective in preventing healthcare providers
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 30 minutes, of
patients with suspected or confirmed diagnosis of
COVID–19 and that the known and potential
benefits of SCONE for such use outweigh its known
and potential risks; and (3) there is no adequate,
approved, and available alternative to the
emergency use of SCONE.
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 product
may be effective in treating COVID–19, by assisting
in identifying severe inflammatory response in
patients with confirmed COVID–19 illness to aid in
determining the risk of intubation with mechanical
ventilation, 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.
21 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 Yale New
Haven Health filtering facepiece respirator
decontamination system may be effective at
decontaminating compatible N95 respirators for
multiple-user reuse by healthcare providers to
prevent exposure to SARS–CoV–2 and other
pathogenic biological airborne particulates, and that
the known and potential benefits of this product,
when used for such use, outweigh the known and
potential risks of the use of such product; and (3)
VerDate Sep<11>2014
18:15 Apr 22, 2021
Jkt 253001
• Everlywell, Inc.’s Everlywell
COVID–19 Test Home Collection Kit
DTC, issued February 13, 2021.22
Dated: April 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–08467 Filed 4–22–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0001]
Model Informed Drug Development
Approaches for Immunogenicity
Assessments; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) Center for
Biologics Evaluation and Research, in
collaboration with the Center for Drug
Evaluation and Research, is announcing
the following public workshop entitled
‘‘Model Informed Drug Development
Approaches for Immunogenicity
Assessments.’’ The purpose of this
public workshop is to discuss the best
practices and future directions of
quantitative methods for predicting
immunogenicity of biological products.
This public workshop is also being
conducted to satisfy one of FDA’s
performance goals included in the sixth
reauthorization of the Prescription Drug
User Fee Amendments (PDUFA VI), part
of the FDA Reauthorization Act of 2017
(FDARA), to hold a series of workshops
SUMMARY:
there is no adequate, approved, and available
alternative to the emergency use of the Yale New
Haven Health filtering facepiece respirator
Decontamination System for decontaminating
compatible N95 respirators for multiple-user reuse
by healthcare providers to prevent exposure to
SARS–CoV–2 and other pathogenic biological
airborne particulates during filtering facepiece
respirator shortages during the COVID–19
pandemic.
22 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 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.
PO 00000
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Fmt 4703
Sfmt 4703
21753
related to model-informed drug
development (MIDD).
DATES: The public workshop will be
held virtually on June 9, 2021, from 8
a.m. to 5 p.m., Eastern Time. See the
SUPPLEMENTARY INFORMATION section for
registration date and information.
ADDRESSES: Please note that due to the
impact of the COVID–19 pandemic, all
participants will be joining this public
workshop via an online
teleconferencing platform. The public
workshop will be held virtually via
Adobe Connect. Webcast information
will be provided upon completion of
registration.
FOR FURTHER INFORMATION CONTACT: Loni
Warren Henderson or Sherri Revell,
Center for Biologics Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 1118, Silver Spring,
MD 20993, 240–402–8010,
CBERPublicEvents@fda.hhs.gov (subject
line: MIDD Workshop).
SUPPLEMENTARY INFORMATION:
I. Background
Under FDARA, and in accordance
with section I, part J of the PDUFA VI
Performance Goals, FDA agreed to
convene a series of workshops to
identify best practices for MIDD (https://
www.fda.gov/media/99140/download,
see page 27). Each workshop focuses on
current and emerging scientific
approaches, including methodological
limitations. The workshop announced
in this notice fulfills FDA’s performance
commitment under PDUFA VI,
specifically for modeling
immunogenicity and correlates of
protection for evaluating biological
products, including vaccines and blood
products.
II. Topics for Discussion at the Public
Workshop
Topics for discussion include the
following:
1. Current in silico methodologies
used to assess drug immunogenicity;
2. Available data resources and data
needs for MIDD approaches to evaluate
immunogenicity at various stages of
drug development;
3. Possible applications and
limitations of MIDD approaches for
desired immunogenicity of vaccine/
allergenic products; and
4. Insight into the possible future
applications of MIDD and good
modeling practices.
A detailed agenda will be posted in
advance of the workshop at https://
www.fda.gov/vaccines-blood-biologics/
news-events-biologics/workshopsmeetings-conferences-biologics.
