Authorization of Emergency Use of Certain Medical Devices During COVID-19; Availability, 42407-42411 [2020-15137]

Download as PDF Federal Register / Vol. 85, No. 135 / Tuesday, July 14, 2020 / Notices Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002. Send one selfaddressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Charles Viviano, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2680, Silver Spring, MD 20993–0002, 240–402–2975. SUPPLEMENTARY INFORMATION: I. Background FDA has developed this draft guidance to propose select updates to the FDA guidance document ‘‘Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH).’’ The existing guidance on devices used for the treatment of BPH remains in effect, in its current form, until this draft guidance is finalized. FDA intends to incorporate this draft guidance into one final guidance document after obtaining and considering public comment on these select updates. The sections of the existing BPH guidance that are not affected by this select update will not be substantively changed and will remain in effect. II. Significance of Guidance This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Select Updates for Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH).’’ 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. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available 42407 at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Select Updates for Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH)’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1724 and the full title to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information. 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 the following FDA regulations and guidance have been approved by OMB as listed in the following table: 21 CFR part or guidance Topic 58 .............................................................................................. Good Laboratory Practice (GLP) Regulations for Nonclinical Laboratory Studies. Medical Device Labeling Regulations ...................................... Premarket Notification .............................................................. Investigational Device Exemption ............................................ Premarket Approval Applications ............................................. De Novo Classification Process ............................................... 0910–0119 Q-submissions .......................................................................... 0910–0756 800, 801, and 809 .................................................................... 807, subpart E .......................................................................... 812 ............................................................................................ 814, subparts A through E ....................................................... ‘‘De Novo Classification Process (Evaluation of Automatic Class III Designation)’’. ‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff’’. Dated: July 8, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–15089 Filed 7–13–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1584] Authorization of Emergency Use of Certain Medical Devices During COVID–19; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the issuance and reissuance of Emergency Use Authorizations (EUAs) (the SUMMARY: VerDate Sep<11>2014 17:58 Jul 13, 2020 Jkt 250001 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 PO 00000 Frm 00062 Fmt 4703 Sfmt 4703 OMB control No. 0910–0485 0910–0120 0910–0078 0910–0231 0910–0844 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. ADDRESSES: Submit written requests for single copies of the 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. E:\FR\FM\14JYN1.SGM 14JYN1 42408 Federal Register / Vol. 85, No. 135 / Tuesday, July 14, 2020 / Notices See the SUPPLEMENTARY INFORMATION 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 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, 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 17:58 Jul 13, 2020 Jkt 250001 or a significant potential for a public health emergency, that affects, or has a significant potential to affect, national security or the health and security of U.S. citizens living abroad, and that involves a biological, chemical, radiological, or nuclear agent or agents, or a disease or condition that may be attributable to such agent or agents; or (4) the identification of a material threat by the Secretary of Homeland Security pursuant to section 319F–2 of the Public Health Service (PHS) Act (42 U.S.C. 247d–6b) sufficient to affect national security or the health and security of U.S. citizens living abroad. Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the Federal Register a notice of each authorization, and each termination or revocation of an authorization, and an explanation of the reasons for the action. Section 564 of the FD&C Act permits FDA to authorize the introduction into interstate commerce of a drug, device, or biological product intended for use when the Secretary of HHS has declared that circumstances exist justifying the authorization of emergency use. Products appropriate for emergency use may include products and uses that are not approved, cleared, or licensed under sections 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; 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 00063 Fmt 4703 Sfmt 4703 or (ii) a serious or life-threatening disease or condition caused by a product authorized under section 564, approved or cleared under the FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing, treating, or preventing such a disease or condition caused by such an agent; and (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product, taking into consideration the material threat posed by the agent or agents identified in a declaration under section 564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition; (4) in the case of a determination described in section 564(b)(1)(B)(ii), that the request for emergency use is made by the Secretary of Defense; and (5) that such other criteria as may be prescribed by regulation are satisfied. No other criteria for issuance have been prescribed by regulation under section 564(c)(4) of the FD&C Act. III. Electronic Access An electronic version of this document and the full text of the Authorizations are available on the internet at