[Federal Register Volume 85, Number 109 (Friday, June 5, 2020)]
[Notices]
[Pages 34638-34641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12117]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1335]


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 significant potential 
to affect national security or the health and security of U.S. citizens 
living abroad, which 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 in this document.

DATES: These Authorizations are effective on their date of issuance.

ADDRESSES: Submit written requests for single copies of the EUAs to the 
Office of Counterterrorism and Emerging Threats, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request or include a Fax number to which 
the Authorization may be sent. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the Authorizations.

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, U.S. Code, of attack with (i) a 
biological, chemical, radiological, or nuclear agent or agents; or (ii) 
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,

[[Page 34639]]

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 
sections 505, 510(k), 512, or 515 of the FD&C Act (21 U.S.C. 355, 
360(k), 360b and 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. Because the statute is self-
executing, regulations or guidance are not required for FDA to 
implement the EUA authority.

II. Electronic Access

    An electronic version of this document and the full text of the 
Authorizations are available on the internet at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.

III. The Authorizations

    Having concluded that the criteria for the issuance 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, through April 10, 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 in vitro diagnostics:\3\
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    \3\ As set forth in the EUAs for these devices, 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 devices may be effective in 
diagnosing COVID-19, and that the known and potential benefits of 
the devices, when used for diagnosing COVID-19, outweigh the known 
and potential risks of such devices; and (3) there is no adequate, 
approved, and available alternative to the emergency use of the 
devices.
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     CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR 
Diagnostic Panel (CDC), issued February 4, 2020, and reissued March 15, 
2020;
     New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-
PCR Diagnostic Panel (Wadsworth Center, NYSDOH), issued February 29, 
2020, and reissued March 10, 2020;
     Roche Molecular Systems, Inc.'s (RMS) cobas SARS-CoV-2, 
issued March 12, 2020;
     Thermo Fisher Scientific, Inc.'s TaqPath COVID-19 Combo 
Kit, issued March 13, 2020;
     Hologic, Inc.'s Panther Fusion SARS-CoV-2, issued March 
16, 2020;
     Laboratory Corporation of America's COVID-19 RT-PCR Test, 
issued March 16, 2020;
     Quidel Corp.'s Lyra SARS-CoV-2 Assay, issued March 17, 
2020;
     Quest Diagnostics Infectious Disease, Inc.'s Quest SARS-
CoV-2 rRT-PCR, issued March 17, 2020;
     Abbott Molecular's Abbott RealTime SARS-CoV-2 assay, 
issued March 18, 2020;
     DiaSorin Molecular LLC's Simplexa COVID-19 Direct assay, 
issued March 19, 2020;
     GenMark Diagnostics, Inc.'s ePlex SARS-CoV-2 Test, issued 
March 19, 2020;
     Primerdesign Ltd's Primerdesign Ltd COVID-19 genesig Real-
Time PCR assay, issued March 20, 2020;
     Cepheid's Xpert Xpress SARS-CoV-2 test, issued March 20, 
2020;
     BioFire Defense, LLC's BioFire COVID-19 Test, issued March 
23, 2020;
     Mesa Biotech Inc.'s Accula SARS-Cov-2 Test, issued March 
23, 2020;
     PerkinElmer, Inc.'s PerkinElmer New Coronavirus Nucleic 
Acid Detection Kit, issued March 24, 2020;
     Avellino Lab USA, Inc.'s AvellinoCoV2 test, issued March 
25, 2020;
     BGI Genomics Co. Ltd.'s Real-Time Fluorescent RT-PCR Kit 
for Detecting SARS-2019-nCoV, issued March 26, 2020;

[[Page 34640]]