E:\FR\FM\23APN1.SGM
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]]>Agencies
[Federal Register Volume 86, Number 77 (Friday, April 23, 2021)]
[Notices]
[Pages 21749-21753]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08467]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 are
available on FDA's website at 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 (CDC) (to the extent feasible and appropriate given the
applicable
[[Page 21750]]
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
II. Electronic Access
An electronic version of this document and the full text of the
Authorizations are available on the internet at 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, are available on
the internet 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 September 15, 2020, through February 15,
2021, and we have included explanations of the reasons for their
issuance, as required by section 564(h)(1) of the FD&C Act. In
addition, the EUAs that have been reissued can be accessed from FDA's
web page: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. FDA
is hereby announcing the following Authorizations for molecular
diagnostic and antigen tests for COVID-19, excluding multi-analyte
tests: \3\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
Visby Medical, Inc.'s Visby Medical COVID-19, issued
September 16, 2020;
GK Pharmaceuticals Contract Manufacturing Operations' GK
ACCU-RIGHT SARS-CoV-2 RT-PCR KIT, issued September 18, 2020;
KimForest Enterprise Co., Ltd.'s KimForest SARS-CoV-2
Detection Kit v1, issued September 21, 2020;
Vela Operations Singapore Pte. Ltd.'s ViroKey SARS-CoV-2
RT-PCR Test v2.0, issued September 22, 2020;
Quadrant Biosciences Inc.'s Clarifi COVID-19 Test Kit,
issued September 22, 2020;
Clear Labs, Inc.'s Clear Dx SARS-CoV-2 Test, issued
September 23, 2020;
Genetrack Biolabs, Inc.'s Genetrack SARS-CoV-2 Molecular
Assay, issued September 25, 2020;
National Jewish Health's SARS-CoV-2 MassArray Test, issued
September 29, 2020;
Akron Children's Hospital's Akron Children's Hospital
SARS-CoV-2 Assay, issued September 29, 2020;
CENTOGENE US, LLC's CentoSure SARS-CoV-2 RT-PCR Assay,
issued September 29, 2020;
Aeon Global Health's Aeon Global Health SARS-CoV-2 Assay,
issued September 30, 2020;
Alimetrix, Inc.'s Alimetrix SARS-CoV-2 RT-PCR Assay,
issued September 30, 2020;
Tempus Labs, Inc.'s iC SARS-CoV2 Test, issued October 1,
2020;
UMass Memorial Medical Center's UMass Molecular Virology
Laboratory 2019-nCoV rRT-PCR Dx Panel, issued October 1, 2020;
SEASUN BIOMATERIALS, Inc.'s AQ-TOP COVID-19 Rapid
Detection Kit PLUS, issued October 5, 2020;
University of California, Los Angeles's (UCLA's) UCLA
SwabSeq COVID-19 Diagnostic Platform, issued October 6, 2020;
Access Bio, Inc.'s CareStart COVID-19 Antigen, issued
October 8, 2020;
LumiraDx UK Ltd.'s LumiraDx SARS-CoV-2 RNA STAR Complete,
issued October 14, 2020;
Celltrion USA, Inc.'s Sampinute COVID-19 Antigen MIA,
issued October 23, 2020;
Agena Bioscience, Inc.'s MassARRAY SARS-CoV-2 Panel,
issued October 26, 2020;
Lucira Health, Inc.'s Lucira COVID-19 All-In-One Test Kit,
issued November 17, 2020;
Gravity Diagnostics, LLC's Gravity Diagnostics SARS-CoV-2
RT-PCR Assay, issued November 23, 2020;
Cepheid's Xpert Omni SARS-CoV-2, issued November 27, 202;
Luminostics, Inc.'s Clip COVID Rapid Antigen Test, issued
December 7, 2020;
Laboratory Corporation of America's Pixel by LabCorp
COVID-19 Test Home Collection Kit, issued December 9, 2020;
ResearchDx, Inc., DBA Pacific Diagnostics' PacificDx
Covid-19 Test, issued December 11, 2020;
RCA Laboratory Services LLC dba GENETWORx's GENETWORx
Covid-19 Nasal Swab Test, issued December 15, 2020;
Ellume Limited's Ellume COVID-19 Home Test, issued
December 15, 2020;
