Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability, 34638-34641 [2020-12117]

Download as PDF 34638 Federal Register / Vol. 85, No. 109 / Friday, June 5, 2020 / Notices Estimated Total Annual Burden Hours: 9,900. Comments: The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. (Authority: 5 U.S.C. 301; 42 U.S.C. 470, 620 et seq., 622(b), 629b(a), 652(b), 654A, 670 et seq., 671(a), 1302, and 1396a(a)) Mary B. Jones, ACF/OPRE Certifying Officer. [FR Doc. 2020–12125 Filed 6–4–20; 8:45 am] BILLING CODE 4184–25–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–D–1301] Q3C(R8) Recommendations for the Permitted Daily Exposures for Three Solvents—2-Methyltetrahydrofuran, Cyclopentyl Methyl Ether, and TertButyl Alcohol—According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents; International Council for Harmonisation; Draft Guidance for Industry; Availability Correction In notice document 2020–11280, appearing on pages 31785 through 31786 in the issue of Wednesday, May 27, 2020 make the following correction. On page 31785, in the first column, on the last line, ‘‘July 26, 2024’’ should read ‘‘July 27, 2020’’. lotter on DSK9F5VC42PROD with NOTICES [FR Doc. C1–2020–11280 Filed 6–4–20; 8:45 am] BILLING CODE 1300–01–D VerDate Sep<11>2014 18:21 Jun 04, 2020 Jkt 250001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1335] Authorization of Emergency Use of Certain Medical Devices During COVID–19; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the issuance and reissuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related to the coronavirus disease 2019 (COVID–19) public health emergency. FDA has issued, and in some cases reissued, the Authorizations listed in this document under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the February 4, 2020, determination by Secretary of Health and Human Services (HHS) that there is a public health emergency that has significant potential to affect national security or the health and security of U.S. citizens living abroad, which involves the virus that causes COVID–19, and the subsequent declarations on February 4, 2020, March 2, 2020, and March 24, 2020, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID–19, personal respiratory protective devices, and medical devices, including alternative products used as medical devices, respectively, subject to the terms of any authorization issued under the FD&C Act. These Authorizations, which include an explanation of the reasons for issuance and reissuance, are listed in this document and are available on FDA’s website at the links indicated in this document. SUMMARY: These Authorizations are effective on their date of issuance. ADDRESSES: Submit written requests for single copies of the EUAs to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your request or include a Fax number to which the Authorization may be sent. See the SUPPLEMENTARY INFORMATION DATES: PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 section for electronic access to the Authorizations. FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993–0002, 301–796–8510 (this is not a toll-free number). SUPPLEMENTARY INFORMATION: I. Background Section 564 of the FD&C Act (21 U.S.C. 360bbb–3) allows FDA to strengthen the public health protections against biological, chemical, radiological, or nuclear agent or agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help ensure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or 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, U.S. Code, of attack with (i) a biological, chemical, radiological, or nuclear agent or agents; or (ii) an agent or agents that may cause, or are otherwise associated with, an imminently life-threatening and specific risk to U.S. military forces; 1 (3) a determination by the Secretary of HHS that there is a public health emergency, or a significant potential for a public health emergency, 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. E:\FR\FM\05JNN1.SGM 05JNN1 lotter on DSK9F5VC42PROD with NOTICES Federal Register / Vol. 85, No. 109 / Friday, June 5, 2020 / Notices 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 sections 505, 510(k), 512, or 515 of the FD&C Act (21 U.S.C. 355, 360(k), 360b and 360e) or section 351 of the PHS Act (42 U.S.C. 262), or conditionally approved under section 571 of the FD&C Act (21 U.S.C. 360ccc). FDA may issue an EUA only if, after consultation with the HHS Assistant Secretary for Preparedness and Response, the Director of the National Institutes of Health, and the Director of the Centers for Disease Control and Prevention (to the extent feasible and appropriate given the applicable circumstances), FDA 2 concludes: (1) That an agent referred to in a declaration of emergency or threat can cause a serious or life-threatening disease or condition; (2) that, based on the totality of scientific evidence available to FDA, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that: (A) The product may be effective in diagnosing, treating, or preventing (i) such disease or condition; or (ii) a serious or life-threatening 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. VerDate Sep<11>2014 18:21 Jun 04, 2020 Jkt 250001 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. Because the statute is self-executing, regulations or guidance are not required for FDA to implement the EUA authority. II. Electronic Access An electronic version of this document and the full text of the Authorizations are available on the internet at https://www.fda.gov/ emergency-preparedness-and-response/ mcm-legal-regulatory-and-policyframework/emergency-useauthorization. III. The Authorizations Having concluded that the criteria for the issuance and, in some cases reissuance, of the following Authorizations under section 564(c) of the FD&C Act are met, FDA