[Federal Register Volume 85, Number 225 (Friday, November 20, 2020)]
[Notices]
[Pages 74346-74352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25603]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1584]
Authorization of Emergency Use of Certain Medical Devices During
COVID-19; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance and reissuance 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, and in
some cases reissued, 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 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 and reissuance, are listed in this document, and are available
on FDA's website at the links indicated.
DATES: These Authorizations are applicable on their date of issuance/
reissuance.
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 74347]]
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. 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.
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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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No other criteria for issuance have been prescribed by regulation
under section 564(c)(4) of the FD&C Act.
III. 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.
IV. The Authorizations
Having concluded that the criteria for the issuance and, in some
cases reissuance, 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, in some cases reissued, from May 16, 2020,
through September 14, 2020, and we have included explanations of the
reasons for their issuance, as required by section 564(h)(1) of the
FD&C Act. FDA is hereby announcing the following Authorizations for
molecular diagnostic
[[Page 74348]]
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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Color Genomics, Inc.'s Color SARS-CoV-2 LAMP Diagnostic
Assay, issued May 18, 2020, and reissued July 24, 2020;
Quidel Corp.'s Lyra Direct SARS-CoV-2 Assay, issued May
18, 2020;
P23 Labs, LLC's P23 Labs TaqPath SARSd-CoV-2 Assay, issued
May 21, 2020, and reissued July 10, 2020;
SEASUN BIOMATERIALS, Inc.'s AQ-TOP COVID-19 Rapid
Detection Kit, issued May 21, 2020;
SolGent Co., Ltd.'s DiaPlexQ Novel Coronavirus (2019-nCoV)
Detection Kit, issued May 21, 2020;
BioCore Co., Ltd.'s BioCore 2019-nCoV Real Time PCR Kit,
issued May 21, 2020;
Exact Sciences Laboratories' SARSd-CoV-2 (N gene
detection) Test, issued May 22, 2020, and reissued August 3, 2020;
dba SpectronRx's Hymon SARSd-CoV-2 Test Kit, issued May
22, 2020;
PrivaPath Diagnostics, Inc.'s LetsGetChecked Coronavirus
(COVID-19) Test, issued May 28, 2020, and reissued August 14, 2020;
Gravity Diagnostics, LLC's Gravity Diagnostics COVID-19
Assay, issued June 1, 2020;
Phosphorus Diagnostics LLC's Phosphorus COVID-19 RT-qPCR
Test, issued June 4, 2020;
Genetron Health (Beijing) Co., Ltd.'s Genetron SARSd-CoV-2
RNA Test, issued June 5, 2020;
Euroimmun US Inc.'s EURORealTime SARSd-CoV-2, issued June
8, 2020;
ChromaCode Inc.'s HDPCR SARSd-CoV-2 Assay, issued June 9,
2020;
Illumina, Inc.'s Illumina COVIDSeq Test, issued June 9,
2020;
Tide Laboratories, LLC's DTPM COVID-19 RT-PCR Test, issued
June 10, 2020;
TBG Biotechnology Corp.'s ExProbe SARSd-CoV-2 Testing Kit,
issued June 10, 2020;
Cue Health, Inc.'s Cue COVID-19 Test, issued June 10,
2020;
