Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability

Published date20 November 2020
Record Number2020-25603
SectionNotices
CourtFood And Drug Administration,Health And Human Services Department
74346
Federal Register / Vol. 85, No. 225 / Friday, November 20, 2020 / Notices
Additional Draft Q&As on Biosimilar
Development and the BPCI Act.’’ The
Q&A format is intended to inform
prospective applicants and facilitate the
development of proposed biosimilars
and proposed interchangeable
biosimilars, as well as to describe FDA’s
interpretation of certain statutory
requirements added by the BPCI Act.
The BPCI Act created an abbreviated
licensure pathway in section 351(k) of
the PHS Act (42 U.S.C. 262(k)) for
biological products shown to be
biosimilar to, or interchangeable with,
an FDA-licensed biological reference
product (see sections 7001 through 7003
of the Patient Protection and Affordable
Care Act (Pub. L. 111–148)). FDA
believes that guidance for industry that
provides answers to commonly asked
questions regarding FDA’s
interpretation of the BPCI Act will
enhance transparency and facilitate the
development and approval of biosimilar
and interchangeable products.
FDA has been using the format of
Q&A guidance to describe the Agency’s
thinking on and update certain
information and recommendations
relevant to the development of
biosimilar and interchangeable
products. This draft guidance document
contains only Q&As that are in draft
form. After FDA has considered any
comments on the Q&As contained in
this draft guidance received during the
relevant comment period and, as
appropriate, incorporated suggested
changes to the Q&A, individual Q&As
will be finalized and moved to the final
guidance document ‘‘Questions and
Answers on Biosimilar Development
and the BPCI Act,’’ which is updated as
appropriate. The final guidance contains
Q&As that have been through the public
comment process and reflects FDA’s
current thinking on the topics
described. A Q&A may be withdrawn
and removed from the Q&A guidance
documents if, for instance, the issue
addressed in the Q&A has been
addressed in another FDA guidance
document. No such changes to currently
issued draft or final guidance
documents are being made in
connection with the issuance of this
draft guidance.
FDA has maintained the original
numbering of the Q&As used in the
December 2018 final guidance
‘‘Questions and Answers on Biosimilar
Development and the BPCI Act’’ and the
December 2018 draft guidance ‘‘New
and Revised Draft Q&As on Biosimilar
Development and the BPCI Act
(Revision 2).’’ This draft guidance
document provides new Q&As. It does
not replace the draft guidance document
entitled ‘‘New and Revised Draft Q&As
on Biosimilar Development and the
BPCI Act (Revision 2),’’ issued
December 12, 2018.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The Q&As in this draft guidance, when
finalized, will appear in the final
guidance, and the final guidance will
represent the current thinking of FDA
on the Q&As posed in the ‘‘Biosimilarity
and Interchangeability: Additional Draft
Q&As on Biosimilar Development and
the BPCI Act.’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3521). The collections
of information in 21 CFR part 312 for
submission of an investigational new
drug application have been approved
under OMB control number 0910–0014.
The collections of information in 21
CFR 314.50 for submission of a new
drug application have been approved
under OMB control number 0910–0001.
The collections of information in
section 351(a) of the PHS Act and 21
CFR part 601 for submission of a
biologics license application (BLA) have
been approved under OMB control
number 0910–0338. The collections of
information in section 351(k) of the PHS
Act and 21 CFR part 601 for submission
of a BLA have been approved under
OMB control number 0910–0719.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatory-
information-biologics/biologics-
guidances, or https://
www.regulations.gov.
Dated: November 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–25606 Filed 11–19–20; 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.
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
VerDate Sep<11>2014 17:08 Nov 19, 2020 Jkt 253001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\20NON1.SGM 20NON1
khammond on DSKJM1Z7X2PROD with NOTICES
74347
Federal Register / Vol. 85, No. 225 / Friday, November 20, 2020 / Notices
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.
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.
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.
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.
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
VerDate Sep<11>2014 17:08 Nov 19, 2020 Jkt 253001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\20NON1.SGM 20NON1
khammond on DSKJM1Z7X2PROD with NOTICES
74348
Federal Register / Vol. 85, No. 225 / Friday, November 20, 2020 / Notices
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.
and antigen tests for COVID–19,
excluding multianalyte tests:
3
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;
VerDate Sep<11>2014 17:08 Nov 19, 2020 Jkt 253001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\20NON1.SGM 20NON1
khammond on DSKJM1Z7X2PROD with NOTICES
74349
Federal Register / Vol. 85, No. 225 / Friday, November 20, 2020 / Notices
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.