has authorized the emergency use of the following products for diagnosing, treating, or preventing COVID–19 subject to the terms of each Authorization. The Authorizations in their entirety, including any authorized fact sheets and other written materials, are available on the internet from the FDA web page entitled ‘‘Emergency Use Authorization,’’ available at https:// www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatoryand-policy-framework/emergency-useauthorization. The lists that follow include Authorizations issued, in some cases reissued, through April 10, 2020, and we have included explanations of the reasons for their issuance, as required by section 564(h)(1) of the PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 34639 FD&C Act. FDA is hereby announcing the following Authorizations for in vitro diagnostics: 3 • CDC 2019–Novel Coronavirus (2019–nCoV) Real-Time RT–PCR Diagnostic Panel (CDC), issued February 4, 2020, and reissued March 15, 2020; • New York SARS–CoV–2 Real-time Reverse Transcriptase (RT)–PCR Diagnostic Panel (Wadsworth Center, NYSDOH), issued February 29, 2020, and reissued March 10, 2020; • Roche Molecular Systems, Inc.’s (RMS) cobas SARS–CoV–2, issued March 12, 2020; • Thermo Fisher Scientific, Inc.’s TaqPath COVID–19 Combo Kit, issued March 13, 2020; • Hologic, Inc.’s Panther Fusion SARS–CoV–2, issued March 16, 2020; • Laboratory Corporation of America’s COVID–19 RT–PCR Test, issued March 16, 2020; • Quidel Corp.’s Lyra SARS–CoV–2 Assay, issued March 17, 2020; • Quest Diagnostics Infectious Disease, Inc.’s Quest SARS–CoV–2 rRT– PCR, issued March 17, 2020; • Abbott Molecular’s Abbott RealTime SARS–CoV–2 assay, issued March 18, 2020; • DiaSorin Molecular LLC’s Simplexa COVID–19 Direct assay, issued March 19, 2020; • GenMark Diagnostics, Inc.’s ePlex SARS–CoV–2 Test, issued March 19, 2020; • Primerdesign Ltd’s Primerdesign Ltd COVID–19 genesig Real-Time PCR assay, issued March 20, 2020; • Cepheid’s Xpert Xpress SARS– CoV–2 test, issued March 20, 2020; • BioFire Defense, LLC’s BioFire COVID–19 Test, issued March 23, 2020; • Mesa Biotech Inc.’s Accula SARS– Cov–2 Test, issued March 23, 2020; • PerkinElmer, Inc.’s PerkinElmer New Coronavirus Nucleic Acid Detection Kit, issued March 24, 2020; • Avellino Lab USA, Inc.’s AvellinoCoV2 test, issued March 25, 2020; • BGI Genomics Co. Ltd.’s Real-Time Fluorescent RT–PCR Kit for Detecting SARS–2019–nCoV, issued March 26, 2020; 3 As set forth in the EUAs for these devices, FDA has concluded that: (1) SARS–CoV–2, the virus that causes COVID–19, can cause a serious or 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 devices may be effective in diagnosing COVID–19, and that the known and potential benefits of the devices, when used for diagnosing COVID–19, outweigh the known and potential risks of such devices; and (3) there is no adequate, approved, and available alternative to the emergency use of the devices. E:\FR\FM\05JNN1.SGM 05JNN1 34640 Federal Register / Vol. 85, No. 109 / Friday, June 5, 2020 / Notices lotter on DSK9F5VC42PROD with NOTICES • Abbott Diagnostics Scarborough, Inc.’s ID NOW COVID–19, issued March 27, 2020; • Luminex Molecular Diagnostics, Inc. Luminex Molecular Diagnostics, Inc.’s NxTAG CoV Extended Panel Assay, issued March 27, 2020; • NeuMoDx Molecular, Inc.’s NeuMoDx SARS–CoV–2 Assay, issued March 30, 2020; • QIAGEN GmbH’s QIAstat–Dx Respiratory SARS–CoV–2 Panel, issued March 30, 2020; • Cellex Inc.’s qSARS–CoV–2 IgG/ IgM Rapid Test, issued April 1, 2020; • Ipsum Diagnostics, LLC’s COV–19 IDx assay, issued April 1, 2020; • Becton, Dickinson and Company, BioGX SARCoV–2 Reagents for BD MAX System, issued April 2, 2020; • Luminex Corporation, ARIES SARS–CoV–2 Assay, issued April 3, 2020; • ScienCell Research Laboratories, ScienCell SARS–CoV–2 Coronavirus Real-time RT–PCR (RT–qPCR) Detection Kit, issued April 3, 2020; • Co-Diagnostics, Inc., Logix Smart Coronavirus Disease 2019 (COVID–19) kit, issued April 3, 2020; • Gnomegen LLC’s, Gnomegen COVID–19 RT–Digital PCR RT–Digital PCR Detection Kit, issued on April 6, 2020; • InBios International Inc.’s, Smart Detect SARS–CoV–2 rRT–PCR Kit, issued on April 7, 2020; • Becton, Dickinson and Company’s, BD SARS–CoV–2 Reagents for BD MAX System, issued on April 8, 2020; • DiaCarta, Inc.’s QuantiVirus SARS– CoV–2 Test kit, issued on April 8, 2020; • Atila BioSystems, Inc.’s, iAMP COVID–19 Detection Kit, issued on April 10, 2020; and • Certain Molecular-Based Laboratory Developed Tests (LDTs) for COVID–19 that are developed by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests and are authorized for use by the singular developing laboratory, issued on March 31, 2020 (a current list of tests included under this EUA is available at https://www.fda.gov/medical-devices/ emergency-situations-medical-devices/ emergency-use-authorizations). FDA is hereby announcing the following Authorizations for personal respiratory protective devices: 4 4 As set forth in the EUAs, FDA has concluded that: (1) The SARS–CoV–2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus; (2) based on the totality of scientific evidence available to FDA, it is either reasonable to believe that the authorized respirators may be effective in preventing healthcare personnel (HCP) VerDate Sep<11>2014 18:21 Jun 04, 2020 Jkt 250001 • Certain National Institute for Occupational Safety and Health (NIOSH)-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID– 19 Public Health Emergency, issued March 2, 2020, with reissuance on March 27, 2020, and March 28, 2020; • Certain Imported, Non-NIOSHApproved Disposable Filtering Facepiece Respirators, issued March 24, 2020, with reissuance on March 28, 2020 (a current list of respirators included under this EUA is available at https://www.fda.gov/media/136731/ download); and, • Certain Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China, issued April 3, 2020 (a current list of respirators included under this EUA is available at https://www.fda.gov/media/ 136663/download). FDA is hereby announcing the following Authorizations for other medical devices: • Certain ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as ‘‘ventilators’’), ventilator tubing connectors, and ventilator accessories, issued March 24, 2020 (a current list of products included under this EUA is available at https://www.fda.gov/media/ 136528/download); 5 • Battelle Memorial Institute’s Battelle Decontamination System (Battelle CCDS Critical Care Decontamination System), issued March 28, 2020, with reissuance March 29, 2020; 6 exposure to pathogenic biological airborne particulates during Filtering Facepiece Respirator (FFR) shortages, and that the known and potential benefits of the authorized respirators, when used to prevent HCP exposure to such particulates during FFR shortages during COVID–19, outweigh the known and potential risks of such products, and (3) there is no adequate, approved, and available alternative for the emergency use. 5 As set forth in the EUA, FDA has concluded that: (1) SARS–CoV–2, the virus that causes COVID–19, can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus; (2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that the authorized ventilators, ventilator tubing connectors, and ventilator accessories may be effective in treating patients during the COVID–19 pandemic, and the known and potential benefits of such products, when used to treat patients during the COVID–19 pandemic, outweigh the known and potential risks of such products, and (3) there is no adequate, approved, and available alternative to the emergency use of the authorized ventilators, ventilator tubing connectors, and ventilator accessories for treating patients during the COVID– 19 pandemic. 6 As set forth in the EUA, FDA has concluded that: (1) SARS–CoV–2, the virus that causes PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 • STERIS Corporation’s STERIS Sterilization Systems (STERIS V–PRO 1 Plus, maX, and maX2 Low Temperature Sterilization Systems), issued April 9, 2020; 7 • Certain Face Shields, issued April 9, 2020; 8 COVID–19, can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus; (2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that the Battelle Decontamination System may be effective at preventing exposure to pathogenic airborne particulates when there are insufficient supplies of FFRs during the COVID–19 pandemic by decontaminating, for a maximum of 20 decontamination cycles per respirator, compatible N95 respirators that are contaminated or potentially contaminated with SARS–CoV–2 or other pathogenic microorganisms, and that the known and potential benefits of the Battelle Decontamination System, when used to decontaminate compatible N95 respirators for reuse by HCP to prevent exposure to pathogenic airborne particulates during FFR shortages during the COVID–19 pandemic, outweigh the known and potential risks; and (3) there is no adequate, approved, and available alternative to the emergency use of the Battelle Decontamination System for decontaminating compatible N95 respirators for reuse by HCP during FFR shortages during the COVID–19 pandemic. 7 As set forth in the EUA, FDA has concluded that: (1) SARS–CoV–2, the virus that causes COVID–19, can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus; (2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that the STERIS Sterilization Systems may be effective at preventing exposure to pathogenic airborne particulates when there are insufficient supplies of N95 respirators during the COVID19 pandemic by decontaminating for a maximum of 10 decontamination cycles per respirator, compatible N95 respirators that are contaminated or potentially contaminated with SARS–CoV–2 or other pathogenic microorganisms, and that the known and potential benefits of the STERIS Sterilization Systems, when used to decontaminate compatible N95 respirators for single-user reuse by HCP to prevent exposure to pathogenic airborne particulates during N95 respirator shortages during the COVID–19 pandemic, outweigh the known and potential risks; and (3) there is no adequate, approved, and available alternative to the emergency use of the STERIS Sterilization Systems for decontaminating compatible N95 respirators for reuse by HCP during N95 respirator shortages during the COVID–19 pandemic. 8 As set forth in the EUA, FDA has concluded that: (1) SARS–CoV–2, the virus that causes COVID–19, can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus; (2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that the authorized face shields may be effective at preventing HCP exposure to fluid biological airborne particulates during face shield shortages by providing minimal or low barrier HCP protection to the wearer, and that the known and potential benefits of face shields, when used to prevent HCP exposure to such particulates during face shield shortages during COVID–19 outweigh the known and potential risks of such product; and (3) there is no adequate, approved, and available alternative to the emergency use of these face shields for preventing HCP exposure to such particulates during face shield shortages to prevent disease spread during the COVID–19 pandemic. E:\FR\FM\05JNN1.SGM 05JNN1 Federal Register / Vol. 85, No. 109 / Friday, June 5, 2020 / Notices • Terumo BCT Inc. and Marker Therapeutics AG’s, Spectra Optia Apheresis System with the Depuro D2000 Adsorption Cartridge (an Extracorporeal Blood Purification (EBP) Device), issued on April 9, 2020;9 and, • CytoSorbents, Inc.’s, CytoSorb EBP Device, issued on April 10, 2020.10 Dated: May 29, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–12117 Filed 6–4–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Committee on Vital and Health Statistics Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting. lotter on DSK9F5VC42PROD with NOTICES Name: National Committee on Vital and Health Statistics (NCVHS), Full Committee Meeting. Dates and Times: Wednesday, June 17, 2020: 10:00 a.m.