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Reportable Food Registry for Industry
"The Reportable Food Registry (RFR or the Registry) is an electronic portal for Industry to report when there is reasonable probability that an article of food will cause serious adverse health consequences. The Registry helps the FDA better protect public health by tracking patterns and targeting inspections. The Food and Drug Administration Amendments Act of 2007 (Pub. L.110-085), section 1005 directs the FDA to establish a Reportable Food Registry for Industry. The RFR applies to all FDA-regulated categories of food and feed, except dietary supplements and infant formula."
United States. Food and Drug Administration
2010
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Zika Virus Vaccines and Therapeutics
This is a 45-minute presentation on the Zika virus. "Zika virus is a rapidly emerging infectious disease of great public health importance. Although infections are frequently asymptomatic or mildly symptomatic, associations with severe neurologic complications in infants born to mothers infected with Zika virus during pregnancy as well as neurologic complications in adults (e.g., Guillan Barre Syndrome) have made Zika virus a high priority pathogen. At the time of the lecture, there were no licensed vaccines or therapeutics against Zika virus; however, there were numerous vaccine candidates in development. The anti-Zika virus vaccine candidates in the pipeline as well as ongoing efforts to identify therapeutics effective against this pathogen were discussed."
United States. Food and Drug Administration
McArthur, Monica
2017-04-13
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Fact Sheet for Health Care Providers: Interpreting Idylla (TM) Ebola Virus Triage Test Results
Taken from the Disaster Information Management Research Center's Annotation: "This three-page document provides information about the Emergency Use Authorization (EUA) issued to authorize the use of the Biocartis Idylla (TM) Ebola Virus Triage Test with the Biocartis Idylla (TM) Instrument System to test for the presumptive detection of Ebola Zaire virus (detected in the West Africa outbreak in 2014) in EDTA [Ethylenediaminetetraacetic Acid] venous whole blood specimens obtained from individuals with signs and symptoms of Ebola virus infection in conjunction with epidemiological risk factors."
United States. Food and Drug Administration
2016-05-26
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FDA's Role in Medical Device Cybersecurity: Dispelling Myths and Understanding Facts
"As medical devices become more digitally interconnected and interoperable, they can improve the care patients receive and create efficiencies in the health care system. Medical devices, like computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device. By carefully considering possible cybersecurity risks while designing medical devices, and having a plan to manage emerging cybersecurity risks, manufacturers can reduce cybersecurity risks posed to devices and patients. The FDA has published premarket and postmarket guidances that offer recommendations for comprehensive management of medical device cybersecurity risks, continuous improvement throughout the total product life-cycle, and incentivize changing marketed and distributed medical devices to reduce risk. Even with these guidances, the FDA continues to address myths about medical device cybersecurity."
United States. Food and Drug Administration
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Resiliency Roadmap for FDA Inspectional Oversight
From the Background: "The U.S. Food and Drug Administration [FDA] protects the public health by ensuring the safety, effectiveness and security of human and veterinary drugs, medical devices, vaccines and other biological products for human use. The agency also is responsible for the safety and security of our nation's human and animal food supply, cosmetics, dietary supplements, products that emit electromagnetic radiation, and for regulating tobacco products. FDA uses many tools in its oversight of these products. Inspections are an important part of our toolkit and are part of a comprehensive approach to carrying out our oversight responsibilities. [...] Manufacturers of FDA-regulated commodities maintain primary responsibility for ensuring that the products reaching American consumers are safe and of high quality. Manufacturers and processors are generally required to employ a robust quality management system, also referred to as Current Good Manufacturing Practice (CGMP), or as 'preventive controls' in the food industry, to ensure their products are safe and suitable for the U.S. consumer. FDA's role in conducting periodic surveillance inspections, and when using other oversight tools, is to verify that these quality systems are established and operating as required. FDA also conducts inspections to verify that other regulated entities, such as those involved in the conduct and reporting of FDA-regulated research, are complying with regulatory requirements. If problems are found, FDA uses a variety of oversight and enforcement tools to ensure corrections are made, including additional inspections."
United States. Food and Drug Administration
2021-05
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Fact Sheet for Healthcare Providers: Quidel Corporation, Sofia 2 Flu + SARS Antigen FIA
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the Sofia 2 Flu + SARS [severe acute respiratory syndrome] Antigen FIA [fluorescent immunoassay]. The Sofia 2 Flu + SARS Antigen FIA 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 within the first five days of the onset of symptoms."
United States. Food and Drug Administration
2020-10-02
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Fact Sheet for Healthcare Providers: Shenzhen New Industries Biomedical Engineering Co., Ltd. (SNIBE), MAGLUMI 2019-nCoV IgM/IgG
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the MAGLUMI 2019-nCoV [Novel Coronavirus] IgM/IgG [Immunoglobulin M/Immunoglobulin G]."
