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Fact Sheet for Healthcare Providers: DetectaChem Inc, MobileDetect Bio BCC19 Test Kit
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the MobileDetect Bio BCC19 Test Kit. The MobileDetect Bio BCC19 Test Kit is authorized for use with certain respiratory specimens collected from individuals suspected of COVID-19 [coronavirus disease 2019] by their healthcare provider."
United States. Food and Drug Administration
2020-10-02
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Updated Evidence to Support the Emergency Use of COVID-19 Convalescent Plasma - As of 9/23/2020
From the Document: "On August 23, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for COVID-19 [coronavirus disease 2019] Convalescent Plasma for the treatment of hospitalized patients with COVID-19. The issuance of this authorization followed the agency's evaluation of the totality of the available evidence regarding the safety and the efficacy of the product and the agency's finding that the product met the criteria for issuance of an EUA. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), the issuance of an EUA during a declared public health emergency does not require the same evidentiary standard as required for approval or licensure of a drug or biological product.' Instead, the FD&C Act requires that the product 'may be effective' for its intended use, and that the 'potential benefits outweigh the known and potential risks.' FDA will continue to review the circumstances and appropriateness of the EUA. Four lines of evidence continue to support the emergency use of COVID-19 Convalescent Plasma at this time one month after initial issuance of the EUA: 1) historical data regarding prior experience with the use of convalescent plasma in other outbreak settings, 2) data from animal studies, 3) data that continues to emerge in the published literature from clinical studies performed during the current outbreak, and 4) results obtained from a large expanded access treatment protocol (National Expanded Program)."
United States. Food and Drug Administration
2020-09-23
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Fact Sheet for Healthcare Providers: Emergency Use of the Duke University COVIAGE
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of COVIAGE [patient isolation carriage]. This device is authorized for use by healthcare personnel (HCP) as an extra layer of protection in addition to personal protective equipment (PPE) to prevent HCP exposure to pathogenic biological airborne particulates by providing isolation of hospitalized patients with suspected or confirmed diagnosis of COVID-19 [coronavirus disease 2019], at the time of definitive airway management, when performing airway-related medical procedures, or during certain transport of such patients during the COVID-19 pandemic."
United States. Food and Drug Administration
2020-09-24
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Fact Sheet for Healthcare Providers: JIANGSU WELL BIOTECH CO., LTD., Orawell IgM/IgG Rapid Test
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the Orawell IgM/IgG [Immunoglobulin M/ Immunoglobulin G] Rapid Test."
United States. Food and Drug Administration
2020-09-23
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Fact Sheet for Healthcare Providers: Quadrant Biosciences Inc., Clarifi COVID-19 Test Kit
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the Clarifi COVID-19 [coronavirus disease 2019] Test Kit. The Clarifi COVID-19 Test Kit is authorized for use with saliva swab specimens collected from individuals suspected of COVID-19 by their healthcare provider."
United States. Food and Drug Administration
2020-09-22
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Fact Sheet for Healthcare Providers: Kimforest Enterprise Co., Ltd, KimForest SARS-CoV-2 Detection Kit v1
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the KimForest SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] Detection Kit v1 [version 1]. The KimForest SARS-CoV-2 Detection Kit v1 is authorized for use with respiratory specimens collected from individuals suspected of COVID-19 [coronavirus disease 2019] by their healthcare provider."
United States. Food and Drug Administration
2020-09-21
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Fact Sheet for Healthcare Providers: Genetrack Biolabs, Inc., Genetrack SARS-CoV-2 Molecular Assay
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the Genetrack SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] Molecular Assay. The Genetrack SARS-CoV-2 Molecular Assay is authorized for use with anterior nasal swab specimens self-collected at home using the Vo' COVID-19 [coronavirus disease 2019] Test Home Collection Kit by individuals suspected of COVID-19 when home collection is determined to be appropriate by their healthcare provider."
United States. Food and Drug Administration
2020-09-25
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Fact Sheet for Healthcare Providers: QUOTIENT SUISSE SA, MosaiQ COVID-19 Antibody Magazine
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the MosaiQ COVID-19 [coronavirus disease 2019] Antibody Magazine."
United States. Food and Drug Administration
2020-09-25
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Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [SARS-CoV-2 Mass Array Test]
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of a Molecular LDT [Laboratory Developed Test] COVID-19 [coronavirus disease 2019] Authorized Test called the SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] Mass Array Test that has been issued an Emergency Use Authorization (EUA) by FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider."
United States. Food and Drug Administration
2020?