https://www.fda.gov/ emergency-preparedness-and-response/ mcm-legal-regulatory-and-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 April 11, 2020, through May 15, 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 E:\FR\FM\14JYN1.SGM 14JYN1 Federal Register / Vol. 85, No. 135 / Tuesday, July 14, 2020 / Notices hereby announcing the following Authorizations for in vitro diagnostics: 3 • Ortho-Clinical Diagnostics, Inc.’s VITROS Immunodiagnostic Products Anti-SARS–CoV–2 Total Reagent Pack, issued April 14, 2020; • Chembio Diagnostic System, Inc.’s DPP COVID–19 IgM/IgG System, issued April 14, 2020; • Mount Sinai Laboratory’s COVID– 19 [enzyme-linked immunosorbent assay] ELISA IgG Antibody Test, issued April 15, 2020; • Maccura Biotechnology (USA) LLC’s SARS–CoV–2 Fluorescent PCR Kit, issued April 15, 2020; • GenoSensor, LLC’s GS COVID–19 RT–PCR KIT, issued April 16, 2020; • KorvaLabs Inc.’s Curative-Korva SARS–CoV–2 Assay, issued April 16, 2020; • Fosun Pharma USA Inc.’s Fosun COVID–19 RT–PCR Detection Kit, issued April 17, 2020; • OSANG Healthcare’s GeneFinder COVID–19 Plus RealAmp Kit, issued April 18, 2020; • Trax Management Services Inc.’s PhoenixDx 2019–CoV, issued April 20, 2020; • Laboratory Corporation of America’s COVID–19 RT–PCR Test, reissued April 20, 2020 (original issuance March 16, 2020); • Seegene, Inc.’s Allplex 2019–nCoV Assay, issued April 21, 2020; • altona Diagnostics GmbH’s RealStar SARS–CoV–2 RT–PCR Kits U.S., issued April 22, 2020; • SD Biosensor, Inc.’s STANDARD M nCoV Real-Time Detection Kit, issued April 23, 2020; • Autobio Diagnostics Co. Ltd.’s AntiSARS–CoV–2 Rapid Test, issued April 24, 2020; • Ortho-Clinical Diagnostics, Inc.’s VITROS Immunodiagnostic Products Anti-SARS–CoV–2 IgG Reagent Pack, issued April 24, 2020; • DiaSorin Inc.’s LIAISON SARS– CoV–2 S1/S2 IgG, issued April 24, 2020; • Abbott Laboratories Inc.’s SARS– CoV–2 IgG assay, issued April 26, 2020; • SEASUN BIOMATERIALS’s U–TOP COVID–19 Detection Kit, issued April 27, 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. VerDate Sep<11>2014 17:58 Jul 13, 2020 Jkt 250001 • Bio-Rad Laboratories, Inc’s Platelia SARS–CoV–2 Total Ab assay, issued April 29, 2020; • Rheonix, Inc.’s Rheonix COVID–19 MDx Assay, issued April 29, 2020; • LabGenomics Co., Ltd.’s LabGun COVID–19 RT–PCR Kit, issued April 29, 2020; • Wadsworth Center, New York State Department of Health’s New York SARS–CoV Microsphere Immunoassay for Antibody Detection, issued April 30, 2020; • BioFire Diagnostics, LLC’s BioFire Respiratory Panel 2.1 (RP2.1), issued May 1, 2020; • Bio-Rad Laboratories, Inc.’s Bio-Rad SARS–CoV–2 ddPCR Test, issued May 1, 2020; • Roche Diagnostics’s Elecsys AntiSARS–CoV–2, issued May 2, 2020; • Sansure BioTech Inc.’s Novel Coronavirus (2019–nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing), issued May 4, 2020; • EUROIMUN US Inc.’s Anti-SARS– CoV–2 ELISA (IgG), issued May 4, 2020; • Fast Track Diagnostics Luxembourg S.a´.r.l’s. (a Siemens Healthineers Company) FTD SARS–CoV–2, issued May 5, 2020; • BioMe´rieux SA’s SARS–COV–2 R– GENE, issued May 6, 2020; • Sherlock BioSciences, Inc.’s Sherlock CRISPR SARS–CoV–2 Kit, issued May 6, 2020; • OPTI Medical Systems, Inc.’s OPTI SARS–CoV–2 RT PCR Test, issued May 6, 2020; • Zymo Research Corp.’s Quick SARS–Cov–2rRT–PCR Kit, issued May 7, 2020; • Rutgers Clinical Genomics Laboratory at RUCDR Infinite BiologicsRutgers University’s Rutgers Clinical Genomics Laboratory TaqPath SARS– CoV–2 Assay, reissued May 7, 2020 (original issuance April 10, 2020); • Gnomegen LLC’s Gnomegen COVID–19–RT–qPCR Detection Kit, issued May 8, 2020; • Quidel Corporation’s Sofia 2 SARS Antigen FIA, issued May 8, 2020; • Abbott Molecular Inc.’s Alinity m SARS–CoV–2 assay, issued May 11, 2020; • 1drop Inc.’s 1copy COVID–19 qPR Multi Kit, issued May 11, 2020; • Applied DNA Sciences, Inc.’s Linea COVID–19 Assay Kit, issued May 13, 2020; • GeneMatrix, Inc.’s NeoPlex COVID– 19 Detection Kit, issued May 14, 2020; • Hologic, Inc., Aptima SARS–CoV–2 assay, issued May 14, 2020; • Assurance Scientific Laboratories’ Assurance SARS–CoV–2 Panel, issued May 15, 2020; PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 42409 • Fulgent Therapeutics, LLC’s Fulgent COVID–19 by RT–PCR Test, issued May 15, 2020; and • Certain SARS–CoV–2 Antibody Tests (lateral flow or ELISA tests) that are for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988, 42 U.S.C. 263a, to perform moderate or high complexity tests, issued on April 28, 2020 (a current list of tests included under this EUA is available at https:// www.fda.gov/media/137471/download). FDA is hereby announcing the following Authorizations for personal respiratory protective devices: 4 • Certain Non-[National Institute of Industrial and Occupational Safety]NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China, reissued May 7, 2020, (original issuance 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: • B. Braun Medical, Inc.’s B. Braun Space and Outlook Pumps, issued April 11, 2020; 5 • Advanced Sterilization Products, Inc.’s ASP STERRAD Sterilization Systems, issued April 11, 2020; 6 4 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 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 to the emergency use of this product. 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 B. Braun Space and Outlook Pumps may be effective for use in the tracheal delivery of continuous nebulized medications into a nebulizer to treat COVID–19 patients of all ages and for the ground medical transport use of the Infusomat Space Volumetric Infusion Pump System, and that the known and potential benefits of the B. Braun Space and Outlook Pumps for these uses, outweigh the known and potential risks of such product; and (3) there is no adequate, approved, and available alternative to the emergency use of this product. 6 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 E:\FR\FM\14JYN1.SGM Continued 14JYN1 42410 Federal Register / Vol. 85, No. 135 / Tuesday, July 14, 2020 / Notices • Certain Face Shields, reissued April 13, 2020 (original issuance April 9, 2020); 7 • Synapse Biomedical, Inc.’s TransAeris Diaphragm Pacing System, issued April 13, 2020; 8 • Stryker Instruments’ STERIZONE VP4 Sterilizer, issued April 14, 2020; 9 FDA, it is reasonable to believe that the ASP STERRAD Sterilization Systems may be effective at preventing exposure to pathogenic airborne particulates when there are insufficient supplies of N95 respirators during the COVID–19 pandemic by decontaminating, for a maximum of two 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 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 this product. 