Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability, 74346-74352 [2020-25603]

Download as PDF khammond on DSKJM1Z7X2PROD with NOTICES 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 This draft guidance document contains only Q&As that are in draft form. After FDA has considered any comments on the Q&As contained in this draft guidance received during the relevant comment period and, as appropriate, incorporated suggested changes to the Q&A, individual Q&As will be finalized and moved to the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 A Q&A may be withdrawn and removed from the Q&A guidance documents if, for instance, the issue addressed in the Q&A has been addressed in another FDA guidance document.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changes to currently issued draft or final guidance documents are being made in connection with the issuance of this draft guidance.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December 2018 final guidance ‘‘Questions and Answers on Biosimilar Development and the BPCI Act’’ and the December 2018 draft guidance ‘‘New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 2).’’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 VerDate Sep<11>2014 17:08 Nov 19, 2020 Jkt 253001 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-regulatoryinformation-biologics/biologicsguidances, 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 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1584] Authorization of Emergency Use of Certain Medical Devices During COVID–19; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the issuance 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. SUMMARY: 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 ADDRESSES: E:\FR\FM\20NON1.SGM 20NON1 Federal Register / Vol. 85, No. 225 / Friday, November 20, 2020 / Notices section for electronic access to the Authorization. FOR FURTHER INFORMATION CONTACT: khammond on DSKJM1Z7X2PROD with NOTICES 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 lifethreatening diseases or conditions caused by a biological, chemical, radiological, or nuclear agent or agents when there are no adequate, approved, and available alternatives. Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds: (1) A determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, or nuclear agent or agents; (2) a determination by the Secretary of Defense that there is a military emergency, or a significant potential for a military emergency, involving a heightened risk to U.S. military forces, including personnel operating under the authority of title 10 or title 50 of the U.S. Code, of attack with (A) a biological, chemical, radiological, or nuclear agent or agents; or (B) an agent 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 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. VerDate Sep<11>2014 17:08 Nov 19, 2020 Jkt 253001 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 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. PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 74347 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-policyframework/emergency-useauthorization. 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-preparednessand-response/mcm-legal-regulatoryand-policy-framework/emergency-useauthorization. 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 E:\FR\FM\20NON1.SGM 20NON1 74348 Federal Register / Vol. 85, No. 225 / Friday, November 20, 2020 / Notices khammond on DSKJM1Z7X2PROD with NOTICES 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 3 As set forth in the EUAs for these products, FDA has concluded that: (1) SARS–CoV–2, the virus that causes COVID–19, can cause a serious or lifethreatening disease or condition, including severe respiratory illness, to humans infected by this virus; (2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that the products may be effective in diagnosing COVID–19, and that the known and potential benefits of the products, when used for diagnosing COVID–19, outweigh the known and potential risks of such products; and (3) there is no adequate, approved, and available alternative to the emergency use of the products. VerDate Sep<11>2014 17:08 Nov 19, 2020 Jkt 253001 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 Highthroughput 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; PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 • 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 (PCRFluorescence 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; E:\FR\FM\20NON1.SGM 20NON1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 85, No. 225 / Friday, November 20, 2020 / Notices • 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; VerDate Sep<11>2014 17:08 Nov 19, 2020 Jkt 253001 • Assurance Scientific Laboratories’ Assurance SARSd–CoV–2 Panel, reissued August 19, 2020 (original issuance May 15, 2020); • Guardant Health, Inc.’s Guardant19, 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 qSangerCOVID–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 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 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 74349 • 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; 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. E:\FR\FM\20NON1.SGM 20NON1 khammond on DSKJM1Z7X2PROD with NOTICES 74350 Federal Register / Vol. 85, No. 225 / Friday, November 20, 2020 / Notices • 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 5 As set forth in the EUAs, FDA has concluded that: (1) SARS–CoV–2 can cause a serious or lifethreatening disease or condition, including severe respiratory illness, to humans infected by this virus; (2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that the products may be effective in diagnosing COVID–19 through the simultaneous detection and VerDate Sep<11>2014 17:08 Nov 19, 2020 Jkt 253001 • 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-disease2019-covid-19-emergency-useauthorizations-medical-devices/ personal-protective-equipmenteuas#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-19emergency-use-authorizations-medicaldevices/personal-protective-equipmenteuas#exhibit1. FDA is hereby announcing the following Authorizations for other medical devices: • Baxter Healthcare Corp.’s Prismaflex ST Set, issued May 20, 2020; 7 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 lifethreatening disease or condition, including severe respiratory illness, to humans infected by this virus; (2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that the 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 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 • 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 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 E:\FR\FM\20NON1.SGM 20NON1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 85, No. 225 / Friday, November 20, 2020 / Notices • 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); 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) VerDate Sep<11>2014 17:08 Nov 19, 2020 Jkt 253001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 74351 • 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 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 lifethreatening disease or condition, including severe respiratory illness, to humans infected by this virus; (2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that the 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 lifethreatening disease or condition, including severe respiratory illness, to humans infected by this virus; E:\FR\FM\20NON1.SGM Continued 20NON1 74352 Federal Register / Vol. 85, No. 225 / Friday, November 20, 2020 / Notices khammond on DSKJM1Z7X2PROD with NOTICES • 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 (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 VerDate Sep<11>2014 17:08 Nov 19, 2020 Jkt 253001 • 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-19emergency-use-authorizations-medicaldevices/personal-protective-equipmenteuas#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 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 lifethreatening disease or condition, including severe respiratory illness, to humans infected by this virus; PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 • 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. 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: SUMMARY: (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 lifethreatening disease or condition, including severe respiratory illness, to humans infected by this virus; (2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that 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. E:\FR\FM\20NON1.SGM 20NON1

Agencies

[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]


-----------------------------------------------------------------------

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

[[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.
---------------------------------------------------------------------------

    \1\ In the case of a determination by the Secretary of Defense, 
the Secretary of HHS shall determine within 45 calendar days of such 
determination, whether to make a declaration under section 564(b)(1) 
of the FD&C Act, and, if appropriate, shall promptly make such a 
declaration.
---------------------------------------------------------------------------

    Once the Secretary of HHS has declared that circumstances exist 
justifying an authorization under section 564 of the FD&C Act, FDA may 
authorize the emergency use of a drug, device, or biological product if 
the Agency concludes that the statutory criteria are satisfied. Under 
section 564(h)(1) of the FD&C Act, FDA is required to publish in the 
Federal Register a notice of each authorization, and each termination 
or revocation of an authorization, and an explanation of the reasons 
for the action. 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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

     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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

     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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

     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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

     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.

---------------------------------------------------------------------------

[[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.

---------------------------------------------------------------------------

[[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

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.