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Fact Sheet for Healthcare Providers: Cepheid, Xpert Xpress SARS-CoV-2/Flu/RSV
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the Xpert Xpress SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2]/Flu/RSV [respiratory syncytial virus] test. The Xpert Xpress SARS-CoV-2/Flu/RSV test is authorized for use with certain respiratory specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 [coronavirus disease 2019] by their healthcare provider."
United States. Food and Drug Administration
2020-10-01
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Fact Sheet for Healthcare Providers: Nirmidas Biotech, Inc., Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the Nirmidas COVID-19 [coronavirus disease 2019] (SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2]) IgM/IgG [Immunoglobulin M/Immunoglobulin G] Antibody Detection Kit."
United States. Food and Drug Administration
2020-09-29
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Fact Sheet for Healthcare Providers: NanoEntek America, Inc., FREND COVID-19 total Ab
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the FREND COVID-19 [coronavirus disease 2019] total Ab."
United States. Food and Drug Administration
2020-09-29
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Fact Sheet for Healthcare Providers: CENTOGENE US, LLC, CentoSure SARS-CoV-2 RT-PCR Assay
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the CentoSure SARS-CoV-2 RT-PCR [severe acute respiratory syndrome coronavirus 2 reverse transcription polymerase chain reaction] Assay. The CentoSure SARS-CoV-2 RT-PCR Assay is authorized for use with dry oropharyngeal swab specimens from individuals without symptoms or other reasons to suspect COVID-19 [coronavirus disease 2019]."
United States. Food and Drug Administration
2020-09-29
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Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Akron Children's Hospital SARS-CoV-2 Assay]
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of a Molecular LDT [Laboratory Developed Test] COVID-19 [coronavirus disease 2019] Authorized Test called the Akron Children's Hospital SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] Assay that has been issued an Emergency Use Authorization (EUA) by FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider."
United States. Food and Drug Administration
2020?
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Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Aeon Global Health SARS-CoV-2 Assay]
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of a Molecular LDT [Laboratory Developed Test] COVID-19 [coronavirus disease 2019] Authorized Test called the Aeon Global Health SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] Assay that has been issued an Emergency Use Authorization (EUA) by FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider."
United States. Food and Drug Administration
2020?
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Fact Sheet for Healthcare Providers: CentoFast-SARS-COV-2 RT-PCR Assay -- CENTOGENE US, LLC
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the CentoFast-SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] RT-PCR [reverse transcription polymerase chain reaction] Assay. The CentoFast-SARS-CoV-2 RT-PCR Assay is authorized for use with dry oropharyngeal swab specimens collected from individuals suspected of COVID-19 [coronavirus disease 2019] by their healthcare provider."
United States. Food and Drug Administration
2020-07-01
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Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency: Guidance for Industry, Investigators, and Institutional Review Boards
From the Introduction: "FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to provide general considerations to assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency. The appendix to this guidance further explains those general considerations by providing answers to questions that the Agency has received about conducting clinical trials during the COVID-19 public health emergency."
United States. Food and Drug Administration
2020-12-04
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Fact Sheet for Healthcare Providers: Tempus Labs, Inc., iC SARS-CoV2 Test
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the iC SARS-CoV2 [severe acute respiratory syndrome coronavirus 2] Test. The iC SARS-CoV2 Test is authorized for use with upper respiratory tract specimens collected from individuals suspected of COVID-19 [coronavirus disease 2019] by their healthcare provider."
United States. Food and Drug Administration
2020-10-01
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Fact Sheet for Healthcare Providers: Access IL-6 - Beckman Coulter, Inc.
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the Access IL-6. The Access IL-6 is authorized for use in human serum and plasma specimens collected from patients with confirmed Coronavirus Disease-2019 (COVID-19) to assist in identifying severe inflammatory response to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing."
United States. Food and Drug Administration
2020-10-01
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Fact Sheet for Healthcare Providers: Roche Molecular Systems, Inc., cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the cobas SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] & Influenza A/B Nucleic Acid Test for use on the cobas Liat System. Testing is to be conducted on specimens from individuals suspected of respiratory viral infection consistent with COVID-19 [coronavirus disease 2019] by a healthcare provider. Symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar."
United States. Food and Drug Administration
2020-09-14
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Fact Sheet for Healthcare Providers: Azure Biotech Inc., Assure COVID-19 IgG/IgM Rapid Test Device
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the Assure COVID-19 [coronavirus disease 2019] IgG/IgM [Immunoglobulin G/Immunoglobulin M] Rapid Test Device."