RTA Laboratories Biological Products Pharmaceutical and
Machinery Industry's Diagnovital SARSd-CoV-2 Real-Time PCR Kit, issued
June 12, 2020;
Kaiser Permanente Mid-Atlantic States's KPMAS COVID-19
Test, issued June 13, 2020, and reissued September 9, 2020;
Applied BioCode, Inc.'s BioCode SARSd-CoV-2 Assay, issued
June 15, 2020;
The Ohio State University Wexner Medical Center's OSUWMC
COVID-19 RT-PCR test, issued June 17, 2020;
Omnipathology Solutions Medical Corp.'s Omni COVID-19
Assay by RT-PCR, issued June 17, 2020;
Jiangsu Bioperfectus Technologies Co., Ltd.'s COVID-19
Coronavirus Real Time PCR Kit, issued June 18, 2020;
3B Blackbio Biotech India Ltd., a subsidiary of Kilpest
India Ltd.'s TRUPCR SARSd-CoV-2 Kit, issued June 18, 2020;
HealthQuest Esoterics's HealthQuest Esoterics TaqPath
SARSd-CoV-2 Assay, issued June 23, 2020;
University of Alabama at Birmingham Fungal Reference Lab's
FRL SARS CoV-2 Test, issued June 23, 2020;
Gencurix, Inc.'s GenePro SARSd-CoV-2 Test, issued June 23,
2020;
University of Texas MD Anderson Cancer Center, Molecular
Diagnostics Laboratory's MD Anderson High-throughput SARSd-CoV-2 RT-PCR
Assay, issued June 24, 2020;
Diagnostic Solutions Laboratory, LLC's DSL COVID-19 Assay,
issued June 25, 2020;
PreciGenome LLC's FastPlex Triplex SARSd-CoV-2 detection
kit (RT-Digital PCR), issued June 25, 2020;
PlexBio Co., Ltd.'s IntelliPlex SARSd-CoV-2 Detection Kit,
issued June 25, 2020;
Inform Diagnostics, Inc.'s Inform Diagnostics SARSd-CoV-2
RT-PCR Assay, issued June 26, 2020;
Acupath Laboratories, Inc.'s Acupath COVID-19 Real-Time
(RT-PCR) Assay, issued June 29, 2020;
LifeHope Labs' LifeHope 2019-nCoV Real-Time RT-PCR
Diagnostic Panel, issued June 29, 2020;
Psomagen, Inc.'s Psoma COVID-19 RT Test, issued June 30,
2020;
TNS Co., Ltd.'s (Bio TNS) COVID-19 RT-PCR Peptide Nucleic
Acid (PNA) kit, issued June 30, 2020;
The Kroger Co.'s Kroger Health COVID-19 Test Home
Collection Kit, issued June 30, 2020;
CENTOGENE US, LLC's CentoFast-SARSd-CoV-2 RT-PCR Assay,
issued July 1, 2020;
Becton, Dickinson and Co.'s BD Veritor System for Rapid
Detection of SARSd-CoV-2, issued July 2, 2020;
Laboratorio Clinico Toledo's Laboratorio Clinico Toledo
SARSd-CoV-2 Assay, issued July 6, 2020;
Gene By Gene's Gene By Gene SARSd-CoV-2 Detection Test,
issued July 7, 2020;
Access Bio, Inc.'s CareStart COVID-19 MDx RT-PCR, issued
July 7, 2020;
Enzo Life Sciences, Inc.'s AMPIPROBE SARSd-CoV-2 Test
System, issued July 7, 2020;
Clinical Research Sequencing Platform (CRSP), LLC at the
Broad Institute of MIT and Harvard's CRSP SARSd-CoV-2 Real-time Reverse
Transcriptase (RT)-PCR Diagnostic Assay, issued July 8, 2020;
BioSewoom, Inc.'s Real-Q 2019-nCoV Detection Kit, issued
July 9, 2020;
UCSF Health Clinical Laboratories, UCSF Clinical Labs at
China Basin's SARSd-CoV-2 RNA DETECTR Assay, issued July 9, 2020;
Boston Medical Center's BMC-CReM COVID-19 Test, issued
July 10, 2020;
KogeneBiotech Co., Ltd.'s PowerChek 2019-nCoV Real-time
PCR Kit, issued July 13, 2020;
Trax Management Services Inc.'s PhoenixDx SARSd-CoV-2
Multiplex, issued July 13, 2020;
Compass Laboratory Services, LLC's Compass Laboratory
Services SARSd-CoV2 Assay, issued July 13, 2020;
Quest Diagnostics Infectious Disease, Inc.'s Quest
Diagnostics PF SARSd-CoV-2 Assay, issued July 15, 2020, and reissued