7 As set forth in the EUA, FDA has concluded that: (1) SARS–CoV–2, the virus that causes COVID–19, can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus; (2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that the 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 this 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 product may be effective for emergency use to treat patients by assisting in weaning patients off ventilators in healthcare settings during the COVID–19 pandemic, and that the known and potential benefits of the such product, for such use, outweigh the known and potential risks of such product; and (3) there is no adequate, approved, and available alternative. 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 STERIZONE VP4 N95 Respirator Decontamination Cycle may be effective at preventing exposure to pathogenic airborne particulates by decontaminating, for a maximum of two 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 this device, 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 STERIZONE VP4 N95 Respirator Decontamination Cycle for decontaminating compatible N95 respirators for single-user reuse by HCPs during FFR shortages during the COVID–19 pandemic. VerDate Sep<11>2014 17:58 Jul 13, 2020 Jkt 250001 • Lungpacer Medical USA, Inc.’s Lungpacer DPTS, issued April 14, 2020 (see footnote 8); • ExThera Medical Corporation’s Seraph 100 Microbind Affinity Blood Filter, issued April 17, 2020; 10 • Certain Face Masks, issued April 18, 2020, and reissued April 24, 2020; 11 • Sterilucent, Inc.’s Sterilucent Sterilizer System, issued April 20, 2020; 12 • Philips Medizin Systeme Boeblingen GmbH’s IntelliVue Patient Monitors, issued April 21, 2020; 13 • ALung Technologies, Inc.’s Hemolung RAS, issued April 22, 2020; 14 • Baxter Healthcare Corp.’s oXiris Set device, issued April 23, 2020; 15 • VitalConnect, Inc.’s VitalPatch, issued April 26, 2020; 16 • Fresenius Medical Care’s multiFiltrate PRO System and multiBic/ multiPlus Solutions to provide continuous renal replacement therapy, issued May 1, 2020; 17 • Liberate Medical, LLC’s VentFree, issued May 1, 2020; 18 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 Seraph 100 Microbind Affinity Blood Filter device 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 Seraph 100 Microbind Affinity Blood Filter device, when used to treat such patients, outweigh the known and potential risks of the device; and (3) there is no adequate, approved, and available alternative to the emergency use of this 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 authorized face masks may be effective as source control to help prevent the spread of SARS–CoV–2 by infected individuals who may or may not have symptoms of COVID–19 during the COVID–19 pandemic, and that the known and potential benefits of face masks, when used in accordance with the scope of this 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 this 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 Sterilucent Sterilization System may be effective at decontaminating compatible N95 respirators for single-user reuse by HCPs to prevent exposure to pathogenic biological airborne particulates, and that the known and potential benefits of this device, 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 this 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 IntelliVue Patient Monitors may be effective in preventing COVID–19 exposure in healthcare providers, through use of remote patient monitoring, and that the known and potential benefits of such products, for such use, outweigh the known and potential risks of the IntelliVue Patient Monitors; and (3) there is no adequate, approved, and available alternative to the emergency use of this 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 Hemolung RAS may be effective in treating lung failure when used as described in the Scope of Authorization, and that the known and potential benefits of the Hemolung RAS for treating these patients, outweigh the known and potential risks; and (3) there is no adequate, approved, and available alternative to the emergency use of this 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 oXiris Set 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 in need of blood purification, including use in continuous renal replacement therapy, and that the known and potential benefits of the oXiris Set device, when used to treat such patients, outweigh the known and potential risks of the oXiris Set device; and (3) there is no adequate, approved, and available alternative to the emergency use of this product. 16 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 product may be effective in remotely monitoring and detecting QT interval changes of an ECG in patients who are undergoing treatment in a hospital setting for COVID–19 with drugs that can prolong QT intervals and may cause life threatening arrhythmias (e.g., hydroxychloroquine or chloroquine, especially when used in combination with azithromycin), the known and potential benefits of product for such use, outweigh the known and potential risks; and (3) there is no adequate, approved, and available alternative to the emergency use of this 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 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 your multiFiltrate PRO System and multiBic/multiPlus Solutions may be effective in delivering CRRT in an acute care environment, and that the known and potential benefits of the multiFiltrate PRO System and multiBic/multiPlus Solutions, for such use, outweigh the known and potential risks; and (3) there is no adequate, approved, and available alternative to the emergency use of this product. 