United States. Food and Drug Administration
2020-09-14
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Fact Sheet for Healthcare Providers: Vela Operations Singapore Pte. Ltd., Virokey SARS-CoV-2 RT-PCR Test v2.0
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the ViroKey SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] RT-PCR [reverse transcription polymerase chain reaction] Test v2.0. The ViroKey SARS-CoV-2 RT-PCR Test v2.0 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
2020-09-22
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Fact Sheet for Healthcare Providers: University of California, Los Angeles (UCLA), UCLA SwabSeq COVID-19 Diagnostic Platform
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the UCLA [University of California, Los Angeles] SwabSeq COVID-19 [coronavirus disease 2019] Diagnostic Platform. The UCLA SwabSeq COVID19 Diagnostic Platform is authorized for use with upper respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider."
United States. Food and Drug Administration
2020-10-06
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Fact Sheet for Healthcare Providers: Clear Labs, Inc., Clear Dx SARS-CoV-2 Test
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the Clear Dx SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] Test. The Clear Dx SARS-CoV-2 Test 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
2020-09-23
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Fact Sheet for Healthcare Providers: Emergency Use of the COViage System During the COVID-19 Pandemic
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the 'COViage' System (or 'COViage') for use by healthcare providers (HCP) in the hospital setting for adult patients (18 years of age or older who are admitted to the hospital) with confirmed COVID-19 [coronavirus disease 2019] (based on a positive PCR [polymerase chain reaction] test result) for the computation of proprietary patient status indices referred to as Respiratory Decompensation Status and Hemodynamic Instability Status as an adjunct to patient monitoring during the COVID-19 outbreak. The COViage indices provide HCP with predictive screening information as a diagnostic aid to assist with the early identification of COVID-19 patients who are likely to be diagnosed with hemodynamic instability or respiratory decompensation, which are common complications associated with COVID-19."
United States. Food and Drug Administration
2020-09-24
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Fact Sheet for Healthcare Providers: GK Pharmaceuticals Contract Manufacturing Operations, GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT [severe acute respiratory syndrome coronavirus 2 real time/reverse transcription polymerase chain reaction kit]. The GK ACCU-RIGHT SARS-CoV-2 RT-PCR KIT 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
2020-09-18
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Fact Sheet for Healthcare Providers: BioFire Diagnostics, LLC, BioFire® Respiratory Panel 2.1-EZ (RP2.1-EZ)
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the BioFire Respiratory Panel 2.1-EZ (RP2.1-EZ). The BioFire RP2.1-EZ is a multiplexed polymerase chain reaction (PCR) test authorized for use with nasopharyngeal swab specimens collected from individuals suspected of COVID-19 [coronavirus disease 2019] by their healthcare provider."
United States. Food and Drug Administration
2020-11-22
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Fact Sheet for Healthcare Providers: Thermo Fisher Scientific, OmniPATH COVID-19 Total Antibody ELISA Test
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the OmniPATH COVID-19 [coronavirus disease 2019] Total Antibody ELISA [enzyme-linked immunosorbent assay] Test."
United States. Food and Drug Administration
2020-10-02
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Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [UMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel]
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 UMass [University of Massachusetts] Molecular Virology Laboratory 2019-nCoV rRT-PCR [novel coronavirus real-time reverse transcription polymerase chain reaction] Dx [diagnosis] Panel 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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FDA Briefing Document: Development, Authorization and Licensure of Vaccines to Prevent COVID-19
From the Introduction: "The SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] pandemic presents an extraordinary challenge to global health and, as of September 22, 2020, has caused more than 30 million cases of COVID-19 [coronavirus disease 2019] and claimed the lives of more than 900,000 people worldwide. On January 31, 2020, the U.S. Secretary of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. On March 13, 2020, the President declared a national emergency in response to COVID-19. In addition, the WHO [World Health Organization] declared the novel coronavirus a pandemic on March 11, 2020. The rapid spread of SARS-CoV-2 requires expedited timelines to develop COVID-19 vaccine candidates and test them in clinical trials that can provide the data to meet the relevant legal standards for safety and effectiveness. Currently, numerous COVID-19 vaccine candidates intended to prevent COVID-19 are in development globally. These candidates are based on a variety of different vaccine technologies and platforms. Some of these vaccines have entered Phase 3 clinical trials intended to demonstrate their safety and effectiveness. The U.S. Food and Drug Administration (FDA) is committed to facilitating the scientific development and evaluation of safe and effective COVID-19 vaccines and to providing as much transparency as possible to the American public, while adhering to applicable confidentiality requirements."