     Abbott Diagnostics Scarborough, Inc.'s ID NOW COVID-19, 
issued March 27, 2020;
     Luminex Molecular Diagnostics, Inc. Luminex Molecular 
Diagnostics, Inc.'s NxTAG CoV Extended Panel Assay, issued March 27, 
2020;
     NeuMoDx Molecular, Inc.'s NeuMoDx SARS-CoV-2 Assay, issued 
March 30, 2020;
     QIAGEN GmbH's QIAstat-Dx Respiratory SARS-CoV-2 Panel, 
issued March 30, 2020;
     Cellex Inc.'s qSARS-CoV-2 IgG/IgM Rapid Test, issued April 
1, 2020;
     Ipsum Diagnostics, LLC's COV-19 IDx assay, issued April 1, 
2020;
     Becton, Dickinson and Company, BioGX SARCoV-2 Reagents for 
BD MAX System, issued April 2, 2020;
     Luminex Corporation, ARIES SARS-CoV-2 Assay, issued April 
3, 2020;
     ScienCell Research Laboratories, ScienCell SARS-CoV-2 
Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit, issued April 3, 
2020;
     Co-Diagnostics, Inc., Logix Smart Coronavirus Disease 2019 
(COVID-19) kit, issued April 3, 2020;
     Gnomegen LLC's, Gnomegen COVID-19 RT-Digital PCR RT-
Digital PCR Detection Kit, issued on April 6, 2020;
     InBios International Inc.'s, Smart Detect SARS-CoV-2 rRT-
PCR Kit, issued on April 7, 2020;
     Becton, Dickinson and Company's, BD SARS-CoV-2 Reagents 
for BD MAX System, issued on April 8, 2020;
     DiaCarta, Inc.'s QuantiVirus SARS-CoV-2 Test kit, issued 
on April 8, 2020;
     Atila BioSystems, Inc.'s, iAMP COVID-19 Detection Kit, 
issued on April 10, 2020; and
     Certain Molecular-Based Laboratory Developed Tests (LDTs) 
for COVID-19 that are developed by laboratories certified under the 
Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform 
high complexity tests and are authorized for use by the singular 
developing laboratory, issued on March 31, 2020 (a current list of 
tests included under this EUA is available at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations).
    FDA is hereby announcing the following Authorizations for personal 
respiratory protective devices:\4\
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    \4\ As set forth in the EUAs, FDA has concluded that: (1) The 
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 either 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 for the emergency use.
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     Certain National Institute for Occupational Safety and 
Health (NIOSH)-Approved Air Purifying Respirators for Use in Health 
Care Settings During Response to the COVID-19 Public Health Emergency, 
issued March 2, 2020, with reissuance on March 27, 2020, and March 28, 
2020;
     Certain Imported, Non-NIOSH-Approved Disposable Filtering 
Facepiece Respirators, issued March 24, 2020, with reissuance on March 
28, 2020 (a current list of respirators included under this EUA is 
available at https://www.fda.gov/media/136731/download); and,
     Certain Non-NIOSH-Approved Disposable Filtering Facepiece 
Respirators Manufactured in China, issued April 3, 2020 (a current list 
of respirators included under this EUA is available at https://www.fda.gov/media/136663/download).
    FDA is hereby announcing the following Authorizations for other 
medical devices:
     Certain ventilators, anesthesia gas machines modified for 
use as ventilators, and positive pressure breathing devices modified 
for use as ventilators (collectively referred to as ``ventilators''), 
ventilator tubing connectors, and ventilator accessories, issued March 
24, 2020 (a current list of products included under this EUA is 
available at https://www.fda.gov/media/136528/download);\5\
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    \5\ 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 ventilators, ventilator tubing connectors, and 
ventilator accessories may be effective in treating patients during 
the COVID-19 pandemic, and the known and potential benefits of such 
products, when used to treat patients during the COVID-19 pandemic, 
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 authorized ventilators, ventilator tubing 
connectors, and ventilator accessories for treating patients during 
the COVID-19 pandemic.
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     Battelle Memorial Institute's Battelle Decontamination 
System (Battelle CCDS Critical Care Decontamination System), issued 
March 28, 2020, with reissuance March 29, 2020;\6\
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    \6\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that the Battelle Decontamination System may be effective at 
preventing exposure to pathogenic airborne particulates when there 
are insufficient supplies of FFRs during the COVID-19 pandemic by 
decontaminating, for a maximum of 20 decontamination cycles per 
respirator, compatible N95 respirators that are contaminated or 
potentially contaminated with SARS-CoV-2 or other pathogenic 
microorganisms, and that the known and potential benefits of the 
Battelle Decontamination System, when used to decontaminate 
compatible N95 respirators for reuse by HCP to prevent exposure to 
pathogenic airborne particulates during FFR shortages during the 
COVID-19 pandemic, outweigh the known and potential risks; and (3) 
there is no adequate, approved, and available alternative to the 
emergency use of the Battelle Decontamination System for 
decontaminating compatible N95 respirators for reuse by HCP during 
FFR shortages during the COVID-19 pandemic.
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     STERIS Corporation's STERIS Sterilization Systems (STERIS 
V-PRO 1 Plus, maX, and maX2 Low Temperature Sterilization Systems), 
issued April 9, 2020;\7\
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    \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 STERIS Sterilization Systems may be effective at preventing 
exposure to pathogenic airborne particulates when there are 
insufficient supplies of N95 respirators during the COVID19 pandemic 
by decontaminating for a maximum of 10 decontamination cycles per 
respirator, compatible N95 respirators that are contaminated or 
potentially contaminated with SARS-CoV-2 or other pathogenic 
microorganisms, and that the known and potential benefits of the 
STERIS Sterilization Systems, when used to decontaminate compatible 
N95 respirators for single-user reuse by HCP to prevent exposure to 
pathogenic airborne particulates during N95 respirator shortages 
during the COVID-19 pandemic, outweigh the known and potential 
risks; and (3) there is no adequate, approved, and available 
alternative to the emergency use of the STERIS Sterilization Systems 
for decontaminating compatible N95 respirators for reuse by HCP 
during N95 respirator shortages during the COVID-19 pandemic.
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     Certain Face Shields, issued April 9, 2020;\8\
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    \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 authorized face shields may be effective at preventing HCP 
exposure to fluid biological airborne particulates during face 
shield shortages by providing minimal or low barrier HCP protection 
to the wearer, and that the known and potential benefits of face 
shields, when used to prevent HCP exposure to such particulates 
during face shield shortages during COVID-19 outweigh the known and 
potential risks of such product; and (3) there is no adequate, 
approved, and available alternative to the emergency use of these 
face shields for preventing HCP exposure to such particulates during 
face shield shortages to prevent disease spread during the COVID-19 
pandemic.