August 21, 2020;
Quest Diagnostics Infectious Disease, Inc.'s Quest
Diagnostics RC SARSd-CoV-2 Assay, issued July 15, 2020, and reissued
August 21, 2020;
Quest Diagnostics Infectious Disease, Inc.'s Quest
Diagnostics HA SARSd-CoV-2 Assay, issued July 15, 2020, and reissued
August 21, 2020;
Boston Heart Diagnostics' Boston Heart COVID-19 RT-PCR
Test, issued July 16, 2020;
Access Genetics, LLC's OraRisk COVID-19 RT-PCR, issued
July 17, 2020;
DiaCarta, Inc.'s QuantiVirus SARSd-CoV-2 Multiplex Test
Kit, issued July 21, 2020;
Helix OpCo LLC's (dba Helix's) Helix COVID-19 Test, issued
July 23, 2020;
Jiangsu CoWin Biotech Co., Ltd.'s Novel Coronavirus
(SARSd-CoV-2) Fast Nucleic Acid Detection Kit (PCR-Fluorescence
Probing), issued July 24, 2020;
LabCorp's COVID-19 RT-PCR Test, reissued July 24, 2020
(original issuance March 16, 2020);
Eli Lilly and Co.'s Lilly SARSd-CoV-2 Assay, issued July
27, 2020;
[[Page 74349]]
Sandia National Laboratories' SNL-NM 2019 nCoV Real-Time
RT-PCR Diagnostic Assay, issued July 27, 2020;
Clinical Reference Laboratory, Inc.'s CRL Rapid Response,
issued July 30, 2020;
University of California San Diego Health's UCSD RC SARSd-
CoV-2 Assay, issued July 31, 2020;
Xiamen Zeesan Biotech Co., Ltd.'s SARSd-CoV-2 Test Kit
(Real-time PCR), issued July 31, 2020;
ISPM Labs, LLC dba Capstone Healthcare's Genus SARSd-CoV-2
Assay, issued August 3, 2020;
Poplar Healthcare's Poplar SARSd-CoV-2 TMA Pooling assay,
issued August 3, 2020;
Cleveland Clinic Robert J. Tomsich Pathology and
Laboratory Medicine Institute's Cleveland Clinic SARSd-CoV-2 Assay,
issued August 3, 2020;
Ethos Laboratories' Ethos Laboratories SARSd-CoV-2 MALDI-
TOF Assay, issued August 3, 2020;
Wren Laboratories LLC's Wren Laboratories COVID-19 PCR
Test, issued August 3, 2020;
Vela Operations Singapore Pte Ltd.'s ViroKey SARSd-CoV-2
RT-PCR Test, issued August 5, 2020;
Helix OpCo LLC's (dba Helix) Helix COVID-19 NGS Test,
issued August 6, 2020;
George Washington University Public Health Laboratory's
GWU SARSd-CoV-2 RT-PCR Test, issued August 7, 2020;
Quest Diagnostics Infectious Disease, Inc.'s SARSd-CoV-2
RNA, Qualitative Real-Time RT-PCR, reissued August 7, 2020 (original
issuance March 17, 2020);
Alpha Genomix Laboratories' Alpha Genomix TaqPath SARSd-
CoV-2 Combo Assay, issued August 10, 2020;
Solaris Diagnostics' Solaris Multiplex SARSd-CoV-2 Assay,
issued August 10, 2020;
Biomeme, Inc.'s Biomeme SARSd-CoV-2 Real-Time RT-PCR Test,
issued August 11, 2020;
LumiraDx UK Ltd.'s LumiraDx SARS-CoV-2 RNA STAR, issued
August 11, 2020;
Pro-Lab Diagnostics' Pro-AmpRT SARSd-CoV-2 Test, issued
August 13, 2020;
Yale School of Public Health, Department of Epidemiology
of Microbial Diseases' SalivaDirect, issued August 15, 2020, and
reissued August 28, 2020;
ZhuHai Sinochips Bioscience Co., Ltd.'s COVID-19 Nucleic
Acid RT-PCR Test Kit, issued August 17, 2020;
LumiraDx UK Ltd.'s LumiraDx SARSd-CoV-2 Ag Test, issued
August 18, 2020;
Assurance Scientific Laboratories' Assurance SARSd-CoV-2
Panel, reissued August 19, 2020 (original issuance May 15, 2020);
Guardant Health, Inc.'s Guardant-19, issued August 21,
2020;
DxTerity Diagnostics, Inc.'s DxTerity SARSd-CoV-2 RT-PCR
Test, issued August 21, 2020;
Texas Department of State Health Services, Laboratory