Abbott Diagnostics Scarborough, Inc.'s BinaxNOW COVID-19
Ag Card Home Test, issued December 16, 2020;
Materials and Machines Corporation of America's (DBA
MatmaCorp, Inc.) MatMaCorp COVID-19 2SF Test, issued December 17, 2020;
Quidel Corporation's QuickVue SARS Antigen Test, issued
December 18, 2020;
Quidel Corporation's Solana SARS-CoV-2 Assay, issued
December 23, 2020;
Cepheid's Xpert Xpress SARS-CoV-2 DoD, issued December 23,
2020;
Quanterix Corporation's Simoa SARS-CoV-2 N Protein Antigen
Test, issued January 5, 2021;
[[Page 21751]]
Ortho Clinical Diagnostics, Inc.'s VITROS Immunodiagnostic
Products SARS-CoV-2 Antigen Reagent Pack used in combination with the
VITROS Immunodiagnostic Products SARS-CoV-2 Antigen Calibrator, issued
January 11, 2021;
SML GENETREE Co., Ltd.'s Ezplex SARS-CoV-2 G Kit, issued
January 13, 2021;
Bio-Rad Laboratories, Inc.'s Bio-Rad Reliance SARS-CoV-2
RT-PCR Assay Kit, issued January 15, 2021;
Ambry Genetics Laboratory's Ambry COVID-19 RT-PCR Test,
issued January 22, 2021;
Clinomics USA Inc.'s Clinomics TrioDx RT-PCR COVID-19
Test, issued February 4, 2021;
Visby Medical, Inc.'s Visby Medical COVID-19 Point of Care
Test, issued February 8, 2021;
Grifols Diagnostic Solutions Inc.'s Procleix SARS-CoV-2
Assay, issued February 10, 2021;
Assurance Scientific Laboratories' Assurance SARS-CoV-2
Panel DTC, issued February 13, 2021; and
Gravity Diagnostics, LLC's Gravity Diagnostics SARS-CoV-2
RT-PCR for use with DTC kits, issued February 13, 2021.
FDA is hereby announcing the following Authorizations for serology
tests: \4\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
Jiangsu Well Biotech Co., Ltd.'s Orawell IgM/IgG Rapid
Test, issued September 23, 2020;
Quotient Suisse SA's MosaiQ COVID-19 Antibody Magazine,
issued September 25, 2020;
Nirmidas Biotech, Inc.'s Nirmidas COVID-19 (SARS-CoV-2)
IgM/IgG Antibody Detection Kit, issued September 29, 2020;
NanoEntek America, Inc.'s FREND COVID-19 total Ab, issued
September 29, 2020;
DiaSorin, Inc.'s DiaSorin LIAISON SARS-CoV-2 IgM Assay,
issued September 29, 2020;
Thermo Fisher Scientific's OmniPATH COVID-19 Total
Antibody ELISA Test, issued October 2, 2020;
ZEUS Scientific, Inc.'s ZEUS ELISA SARS-CoV-2 IgG Test
System Company, issued October 6, 2020;
Genalyte, Inc.'s Maverick SARS-CoV-2 Multi-Antigen
Serology Panel v2, issued October 8, 2020;
Beckman Coulter, Inc.'s Access SARS-CoV-2 IgM, issued
October 8, 2020;
Abbott Laboratories Inc.'s AdviseDx SARS-CoV-2 IgM, issued
October 9, 2020;
Quansys Biosciences, Inc.'s Q-Plex SARS-CoV-2 Human IgG (4
Plex), issued October 28, 2020;
GenScript USA Inc.'s cPass SARS-CoV-2 Neutralization
Antibody Detection Kit, issued November 6, 2020;
Innovita (Tangshan) Biological Technology Co., Ltd.'s
Innovita 2019-nCoV Ab Test (Colloidal Gold), issued November 23, 2020;
Kantaro Biosciences, LLC's COVID-SeroKlir, Kantaro Semi-
Quantitative SARS-CoV-2 IgG Antibody Kit, issued November 24, 2020;
Roche Diagnostics, Inc.'s Elecsys Anti-SARS-CoV-2 S,
issued November 25, 2020;
ACON Laboratories, Inc.'s ACON SARS-CoV-2 IgG/IgM Rapid
Test, issued December 15, 2020;
Quanterix Corporation's Simoa Semi-Quantitative SARS-CoV-2
IgG Antibody Test, issued December 23, 2020;
Nirmidas Biotech, Inc.'s MidaSpot COVID-19 Antibody Combo
Detection Kit, issued December 31, 2020;
Siemens Healthcare Diagnostics Inc.'s Dimension Vista
SARS-CoV-2 IgG (COV2G), issued January 8, 2021;
Siemens Healthcare Diagnostics Inc.'s Dimension EXL SARS-
CoV-2 IgG (CV2G), issued January 8, 2021;
ADVAITE, Inc.'s RapCov Rapid COVID-19 Test, issued January
11, 2021;
Phadia AB's EliA SARS-CoV-2-Sp1 IgG Test, issued January
11, 2021;
United Biomedical, Inc.'s UBI SARS-CoV-2 ELISA, issued
January 15, 2021; and
Immunodiagnostic Systems Ltd's IDS SARS-CoV-2 IgG, issued
February 10, 2021.
