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  1. MCM Legal, Regulatory and Policy Framework

Emergency Use Authorization

Emergency Use Authorization (EUA) information, and list of all current EUAs

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About Emergency Use Authorizations (EUAs)

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies. 

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.

Section 564 of the FD&C Act was amended by the Project Bioshield Act of 2004 and was further amended by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the 21st Century Cures Act of 2016, and Public Law 115-92 of 2017.

Guidance

In January 2017, FDA finalized the guidance: Emergency Use Authorization of Medical Products and Related Authorities. For more information, please see the January 13, 2017 Federal Register notice.

Printable PDF (288 KB)

In addition, in January 2014, FDA issued a question and answer document (PDF, 762K) to respond to questions raised by public health stakeholders about PAHPRA’s amendments to the EUA authority and establishment of new authorities related to the emergency use of MCMs during CBRN emergencies.

General Emergency Diagnostics Information

Coronavirus Disease 2019 (COVID-19) EUA Information

In Vitro Diagnostic Products

On February 4, 2020, the HHS Secretary determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. On the basis of this determination, the Secretary then declared 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. The EUAs subsequently issued by FDA are listed in the table below this blue box.

In continuing response to the COVID-19 pandemic, on March 24, 2020, and based on the February 4, 2020 HHS EUA determination, the HHS Secretary declared that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, due to shortages during the COVID-19 outbreak.

On February 29, 2020, the FDA issued an immediately in effect guidance with policy specific to development of in vitro diagnostic tests during this public health emergency. This guidance was updated on March 16, 2020, May 4, 2020, and May 11, 2020.

CDC has granted a right of reference to the performance data contained in CDC's EUA (FDA submission number EUA200001) to any entity seeking an FDA EUA for a COVID-19 diagnostic device.

Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA.

If you need additional information, please refer to the FAQs on Diagnostic Testing for SARS-CoV-2.

The HHS Secretary issued a Declaration pursuant to section 319F-3 of the Public Health Service Act to provide liability immunity for activities related to medical countermeasures against COVID-19.

Please note: a determination under section 319 of the Public Health Service Act that a public health emergency exists, such as the one issued on January 31, 2020, does not enable FDA to issue EUAs. A separate determination and declaration are needed under section 564 of the Federal Food, Drug and Cosmetic Act to enable FDA to issue EUAs, provided other statutory criteria are met.

 

Date EUA First Issued Entity Diagnostic (Most Recent Letter of Authorization) in PDF Technology Authorized Setting(s)1 Authorization Labeling2 in PDF Amendments and Other Documents in PDF Federal Register Notice for EUA
04/23/2020 SD Biosensor, Inc. STANDARD M nCoV Real-Time Detection Kit (129KB) Molecular H HCP (136KB)
Patients (124KB)
IFU (548KB)		  
  • None Currently
02/04/2020 CDC CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel (286KB) (Reiussed 03/15/2020) Molecular H HCP (144KB)
Patients (121KB)
IFU (1.7MB)
  • None currently.
02/29/2020 Wadsworth Center, NYSDOH New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel (312KB) (Reissued 03/10/2020) Molecular H HCP (140KB)
Patients (117KB)
IFU (314KB)
  • None currently.
03/12/2020 Roche Molecular Systems, Inc. (RMS) cobas SARS-CoV-2 (111KB) Molecular H, M HCP (250KB)
Patients (193KB)
IFU (1.58MB)
  • None currently.
03/13/2020 Thermo Fisher Scientific, Inc. TaqPath COVID-19 Combo Kit (105KB) Molecular H HCP (135KB)
Patients (122KB)
IFU (629KB)
  • None currently.
03/16/2020 Hologic, Inc. Panther Fusion SARS-CoV-2 Assay (290KB) Molecular H HCP (135KB)
Patients (124KB)
IFU (423KB)
  • None currently.
03/16/2020 Laboratory Corporation of America COVID-19 RT-PCR Test (296KB) (reissued April 20, 2020) Molecular H HCP (138KB)
Patients (122KB)
EUA Summary (426KB)
IFU - Home Collection (2.24MB)
  • None currently.
03/17/2020 Quidel Corp. Lyra SARS-CoV-2 Assay (294KB) Molecular H HCP (133KB)
Patients (121KB)
IFU (479KB)
  • None currently.
03/17/2020 Quest Diagnostics Infectious Disease, Inc.