Services Section's Texas Department of State Health Services SARSd-CoV-
2 Assay, issued August 21, 2020;
Fluidigm Corp.'s Advanta Dx SARSd-CoV-2 RT-PCR Assay,
issued August 25, 2020;
QDx Pathology Services' QDX SARSd-CoV-2 Assay, issued
August 25, 2020;
Cuur Diagnostics' Cuur Diagnostics SARSd-CoV-2 Molecular
Assay, issued August 26, 2020;
Abbott Diagnostics Scarborough, Inc.'s BinaxNOW COVID-19
Ag Card, issued August 26, 2020;
Patients Choice Laboratories, LLC's PCL SARSd-CoV-2 Real-
Time RT-PCR Assay, issued August 28, 2020;
DxTerity Diagnostics, Inc.'s DxTerity SARSd-CoV-2 RT PCR
CE Test, issued August 28, 2020;
T2 Biosystems, Inc.'s T2SARSd-CoV-2 Panel, issued August
31, 2020;
MiraDx's MiraDx SARSd-CoV-2 RT-PCR assay, issued August
31, 2020;
Mammoth Biosciences, Inc.'s SARSd-CoV-2 DETECTR Reagent
Kit, issued August 31, 2020;
BayCare Laboratories, LLC's BayCare SARSd-CoV-2 RT PCR
Assay, issued August 31, 2020;
Detectachem Inc.'s MobileDetect Bio BCC19 (MD-Bio BCC19)
Test Kit, issued September 1, 2020;
OPTOLANE Technologies, Inc.'s Kaira 2019-nCoV Detection
Kit, issued September 1, 2020;
Bioeksen R&D Technologies Ltd.'s Bio-Speedy Direct RT-qPCR
SARSd-CoV-2, issued September 2, 2020;
BillionToOne, Inc.'s qSanger-COVID-19 Assay, issued
September 4, 2020;
Verily Life Sciences' Verily COVID-19 RT-PCR Test, issued
September 8, 2020; and
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.'s
Wantai SARSd-CoV-2 RT-PCR Kit, issued September 9, 2020.
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) SARSd-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 SARSd-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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Healgen Scientific LLC's COVID-19 IgG/IgM Rapid Test
Cassette (Whole Blood/Serum/Plasma), issued May 29, 2020;
Siemens Healthcare Diagnostics Inc.'s Atellica IM SARSd-
CoV-2 Total (COV2T), issued May 29, 2020;
Siemens Healthcare Diagnostics Inc.'s ADVIA Centaur SARSd-
CoV-2 Total (COV2T), issued May 29, 2020;
Hangzhou Biotest Biotech Co., Ltd.'s RightSign COVID-19
IgG/IgM Rapid Test Cassette, issued June 4, 2020;
Vibrant America Clinical Labs' Vibrant COVID-19 Ab Assay,
issued June 4, 2020;
Siemens Healthcare Diagnostics Inc.'s Dimension Vista
SARSd-CoV-2 Total antibody assay (COV2T), issued June 8, 2020;
Siemens Healthcare Diagnostics Inc.'s Dimension EXL SARSd-
CoV-2 Total antibody assay (CV2T), issued June 8, 2020;
InBios International, Inc.'s SCoV-2 Detect IgG ELISA
[enzyme-linked immunosorbent assay], issued June 10, 2020;
Cellex Inc.'s qSARSd-CoV-2 IgG/IgM Rapid Test, reissued
June 12, 2020 (original issuance April 1, 2020);
Emory Medical Laboratories' SARSd-CoV-2 RBD IgG test,
issued June 15, 2020;
Biohit Healthcare (Hefei) Co. Ltd.'s Biohit SARSd-CoV-2
IgM/IgG Antibody Test Kit, issued June 18, 2020;
Hangzhou Laihe Biotech Co., Ltd.'s LYHER Novel Coronavirus
(2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold), issued
June 19, 2020;
Babson Diagnostics, Inc.'s Babson Diagnostics aC19G1,
issued June 23, 2020;
Beckman Coulter, Inc.'s Access SARSd-CoV-2 IgG, issued
June 26, 2020;
InBios International, Inc.'s SCoV-2 Detect IgM ELISA,
issued June 30, 2020;
Assure Tech.'s (Hangzhou Co., Ltd.) Assure COVID-19 IgG/
IgM Rapid Test Device, issued July 6, 2020;
Diazyme Laboratories, Inc.'s Diazyme DZ-Lite SARSd-CoV-2