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
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;
VerDate Sep<11>2014 17:08 Nov 19, 2020 Jkt 253001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\20NON1.SGM 20NON1
khammond on DSKJM1Z7X2PROD with NOTICES
74350
Federal Register / Vol. 85, No. 225 / Friday, November 20, 2020 / Notices
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.
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.
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.
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.
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.
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.
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
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;
bioMe
´rieux SA’s VIDAS SARSd–
CoV–2 IgM, issued August 6, 2020;
bioMe
´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
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
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
STERIS Corp.’s AMSCO Medium
Steam Sterilizers + the STERIS STEAM
Decon Cycle, issued May 21, 2020;
8
Certain Gowns and Other Apparel,
issued May 22, 2020;
9
CLEW Medical Ltd.’s CLEWICU
System, issued May 26, 2020;
10
Abiomed, Inc.’s Impella RP System,
issued May 29, 2020;
11
VerDate Sep<11>2014 17:08 Nov 19, 2020 Jkt 253001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\20NON1.SGM 20NON1
khammond on DSKJM1Z7X2PROD with NOTICES
74351
Federal Register / Vol. 85, No. 225 / Friday, November 20, 2020 / Notices
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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;
Continued
Roche Diagnostics’ Elecsys IL–6,
issued on June 2, 2020;
12
Battelle Memorial Institute’s
Battelle CCDS Critical Care
Decontamination System (‘‘Batelle
Decontamination System’’), reissued
June 6, 2020
13
(original issuance March
29, 2020);
STERIS Corp.’s STERIS
Sterilization System, reissued June 6,
2020
14
(original issuance April 9, 2020);
Stryker Instruments’ STERIZONE
VP4 N95 Respirator Decontamination
Cycle, reissued June 6, 2020
15
(original
issuance on April 14, 2020);
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);
Stryker Sustainability Solutions’
(SSS) SSS VHP N95 Respirator
Decontamination System, issued May
27, 2020, reissued June 6, 2020;
17
Sterilucent, Inc.’s Sterilucent HC
80TT Hydrogen Peroxide Sterilizer
(‘‘Sterilucent Sterilization System’’),
reissued June 6, 2020
18
(original
issuance April 20, 2020);
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);
Technical Safety Services LLC’s 20–
CS Decontamination System, issued
June 13, 2020;
20
Oceanetics, Inc.’s Negative-pressure
Respiratory System with Advanced
Ventilation Return (‘‘NRSAVR–100’’),
issued June 13, 2020;
21
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
VerDate Sep<11>2014 17:08 Nov 19, 2020 Jkt 253001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\20NON1.SGM 20NON1
khammond on DSKJM1Z7X2PROD with NOTICES
74352
Federal Register / Vol. 85, No. 225 / Friday, November 20, 2020 / Notices
(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.
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.
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.
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.
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.
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.
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.
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.
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.
electroCore, Inc.’s gammaCore
Sapphire CV, issued July 10, 2020;
23
Michigan State University Animal
Care Program’s MSU Decontamination
System, issued July 24, 2020;
24
IkonX, Inc.’s Airway Dome, issued
July 24, 2020;
25
Abiomed, Inc.’s Impella Left
Ventricular (LV) Support Systems,
issued August 3, 2020;
26
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;
Baxter Healthcare Corp.’s
Prismaflex HF20 Set, issued August 10,
2020;
28
NovaSterilis, Inc.’s Nova2200 using
the NovaClean decontamination process
for decontaminating compatible N95
respirators, issued August 20, 2020;
29
and
Color Genomics, Inc.’s Color
COVID–19 Self-Swab Collection Kit,
issued August 31, 2020.
30
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–2107]
Cross Labeling Oncology Drugs in
Combination Drug Regimens; Draft
Guidance for Industry; Availability
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice of availability.
SUMMARY
: The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Cross
Labeling Oncology Drugs in
Combination Drug Regimens.’’ This
guidance describes FDA’s current
recommendations on including relevant
information in labeling for oncology
drugs approved for use in combination
drug regimens.
DATES
: Submit either electronic or
written comments on the draft guidance
by January 19, 2021 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES
: You may submit comments
on any guidance at any time as follows:
VerDate Sep<11>2014 17:08 Nov 19, 2020 Jkt 253001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\20NON1.SGM 20NON1
khammond on DSKJM1Z7X2PROD with NOTICES

VLEX uses login cookies to provide you with a better browsing experience. If you click on 'Accept' or continue browsing this site we consider that you accept our cookie policy. ACCEPT