FDA is hereby announcing the following Authorizations for multi-
analyte in vitro diagnostics: \5\
---------------------------------------------------------------------------
\5\ As set forth in the EUAs, 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 COVID-19 (through the simultaneous detection and
differentiation of SARS-CoV-2 and various other pathogens (see
individual EUAs for specific other pathogens)) and that the known
and potential benefits of the products when used for such a 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.
---------------------------------------------------------------------------
Cepheid's Xpert Xpress SARS-CoV-2/Flu/RSV, issued
September 24, 2020;
BioFire Diagnostics, LLC's BioFire Respiratory Panel 2.1-
EZ (RP2.1-EZ), issued October 2, 2020;
Quidel Corporation's Sofia 2 Flu + SARS Antigen FIA,
issued October 2, 2020;
GenMark Diagnostics, Inc.'s ePlex Respiratory Pathogen
Panel 2 (ePlex RP2 Panel), issued October 7, 2020;
Quest Diagnostics Infectious Disease, Inc.'s Quest
Diagnostics RC COVID-19 +Flu RT-PCR, issued December 4, 2020;
Hologic, Inc.'s Aptima SARS-CoV-2/Flu assay, issued
December 16, 2020;
Princeton BioMeditech Corp.'s Status COVID-19/Flu, issued
February 4, 2021;
Becton, Dickinson and Company's BD SARS-CoV-2/Flu for BD
MAX System, issued February 10, 2021;
Thermo Fisher Scientific's TaqPath COVID-19, FluA, FluB
Combo Kit, issued February 10, 2021; and
Bio-Rad Laboratories, Inc.'s Bio-Rad Reliance SARS-CoV-2/
FluA/FluB RT-PCR Assay Kit, issued February 11, 2021.
FDA is hereby announcing the following Authorizations for other
medical devices:
Duke University's COVIAGE, issued September 24, 2020; \6\
---------------------------------------------------------------------------
\6\ 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 COVIAGE may be effective in preventing healthcare providers'
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 of patients with suspected or confirmed diagnosis of
COVID-19 and that the known and potential benefits of COVIAGE for
such use outweigh its known and potential risks; and (3) there is no
adequate, approved, and available alternative to the emergency use
of COVIAGE.
---------------------------------------------------------------------------
Dascena, Inc.'s COViage Hemodynamic Instability and
Respiratory Decompensation Prediction System (COViage), issued
September 24, 2020; \7\
---------------------------------------------------------------------------
\7\ 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 COViage may be effective when used by healthcare providers as a
diagnostic aid to assist with the early identification of adult
COVID-19 patients (18 years of age or older who are admitted to the
hospital) who are likely to be diagnosed with hemodynamic
instability or respiratory decompensation, which are common
complications associated with COVID-19, and that the known and
potential benefits of COViage, for such use, outweigh the known and
potential risks; and (3) there is no adequate, approved, and
available alternative to the emergency use of COViage when used by
healthcare providers as a diagnostic aid to assist with the early
identification of adult COVID-19 patients who are likely to be
diagnosed with hemodynamic instability or respiratory
decompensation, which are common complications associated with
COVID-19.