Quest SARS-CoV-2 rRT-PCR (297KB) (reissued May 27, 2020)

 Molecular H HCP (138KB)
Patients (126KB)
IFU (257KB)
IFU (Home Collect) (627KB)
  • None currently.
03/18/2020 Abbott Molecular Abbott RealTime SARS-CoV-2 assay (324KB) Molecular H HCP (155KB)
Patients (144KB)
IFU (351KB)
  • None currently.
03/19/2020 DiaSorin Molecular LLC Simplexa COVID-19 Direct (103KB) Molecular H, M HCP (135KB)
Patients (122KB)
IFU (291KB)
  • None currently.
03/19/2020 GenMark Diagnostics, Inc. ePlex SARS-CoV-2 Test (126KB) Molecular H, M HCP (143KB)
Patients (128KB)
IFU (257KB)
  • None currently.
  • None currently.
03/20/2020 Primerdesign Ltd Primerdesign Ltd COVID-19 genesig Real-Time PCR assay (132KB) Molecular H HCP (137KB)
Patients (125KB)
IFU (1,013KB)
  • None currently.
03/20/2020 Cepheid Xpert Xpress SARS-CoV-2 test (140 KB) Molecular H, M, W HCP (135KB)
Patients (121KB)
IFU - Laboratories (310KB)
IFU - Point of Care (1.47MB)
  • None currently.
  • None currently.
03/23/2020 BioFire Defense, LLC BioFire COVID-19 Test (317 KB) Molecular H, M HCP (135KB)
Patients (123KB)
IFU (3.44MB)
  • None currently.
03/23/2020 Mesa Biotech Inc. Accula SARS-Cov-2 Test (322 KB) Molecular H, M, W HCP (135KB)
Patients (123KB)
IFU (2.29MB)
  • None currently.
03/24/2020 PerkinElmer, Inc. PerkinElmer New Coronavirus Nucleic Acid Detection Kit (319 KB) Molecular H HCP (133KB)
Patients (121KB)
IFU (374KB)
  • None currently.
03/25/2020 Avellino Lab USA, Inc. AvellinoCoV2 test (284KB) Molecular H HCP (139KB)
Patients (120KB)
EUA Summary (135KB)
  • None currently.
  • None currently.
03/26/2020 BGI Genomics Co. Ltd Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2 (131KB) Molecular H HCP (163KB)
Patients (151KB)
IFU (1.07MB)
  • None currently.
03/27/2020 Abbott Diagnostics Scarborough, Inc. ID NOW COVID-19 (356KB) Molecular H, M, W HCP (137KB)
Patients (124KB)
IFU (2.95MB)
  • None currently.
  • None currently.
03/27/2020 Luminex Molecular Diagnostics, Inc. NxTAG CoV Extended Panel Assay (318KB) Molecular H HCP (136KB)
Patients (123KB)
IFU (768KB)
  • None currently.
  • None currently.
03/30/2020 NeuMoDx Molecular, Inc. NeuMoDx SARS-CoV-2 Assay (127KB)
 		 Molecular H, M HCP (135KB)
Patients (124KB)
IFU (441KB)
  • None currently.
  • None currently.
03/30/2020 QIAGEN GmbH QIAstat-Dx Respiratory SARS-CoV-2 Panel (128KB) Molecular H, M HCP (140KB)
Patients (124KB)
IFU (1.81MB)
  • None currently.
04/01/2020 Cellex Inc. qSARS-CoV-2 IgG/IgM Rapid Test (328KB) Serology IgM and IgG H, M HCP (139KB)
Patients (126KB)
IFU (325KB)
  • None currently.
  • None currently.
04/01/2020 Ipsum Diagnostics, LLC COV-19 IDx assay (288KB) Molecular H HCP (133KB)
Patients (121KB)
EUA Summary (130KB)
  • None currently.
  • None currently.
04/02/2020 Becton, Dickinson & Company (BD) BioGX SARS-CoV-2 Reagents for BD MAX System (154KB) Molecular H, M HCP (143KB)
Patients (131KB)
IFU (1.68MB)
  • None currently.
  • None currently.
04/03/2020 Luminex Corporation ARIES SARS-CoV-2 Assay (125KB) Molecular H, M HCP (138KB)
Patients (124KB)
IFU (5.22MB)
  • None currently.
04/03/2020 ScienCell Research Laboratories ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit (319KB) Molecular H HCP (141KB)
Patients (129KB)
IFU (376KB)
  • None currently.
  • None currently.
04/03/2020 Co-Diagnostics, Inc. Logix Smart Coronavirus Disease 2019 (COVID-19) Kit (317KB) Molecular H HCP (135KB)
Patients (123KB)
IFU (476KB)
  • None currently.
  • None currently.
04/06/2020 Gnomegen LLC Gnomegen COVID-19 RT-Digital PCR Detection Kit (320KB) Molecular H HCP (135KB)
Patients (123KB)
IFU (227KB)
  • None currently.
  • None currently.
04/07/2020 InBios International, Inc. Smart Detect SARS-CoV-2 rRT-PCR Kit (128KB) Molecular H HCP (158KB)
Patients (144KB)
IFU (252KB)
  • None currently.
  • None currently.
04/08/2020 Becton, Dickinson & Company BD SARS-CoV-2Reagents for BD MAX System (212KB) Molecular H, M HCP (160KB)
Patients (139KB)
IFU (1.5MB)
  • None currently.
  • None currently.
04/08/2020 DiaCarta, Inc. QuantiVirus SARS-CoV-2 Test kit (319KB) Molecular H HCP (135KB)
Patients (123KB)
IFU (687KB)
  • None currently.
  • None currently.
04/10/2020 Atila BioSystems, Inc. iAMP COVID-19 Detection Kit (124KB) Molecular H HCP (137KB)
Patients (124KB)
IFU (434KB)
  • None currently.
  • None currently.
04/14/2020 Ortho Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack (379KB) Serology Total Antibody H, M HCP (232KB)
Recipients (187KB)
IFU (370KB)
  • None currently.
  • None currently.
04/14/2020 Chembio Diagnostic System, Inc. DPP COVID-19 IgM/IgG System (369KB) Serology IgM and IgG H, M HCP (236KB)
Patients (213KB)
IFU (1.06MB)
  • None currently.
04/15/2020 Maccura Biotechnology (USA) LLC SARS-CoV-2 Fluorescent PCR Kit (154KB) Molecular H HCP (138KB)
Patients (139KB)
IFU (1.25MB)
  • None currently.
  • None currently.
04/15/2020 Mount Sinai Laboratory COVID-19 ELISA IgG Antibody Test (339KB) Serology IgG H HCP (334KB)
Patients (256KB)
EUA Summary (301KB)
  • None currently.
  • None currently.
04/16/2020 GenoSensor, LLC GS COVID-19 RT-PCR KIT (317KB) Molecular H HCP (133KB)
Patients (121KB)
IFU (408KB)
  • None currently.
  • None currently.
04/16/2020 KorvaLabs Inc. Curative-Korva SARS-Cov-2 Assay (280KB) Molecular H HCP (135KB)
Patients (123KB)
EUA Summary (273KB)
  • None currently.
  • None currently.
04/17/2020 Fosun Pharma USA Inc. Fosun COVID-19 RT-PCR Detection Kit (317KB) Molecular H HCP (249KB)
Patients (190KB)
IFU (391KB)
  • None currently.
  • None currently.
04/18/2020 OSANG Healthcare GeneFinder COVID-19 Plus RealAmp Kit (320KB) Molecular H HCP (137KB)
Patients (125KB)
IFU (494KB)
  • None currently.
  • None currently.
04/20/2020 Trax Management Services Inc. PhoenixDx 2019-CoV (134KB) Molecular H