– 5:00 p.m. EDT Thursday, June 18, 2020 10:00 a.m.–4:00 p.m. EDT 9 As set forth in the EUA, FDA has concluded that: (1) SARS–CoV–2, the virus that causes COVID–19, can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus; (2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that the Spectra Optia Apheresis System with the Depuro D2000 Adsorption Cartridge may be effective in treating patients 18 years of age or older with confirmed COVID–19 admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure, and that the known and potential benefits of the Spectra Optia Apheresis System with the Depuro D2000 Adsorption Cartridge, when used to treat COVID– 19 patients 18 years of age or older, outweigh the known and potential risks of the Spectra Optia Apheresis System with the Depuro D2000 Adsorption Cartridge; and (3) there is no adequate, approved, and available alternative to the emergency use of the Spectra Optia Apheresis System with the Depuro D2000 Adsorption Cartridge for the treatment of these COVID–19 patients. 10 As set forth in the EUA, FDA has concluded that: (1) SARS–CoV–2, the virus that causes COVID–19, can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus; (2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that the CytoSorb device may be effective in treating patients 18 years of age or older with confirmed COVID–19 admitted to the ICU with confirmed or imminent respiratory failure, and that the known and potential benefits of the CytoSorb device, when used to treat such patients, outweigh the known and potential risks of the CytoSorb device; and (3) there is no adequate, approved, and available alternative to the emergency use of the CytoSorb device for the treatment of these COVID–19 patients. VerDate Sep<11>2014 21:06 Jun 04, 2020 Jkt 250001 Place: Virtual. Status: Open. Purpose: At the June 17–18, 2020 meeting, the Committee will receive briefings from HHS officials, hold discussions on several health data policy topics and refine its workplan for the upcoming 12-month period. The Subcommittee on Privacy, Confidentiality and Security will lead a discussion with the full Committee to reach consensus on plans for a project focused on data privacy and security protections related to current public health surveillance activities. The Subcommittee on Standards will provide updates on plans for the upcoming August hearing intended to solicit information about the costs and benefits of a new operating rule for connectivity and operating rules for the prior authorization transaction proposed by the Council for Affordable Quality Healthcare (CAQH), Committee on Operating Rules for Information Exchange (CORE) Board. The Subcommittee also will provide an update on progress of the Office of the National Coordinator (ONC) Health Information Technology Advisory Committee (HITAC) Task Force on Intersection of Clinical and Administrative Data (ICAD), on which four NCVHS members participate. The Committee will initiate a discussion of the NCVHS 14th Report to Congress, including a proposed approach, major themes, and timeline including reflection on previous reports to Congress for context. The Committee has invited presentations from the HHS Office of the Assistant Secretary for Planning and Evaluation, Science and Data Policy Division, the National Center for Health Statistics (NCHS), and CDC’s Deputy Director for Public Health Science and Surveillance (DDPHSS), to inform Committee discussion of the data landscape transformed by the COVID– 19 epidemic. The Committee also has invited CMS’s Division of National Standards to provide an update on its activities and plans. On the afternoon of the second day, members will consider and discuss priorities for Committee focus and revise the Committee workplan based on information presented during the meeting. A public comment period will be offered on the second day. Meeting times and topics are subject to change. Please refer to the posted agenda for any updates. For Further Information Contact: Substantive program information may be obtained from Rebecca Hines, MHS, Executive Secretary, NCVHS, National Center for Health Statistics, Centers for PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 34641 Disease Control and Prevention, 3311 Toledo Road, Hyattsville, Maryland 20782, telephone (301) 458–4715. Summaries of meetings and a roster of Committee members are available on the home page of the NCVHS website: ncvhs.hhs.gov, where further information including an agenda and instructions to access the broadcast of the meeting will also be posted. Should you require reasonable accommodation, please contact the CDC Office of Equal Employment Opportunity on (770) 488–3210 as soon as possible. Sharon Arnold, Associate Deputy Assistant Secretary for Planning and Evaluation, Science and Data Policy, Office of the Assistant Secretary for Planning and Evaluation. [FR Doc. 2020–12236 Filed 6–4–20; 8:45 am] BILLING CODE 4150–05–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel Vaccine and Treatment Evaluation Units (VTEUs): Enhancing Capability and Capacity (UM1 Clinical Trial Required). Date: July 7, 2020. Time: 10:00 a.m. to 3:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3F21B, Rockville, MD 20892 (Telephone Conference Call). Contact Person: Maryam Feili-Hariri, Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural Activities, National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3F21B, E:\FR\FM\05JNN1.SGM 05JNN1