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     Terumo BCT Inc. and Marker Therapeutics AG's, Spectra 
Optia Apheresis System with the Depuro D2000 Adsorption Cartridge (an 
Extracorporeal Blood Purification (EBP) Device), issued on April 9, 
2020;\9\ and,
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    \9\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that the Spectra Optia Apheresis System with the Depuro D2000 
Adsorption Cartridge may be effective in treating patients 18 years 
of age or older with confirmed COVID-19 admitted to the intensive 
care unit (ICU) with confirmed or imminent respiratory failure, and 
that the known and potential benefits of the Spectra Optia Apheresis 
System with the Depuro D2000 Adsorption Cartridge, when used to 
treat COVID-19 patients 18 years of age or older, outweigh the known 
and potential risks of the Spectra Optia Apheresis System with the 
Depuro D2000 Adsorption Cartridge; and (3) there is no adequate, 
approved, and available alternative to the emergency use of the 
Spectra Optia Apheresis System with the Depuro D2000 Adsorption 
Cartridge for the treatment of these COVID-19 patients.
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     CytoSorbents, Inc.'s, CytoSorb EBP Device, issued on April 
10, 2020.\10\
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    \10\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that the CytoSorb device may be effective in treating patients 18 
years of age or older with confirmed COVID-19 admitted to the ICU 
with confirmed or imminent respiratory failure, and that the known 
and potential benefits of the CytoSorb device, when used to treat 
such patients, outweigh the known and potential risks of the 
CytoSorb device; and (3) there is no adequate, approved, and 
available alternative to the emergency use of the CytoSorb device 
for the treatment of these COVID-19 patients.

    Dated: May 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-12117 Filed 6-4-20; 8:45 am]
 BILLING CODE 4164-01-P