HCP (148KB)
Patients (134KB)
IFU (445KB)
  • None currently.
04/21/2020 Seegene, Inc. Allplex 2019-nCoV Assay (124KB) Molecular H HCP (135KB)
Patients (121KB)
IFU (2.04MB)
  • None currently.
  • None currently.
04/22/2020 altona Diagnostics GmbH RealStar SARS-CoV02 RT-PCR Kits U.S. (130KB) Molecular H HCP (138KB)
Patients (126KB)
IFU (566KB)
  • None currently.
  • None currently.
04/24/2020 DiaSorin Inc. LIAISON SARS-CoV-2 S1/S2 IgG (368KB) Serology IgG only H, M HCP (139KB)
Recipients (124KB)
IFU (306KB)
  • None currently.
  • None currently.
04/24/2020 Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack (370KB) Serology IgG only H, M HCP (150KB)
Recipients (135KB)
IFU (325KB)
  • None currently
04/24/2020 Autobio Diagnostics Co. Ltd. Anti-SARS-CoV-2 Rapid Test (329KB) Serology IgM and IgG H, M HCP (83KB)
Recipients (92KB)
IFU (350KB)
  • None currently
  • None currently
04/27/2020 SEASUN BIOMATERIALS U-TOP COVID-19 Detection Kit (129KB) Molecular H HCP (143KB)
Patients (125KB)
IFU (1.04MB)
  • None currently.
  • None currently.
04/26/2020 Abbott Laboratories Inc. SARS-CoV-2 IgG assay (367KB) Serology IgG only  H, M HCP (112KB)
Recipients (98KB)
IFU-ARCHITECT (566KB)
IFU-Alinityi (2.51MB)
  • None currently.
04/29/2020 LabGenomics Co., Ltd. LabGun COVID-19 RT-PCR Kit (134KB) Molecular H HCP (109KB)
Patients (98KB)
IFU (1.39MB)
  • None currently.
  • None currently
04/29/2020 Rheonix, Inc. Rheonix COVID-19 MDx Assay (133KB) Molecular H HCP (107KB)
Patients (97KB)
IFU (3.47MB)
  • None currently
  • None currently
04/29/2020 Bio-Rad Laboratories Platelia SARS-CoV-2 Total Ab assay (141KB) Serology Total Antibody H HCP (110KB)
Recipients (96KB)
IFU (293KB)
  • None currently
  • None currently
04/30/2020 Wadsworth Center, New York State Department of Health New York SARS-CoV Microsphere Immunoassay for Antibody Detection (115KB) Serology Total Antibody H HCP (158KB)
Recipients (140KB)
EUA Summary (92KB)
  • None currently
  • None currently
05/01/2020 Bio-Rad Laboratories, Inc. Bio-Rad SARS-CoV-2 ddPCR Test (319KB) Molecular H HCP (137KB)
Patients (125KB)
IFU (1.54MB)
  • None currently
  • None currently
05/01/2020 BioFire Diagnostics, LLC BioFire Respiratory Panel 2.1 (RP2.1) (400KB) Molecular H, M HCP (139KB)
Patients (126KB)
IFU (1.24MB)
  • None currently
  • None currently
05/02/2020 Roche Diagnostics Elecsys Anti-SARS-CoV-2 (302KB) Serology Antibody H, M HCP (145KB)
Recipients (125KB)
IFU (136KB)
  • None currently
  • None currently
05/04/2020 EUROIMMUN US Inc. Anti-SARS-CoV-2 ELISA (IgG) (333KB) Serology IgG H HCP (42KB)
Recipients (51KB)
IFU (241KB)
  • None currently
  • None currently
05/04/2020 Sansure BioTech Inc.  Novel Coronavirus (2019-nCoV) Nucleic Acid Diagnostic Kit (PCR-Fluorescence Probing) (360KB) Molecular H HCP (212KB)
Patients (171KB)
IFU (988KB)
  • None currently
  • None currently
05/05/2020 Fast Track Diagnostics Luxembourg S.á.r.l. (a Siemens Healthineers Company) FTD SARS-CoV-2 (300KB) Molecular H HCP (141KB)
Patients (129KB)
IFU (944KB)
  • None currently
  • None currently
05/06/2020 OPTI Medical Systems, Inc. OPTI SARS-CoV-2 RT PCR Test (396KB) Molecular H HCP (312KB)
Patients (231KB)
IFU (1.04MB)
  • None currently
  • None currently
05/06/2020 Sherlock BioSciences, Inc. Sherlock CRISPR SARS-CoV-2 Kit (397KB) Molecular H HCP (250KB)
Patients (190KB)
IFU (1.15MB)
  • None currently
  • None currently