18 As set forth in the EUA, FDA has concluded that: (1) SARS–CoV–2, the virus that causes PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\14JYN1.SGM 14JYN1 Federal Register / Vol. 85, No. 135 / Tuesday, July 14, 2020 / Notices • Certain Protective Barrier Enclosures, issued May 1, 2020; 19 • PhsiolGuard Corp. Ltd.’s PhysiolGuard ECG–QT Analysis System, issued May 5, 2020 (refer to footnote 15); • Duke University Health System’s Duke Decontamination System, issued May 7, 2020; 20 • Comunale’s Patient Isolation Transport Unit, issued May 8, 2020; 21 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 VentFree may be effective for emergency use by HCP in healthcare settings to treat adult patients by reducing disuse atrophy of the abdominal wall muscles, which may reduce the number of days of ventilator support in patients who require mechanical ventilation during the COVID–19 pandemic, and that the known and potential benefits of the such products, 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 this 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 authorized protective barrier enclosures may be effective at preventing HCP exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection in addition to PPE when caring for or performing medical procedures on patients who are known or suspected to have COVID–19 in healthcare settings and that the known and potential benefits of protective barrier enclosures, 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 this 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 Duke Decontamination System may be effective at decontaminating compatible N95 respirators for 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 this product. 21 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 PITU may be effective in preventing HCP exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection in addition to PPE, and that the known and potential benefits of such products, when used by HCP for temporary isolation and transport of patients with suspected or confirmed diagnosis of COVID–19 requiring airborne or droplet isolation precautions in healthcare settings to prevent HCP exposure to pathogenic biological airborne particulates by providing an extra layer of barrier protection in VerDate Sep<11>2014 20:50 Jul 13, 2020 Jkt 250001 • Ascom (US) Inc.’s teleCARE IP Nurse Call System, issued May 11, 2020; 22 • Eko Devices, Inc.’s Eko ELEFT, issued May 11, 2020; 23 • Certain Infusion Pumps and Infusion Pump Accessories, issued May 13, 2020; 24 • G Medical Innovations Ltd.’s VSMS Patch, issued May 14, 2020; 25 and addition to PPE, outweigh the known and potential risks of the PITU; and (3) there is no adequate, approved, and available alternative to the emergency use of this product. 22 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 use of the teleCARE IP Nurse Call System in healthcare environments may be effective for preventing COVID–19 exposure in healthcare providers by enabling remote communication between patients and healthcare providers, and, for those patients utilizing a ventilator, remote monitoring of ventilator status updates to alert the healthcare provider. FDA concluded that the known and potential benefits of the teleCARE IP Nurse Call System, for such use, outweigh the known and potential risks of the product; and (3) there is no adequate, approved, and available alternative to the emergency use of this 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 ELEFT may be effective for use by HCP to provide an assessment of LVEF for use as a diagnostic aid to screen for potential cardiac complications associated with COVID–19 or underlying cardiac conditions that may affect clinical management of COVID–19, in adult patients having or suspected of having COVID–19 and that the known and potential benefits of ELEFT, for such use, outweigh the known and potential risks; and (3) there is no adequate, approved, and available alternative to the emergency use of this 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 authorized infusion pumps and infusion pump accessories may be effective for use by HCPs to treat conditions caused by COVID–19 with the controlled infusion of medications, TPN, and/or other fluids, and that the known and potential benefits of such products, 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 this product. 25 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 VSMS Patchmay be effective in remotely monitoring QT interval prolongation on an ECG in patients who are undergoing treatment in a hospital setting for COVID–19 with drugs that can prolong QT intervals and may cause life-threatening arrhythmias (e.g., hydroxychloroquine or chloroquine, especially when used in combination PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 42411 • Everlywell Inc.’s Everlywell COVID–19 Test Home Collection Kit, issued May 15, 2020.26 Dated: July 8, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020–15137 Filed 7–13–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1313] Electronic Submissions; Data Standards; Support for Standard for the Exchange of Nonclinical Data AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) Center for Biologics Evaluation and Research (CBER) is announcing support for the current version of Clinical Data Interchange Standards Consortium (CDISC) Standard for the Exchange of Nonclinical Data (SEND) and an update to the FDA Data Standards Catalog for the submission of nonclinical data in new drug applications (NDAs), abbreviated new drug applications (ANDAs), certain biologics license applications (BLAs), and certain investigational new drug applications (INDs). This update does not apply to noncommercial INDs for a product that is not intended for commercial distribution (research and investigatorsponsored INDs); INDs and BLAs for devices that are regulated by CBER as biological products under the Public Health Services (PHS) Act; and submissions for blood and blood components, including Source Plasma. SUMMARY: with azithromycin), the known and potential benefits of the VSMS Patch, for such use, outweigh the known and potential risks; and (3) there is no adequate, approved, and available alternative to the emergency use of this product. 26 As set forth in the EUA, FDA has concluded that: (1) SARS–CoV–2, the virus that causes COVID–19, can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus; (2) based on the totality of scientific evidence available to FDA, it is reasonable to believe that the 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 home-collected human specimen, and that the known and potential benefits of the product when used for such use, outweigh the known and potential risks of the product; and (3) there is no adequate, approved, and available alternative to the emergency use of the product. E:\FR\FM\14JYN1.SGM 14JYN1

