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

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

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

DATES:

These Authorizations are applicable on their date of issuance.

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

Once the Secretary of HHS has declared that circumstances exist justifying an authorization under section 564 of the FD&C Act, FDA may authorize the emergency use of a drug, device, or biological product if the Agency concludes that the statutory criteria are satisfied. Under section 564(h)(1) of the FD&C Act, FDA is required to publish in the Federal Register a notice of each authorization, and each termination or revocation of an authorization, and an explanation of the reasons for the action. Section 564 of the FD&C Act permits FDA to authorize the introduction into interstate commerce of a drug, device, or biological product intended for use when the Secretary of HHS has declared that circumstances exist justifying the authorization of emergency use. Products appropriate for emergency use may include products and uses that are not approved, cleared, or licensed under 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 concludes: (1) That an agent referred to in a declaration of emergency or threat can cause a serious or life-threatening disease or condition; (2) that, based on the totality of scientific evidence available to FDA, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that (A) the product may be effective in diagnosing, treating, or preventing (i) such disease or condition; or (ii) a serious or life-threatening disease or condition caused by a product authorized under section 564, approved or cleared under the FD&C Act, or licensed under section 351 of the PHS Act, for diagnosing, treating, or preventing such a disease or condition caused by such an agent; and (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product, taking into consideration the material threat posed by the agent or agents identified in a declaration under section 564(b)(1)(D) of the FD&C Act, if applicable; (3) that there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition; (4) in the case of a determination described in section 564(b)(1)(B)(ii), that the request for emergency use is made by the Secretary of Defense; and (5) that such other criteria as may be prescribed by regulation are satisfied.

No other criteria for issuance have been prescribed by regulation under section 564(c)(4) of the FD&C Act.

III. Electronic Access

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

IV. The Authorizations

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

• 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.á.r.l's. (a Siemens Healthineers Company) FTD SARS-CoV-2, issued May 5, 2020;
• BioMérieux 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:

• 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;

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

• Certain Face Shields, reissued April 13, 2020 (original issuance April 9, 2020);

• Synapse Biomedical, Inc.'s TransAeris Diaphragm Pacing System, issued April 13, 2020;

• Stryker Instruments' STERIZONE VP4 Sterilizer, issued April 14, 2020;

• 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;

• Certain Face Masks, issued April 18, 2020, and reissued April 24, 2020;

• Sterilucent, Inc.'s Sterilucent Sterilizer System, issued April 20, 2020;

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

• ALung Technologies, Inc.'s Hemolung RAS, issued April 22, 2020;

• Baxter Healthcare Corp.'s oXiris Set device, issued April 23, 2020;

• VitalConnect, Inc.'s VitalPatch, issued April 26, 2020;

• Fresenius Medical Care's multiFiltrate PRO System and multiBic/multiPlus Solutions to provide continuous renal replacement therapy, issued May 1, 2020;

• Liberate Medical, LLC's VentFree, issued May 1, 2020;

• Certain Protective Barrier Enclosures, issued May 1, 2020;

• 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;

• Comunale's Patient Isolation Transport Unit, issued May 8, 2020;

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

• Eko Devices, Inc.'s Eko ELEFT, issued May 11, 2020;

• Certain Infusion Pumps and Infusion Pump Accessories, issued May 13, 2020;

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

• Everlywell Inc.'s Everlywell COVID-19 Test Home Collection Kit, issued May 15, 2020.