05/06/2020 BioMérieux SA SARS-COV-2 R-GENE (422KB) Molecular H HCP (254KB)
Patients (191KB)
IFU (1.16MB)
  • None currently
  • None currently
05/07/2020 Zymo Research Corporation Quick SARS-CoV-2rRT-PCR Kit (396KB) Molecular H HCP (289KB)
Patients (245KB)
IFU (630KB)
  • None currently
05/07/2020 Rutgers Clinical Genomics Laboratory at RUCDR Infinite Biologics - Rutgers University Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2-Assay (381KB) Molecular H HCP (253KB)
Patients (193KB)
IFU (551KB)
EUA Summary (252KB)
  • None currently
  • None currently
05/08/2020 Quidel Corporation Sofia 2 SARS Antigen FIA (138KB) Antigen H, M, W HCP (110KB)
Patients (100KB)
IFU (1.3MB)
  • None currently
  • None currently
05/08/2020 Gnomegen LLC Gnomegen COVID-19-RT-qPCR Detection Kit (314KB) Molecular H HCP (135KB)
Patients (123KB)
IFU (1.36MB)
  • None currently
  • None currently
05/11/2020 1drop Inc. 1copy COVID-19 qPCR Multi Kit (395KB) Molecular H HCP (347KB)
Patients (264KB)
IFU (2.61MB)
  • None currently
  • None currently
05/11/2020 Abbott Molecular Inc. Alinity m SARS-CoV-2 assay (394KB) Molecular H HCP (248KB)
Patients (189KB)
IFU (960KB)
  • None currently
  • None currently
05/13/2020 Applied DNA Sciences, Inc. Linea COVID-19 Assay Kit (393KB) Molecular H HCP (252KB)
Patients (191KB)
IFU (210KB)
  • None currently
  • None currently
05/14/2020 Hologic, Inc. Aptima SARS-CoV-2 assay (131KB) Molecular H HCP (108KB)
Patients (97KB)
IFU (403KB)
  • None currently
  • None currently
05/14/2020 GeneMatrix, Inc. NeoPlex COVID-19 Detection Kit (135KB) Molecular H HCP (109KB)
Patients (98KB)
IFU (847KB)
  • None currently
  • None currently
05/15/2020 Everlywell, Inc. Everlywell COVID-19 Test Home Collection Kit (307KB) Home Collection Kit N/A IFU (624KB)
EUA Summary (351KB)
  • None currently
  • None currently
05/15/2020 Fulgent Therapeutics, LLC Fulgent COVID-19 by RT-PCR Test (288KB) Molecular H HCP (138KB)
Patients (126KB)
EUA Summary (385KB)
  • None currently
  • None currently
05/15/2020 Assurance Scientific Laboratories Assurance SARS-CoV-2 Panel (287KB) Molecular H HCP (137KB)
Patients (125KB)
EUA Summary (420KB)
  • None currently
  • None currently
05/18/2020 Quidel Corporation Lyra Direct SARS-CoV-2 Assay (396KB) Molecular H HCP (250KB)
Patients (190KB)
IFU (596KB)
  • None currently
  • None currently
05/21/2020 BioCore Co., Ltd. BioCore 2019-nCoV Real Time PCR Kit (415KB) Molecular H HCP (252KB)
Patients (190KB)
IFU (1.87MB)
  • None currently
  • None currently
05/21/2020 SolGent Co., Ltd. DiaPlexQ Novel Coronavirus (2019-nCoV) Detection Kit (393KB) Molecular H HCP (250KB)
Patients (209KB)
IFU (2.06MB)
  • None currently
  • None currently
05/21/2020 Seasun Biomaterials, Inc. AQ-TOP COVID-19 Rapid Detection Kit (395KB) Molecular H HCP (254KB)
Patients (192KB)
IFU (1.02MB)
  • None currently
  • None currently
05/21/2020 P23 Labs, LLC. P23 Labs TaqPath SARS-CoV-2 Assay (372KB) Molecular H HCP (260KB)
Patients (190KB)
IFU- Home Collect (964KB)
EUA Summary (629KB)
  • None currently
  • None currently
05/22/2020 dba SpectronRx Hymon SARS-CoV-2 Test Kit (133KB) Molecular H HCP (109KB)
Patients (97KB)
IFU (232KB)
  • None currently
  • None currently
05/28/2020 PrivaPath Diagnostics, Inc. LetsGetChecked Coronavirus (COVID-19) Test (295KB) Molecular H HCP (142KB)
Patients (129KB)
IFU- Home Collect (459KB)
EUA Summary (92KB)
  • None currently
  • None currently