IgG CLIA Kit, issued July 8, 2020;
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.'s
WANTAI SARSd-CoV-2 Ab Rapid Test, July 10, 2020;
[[Page 74350]]
Salofa Oy's Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM
Rapid Test Cassette, issued July 13, 2020;
Luminex Corp.'s xMAP SARSd-CoV-2 Multi-Antigen IgG Assay,
issued July 16, 2020;
Megna Health, Inc.'s Rapid COVID-19 IgM/IgG Combo Test
Kit, issued July 17, 2020;
Access Bio, Inc.'s CareStart COVID-19 IgM/IgG, issued July
24, 2020;
Xiamen Biotime Biotechnology Co., Ltd.'s BIOTIME SARSd-
CoV-2 IgG/IgM Rapid Qualitative Test, issued July 24, 2020;
Siemens Healthcare Diagnostics Inc.'s ADVIA Centaur SARSd-
CoV-2 IgG (COV2G), issued July 31, 2020;
Siemens Healthcare Diagnostics Inc.'s Atellica IM SARSd-
CoV-2 IgG (COV2G), issued July 31, 2020;
Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.'s
WANTAI SARSd-CoV-2 Ab ELISA, issued August 5, 2020;
bioM[eacute]rieux SA's VIDAS SARSd-CoV-2 IgM, issued
August 6, 2020;
bioM[eacute]rieux SA's VIDAS SARSd-CoV-2 IgG, issued
August 6, 2020;
Diazyme Laboratories, Inc.'s Diazyme DZ-Lite SARSd-CoV-2
IgM CLIA Kit, issued August 17, 2020;
BioCheck, Inc.'s BioCheck SARSd-CoV-2 IgG and IgM Combo
Test, issued August 17, 2020;
Biocan Diagnostics Inc.'s Tell Me Fast Novel Coronavirus
(COVID-19) IgG/IgM Antibody Test, issued August 25, 2020;
TBG Biotechnology Corp.'s TBG SARSd-CoV-2 IgG/IgM Rapid
Test Kit, issued August 31, 2020;
University of Arizona Genetics Core for Clinical Services'
COVID-19 ELISA pan-Ig Antibody Test, issued August 31, 2020;
Sugentech, Inc.'s SGTi-flex COVID-19 IgG, issued September
3, 2020;
BioCheck, Inc.'s BioCheck SARS-CoV-2 IgG Antibody Test
Kit, issued September 9, 2020;
BioCheck, Inc.'s BioCheck SARS-CoV-2 IgM Antibody Test
Kit, issued September 9, 2020; and
Shenzhen New Industries Biomedical Engineering Co., Ltd.'s
MAGLUMI 2019-nCoV IgM/IgG, issued September 14, 2020.
FDA is hereby announcing the following Authorizations for
multianalyte in vitro diagnostics: \5\
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\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, influenza A virus, and/or influenza B
virus nucleic acids 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.
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Centers for Disease Control and Prevention's Influenza
SARS-CoV-2 (Flu SC2) Multiplex Assay, issued July 2, 2020;
Roche Molecular Systems, Inc.'s cobas SARS-CoV-2 &
Influenza A/B, issued September 3, 2020; and
Roche Molecular Systems, Inc.'s cobas SARS-CoV-2 &
Influenza A/B Nucleic Acid Test for use on the cobas Liat System,
issued September 14, 2020.
FDA is hereby announcing the following Authorizations for personal
respiratory protective devices: \6\
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\6\ 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 authorized respirators may
be effective in preventing healthcare personnel (HCP) exposure to
pathogenic biological airborne particulates during Filtering
Facepiece Respirator (FFR) shortages, and that the known and
potential benefits of the authorized respirators, when used to
prevent HCP exposure to such particulates during FFR shortages
during 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 this product.