Agencies

[Federal Register Volume 85, Number 135 (Tuesday, July 14, 2020)]
[Notices]
[Pages 42407-42411]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-15137]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1584]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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

ADDRESSES: Submit written requests for single copies of the 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.

[[Page 42408]]

See the SUPPLEMENTARY INFORMATION section for electronic access to the 
Authorization.

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

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) allows FDA to 
strengthen the public health protections against biological, chemical, 
radiological, or nuclear agent or agents. Among other things, section 
564 of the FD&C Act allows FDA to authorize the use of an unapproved 
medical product or an unapproved use of an approved medical product in 
certain situations. With this EUA authority, FDA can help ensure that 
medical countermeasures may be used in emergencies to diagnose, treat, 
or prevent serious or life-threatening diseases or conditions caused by 
a biological, chemical, radiological, or nuclear agent or agents when 
there are no adequate, approved, and available alternatives.
    Section 564(b)(1) of the FD&C Act provides that, before an EUA may 
be issued, the Secretary of HHS must declare that circumstances exist 
justifying the authorization based on one of the following grounds: (1) 
A determination by the Secretary of Homeland Security that there is a 
domestic emergency, or a significant potential for a domestic 
emergency, involving a heightened risk of attack with a biological, 
chemical, radiological, or nuclear agent or agents; (2) a determination 
by the Secretary of Defense that there is a military emergency, or a 
significant potential for a military emergency, involving a heightened 
risk to U.S. military forces, including personnel operating under the 
authority of title 10 or title 50 of the U.S. Code, of attack with (A) 
a biological, chemical, radiological, or nuclear agent or agents; or 
(B) an agent or agents that may cause, or are otherwise associated 
with, an imminently life-threatening and specific risk to U.S. military 
forces; \1\ (3) a determination by the Secretary of HHS that there is a 
public health emergency, or a significant potential for a public health 
emergency, that affects, or has a significant potential to affect, 
national security or the health and security of U.S. citizens living 
abroad, and that involves a biological, chemical, radiological, or 
nuclear agent or agents, or a disease or condition that may be 
attributable to such agent or agents; or (4) the identification of a 
material threat by the Secretary of Homeland Security pursuant to 
section 319F-2 of the Public Health Service (PHS) Act (42 U.S.C. 247d-
6b) sufficient to affect national security or the health and security 
of U.S. citizens living abroad.
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    \1\ In the case of a determination by the Secretary of Defense, 
the Secretary of HHS shall determine within 45 calendar days of such 
determination, whether to make a declaration under section 564(b)(1) 
of the FD&C Act, and, if appropriate, shall promptly make such a 
declaration.
---------------------------------------------------------------------------

    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, 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 April 11, 2020, 
through May 15, 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

[[Page 42409]]