Agencies

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


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
issuance and reissuance of Emergency Use Authorizations (EUAs) (the 
Authorizations) for certain medical devices related to the coronavirus 
disease 2019 (COVID-19) public health emergency. FDA has issued, and in 
some cases reissued, the Authorizations listed in this document under 
the Federal Food, Drug, and Cosmetic Act (FD&C Act). These 
Authorizations contain, among other things, conditions on the emergency 
use of the authorized products. The Authorizations follow the February 
4, 2020, determination by Secretary of Health and Human Services (HHS) 
that there is a public health emergency that has significant potential 
to affect national security or the health and security of U.S. citizens 
living abroad, which involves the virus that causes COVID-19, and the 
subsequent declarations on February 4, 2020, March 2, 2020, and March 
24, 2020, that circumstances exist justifying the authorization of 
emergency use of in vitro diagnostics for detection and/or diagnosis of 
the virus that causes COVID-19, personal respiratory protective 
devices, and medical devices, including alternative products used as 
medical devices, respectively, subject to the terms of any 
authorization issued under the FD&C Act. These Authorizations, which 
include an explanation of the reasons for issuance and reissuance, are 
listed in this document and are available on FDA's website at the links 
indicated in this document.

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

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

FOR FURTHER INFORMATION CONTACT: Jennifer J. Ross, Office of 
Counterterrorism and Emerging Threats, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 1, Rm. 4332, Silver Spring, MD 20993-
0002, 301-796-8510 (this is not a toll-free number).

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to 
strengthen the public health protections against biological, chemical, 
radiological, or nuclear agent or agents. Among other things, section 
564 of the FD&C Act allows FDA to authorize the use of an unapproved 
medical product or an unapproved use of an approved medical product in 
certain situations. With this EUA authority, FDA can help ensure that 
medical countermeasures may be used in emergencies to diagnose, treat, 
or prevent serious or life-threatening diseases or conditions caused by 
a biological, chemical, radiological, or nuclear agent or agents when 
there are no adequate, approved, and available alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may 
be issued, the Secretary of HHS must declare that circumstances exist 
justifying the authorization based on one of the following grounds: (1) 
A determination by the Secretary of Homeland Security that there is a 
domestic emergency, or a significant potential for a domestic 
emergency, involving a heightened risk of attack with a biological, 
chemical, radiological, or nuclear agent or agents; (2) a determination 
by the Secretary of Defense that there is a military emergency, or a 
significant potential for a military emergency, involving a heightened 
risk to U.S. military forces, including personnel operating under the 
authority of title 10 or title 50, U.S. Code, of attack with (i) a 
biological, chemical, radiological, or nuclear agent or agents; or (ii) 
an agent or agents that may cause, or are otherwise associated with, an 
imminently life-threatening and specific risk to U.S. military forces; 
\1\ (3) a determination by the Secretary of HHS that there is a public 
health emergency, or a significant potential for a public health 
emergency,