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Certain Non-National Institute of Industrial and
Occupational Safety (NIOSH)-Approved Disposable Filtering Facepiece
Respirators Manufactured in China, reissued June 6, 2020 (original
issuance April 3, 2020). A current list of respirator models authorized
by this EUA is available at https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas#appendixa; and
Certain Imported, Non-NIOSH Approved Disposable Filtering
Facepiece Respirators, reissued June 6, 2020 (original issuance March
24, 2020). A current list of respirator models authorized by this EUA
is available at https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas#exhibit1.
FDA is hereby announcing the following Authorizations for other
medical devices:
Baxter Healthcare Corp.'s Prismaflex ST Set, issued May
20, 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 the Prismaflex ST Set may be effective to treat patients in an
acute care environment during the COVID-19 pandemic, and that the
known and potential benefits of the Prismaflex ST Set, when used for
such use, outweigh the known and potential risks of the Prismaflex
ST Set; and (3) there is no adequate, approved, and available
alternative to the emergency use of the product.
---------------------------------------------------------------------------
STERIS Corp.'s AMSCO Medium Steam Sterilizers + the STERIS
STEAM Decon Cycle, issued May 21, 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 STERIS STEAM Decon Cycle in AMSCO Medium Steam Sterilizers
may be effective at decontaminating compatible N95 respirators for
single-user reuse by HCPs to prevent exposure to SARS-CoV-2 and
other pathogenic biological airborne particulates for a maximum of
10 decontamination cycles per respirator, and that the known and
potential benefits of this product, when used as described, 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 product.
---------------------------------------------------------------------------
Certain Gowns and Other Apparel, issued May 22, 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 authorized gowns and other apparel worn by HCPs may be
effective at preventing the transfer of microorganisms, bodily
fluids, and particulate material in low or minimal risk situations
by providing minimal-to-low barrier protection to HCP and patients
to prevent the spread of COVID-19, and that the known and potential
benefits of gowns and other apparel for such use, outweigh the known
and potential risks of such products; and (3) there is no adequate,
approved, and available alternative to the emergency use of these
products.
---------------------------------------------------------------------------
CLEW Medical Ltd.'s CLEWICU System, issued May 26, 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 CLEWICU System may be effective in treating COVID-19, when
used by HCP in the intensive care unit (ICU) as a diagnostic aid to
assist with the early identification of adult patients who are
likely to be diagnosed with respiratory failure or hemodynamic
instability which are common complications associated with COVID-19,
and that the known and potential benefits of the CLEWICU System, 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 product.
---------------------------------------------------------------------------
Abiomed, Inc.'s Impella RP System, issued May 29, 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 Impella RP may be effective in providing temporary right
ventricular support for up to 14 days in critical care patients with
a body surface area >=1.5 m2, for the treatment of acute right heart
failure or decompensation caused by complications related COVID-19,
including pulmonary embolism, and that the known and potential
benefits of the Impella RP, 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 product.
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[[Page 74351]]
Roche Diagnostics' Elecsys IL-6, issued on June 2, 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 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 this product when used for such use, outweigh
the known and potential risks of this product; and (3) there is no
adequate, approved, and available alternative to the emergency use
of the product.
---------------------------------------------------------------------------
Battelle Memorial Institute's Battelle CCDS Critical Care
Decontamination System (``Batelle Decontamination System''), reissued
June 6, 2020 \13\ (original issuance March 29, 2020);
---------------------------------------------------------------------------
\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 Battelle Decontamination System may be effective at
decontaminating compatible N95 respirators for multiple-user reuse
by HCPs 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 product.
---------------------------------------------------------------------------
STERIS Corp.'s STERIS Sterilization System, reissued June
6, 2020 \14\ (original issuance April 9, 2020);
---------------------------------------------------------------------------
\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 STERIS Sterilization Systems may be effective at
decontaminating compatible N95 respirators for single-user reuse by
HCPs 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 product.
---------------------------------------------------------------------------
Stryker Instruments' STERIZONE VP4 N95 Respirator
Decontamination Cycle, reissued June 6, 2020 \15\ (original issuance on
April 14, 2020);
---------------------------------------------------------------------------
\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 STERIZONE VP4 N95 Respirator Decontamination Cycle may be
effective at preventing exposure to pathogenic biological airborne
particulates by decontaminating, for a maximum of 2 decontamination
cycles per respirator, comparable N95 respirators that are
contaminated with SARS-CoV-2 or other pathogenic microorganisms, and
that the known and potential benefits of this product, when used as
described, outweigh the known and potential risks; and (3) there is
no adequate, approved, and available alternative to the emergency
use of the product.