1 Settings for use include the following:

  • H - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
  • M - Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests. 
  • W - Patient care settings operating under a CLIA Certificate of Waiver.

2 Authorization Documents include the Healthcare Provider (HCP) and Patient Fact Sheets and either the Manufacture Instructions/Package Insert (abbreviated to IFU) or the EUA Summary.

High Complexity Molecular-Based Laboratory Developed Tests

On March 31, 2020, the FDA concluded based on the totality of scientific evidence available that molecular-based laboratory developed tests (LDTs) that are authorized for use by the singular developing laboratory are appropriate to protect the public health or safety (as described under the Scope of Authorization (Section II)) under section 564 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360bbb-3). Under this EUA, authorized tests are authorized for use in the single laboratory that developed the authorized test and that is certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a to perform high complexity tests.

Date of EUA Issuance Laboratory Letter Granting Inclusion Under EUA in PDF EUA Summary in PDF
03/31/2020 Yale New Haven Hospital, Clinical Virology Laboratory SARS-CoV-2 PCR test (72KB) EUA Summary (121KB)
04/02/2020 Infectious Disease Diagnostics Laboratory - Children's Hospital of Philadelphia SARS-CoV-2 RT-PCR test (121KB) EUA Summary (333 KB)
04/02/2020 Diagnostic Molecular Laboratory - Northwestern Medicine SARS-Cov-2 Assay (152KB) EUA Summary (272KB)
04/03/2020 Massachusetts General Hospital MGH COVID-19 qPCR assay (68KB) EUA Summary (122KB)
04/06/2020 Viracor Eurofins Clinical Diagnostics Viracor SARS-CoV-2 assay (120KB) EUA Summary (65KB)
04/08/2020 Stanford Health Care Clinical Virology Laboratory Stanford SARS-CoV-2 assay (79KB) EUA Summary (180KB)
04/10/2020 Specialty Diagnostic (SDI) Laboratories SDI SARS-CoV-2 AssayLetter Granting Inclusion (68KB) EUA Summary (160KB)
04/10/2020 Orig3n, Inc. Orig3n 2019 Novel Coronavirus (COVID-19) Test (68KB) EUA Summary (140KB)
04/10/2020 University of North Carolina Medical Center UNC Health SARS-CoV-2 real-time RT-PCR test (120KB) EUA Summary (611KB)
04/13/2020 Pathology/Laboratory Medicine Lab of Baptist Hospital Miami COVID-19 RT-PCR Test (121KB) EUA Summary (351KB)
04/13/2020 Integrity Laboratories SARS-CoV-2 Assay (121KB) EUA Summary (409KB)
04/14/2020 Exact Sciences Laboratories SARS-CoV-2 Test (120KB) EUA Summary (513KB)
04/14/2020 Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children's Hospital Childrens-Altona-SARS-CoV-2 Assay (145KB) EUA Summary (346KB)
04/15/2020 CirrusDx Laboratories CirrusDx SARS-CoV-2 Assay (164KB) EUA Summary (411KB)
04/15/2020 Hackensack University Medical Center (HUMC) Molecular Pathology Laboratory CDI Enhanced COVID-19 Test (218KB) EUA Summary (355KB)
04/20/2020 Mayo Clinic Laboratories, Rochester, MN SARS-CoV-2 Molecular Detection Assay (68KB) EUA Summary (171KB)
04/22/2020 Diatherix Eurofins Laboratory SARS-CoV-2 PCR Test (68KB) EUA Summary (151KB)
04/23/2020 Southwest Regional PCR Laboratory LLC. dba MicroGen DX COVID-19 Key (121KB) EUA Summary (419KB)
04/24/2020 AIT Laboratories SARS-CoV-2 Assay (120KB) EUA Summary (423KB)
04/24/2020 Ultimate Dx Laboratory UDX SARS-CoV-2 Molecular Assay (120KB) EUA Summary (554KB)
04/27/2020 Nationwide Children’s Hospital SARS-CoV-2 Assay (67KB) EUA Summary (185KB)
04/30/2020 Altru Diagnostics, Inc. Altru Dx SARS-CoV-2 RT-PCR assay (78KB) EUA Summary (143KB)