[[Page 34639]]

that affects, or has a significant potential to affect, national 
security or the health and security of U.S. citizens living abroad, and 
that involves a biological, chemical, radiological, or nuclear agent or 
agents, or a disease or condition that may be attributable to such 
agent or agents; or (4) the identification of a material threat by the 
Secretary of Homeland Security pursuant to section 319F-2 of the Public 
Health Service (PHS) Act (42 U.S.C. 247d-6b) sufficient to affect 
national security or the health and security of U.S. citizens living 
abroad.
---------------------------------------------------------------------------

    \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 
sections 505, 510(k), 512, or 515 of the FD&C Act (21 U.S.C. 355, 
360(k), 360b and 360e) or section 351 of the PHS Act (42 U.S.C. 262), 
or conditionally approved under section 571 of the FD&C Act (21 U.S.C. 
360ccc). FDA may issue an EUA only if, after consultation with the HHS 
Assistant Secretary for Preparedness and Response, the Director of the 
National Institutes of Health, and the Director of the Centers for 
Disease Control and Prevention (to the extent feasible and appropriate 
given the applicable circumstances), FDA \2\ concludes: (1) That an 
agent referred to in a declaration of emergency or threat can cause a 
serious or life-threatening disease or condition; (2) that, based on 
the totality of scientific evidence available to FDA, including data 
from adequate and well-controlled clinical trials, if available, it is 
reasonable to believe that: (A) The product may be effective in 
diagnosing, treating, or preventing (i) such disease or condition; or 
(ii) a serious or life-threatening disease or condition caused by a 
product authorized under section 564, approved or cleared under the 
FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing, 
treating, or preventing such a disease or condition caused by such an 
agent; and (B) the known and potential benefits of the product, when 
used to diagnose, prevent, or treat such disease or condition, outweigh 
the known and potential risks of the product, taking into consideration 
the material threat posed by the agent or agents identified in a 
declaration under section 564(b)(1)(D) of the FD&C Act, if applicable; 
(3) that there is no adequate, approved, and available alternative to 
the product for diagnosing, preventing, or treating such disease or 
condition; (4) in the case of a determination described in section 
564(b)(1)(B)(ii), that the request for emergency use is made by the 
Secretary of Defense; and (5) that such other criteria as may be 
prescribed by regulation are satisfied.
---------------------------------------------------------------------------

    \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. Because the statute is self-
executing, regulations or guidance are not required for FDA to 
implement the EUA authority.

II. Electronic Access

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

III. The Authorizations

    Having concluded that the criteria for the issuance and, in some 
cases reissuance, of the following Authorizations under section 564(c) 
of the FD&C Act are met, FDA has authorized the emergency use of the 
following products for diagnosing, treating, or preventing COVID-19 
subject to the terms of each Authorization. The Authorizations in their 
entirety, including any authorized fact sheets and other written 
materials, are available on the internet from the FDA web page entitled 
``Emergency Use Authorization,'' available at https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization. The lists that follow include 
Authorizations issued, in some cases reissued, through April 10, 2020, 
and we have included explanations of the reasons for their issuance, as 
required by section 564(h)(1) of the FD&C Act. FDA is hereby announcing 
the following Authorizations for in vitro diagnostics:\3\
---------------------------------------------------------------------------

    \3\ As set forth in the EUAs for these devices, FDA has 
concluded that: (1) SARS-CoV-2, the virus that causes COVID-19, can 
cause a serious or life-threatening disease or condition, including 
severe respiratory illness, to humans infected by this virus; (2) 
based on the totality of scientific evidence available to FDA, it is 
reasonable to believe that the devices may be effective in 
diagnosing COVID-19, and that the known and potential benefits of 
the devices, when used for diagnosing COVID-19, outweigh the known 
and potential risks of such devices; and (3) there is no adequate, 
approved, and available alternative to the emergency use of the 
devices.
---------------------------------------------------------------------------

     CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR 
Diagnostic Panel (CDC), issued February 4, 2020, and reissued March 15, 
2020;
     New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-
PCR Diagnostic Panel (Wadsworth Center, NYSDOH), issued February 29, 
2020, and reissued March 10, 2020;
     Roche Molecular Systems, Inc.'s (RMS) cobas SARS-CoV-2, 
issued March 12, 2020;
     Thermo Fisher Scientific, Inc.'s TaqPath COVID-19 Combo 
Kit, issued March 13, 2020;
     Hologic, Inc.'s Panther Fusion SARS-CoV-2, issued March 
16, 2020;
     Laboratory Corporation of America's COVID-19 RT-PCR Test, 
issued March 16, 2020;
     Quidel Corp.'s Lyra SARS-CoV-2 Assay, issued March 17, 
2020;
     Quest Diagnostics Infectious Disease, Inc.'s Quest SARS-
CoV-2 rRT-PCR, issued March 17, 2020;
     Abbott Molecular's Abbott RealTime SARS-CoV-2 assay, 
issued March 18, 2020;
     DiaSorin Molecular LLC's Simplexa COVID-19 Direct assay, 
issued March 19, 2020;
     GenMark Diagnostics, Inc.'s ePlex SARS-CoV-2 Test, issued 
March 19, 2020;
     Primerdesign Ltd's Primerdesign Ltd COVID-19 genesig Real-
Time PCR assay, issued March 20, 2020;
     Cepheid's Xpert Xpress SARS-CoV-2 test, issued March 20, 
2020;
     BioFire Defense, LLC's BioFire COVID-19 Test, issued March 
23, 2020;
     Mesa Biotech Inc.'s Accula SARS-Cov-2 Test, issued March 
23, 2020;
     PerkinElmer, Inc.'s PerkinElmer New Coronavirus Nucleic 
Acid Detection Kit, issued March 24, 2020;
     Avellino Lab USA, Inc.'s AvellinoCoV2 test, issued March 
25, 2020;
     BGI Genomics Co. Ltd.'s Real-Time Fluorescent RT-PCR Kit 
for Detecting SARS-2019-nCoV, issued March 26, 2020;