---------------------------------------------------------------------------
Advanced Sterilization Products, Inc.'s (ASP) STERRAD
100S, NX, and 100NX Sterilization Systems (``ASP STERRAD Sterilization
Systems''), reissued June 6, 2020 \16\ (original issuance April 11,
2020);
---------------------------------------------------------------------------
\16\ As set forth in this 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 ASP STERRAD Sterilization Systems may be effective at
decontaminating, for a maximum of 2 decontamination cycles per
respirator, compatible N95 respirators for single-user reuse by HCP
to prevent exposure to SARS-CoV-2 and other pathogenic biological
airborne particulates, and that the known and potential benefits of
the ASP STERRAD Sterilization Systems, 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 product.
---------------------------------------------------------------------------
Stryker Sustainability Solutions' (SSS) SSS VHP N95
Respirator Decontamination System, issued May 27, 2020, reissued June
6, 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 SSS VHP N95 Respirator Decontamination may be effective at
decontaminating compatible N95 respirators for multiple-user reuse
by HCP 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 as described, outweigh the known
and potential risks; and (3) there is no adequate, approved, and
available alternative to the emergency use of the product.
---------------------------------------------------------------------------
Sterilucent, Inc.'s Sterilucent HC 80TT Hydrogen Peroxide
Sterilizer (``Sterilucent Sterilization System''), reissued June 6,
2020 \18\ (original issuance April 20, 2020);
---------------------------------------------------------------------------
\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 Sterilucent Sterilization System may be effective at
decontaminating compatible N95 respirators for single-user reuse by
HCP to prevent exposure to pathogenic biological airborne
particulates, and that the known and potential benefits of this
device, 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
product.
---------------------------------------------------------------------------
Duke University Health System's Duke Decontamination
System for Decontamination and Reuse of N95 Respirators with Hydrogen
Peroxide Vapor (``Duke Decontamination System''), reissued June 6, 2020
\19\ (original issuance May 7, 2020);
---------------------------------------------------------------------------
\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 the Duke Decontamination System may be effective at
decontaminating compatible N95 respirators for multiple-user reuse
by HCP 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 product.
---------------------------------------------------------------------------
Technical Safety Services LLC's 20-CS Decontamination
System, issued June 13, 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 20-CS Decontamination System may be effective at
decontaminating compatible N95 respirators for multiple-user reuse
by HCPs 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 as described, 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 product.
---------------------------------------------------------------------------
Oceanetics, Inc.'s Negative-pressure Respiratory System
with Advanced Ventilation Return (``NRSAVR-100''), issued June 13,
2020; \21\
---------------------------------------------------------------------------
\21\ 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 NRSAVR-100 may be
effective in preventing HCP exposure to pathogenic biological
airborne particulates by providing an extra layer of barrier
protection in addition to PPE, at the time of definitive airway
management, or when performing medical procedures, or during
transport of patients with suspected or confirmed diagnosis of
COVID-19 and that the known and potential benefits of the NRSAVR-100
for such use outweigh its known and potential risks; and (3) there
is no adequate, approved available alternative to the emergency use
of this product.
---------------------------------------------------------------------------
US Army and MHS's COVID-19 Airway Management Isolation
Chamber (CAMIC), issued May 19, 2020 and reissued to US Army Medical
Research Development Command June 22, 2020; \22\
---------------------------------------------------------------------------
\22\ 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 CAMIC may be effective in
preventing HCP exposure to pathogenic biological airborne
particulates by providing an extra layer of barrier protection in
addition to PPE when transporting or performing medical procedures
on patients who are known or suspected to have COVID-19, and that
the known and potential benefits of the CAMIC for such use outweigh
its known and potential risks; and (3) there is no adequate,
approved available alternative to the emergency use of the product.