04/28/2020 Biocerna SARS-CoV-2 Test (218KB) EUA Summary (307KB)
05/03/2020 UTMG Pathology Laboratory UTHSC/UCH SARS-CoV-2-RT-PCR Assay (218KB) EUA Summary (269KB)
05/07/2020 Biocollections Worldwide, Inc. Biocollections Worldwide SARS-Co-V-2 Assay (120KB) EUA Summary (365KB)
05/12/2020 Columbia University Laboratory of Personalized Genomic Medicine Triplex CII-CoV-1 rRT-PCR Test (214KB) EUA Summary (768KB)
05/13/2020 One Health Laboratories, LLC SARS-CoV-2 Real-Time RT-PCR-Test (222KB) EUA Summary (394KB
05/13/2020 Cedars-Sinai Medical Center, Department of Pathology and Laboratory Medicine SARS-CoV-2-Assay (223KB) EUA Summary (424KB)
05/18/2020 Color Genomics, Inc. Color SARS CoV-2 Diagnostic Assay (223KB) EUA Summary (630KB)
05/22/2020 Exact Sciences Laboratories  Exact Sciences SARS-CoV-2 (N gene detection) Test (120KB) EUA Summary (191KB)
05/22/2020 Express Gene LLC (dba Molecular Diagnostics Laboratory) Express Gene 2019-nCoV RT-PCR Diagnostic Panel (120KB) EUA Summary (143KB)
05/22/2020 Avera Institute for Human Genetics Avera Institute for Human Genetics SARS-CoV-2 Assay (120KB) EUA Summary (143KB)

SARS-CoV-2 Antibody Tests

On April 28, 2020, FDA issued an Emergency Use Authorization for SARS-CoV-2 Antibody Tests (Lateral flow or Enzyme-linked immunosorbent assay (ELISA) tests) that have been evaluated in an independent validation study performed at the National Institutes of Health’s (NIH) National Cancer Institute (NCI), or by another government agency designated by FDA, and are confirmed by FDA to meet the criteria set forth in the Scope of Authorization (Section II) in the Letter of Authorization under section 564 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. § 360bbb-3). Under this EUA, authorized devices are intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, by detecting antibodies (IgG, or IgG and IgM, or total), as specified in each authorized device’s instructions for use, to SARS-CoV-2 in human plasma and/or serum. 

Emergency use of the authorized devices is limited to the authorized laboratories. Authorized Laboratories are laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate or high complexity tests. Authorized devices will be added to Appendix A (below) upon submission of the information set forth in the Scope of Authorization (Section II) and after confirmation that the applicable performance and labeling criteria set forth in the Scope of Authorization (Section II) have been met.

Personal Protective Equipment and Related Devices

For information on the applicable HHS Secretary determination and declaration supporting a particular EUA in the table below, as well as a link to any applicable PREP Act declaration, please use the expansion buttons on the left hand side of the table.

For additional information, please see Recent Final Medical Device Guidance Documents and Coronavirus (COVID-19) Update: FDA takes action to increase U.S. supplies through instructions for PPE and device manufacturers.

Please also see the Non-NIOSH Approved Respirator FAQ for additional information.

Date of First EUA Issuance Most Recent Letter of Authorization in PDF Appendix in PDF Authorized Labeling in PDF Federal Register Notice for EUA EUA Determination and Declaration (Effective Date) PREP Act Declaration (if applicable)
03/02/2020 NIOSH-Approved Air Purifying Respirators for Use in Health Care Settings During Response to the COVID-19 Public Health Emergency (232KB) (Reissed 03/27/2020 and 03/28/2020)  

Manufacturers of authorized respirators do not need to submit attestation to the FDA to request authorization.