---------------------------------------------------------------------------
[[Page 21752]]
Beckman Coulter, Inc's Access IL-6, issued October 1,
2020; \8\
---------------------------------------------------------------------------
\8\ 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 product may be effective in treating COVID-19, by assisting
in identifying severe inflammatory response in patients with
confirmed COVID-19 illness to aid in determining the risk of
intubation with mechanical ventilation, 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.
---------------------------------------------------------------------------
Spectrum Solutions LLC's SDNA-1000 Saliva Collection
Device, issued October 8, 2020; \9\
---------------------------------------------------------------------------
\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 product may be effective in diagnosing COVID-19 by serving
as an appropriate means to collect, stabilize, and maintain during
transport, unprocessed saliva specimens suspected of containing
SARS-CoV-2 RNA, and that the known and potential benefits of the
products 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.
---------------------------------------------------------------------------
Roxby Development, LLC's Zoe-Ann Decontamination System,
issued October 20, 2020; \10\
---------------------------------------------------------------------------
\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 Zoe-Ann Decontamination System may be effective at
decontaminating compatible N95 respirators for single-user reuse by
healthcare providers to prevent exposure to SARS-CoV-2 and other
pathogenic biological airborne particulates, and that the known and
potential benefits of this product, when used for such use, outweigh
the known and potential risks of the use of such product; and (3)
there is no adequate, approved, and available alternative to the
emergency use of the Zoe-Ann Decontamination System for
decontaminating compatible N95 respirators for single-user reuse by
healthcare providers to prevent exposure to SARS-CoV-2 and other
pathogenic biological airborne particulates during filtering
facepiece respirator shortages during the COVID-19 pandemic.
---------------------------------------------------------------------------
DNA Genotek Inc.'s OMNIgene[middot]ORAL OM-505 and OME-505
(OMNIgene[middot]ORAL) saliva collection devices, issued October 14,
2020; \11\
---------------------------------------------------------------------------
\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 product may be effective in diagnosing COVID-19 by serving
as an appropriate means to collect, stabilize, and maintain during
transport, saliva specimens suspected of containing SARS-CoV-2 RNA,
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.
---------------------------------------------------------------------------
Clinical Enterprise, Inc.'s EmpowerDX At-Home COVID-19 PCR
Test Kit, issued on October 15, 2020; \12\
---------------------------------------------------------------------------
\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 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
self-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.
---------------------------------------------------------------------------
binx health, Inc.'s binx health At-Home Nasal Swab COVID-
19 Sample Collection Kit, issued October 20, 2020; \13\
---------------------------------------------------------------------------
\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 product may be effective in diagnosing COVID-19, by serving
as an appropriate means to collect and transport human nasal swab
specimens so that an authorized laboratory can detect SARS-CoV-2 RNA
from the self-collected 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.
---------------------------------------------------------------------------
DNA Genotek Inc.'s ORAcollectRNA OR-100 and
ORAcollectRNA ORE-100 saliva collection devices, issued October
28, 2020; \14\
---------------------------------------------------------------------------
\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 product may be effective in diagnosing COVID-19 by serving
as an appropriate means to collect, stabilize, and maintain during
transport, saliva specimens suspected of containing SARS-CoV-2 RNA,
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.
---------------------------------------------------------------------------
Terumo Cardiovascular's CAPIOX Emergency Bypass System
(CAPIOX EBS), issued November 21, 2020; \15\
---------------------------------------------------------------------------
\15\ 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 CAPIOX EBS may be effective in treating COVID-19 by
providing long-term (> 6 hours) respiratory or cardiopulmonary
support to treat patients 18 years or older with COVID-19 who have
acute respiratory failure or acute cardiopulmonary failure where
other available treatment options have failed, and continued
clinical deterioration is expected or the risk of death is imminent,
and that the known and potential benefits of the CAPIOX EBS for such
use, outweigh the known and potential risks; and (3) there is no
adequate, approved, and available alternative to the emergency use
of the CAPIOX EBS when there are shortages of FDA-cleared
alternatives during the COVID-19 pandemic.