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[[Page 74352]]
electroCore, Inc.'s gammaCore Sapphire CV, issued July 10,
2020; \23\
---------------------------------------------------------------------------
\23\ 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 gammaCore Sapphire CV may be effective for acute emergency
use at home or in a healthcare setting to treat adult patients with
known or suspected COVID-19 who are experiencing exacerbation of
asthma-related dyspnea and reduced airflow, and for whom approved
drug therapies are not tolerated or provide insufficient symptom
relief as assessed by their HCP, by using non-invasive Vagus Nerve
Stimulation (nVNS) on either side of the patients neck, and that the
known and potential benefits of this product for such use 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.
---------------------------------------------------------------------------
Michigan State University Animal Care Program's MSU
Decontamination System, issued July 24, 2020; \24\
---------------------------------------------------------------------------
\24\ 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 MSU Decontamination System may be effective at
decontaminating compatible N95 respirators for single-user reuse by
HCP 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 product.
---------------------------------------------------------------------------
IkonX, Inc.'s Airway Dome, issued July 24, 2020; \25\
---------------------------------------------------------------------------
\25\ 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 Airway Dome may be effective in preventing HCP exposure to
pathogenic biological airborne particulates by providing an extra
layer of barrier protection in addition to PPE, 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 the Airway Dome for such use outweigh its known and
potential risks; and (3) there is no adequate, approved, and
available alternative to the emergency use of the product.
---------------------------------------------------------------------------
Abiomed, Inc.'s Impella Left Ventricular (LV) Support
Systems, issued August 3, 2020; \26\
---------------------------------------------------------------------------
\26\ 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 Impella LV Support Systems may be effective when used by
HCP in the hospital setting for providing temporary LV unloading and
support to treat critical care patients with confirmed COVID-19
infection who are undergoing ECMO treatment and who develop
pulmonary edema while on V-A ECMO support or late cardiac
decompensation from myocarditis while on V-V ECMO support, and that
the known and potential benefits of the Impella LV Support System,
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 product.
---------------------------------------------------------------------------
Disposable, single-use surgical masks, issued August 5,
2020.\27\ A current list of surgical masks authorized by this EUA is
available here: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/personal-protective-equipment-euas#appendixasurgicalmasks;
---------------------------------------------------------------------------
\27\ 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 authorized surgical masks may be effective for use in
healthcare settings by HCPs as PPE to provide a physical barrier to
fluids and particulate materials to prevent HCP exposure to
respiratory droplets and large particles during surgical mask
shortages resulting from the COVID-19 pandemic, and that the known
and potential benefits of the authorized surgical masks, when used
consistent with the scope of the authorization, 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
products.
---------------------------------------------------------------------------
Baxter Healthcare Corp.'s Prismaflex HF20 Set, issued
August 10, 2020; \28\
---------------------------------------------------------------------------
\28\ 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 and multiple organ failure, including acute kidney injury,
to humans infected by this virus; (2) Based on the totality of
scientific evidence available to FDA, it is reasonable to believe
that the Prismaflex HF20 Set (cartridge, including hemodialyzer plus
tubing set) may be effective at providing continuous renal
replacement therapy (CRRT) to treat low weight patients who have low
blood volume and who have acute renal failure, fluid overload, or
both, and who cannot tolerate a larger extracorporeal circuit volume
in an acute care environment during the COVID-19 emergency and that
the known and potential benefits of the Prismaflex HF20 Set, when
used for such use, outweigh the known and potential risks of the
Prismaflex HF20 Set; and (3) there is no adequate, approved, and
available alternative to the emergency use of the product.
---------------------------------------------------------------------------
NovaSterilis, Inc.'s Nova2200 using the NovaClean
decontamination process for decontaminating compatible N95 respirators,
issued August 20, 2020; \29\ and
---------------------------------------------------------------------------
\29\ 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 Nova2200 may be effective
at decontaminating compatible N95 respirators for single-user reuse
by HCP 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 product.
---------------------------------------------------------------------------
Color Genomics, Inc.'s Color COVID-19 Self-Swab Collection
Kit, issued August 31, 2020.\30\
---------------------------------------------------------------------------
\30\ 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 this 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 this product when used for
such use, outweigh the known and potential risks of this product;
and (3) there is no adequate, approved, and available alternative to
the emergency use of the product.
Dated: November 13, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25603 Filed 11-19-20; 8:45 am]
BILLING CODE 4164-01-P