Strategic stockpilers of authorized expired filtering facepiece respirators (FFRs) do not need to submit a request to the FDA to request authorization.
  • None currently.
03/24/2020 Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators (208KB) (Reissued 03/28/2020)  
  • None currently.
04/03/2020 Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China (332KB) (Reissued May 7, 2020)  
  • None currently.
04/09/2020 Face Shields (209KB) (Reissued 04/13/2020)    
  • None currently.
04/15/2020 Stryker STERIZONE VP4 N95 Respirator Decontamination Cycle (102KB)  
  • None currently.
04/11/2020 Advanced Sterilization Products (ASP) STERRAD Sterilization System (96KB)  
  • None currently.
04/09/2020 STERIS Sterilization Systems for Decontamination of N95 Respirators (342KB)  
  • None currently.
03/29/2020 Battelle Decontamination System (151KB)  
  • None currently.
04/20/2020 Sterilucent, Inc. Sterilization System (167KB)  
  • None currently.
05/01/2020 Protective Barrier Enclosures (295KB)  
  • None currently
05/07/2020 Duke Decontamination System (379KB)  
  • None currently
05/19/2020 COVID-19 Airway Management Isolation Chamber (CAMIC) (346KB)  
  • None currently
05/21/2020 STERIS STEAM Decon Cycle in AMSCO Medium Steam Sterilizers (293KB)  
  • None currently
05/22/2020 Gowns and Other Apparel (310KB)    
  • None currently
05/27/2020 Stryker Sustainability Solutions VHP Decontamination System (137KB)  
  • None currently

 

Ventilators and Other Medical Devices

In continuing response to the COVID-19 pandemic, on March 24, 2020, and based on the February 4, 2020 HHS EUA determination, the HHS Secretary declared that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, due to shortages during the COVID-19 outbreak. The EUAs FDA subsequently authorized based on this determination and declaration are listed in the table below this blue box.

The HHS Secretary issued a Declaration pursuant to section 319F-3 of the Public Health Service Act to provide liability immunity for activities related to medical countermeasures against COVID-19.

Templates for these EUA submissions are available to help facilitate the preparation, submission, and authorization of an EUA.

Date EUA First Issued Device Type Most Recent Letter of Authorization in PDF Appendix to Letter and Other Documents in PDF Fact Sheets in PDF Federal Register Notice for EUA
03/24/2020 Ventilators Ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as "ventilators"), ventilator tubing connectors, and ventilator accessories (359KB)
  • None currently.
04/09/2020 Extracorporeal Blood Purification (EBP) Terumo BCT Inc. and Marker Therapeutics AG Extracorporeal Blood Purification (EBP) Devices (268KB)
  • None currently
04/10/2020 Extracorporeal Blood Purification (EBP) CytoSorbents, Inc. Extracorporeal Blood Purification (EBP) Device (422KB)
  • None currently
04/11/2020 Infusion Pump B. Braun Space and Outlook Pumps (148KB)  
  • None currently.
04/13/2020 Diaphragmatic Pacing Therapy System (DPTS) Synapse Biomedical, Inc. TransAeris Diaphragmatic Pacing Therapy System (DPTS) (422KB)
  • None currently
04/14/2020 Diaphragmatic Pacing Therapy System (DPTS) Lungpacer Medical, Inc. Diaphragm Pacing Therapy System (DPTS) (154KB)
  • None currently
04/17/2020 Extracorporeal Blood Purification (EBP) ExThera Medical Corporation Extracorporeal Blood Purification (EBP) Device (280KB)
  • None currently
04/18/2020 Face Masks Face Masks (non-surgical) (91KB) (Reissued 04/24/2020)  
  • None currently.
04/21/2020 Remote Patient Monitor IntelliVue Patient Monitors, Philips Medizin Systeme Boeblingen GmbH (98KB)
  • None currently
04/22/2020 Extracorporeal Blood Purification (EBP) Baxter Healthcare Corporation Extracorporeal Blood Purification (EBP) Device (744KB)
  • None currently
04/22/2020 Respiratory Assist Device ALung Technologies, Inc., Hemolung RAS (355KB)
  • None currently
04/26/2020 Remote Patient Monitor VitalConnect, Inc., VitalPatch (106KB)
  • None currently
04/30/2020 Continuous Renal Replacement Therapy (CRRT) Fresenius Medical, multiFiltrate PRO System and multiBic/multiPlus Solutions 1 (171KB)
  • None currently
05/01/2020 Respiratory Muscle Stimulator Liberate Medical, LLC VentFree Respiratory Muscle Stimulator Device (347KB)
  • None currently
05/05/2020 Remote Patient QT Interval Monitor PhysiolGuard, ECG-QT Analysis System (109KB)
  • None currently
05/08/2020 Patient Isolation Transport Unit (PITU) Patient Isolation Transport Unit (PITU) Device (400KB)
  • None currently
05/11/2020 LVEF Screen Eko Devices, Inc, ELEFT (379KB)
  • None currently
05/11/2020 Nurse Call System Ascom (US), Inc., teleCARE (357KB)
  • None currently
05/13/2020 Infusion Pumps and Infusion Pump Accessories Infusion Pumps and Infusion Pump Accessories (471KB)
  • None currently
05/14/2020 Remote Patient QT Interval Monitor G Medical Innovations, Ltd., VSMS Patch (107KB)
  • None currently
05/20/2020 CRRT Set Baxter Healthcare Corporation, Prismaflex ST Set (355KB)
  • None currently
05/26/2020 Predictive Screening CLEW Medical Ltd., CLEWICU System (105KB)
  • None currently