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.
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     Ortho-Clinical Diagnostics, Inc.'s VITROS Immunodiagnostic 
Products Anti-SARS-CoV-2 Total Reagent Pack, issued April 14, 2020;
     Chembio Diagnostic System, Inc.'s DPP COVID-19 IgM/IgG 
System, issued April 14, 2020;
     Mount Sinai Laboratory's COVID-19 [enzyme-linked 
immunosorbent assay] ELISA IgG Antibody Test, issued April 15, 2020;
     Maccura Biotechnology (USA) LLC's SARS-CoV-2 Fluorescent 
PCR Kit, issued April 15, 2020;
     GenoSensor, LLC's GS COVID-19 RT-PCR KIT, issued April 16, 
2020;
     KorvaLabs Inc.'s Curative-Korva SARS-CoV-2 Assay, issued 
April 16, 2020;
     Fosun Pharma USA Inc.'s Fosun COVID-19 RT-PCR Detection 
Kit, issued April 17, 2020;
     OSANG Healthcare's GeneFinder COVID-19 Plus RealAmp Kit, 
issued April 18, 2020;
     Trax Management Services Inc.'s PhoenixDx 2019-CoV, issued 
April 20, 2020;
     Laboratory Corporation of America's COVID-19 RT-PCR Test, 
reissued April 20, 2020 (original issuance March 16, 2020);
     Seegene, Inc.'s Allplex 2019-nCoV Assay, issued April 21, 
2020;
     altona Diagnostics GmbH's RealStar SARS-CoV-2 RT-PCR Kits 
U.S., issued April 22, 2020;
     SD Biosensor, Inc.'s STANDARD M nCoV Real-Time Detection 
Kit, issued April 23, 2020;
     Autobio Diagnostics Co. Ltd.'s Anti-SARS-CoV-2 Rapid Test, 
issued April 24, 2020;
     Ortho-Clinical Diagnostics, Inc.'s VITROS Immunodiagnostic 
Products Anti-SARS-CoV-2 IgG Reagent Pack, issued April 24, 2020;
     DiaSorin Inc.'s LIAISON SARS-CoV-2 S1/S2 IgG, issued April 
24, 2020;
     Abbott Laboratories Inc.'s SARS-CoV-2 IgG assay, issued 
April 26, 2020;
     SEASUN BIOMATERIALS's U-TOP COVID-19 Detection Kit, issued 
April 27, 2020;
     Bio-Rad Laboratories, Inc's Platelia SARS-CoV-2 Total Ab 
assay, issued April 29, 2020;
     Rheonix, Inc.'s Rheonix COVID-19 MDx Assay, issued April 
29, 2020;
     LabGenomics Co., Ltd.'s LabGun COVID-19 RT-PCR Kit, issued 
April 29, 2020;
     Wadsworth Center, New York State Department of Health's 
New York SARS-CoV Microsphere Immunoassay for Antibody Detection, 
issued April 30, 2020;
     BioFire Diagnostics, LLC's BioFire Respiratory Panel 2.1 
(RP2.1), issued May 1, 2020;
     Bio-Rad Laboratories, Inc.'s Bio-Rad SARS-CoV-2 ddPCR 
Test, issued May 1, 2020;
     Roche Diagnostics's Elecsys Anti-SARS-CoV-2, issued May 2, 
2020;
     Sansure BioTech Inc.'s Novel Coronavirus (2019-nCoV) 
Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing), issued May 4, 
2020;
     EUROIMUN US Inc.'s Anti-SARS-CoV-2 ELISA (IgG), issued May 
4, 2020;
     Fast Track Diagnostics Luxembourg S.[aacute].r.l's. (a 
Siemens Healthineers Company) FTD SARS-CoV-2, issued May 5, 2020;
     BioM[eacute]rieux SA's SARS-COV-2 R-GENE, issued May 6, 
2020;
     Sherlock BioSciences, Inc.'s Sherlock CRISPR SARS-CoV-2 
Kit, issued May 6, 2020;
     OPTI Medical Systems, Inc.'s OPTI SARS-CoV-2 RT PCR Test, 
issued May 6, 2020;
     Zymo Research Corp.'s Quick SARS-Cov-2rRT-PCR Kit, issued 
May 7, 2020;
     Rutgers Clinical Genomics Laboratory at RUCDR Infinite 
Biologics-Rutgers University's Rutgers Clinical Genomics Laboratory 
TaqPath SARS-CoV-2 Assay, reissued May 7, 2020 (original issuance April 
10, 2020);
     Gnomegen LLC's Gnomegen COVID-19-RT-qPCR Detection Kit, 
issued May 8, 2020;
     Quidel Corporation's Sofia 2 SARS Antigen FIA, issued May 
8, 2020;
     Abbott Molecular Inc.'s Alinity m SARS-CoV-2 assay, issued 
May 11, 2020;
     1drop Inc.'s 1copy COVID-19 qPR Multi Kit, issued May 11, 
2020;
     Applied DNA Sciences, Inc.'s Linea COVID-19 Assay Kit, 
issued May 13, 2020;
     GeneMatrix, Inc.'s NeoPlex COVID-19 Detection Kit, issued 
May 14, 2020;
     Hologic, Inc., Aptima SARS-CoV-2 assay, issued May 14, 
2020;
     Assurance Scientific Laboratories' Assurance SARS-CoV-2 
Panel, issued May 15, 2020;
     Fulgent Therapeutics, LLC's Fulgent COVID-19 by RT-PCR 
Test, issued May 15, 2020; and
     Certain SARS-CoV-2 Antibody Tests (lateral flow or ELISA 
tests) that are for use in laboratories certified under the Clinical 
Laboratory Improvement Amendments of 1988, 42 U.S.C. 263a, to perform 
moderate or high complexity tests, issued on April 28, 2020 (a current 
list of tests included under this EUA is available at https://www.fda.gov/media/137471/download).
    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) 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 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 May 7, 2020, (original 
issuance 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:
     B. Braun Medical, Inc.'s B. Braun Space and Outlook Pumps, 
issued April 11, 2020; \5\
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    \5\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that the B. Braun Space and Outlook Pumps may be effective for use 
in the tracheal delivery of continuous nebulized medications into a 
nebulizer to treat COVID-19 patients of all ages and for the ground 
medical transport use of the Infusomat Space Volumetric Infusion 
Pump System, and that the known and potential benefits of the B. 
Braun Space and Outlook Pumps for these uses, outweigh the known and 
potential risks of such product; and (3) there is no adequate, 
approved, and available alternative to the emergency use of this 
product.
---------------------------------------------------------------------------

     Advanced Sterilization Products, Inc.'s ASP STERRAD 
Sterilization Systems, issued April 11, 2020; \6\
---------------------------------------------------------------------------

    \6\ 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 
preventing exposure to pathogenic airborne particulates when there 
are insufficient supplies of N95 respirators during the COVID-19 
pandemic by decontaminating, for a maximum of two 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 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 this product.