United States. Food and Drug Administration
2020-10-22
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Fact Sheet for Healthcare Providers: Seasun Biomaterials Inc, AQ-TOP COVID-19 Rapid Detection Kit PLUS
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the AQ-TOP COVID-19 [coronavirus disease 2019] Rapid Detection Kit PLUS. The AQ-TOP COVID-19 Rapid Detection Kit PLUS is authorized for use with respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider."
United States. Food and Drug Administration
2020-10-05
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Fact Sheet for Healthcare Providers: Zeus Scientific, Inc., ZEUS ELISA SARS-CoV-2 IgG Test System
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the ZEUS ELISA SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] IgG [Immunoglobulin G] Test System."
United States. Food and Drug Administration
2020-10-06
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FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative: Summary Report
From the Foreword: "The COVID-19 [coronavirus disease 2019] pandemic represents the most profound disruption to daily life in generations. It has reshaped our lives, forcing us to adapt the ways in which we live and work, producing enormous economic hardships, and causing profound personal pain and tragedy - with more than 350,000 deaths and 20 million confirmed cases in the United States alone - and contributed to enormous economic dislocation all over the world. The U.S. Food and Drug Administration (FDA or the 'Agency') has been at the forefront of the nation's response to the pandemic. Our resourceful and resilient workforce of nearly 18,000 strong has continued to make unparalleled contributions and demonstrated unwavering commitment to promote and protect the health and safety of the American public. As the pandemic evolves, there are beacons of hope that we must not lose sight of, including the FDA's emergency use authorization of COVID-19 vaccines, monoclonal antibody therapies, and rapid, more readily accessible tests for COVID-19, such as over-the-counter diagnostic tests. [...] The ideas presented in this report serve as a summary of potential options for the Agency to consider and are deliberative, not exhaustive, and not binding. The potential actions reflect lessons learned from the response so far and serve as a basis for continued learning and progress through and beyond the current pandemic."
United States. Food and Drug Administration
2021-01
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Fact Sheet for Healthcare Providers: Agena Bioscience, Inc., MassARRAY SARS-CoV-2 Panel
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the MassARRAY SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] Panel. The MassARRAY SARS-CoV-2 Panel 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
2020-10-26
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Fact Sheet for Healthcare Personnel: Zoe-Ann Decontamination System for Decontaminating Compatible N95 Respirators
From the Document: "You have been given a 'decontaminated N95 respirator' that has been decontaminated using a decontamination system that is authorized to decontaminate compatible N95 respirators 'for single-user reuse by healthcare personnel (HCP) in a healthcare setting' (i.e., the same respirator is returned for reuse to the same HCP following its decontamination) to help prevent HCP exposure to pathogenic biologic airborne particulates during the COVID-19 [coronavirus disease 2019] pandemic. This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of decontaminated, compatible N95 respirators. These compatible N95 respirators have been decontaminated using the Zoe-Ann Decontamination System (hereafter referred to as 'decontaminated N95 respirators' and 'Z-A Decon System' throughout this Fact Sheet)."
United States. Food and Drug Administration
2020-10-20
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Fact Sheet for Healthcare Providers: Celltrion USA, Inc., Sampinute™ 'COVID-19 Antigen MIA'
From the Document: "A positive test result for COVID-19 [coronavirus disease 2019] indicates that antigens from SARS-CoV-2 [severe acute respiratory syndrome coronavirus 2] was detected, and therefore the patient is infected with the virus and presumed to be contagious. Laboratory test results should always be considered in the context of clinical observations and epidemiological data (such as local prevalence rates and current outbreak/epicenter locations) in making a final diagnosis and patient management decisions. Patient management should be made by a healthcare provider and follow current CDC [Centers for Disease Control and Prevention] guidelines. The Sampinute™ COVID-19 Antigen MIA [magnetic Immunoassay] has been designed to minimize the likelihood of false positive test results. In the event of a false positive result, risks to patients could include the following: a recommendation for isolation of the patient, monitoring of household or other close contacts for symptoms, patient isolation that might limit contact with family or friends and may increase contact with other potentially COVID-19 patients, limits in the ability to work, delayed diagnosis and treatment for the true infection causing the symptoms, unnecessary prescription of a treatment or therapy, or other unintended adverse effects."