1 The multiBic/multiPlus Solutions include multiBic dialysate and replacement fluid and multiPlus dialysate. The  multiFiltrate PRO System, multiBic dialysate and the multiPlus dialysate solutions are regulated as devices by CDRH. The multiBic replacement fluid is regulated as a drug by CDER.

Drug Products

On February 4, 2020, the HHS Secretary determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. On the basis of this determination, the Secretary then declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, effective March 27, 2020. The EUAs subsequently issued by FDA are listed in the table below this blue box.

Date of First EUA Issuance Most Recent Letter of Authorization in PDF Authorized Use 1 Fact Sheets and Manufacturer Instructions/ Package Insert in PDF Federal Register Notice for EUA EUA Determination and Declaration (Effective Date) PREP Act Declaration (if applicable)
05/08/2020 Fresenius Kabi Propoven 2% (209KB) To maintain sedation via continuous infusion in patients older than age 16 with suspected or confirmed COVID-19 who require mechanical ventilation in an ICU setting 2  Healthcare Providers (288KB)

Patients and Parent/Caregivers (39KB)

Propoven 2% Wall Chart (2.4MB)
  • None currently.
 None currently. None currently.
05/01/2020 Remdesivir for Certain Hospitalized COVID-19 Patients (365KB) To only treat adults and children with suspected or laboratory confirmed COVID-19 and severe disease defined as SpO2 94% on room air, requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) Healthcare Providers (537KB)

Patients and Parent/ Caregivers (145KB)

Frequently Asked Questions on the EUA for Remdesivir for Certain Hospitalized Patients (179KB)
  • None currently.
 Declaration That Circumstances Exist Justifying Authorizations Pursuant to Section 564 of the FD&C Act (March 27, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
04/30/2020 Fresenius Medical, multiFiltrate PRO System and multiBic/multiPlus Solutions (171KB) 3
[also listed under Medical Device EUAs]		 To provide continuous renal replacement therapy (CRRT) to treat patients in an acute care environment during the COVID-19 pandemic.

Healthcare Providers (135KB)

Patients (125KB)

Instructions for Use, Bloodline/ Tubing (83KB)

Instructions for Use, UltraFlux (147KB)

Instructions for Use, multiFiltratePRO (15.07MB)

Summary of Product Characteristics (SmPC) (308KB)

Instructions for Use, MultiPlus (110KB)
  • None currently
 Declaration That Circumstances Exist Justifying Authorizations Pursuant to Section 564 of the FD&C Act (March 27, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)
03/28/2020 Chloroquine phosphate and hydroxychloroquine sulfate for treatment of COVID-19 (229KB) To only treat adults and adolescents who weigh 50 kg or more and are hospitalized with COVID-19 for whom a clinical trial is not available or participation is not feasible Chloroquine Phosphate Fact Sheet for Healthcare Providers (217KB) Chloroquine Phosphate Fact Sheet for Patients (147KB) Hydroxychloroquine Sulfate Fact Sheet for Healthcare Providers (206KB)

Hydroxychloroquine Sulfate Fact Sheet for Patients (148KB)

Frequently asked questions on the EUA for Chloroquine Phosphate and Hydroxychloroquine Sulfate (237KB)

Hydroxychloroquine and Chloroquine drug safety communication about use for COVID-19 outside of a hospital setting or clinical trial
  • None currently.
 Declaration That Circumstances Exist Justifying Authorizations Pursuant to Section 564 of the FD&C Act (March 27, 2020) Notice of Declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19 (February 4, 2020)

1 The virus that causes COVID-19 has led to an increased number of patients requiring critical care, such as  with severe respiratory illness. As a result, there is a shortage of adequate, FDA-approved  drugs used for their treatment, such as propofol for sedation of mechanically ventilated patients.  

2 In the circumstances of this public health emergency, it would not be feasible to require healthcare providers to seek to limit Fresenius Propoven 2% Emulsion only to be used for patients with suspected or confirmed COVID-19; therefore, this authorization does not limit use to such patients.

3 The multiBic/multiPlus Solutions include multiBic dialysate and replacement fluid and multiPlus dialysate. The multiBic replacement fluid is regulated as a drug by CDER. The multiFiltrate PRO System, multiBic dialysate and the multiPlus dialysate solutions are regulated as devices by CDRH.

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Other Current EUAs

The tables below provide information on current EUAs:

Information about EUAs that are no longer in effect is available on our EUA archive page.

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