[[Page 34640]]

     Abbott Diagnostics Scarborough, Inc.'s ID NOW COVID-19, 
issued March 27, 2020;
     Luminex Molecular Diagnostics, Inc. Luminex Molecular 
Diagnostics, Inc.'s NxTAG CoV Extended Panel Assay, issued March 27, 
2020;
     NeuMoDx Molecular, Inc.'s NeuMoDx SARS-CoV-2 Assay, issued 
March 30, 2020;
     QIAGEN GmbH's QIAstat-Dx Respiratory SARS-CoV-2 Panel, 
issued March 30, 2020;
     Cellex Inc.'s qSARS-CoV-2 IgG/IgM Rapid Test, issued April 
1, 2020;
     Ipsum Diagnostics, LLC's COV-19 IDx assay, issued April 1, 
2020;
     Becton, Dickinson and Company, BioGX SARCoV-2 Reagents for 
BD MAX System, issued April 2, 2020;
     Luminex Corporation, ARIES SARS-CoV-2 Assay, issued April 
3, 2020;
     ScienCell Research Laboratories, ScienCell SARS-CoV-2 
Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit, issued April 3, 
2020;
     Co-Diagnostics, Inc., Logix Smart Coronavirus Disease 2019 
(COVID-19) kit, issued April 3, 2020;
     Gnomegen LLC's, Gnomegen COVID-19 RT-Digital PCR RT-
Digital PCR Detection Kit, issued on April 6, 2020;
     InBios International Inc.'s, Smart Detect SARS-CoV-2 rRT-
PCR Kit, issued on April 7, 2020;
     Becton, Dickinson and Company's, BD SARS-CoV-2 Reagents 
for BD MAX System, issued on April 8, 2020;
     DiaCarta, Inc.'s QuantiVirus SARS-CoV-2 Test kit, issued 
on April 8, 2020;
     Atila BioSystems, Inc.'s, iAMP COVID-19 Detection Kit, 
issued on April 10, 2020; and
     Certain Molecular-Based Laboratory Developed Tests (LDTs) 
for COVID-19 that are developed by laboratories certified under the 
Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform 
high complexity tests and are authorized for use by the singular 
developing laboratory, issued on March 31, 2020 (a current list of 
tests included under this EUA is available at https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations).
    FDA is hereby announcing the following Authorizations for personal 
respiratory protective devices:\4\
---------------------------------------------------------------------------

    \4\ As set forth in the EUAs, FDA has concluded that: (1) The 
SARS-CoV-2 can cause a serious or life-threatening disease or 
condition, including severe respiratory illness, to humans infected 
by this virus; (2) based on the totality of scientific evidence 
available to FDA, it is either reasonable to believe that the 
authorized respirators may be effective in preventing healthcare 
personnel (HCP) exposure to pathogenic biological airborne 
particulates during Filtering Facepiece Respirator (FFR) shortages, 
and that the known and potential benefits of the authorized 
respirators, when used to prevent HCP exposure to such particulates 
during FFR shortages during COVID-19, outweigh the known and 
potential risks of such products, and (3) there is no adequate, 
approved, and available alternative for the emergency use.
---------------------------------------------------------------------------

     Certain National Institute for Occupational Safety and 
Health (NIOSH)-Approved Air Purifying Respirators for Use in Health 
Care Settings During Response to the COVID-19 Public Health Emergency, 
issued March 2, 2020, with reissuance on March 27, 2020, and March 28, 
2020;
     Certain Imported, Non-NIOSH-Approved Disposable Filtering 
Facepiece Respirators, issued March 24, 2020, with reissuance on March 
28, 2020 (a current list of respirators included under this EUA is 
available at https://www.fda.gov/media/136731/download); and,
     Certain Non-NIOSH-Approved Disposable Filtering Facepiece 
Respirators Manufactured in China, issued April 3, 2020 (a current list 
of respirators included under this EUA is available at https://www.fda.gov/media/136663/download).
    FDA is hereby announcing the following Authorizations for other 
medical devices:
     Certain ventilators, anesthesia gas machines modified for 
use as ventilators, and positive pressure breathing devices modified 
for use as ventilators (collectively referred to as ``ventilators''), 
ventilator tubing connectors, and ventilator accessories, issued March 
24, 2020 (a current list of products included under this EUA is 
available at https://www.fda.gov/media/136528/download);\5\
---------------------------------------------------------------------------