United States. Food and Drug Administration
2020-10-23
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Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry [February 22, 2021]
From the Background: "This guidance describes FDA's current recommendations regarding the data and information needed to support the issuance of an Emergency Use Authorization (EUA) under section 564 of the FD&C Act [Federal Food, Drug, and Cosmetic Act] (21 U.S.C. 360bbb-3) for an investigational vaccine to prevent COVID-19 [coronavirus disease 2019], including chemistry, manufacturing, and controls information (CMC); nonclinical data and information; and clinical data and information, as well as administrative and regulatory information. In addition, the guidance provides recommendations regarding key information and data that should be submitted to a relevant investigational new drug application (IND) or cross-referenced master file (MF) prior to submission of an EUA request in order to facilitate FDA's complete and timely review of such a submission, including convening the Vaccines and Related Biological Products Advisory Committee (VRBPAC). This guidance also discusses FDA's current thinking regarding the circumstances under which the issuance of an EUA for a COVID-19 vaccine would be appropriate, providing additional context to the discussion regarding EUAs in the guidance for industry entitled 'Development and Licensure of Vaccines to Prevent COVID-19.'"
United States. Food and Drug Administration
2021-02-22
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Fact Sheet for Healthcare Providers: ePlex® Respiratory Pathogen Panel 2, GenMark Diagnostics, Inc.
From the Document: "This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of the ePlex Respiratory Pathogen Panel 2. The ePlex Respiratory Pathogen Panel 2 is authorized for use with nasopharyngeal swab specimens collected from individuals suspected of respiratory viral infection consistent with COVID-19 [coronavirus disease 2010] by their health care provider."
United States. Food and Drug Administration
2020-10-07
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Fact Sheet for Healthcare Providers: Beckman Coulter, Inc., Access 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 Access SARS‐CoV‐2 [severe acute respiratory syndrome coronavirus 2] IgM [Immunoglobulin M]. [...] The Access SARS‐CoV‐2 IgM is authorized for the detection of antibodies to SARS-CoV-2 in human serum and plasma."
United States. Food and Drug Administration
2020-10-08
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Food Protection Plan: One-Year Progress Summary
"The [Food Protection Plan (FPP)] One-Year Progress Summary identifies FDA's current food safety goals as well as recent accomplishments toward realizing the complete vision and strategies outlined in the FPP. The FPP program will continue to evolve based on the Agency's understanding of effective prevention practices, successful intervention methods at key points in the food production system, and enhanced emergency capabilities so that the Agency working with its partners can respond immediately when problems are identified. The FDA is committed to sustaining and growing a food protection framework that keeps the American food supply safe."
United States. Food and Drug Administration
2008-12
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U.S. Food and Drug Administration (FDA) [website]
This website is the main page for the U.S. Food and Drug Administration (FDA). It includes pages for topics such as food, drugs, medical devices, vaccines, blood & biologics, animal & veterinary, cosmetics, radiation-emitting products, and combination products. "The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health."
United States. Food and Drug Administration
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FDA's Strategic Plan for Risk Communication
"The purpose of this document is to describe the U.S. Food and Drug Administration's strategy for improving how the agency communicates about regulated products. The strategy is intended to guide program development and research planning in a dynamic environment where rapidly evolving technologies enable patients and consumers to become increasingly involved in managing their health and well-being. We define three key areas-science, capacity, and policy-in which strategic actions can help improve how we communicate about the risks and benefits of regulated products, as well as how we oversee communications produced by regulated entities. The box titled FDA Risk Communication Strategic Plan at a Glance summarizes the three key areas and the associated strategies on which we will focus our efforts. This FDA Strategic Plan for Risk Communication is an ambitious one that will take time and substantial collaboration with stakeholders to implement. However, FDA is confident this strategy will help ensure that FDA-regulated products are used appropriately, a goal critical to the agency's mission of protecting and promoting the public health."
United States. Food and Drug Administration
2009
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U.S. Food and Drug Administration: The Center for Veterinary Medicine and Counterterrorism
The U.S. FDA provides a listing of links related to countering bioterrorism. Link categories include general topics, FAQs, public health initiatives/actions/preparedness, and specific types of biological agents such as anthrax and smallpox. Furthermore,"The Center for Veterinary Medicine (CVM) is working with other federal agencies to help the country prepare for a biological emergency, natural disaster or terrorist attack by making sure there is a safe and adequate supply of animal drug products and a safe animal feed supply system. This page contains information on CVM's role in counterterrorism."
United States. Food and Drug Administration
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Food and Drug Administration's Strategic Action Plan: Protecting and Advancing America's Health: Responding to New Challenges and Opportunities
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. This Strategic Action Plan outlines the following goals: Use science-based efficient risk management in all Agency regulatory activities, so that the Agency's limited resources can provide the most health promotion and protection at the least cost for the public; Enable consumers to make smarter decisions by getting them better information to weigh the benefits and risks of FDA-regulated products; Seek continuous improvements in patient and consumer safety by reducing risks associated with FDA-regulated products; Strengthen FDA's capability to identify, prepare for, and respond to terrorist threats and incidents; Ensure a world-class professional workforce, effective and efficient operations, and adequate resources to accomplish the agency's mission.
United States. Food and Drug Administration
2003-08