---------------------------------------------------------------------------
RapidRona, Inc.'s RapidRona Self-Collection Kit, issued
November 23, 2020; \16\
---------------------------------------------------------------------------
\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 product may be effective in diagnosing COVID-19, by serving
as an appropriate means to collect and transport human nasal swab
specimens so that an authorized laboratory can detect SARS-CoV-2 RNA
from the self-collected 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.
---------------------------------------------------------------------------
3B Medical, Inc.'s Lumin LM3000 Bioburden Reduction UV
System (``Lumin LM3000''), issued December 3, 2020; \17\
---------------------------------------------------------------------------
\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 Lumin LM3000 may be effective at bioburden reduction of
compatible N95 respirators for single-user reuse by healthcare
providers to supplement CDC reuse recommendations to prevent
exposure to SARS-CoV-2 and other pathogenic biological airborne
particulates, and that the known and potential benefits of this
product, when used for such use, outweigh the known and potential
risks of the use of such product; and (3) there is no adequate,
approved, and available alternative to the emergency use of the
Lumin LM3000 for bioburden reduction of compatible N95 respirators
for single-user reuse by healthcare providers to supplement CDC
reuse recommendations to prevent exposure to SARS-CoV-2 and other
pathogenic biological airborne particulates during filtering
facepiece respirator shortages during the COVID-19 pandemic.
---------------------------------------------------------------------------
Ecolab Inc.'s Bioquell Technology System, issued December
4, 2020; \18\
---------------------------------------------------------------------------
\18\ 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 Bioquell Technology System may be effective at
decontaminating compatible N95 respirators for single-user reuse by
healthcare providers to prevent exposure to SARS-CoV-2 and other
pathogenic biological airborne particulates, and that the known and
potential benefits of this product, when used for such use, outweigh
the known and potential risks of the use of such product; and (3)
there is no adequate, approved, and available alternative to the
emergency use of the Bioquell Technology System for decontaminating
compatible N95 respirators for single-user reuse by healthcare
providers to prevent exposure to SARS-CoV-2 and other pathogenic
biological airborne particulates during filtering facepiece
respirator shortages during the COVID-19 pandemic.
---------------------------------------------------------------------------
[[Page 21753]]
SCONE Medical Solutions Inc.'s SCONE, issued December 18,
2020; \19\
---------------------------------------------------------------------------
\19\ 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 SCONE may be effective in preventing healthcare providers
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 30 minutes, of patients
with suspected or confirmed diagnosis of COVID-19 and that the known
and potential benefits of SCONE for such use outweigh its known and
potential risks; and (3) there is no adequate, approved, and
available alternative to the emergency use of SCONE.
---------------------------------------------------------------------------
Siemens Healthcare Diagnostics Inc.'s ADVIA Centaur IL6
assay, issued December 18, 2020; \20\
---------------------------------------------------------------------------
\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 product may be effective in treating COVID-19, by assisting
in identifying severe inflammatory response in patients with
confirmed COVID-19 illness to aid in determining the risk of
intubation with mechanical ventilation, 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.
---------------------------------------------------------------------------
Yale New Haven Health System's Yale New Haven Health
FILTERING FACEPIECE RESPIRATOR Decontamination System, issued January
15, 2021; \21\ and
---------------------------------------------------------------------------
\21\ 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 Yale New Haven Health filtering facepiece respirator
decontamination system may be effective at decontaminating
compatible N95 respirators for multiple-user reuse by healthcare
providers to prevent exposure to SARS-CoV-2 and other pathogenic
biological airborne particulates, and that the known and potential
benefits of this product, when used for such use, outweigh the known
and potential risks of the use of such product; and (3) there is no
adequate, approved, and available alternative to the emergency use
of the Yale New Haven Health filtering facepiece respirator
Decontamination System for decontaminating compatible N95
respirators for multiple-user reuse by healthcare providers to
prevent exposure to SARS-CoV-2 and other pathogenic biological
airborne particulates during filtering facepiece respirator
shortages during the COVID-19 pandemic.
---------------------------------------------------------------------------
Everlywell, Inc.'s Everlywell COVID-19 Test Home
Collection Kit DTC, issued February 13, 2021.\22\
---------------------------------------------------------------------------
\22\ 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 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.
Dated: April 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08467 Filed 4-22-21; 8:45 am]
BILLING CODE 4164-01-P