    \5\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that the authorized ventilators, ventilator tubing connectors, and 
ventilator accessories may be effective in treating patients during 
the COVID-19 pandemic, and the known and potential benefits of such 
products, when used to treat patients during the COVID-19 pandemic, 
outweigh the known and potential risks of such products, and (3) 
there is no adequate, approved, and available alternative to the 
emergency use of the authorized ventilators, ventilator tubing 
connectors, and ventilator accessories for treating patients during 
the COVID-19 pandemic.
---------------------------------------------------------------------------

     Battelle Memorial Institute's Battelle Decontamination 
System (Battelle CCDS Critical Care Decontamination System), issued 
March 28, 2020, with reissuance March 29, 2020;\6\
---------------------------------------------------------------------------

    \6\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that the Battelle Decontamination System may be effective at 
preventing exposure to pathogenic airborne particulates when there 
are insufficient supplies of FFRs during the COVID-19 pandemic by 
decontaminating, for a maximum of 20 decontamination cycles per 
respirator, compatible N95 respirators that are contaminated or 
potentially contaminated with SARS-CoV-2 or other pathogenic 
microorganisms, and that the known and potential benefits of the 
Battelle Decontamination System, when used to decontaminate 
compatible N95 respirators for reuse by HCP to prevent exposure to 
pathogenic airborne particulates during FFR shortages during the 
COVID-19 pandemic, outweigh the known and potential risks; and (3) 
there is no adequate, approved, and available alternative to the 
emergency use of the Battelle Decontamination System for 
decontaminating compatible N95 respirators for reuse by HCP during 
FFR shortages during the COVID-19 pandemic.
---------------------------------------------------------------------------

     STERIS Corporation's STERIS Sterilization Systems (STERIS 
V-PRO 1 Plus, maX, and maX2 Low Temperature Sterilization Systems), 
issued April 9, 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 STERIS Sterilization Systems may be effective at preventing 
exposure to pathogenic airborne particulates when there are 
insufficient supplies of N95 respirators during the COVID19 pandemic 
by decontaminating for a maximum of 10 decontamination cycles per 
respirator, compatible N95 respirators that are contaminated or 
potentially contaminated with SARS-CoV-2 or other pathogenic 
microorganisms, and that the known and potential benefits of the 
STERIS Sterilization Systems, when used to decontaminate compatible 
N95 respirators for single-user reuse by HCP to prevent exposure to 
pathogenic airborne particulates during N95 respirator shortages 
during the COVID-19 pandemic, outweigh the known and potential 
risks; and (3) there is no adequate, approved, and available 
alternative to the emergency use of the STERIS Sterilization Systems 
for decontaminating compatible N95 respirators for reuse by HCP 
during N95 respirator shortages during the COVID-19 pandemic.
---------------------------------------------------------------------------

     Certain Face Shields, issued April 9, 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 authorized face shields may be effective at preventing HCP 
exposure to fluid biological airborne particulates during face 
shield shortages by providing minimal or low barrier HCP protection 
to the wearer, and that the known and potential benefits of face 
shields, when used to prevent HCP exposure to such particulates 
during face shield shortages during COVID-19 outweigh the known and 
potential risks of such product; and (3) there is no adequate, 
approved, and available alternative to the emergency use of these 
face shields for preventing HCP exposure to such particulates during 
face shield shortages to prevent disease spread during the COVID-19 
pandemic.

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[[Page 34641]]

     Terumo BCT Inc. and Marker Therapeutics AG's, Spectra 
Optia Apheresis System with the Depuro D2000 Adsorption Cartridge (an 
Extracorporeal Blood Purification (EBP) Device), issued on April 9, 
2020;\9\ and,
---------------------------------------------------------------------------

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

     CytoSorbents, Inc.'s, CytoSorb EBP Device, issued on April 
10, 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 CytoSorb device may be effective in treating patients 18 
years of age or older with confirmed COVID-19 admitted to the ICU 
with confirmed or imminent respiratory failure, and that the known 
and potential benefits of the CytoSorb device, when used to treat 
such patients, outweigh the known and potential risks of the 
CytoSorb device; and (3) there is no adequate, approved, and 
available alternative to the emergency use of the CytoSorb device 
for the treatment of these COVID-19 patients.

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

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