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[[Page 42410]]

     Certain Face Shields, reissued April 13, 2020 (original 
issuance April 9, 2020); \7\
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    \7\ As set forth in the EUA, FDA has concluded that: (1) SARS-
CoV-2, the virus that causes COVID-19, can cause a serious or life-
threatening disease or condition, including severe respiratory 
illness, to humans infected by this virus; (2) based on the totality 
of scientific evidence available to FDA, it is reasonable to believe 
that the 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 this 
product.
---------------------------------------------------------------------------

     Synapse Biomedical, Inc.'s TransAeris Diaphragm Pacing 
System, issued April 13, 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 product may be effective for emergency use to treat 
patients by assisting in weaning patients off ventilators in 
healthcare settings during the COVID-19 pandemic, and that the known 
and potential benefits of the such product, for such use, outweigh 
the known and potential risks of such product; and (3) there is no 
adequate, approved, and available alternative.
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     Stryker Instruments' STERIZONE VP4 Sterilizer, issued 
April 14, 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 STERIZONE VP4 N95 Respirator Decontamination Cycle may be 
effective at preventing exposure to pathogenic airborne particulates 
by decontaminating, for a maximum of two 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 this 
device, 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 STERIZONE VP4 N95 Respirator 
Decontamination Cycle for decontaminating compatible N95 respirators 
for single-user reuse by HCPs during FFR shortages during the COVID-
19 pandemic.
---------------------------------------------------------------------------

     Lungpacer Medical USA, Inc.'s Lungpacer DPTS, issued April 
14, 2020 (see footnote 8);
     ExThera Medical Corporation's Seraph 100 Microbind 
Affinity Blood Filter, issued April 17, 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 Seraph 100 Microbind Affinity Blood Filter device 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 Seraph 100 Microbind Affinity Blood Filter 
device, when used to treat such patients, outweigh the known and 
potential risks of the device; and (3) there is no adequate, 
approved, and available alternative to the emergency use of this 
product.
---------------------------------------------------------------------------

     Certain Face Masks, issued April 18, 2020, and reissued 
April 24, 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 authorized face masks may be effective as source control to 
help prevent the spread of SARS-CoV-2 by infected individuals who 
may or may not have symptoms of COVID-19 during the COVID-19 
pandemic, and that the known and potential benefits of face masks, 
when used in accordance with the scope of this 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 this product.
---------------------------------------------------------------------------

     Sterilucent, Inc.'s Sterilucent Sterilizer System, issued 
April 20, 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 Sterilucent Sterilization System may be effective at 
decontaminating compatible N95 respirators for single-user reuse by 
HCPs to prevent exposure to pathogenic biological airborne 
particulates, and that the known and potential benefits of this 
device, 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 this 
product.
---------------------------------------------------------------------------

     Philips Medizin Systeme Boeblingen GmbH's IntelliVue 
Patient Monitors, issued April 21, 2020; \13\
---------------------------------------------------------------------------

    \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 IntelliVue Patient Monitors may be effective in preventing 
COVID-19 exposure in healthcare providers, through use of remote 
patient monitoring, and that the known and potential benefits of 
such products, for such use, outweigh the known and potential risks 
of the IntelliVue Patient Monitors; and (3) there is no adequate, 
approved, and available alternative to the emergency use of this 
product.
---------------------------------------------------------------------------

     ALung Technologies, Inc.'s Hemolung RAS, issued April 22, 
2020; \14\
---------------------------------------------------------------------------

    \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 Hemolung RAS may be effective in treating lung failure when 
used as described in the Scope of Authorization, and that the known 
and potential benefits of the Hemolung RAS for treating these 
patients, outweigh the known and potential risks; and (3) there is 
no adequate, approved, and available alternative to the emergency 
use of this product.
---------------------------------------------------------------------------

     Baxter Healthcare Corp.'s oXiris Set device, issued April 
23, 2020; \15\
---------------------------------------------------------------------------

    \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 oXiris Set 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 in need of blood 
purification, including use in continuous renal replacement therapy, 
and that the known and potential benefits of the oXiris Set device, 
when used to treat such patients, outweigh the known and potential 
risks of the oXiris Set device; and (3) there is no adequate, 
approved, and available alternative to the emergency use of this 
product.
---------------------------------------------------------------------------

     VitalConnect, Inc.'s VitalPatch, issued April 26, 2020; 
\16\
---------------------------------------------------------------------------

    \16\ 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 product may be effective 
in remotely monitoring and detecting QT interval changes of an ECG 
in patients who are undergoing treatment in a hospital setting for 
COVID-19 with drugs that can prolong QT intervals and may cause life 
threatening arrhythmias (e.g., hydroxychloroquine or chloroquine, 
especially when used in combination with azithromycin), the known 
and potential benefits of product for such use, outweigh the known 
and potential risks; and (3) there is no adequate, approved, and 
available alternative to the emergency use of this product.
---------------------------------------------------------------------------

     Fresenius Medical Care's multiFiltrate PRO System and 
multiBic/multiPlus Solutions to provide continuous renal replacement 
therapy, issued May 1, 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 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 your multiFiltrate PRO System and multiBic/multiPlus Solutions 
may be effective in delivering CRRT in an acute care environment, 
and that the known and potential benefits of the multiFiltrate PRO 
System and multiBic/multiPlus Solutions, for such use, outweigh the 
known and potential risks; and (3) there is no adequate, approved, 
and available alternative to the emergency use of this product.
---------------------------------------------------------------------------

     Liberate Medical, LLC's VentFree, issued May 1, 2020; \18\
---------------------------------------------------------------------------

    \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 VentFree may be effective for emergency use by HCP in 
healthcare settings to treat adult patients by reducing disuse 
atrophy of the abdominal wall muscles, which may reduce the number 
of days of ventilator support in patients who require mechanical 
ventilation during the COVID-19 pandemic, and that the known and 
potential benefits of the such products, 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 this product.