United States. Food and Drug Administration
2020-09-23
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Fact Sheet for Healthcare Providers: Visby Medical, Inc., Visby Medical COVID-19
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the Visby Medical COVID-19 [coronavirus disease 2019]. The Visby Medical COVID-19 is authorized for use with nasopharyngeal, nasal or mid-turbinate swab specimens collected from individuals suspected of COVID-19 by their healthcare provider."
United States. Food and Drug Administration
2020-09-16
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Fact Sheet for Healthcare Providers: DiaSorin Inc., LIAISON SARS-CoV-2 IgM
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the LIAISON SARS-CoV-2 IgM [severe acute respiratory syndrome coronavirus 2 immunoglobulin M]."
United States. Food and Drug Administration
2020-09-29
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Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Alimetrix SARS-CoV-2 RT-PCR Assay]
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of a Molecular LDT [laboratory developed test] COVID-19 [coronavirus disease 2019] Authorized Test called the Alimetrix SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] RT-PCR [reverse transcription polymerase chain reaction] Assay that has been issued an Emergency Use Authorization (EUA) by FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on certain respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider."
United States. Food and Drug Administration
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Enforcement Policy for Modifications to FDA-Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry and Food and Drug Administration Staff
From the Introduction: "FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to provide a policy to help expand access to certain FDA-cleared molecular assays intended for detection and identification of influenza (flu) viruses, including those molecular influenza assays that also detect and identify respiratory syncytial viruses (RSV), during the influenza season and for the duration of the COVID-19 public health emergency."
United States. Food and Drug Administration
2020-10
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Fact Sheet for Healthcare Providers Lumiradx UK Ltd., LumiraDx SARS-CoV-2 RNA STAR Complete
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the LumiraDx SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] RNA [Ribonucleic acid] STAR [Spliced Transcripts Alignment to a Reference] Complete. The LumiraDx SARS-CoV-2 RNA STAR Complete is authorized for use with upper respiratory specimens collected from individuals suspected of COVID-19 [coronavirus disease 2019] by their healthcare provider."
United States. Food and Drug Administration
2021-02-09
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Fact Sheet for Healthcare Providers: Access Bio, Inc., 'CareStart'™ COVID-19 Antigen
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the 'CareStart'™ COVID-19 [coronavirus disease 2019] Antigen test. The 'CareStart'™ COVID-19 Antigen test is authorized for use using nasopharyngeal or anterior nasal swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within five days of symptom onset."
United States. Food and Drug Administration
2021-02-01
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Fact Sheet for Healthcare Providers: Genalyte, Inc., Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the Maverick SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] Multi-Antigen Serology Panel v2. [...] This test detects human SARS-CoV-2 antibodies that are generated as part of the human adaptive immune response to the COVID-19 [coronavirus disease 2019] virus and is to be performed on only human dipotassium EDTA [ethylenediaminetetraacetic acid] venous whole blood, dipotassium EDTA plasma and serum specimens."
United States. Food and Drug Administration
2020-10-08
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Fact Sheet for Healthcare Providers: Abbott Laboratories, AdviseDx SARS-CoV-2 IgM
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the AdviseDx SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] IgM [Immunoglobulin M] assay. You should not interpret the results of this test as an indication or degree of immunity or protection from reinfection. The AdviseDx SARS-CoV-2 IgM assay is authorized for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum, serum separator tube, and plasma (dipotassium EDTA [Ethylenediaminetetraacetic acid], tripotassium EDTA, lithium heparin, lithium heparin separator tube, sodium heparin)."
United States. Food and Drug Administration
2020-10-09
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FDA Strategy for the Safety of Imported Food
"Today, the nation imports food from more than 200 countries or territories and approximately 125,000 exporting food facilities plus farms. To meet consumers' growing demands, globalization of the food supply and adaptations of the food industry have resulted in more complex supply chains, varying business models, and increased specialization. The Food and Drug Administration (FDA or 'agency') oversees the safety of most of the human and animal food ('food') consumed in the United States. An important aim of the agency's strategy for the safety of imported food is to assure Americans that food imported from abroad is held to the same food safety requirements as food produced domestically. In the past, FDA's imported food safety system focused on intercepting unsafe food at the border and preventing its entrance into the U.S. marketplace. As the volume of imports increased, along with a diversity of products and countries of origin (see Figures 2 and 3) the traditional regulatory oversight model was challenged. In 2019, between 14 and 15 million shipments of imported food are expected to enter the United States."
United States. Food and Drug Administration
2019-02