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

[[Page 42411]]

     Certain Protective Barrier Enclosures, issued May 1, 2020; 
\19\
---------------------------------------------------------------------------

    \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 authorized protective barrier enclosures may be effective 
at preventing HCP exposure to pathogenic biological airborne 
particulates by providing an extra layer of barrier protection in 
addition to PPE when caring for or performing medical procedures on 
patients who are known or suspected to have COVID-19 in healthcare 
settings and that the known and potential benefits of protective 
barrier enclosures, 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 this product.
---------------------------------------------------------------------------

     PhsiolGuard Corp. Ltd.'s PhysiolGuard ECG-QT Analysis 
System, issued May 5, 2020 (refer to footnote 15);
     Duke University Health System's Duke Decontamination 
System, issued May 7, 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 Duke Decontamination System may be effective at 
decontaminating compatible N95 respirators for 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 this product.
---------------------------------------------------------------------------

     Comunale's Patient Isolation Transport Unit, issued May 8, 
2020; \21\
---------------------------------------------------------------------------

    \21\ 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 PITU may be effective in preventing HCP exposure to 
pathogenic biological airborne particulates by providing an extra 
layer of barrier protection in addition to PPE, and that the known 
and potential benefits of such products, when used by HCP for 
temporary isolation and transport of patients with suspected or 
confirmed diagnosis of COVID-19 requiring airborne or droplet 
isolation precautions in healthcare settings to prevent HCP exposure 
to pathogenic biological airborne particulates by providing an extra 
layer of barrier protection in addition to PPE, outweigh the known 
and potential risks of the PITU; and (3) there is no adequate, 
approved, and available alternative to the emergency use of this 
product.
---------------------------------------------------------------------------

     Ascom (US) Inc.'s teleCARE IP Nurse Call System, issued 
May 11, 2020; \22\
---------------------------------------------------------------------------

    \22\ 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 use of the teleCARE IP Nurse Call System in healthcare 
environments may be effective for preventing COVID-19 exposure in 
healthcare providers by enabling remote communication between 
patients and healthcare providers, and, for those patients utilizing 
a ventilator, remote monitoring of ventilator status updates to 
alert the healthcare provider. FDA concluded that the known and 
potential benefits of the teleCARE IP Nurse Call System, for such 
use, outweigh the known and potential risks of the product; and (3) 
there is no adequate, approved, and available alternative to the 
emergency use of this product.
---------------------------------------------------------------------------

     Eko Devices, Inc.'s Eko ELEFT, issued May 11, 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 ELEFT may be effective for use by HCP to provide an 
assessment of LVEF for use as a diagnostic aid to screen for 
potential cardiac complications associated with COVID-19 or 
underlying cardiac conditions that may affect clinical management of 
COVID-19, in adult patients having or suspected of having COVID-19 
and that the known and potential benefits of ELEFT, for such use, 
outweigh the known and potential risks; and (3) there is no 
adequate, approved, and available alternative to the emergency use 
of this product.
---------------------------------------------------------------------------

     Certain Infusion Pumps and Infusion Pump Accessories, 
issued May 13, 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 authorized infusion pumps and infusion pump accessories may be 
effective for use by HCPs to treat conditions caused by COVID-19 
with the controlled infusion of medications, TPN, and/or other 
fluids, and that the known and potential benefits of such products, 
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 this product.
---------------------------------------------------------------------------

     G Medical Innovations Ltd.'s VSMS Patch, issued May 14, 
2020; \25\ and
---------------------------------------------------------------------------

    \25\ 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 VSMS Patchmay be effective 
in remotely monitoring QT interval prolongation on an ECG in 
patients who are undergoing treatment in a hospital setting for 
COVID-19 with drugs that can prolong QT intervals and may cause 
life-threatening arrhythmias (e.g., hydroxychloroquine or 
chloroquine, especially when used in combination with azithromycin), 
the known and potential benefits of the VSMS Patch, for such use, 
outweigh the known and potential risks; and (3) there is no 
adequate, approved, and available alternative to the emergency use 
of this product.
---------------------------------------------------------------------------

     Everlywell Inc.'s Everlywell COVID-19 Test Home Collection 
Kit, issued May 15, 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 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 
home-collected human specimen, and that the known and potential 
benefits of the product when used for such use, outweigh the known 
and potential risks of the product; and (3) there is no adequate, 
approved, and available alternative to the emergency use of the 
product.

    Dated: July 8, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-15137 Filed 7-13-20; 8:45 am]
BILLING CODE 4164-01-P

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