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Chief Financial Officer's Annual Report: Fiscal Year 2000
From the Principal Deputy Commissioner of the Food and Drug Administration: "I present to you the Food and Drug Administration's (FDA) annual financial report for fiscal year (FY) 2000. I am pleased to report that FDA has earned its third consecutive 'clean' opinion on its audited financial statements. By comparing the fiscal information from these statements with performance information reported under the Government Performance and Results Act, taxpayers will realize that FDA is a good investment and that the dollars we spend yield valuable results. As a science-based regulatory agency, FDA's mission affects the health and well being of all Americans. FDA is responsible for overseeing a regulated industry that produces over $1 trillion worth of products. Whether at home, or at work or at play, FDA shields us from public health hazards that range from debilitating to the deadly. FDA protects consumers and consumers trust FDA. Surveys show that FDA's good work performance is recognized both by the public and regulated industries, and this performance is accomplished at the low annual cost of about $4 per person."
United States. Food and Drug Administration
2001?
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Enforcement Strategy Update (of) FDA Regulation 21 CFR 589.2000, The BSE Feed Regulation
This document describes the efforts in accomplishments in conforming to the Regulation to ensure the prevention of the spread of BSE, further goals in this effort and identifies resources needed to meet these goals.
United States. Food and Drug Administration
1998-12
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Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables
"Fresh fruits and vegetables are important to the health and well being of the American consumer. Consumers enjoy one of the safest supplies of fresh produce in the world. However, over the last several years, the detection of outbreaks of foodborne illness associated with both domestic and imported fresh fruits and vegetables has increased. In a January 1997 radio address, President Clinton announced a Food Safety Initiative to improve the safety of the nation's food supply (Ref. 1). In May of 1997, as part of the President's Food Safety Initiative, the Department of Health and Human Services, the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) sent to the President a report that identified produce as an area of concern (Ref. 2). On October 2, 1997, President Clinton announced a plan entitled 'Initiative to Ensure the Safety of Imported and Domestic Fruits and Vegetables' (produce safety initiative) to provide further assurance that fruits and vegetables consumed by Americans, whether grown domestically or imported from other countries, meet the highest health and safety standards (Ref. 3). This guidance document ('the guide') addresses microbial food safety hazards and good agricultural and management practices common to the growing, harvesting, washing, sorting, packing, and transporting of most fruits and vegetables sold to consumers in an unprocessed or minimally processed (raw) form. This voluntary, science-based guidance can be used by both domestic and foreign fresh fruit and vegetable producers to help ensure the safety of their produce. The voluntary guidance is consistent with U.S. trade rights and obligations and will not impose unnecessary or unequal restrictions or barriers on either domestic or foreign producers."
United States. Food and Drug Administration; Centers for Disease Control and Prevention (U.S.)
1998-10-26
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Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations for State and Local Agencies
Recommendations on accidental radioactive contamination of human food and animal feeds were issued in 1982 by the Food and Drug Administration (FDA) (FDA 1982, Shleien et al 1982). Since then, there have been enough significant advancements related to emergency planning to warrant updating the recommendations. New scientific information and radiation protection philosophy are incorporated, experience gained since 1982 is included, and guidance developed by international organizations is taken into account (Schmidt 1988a, l988b, 1990, Burnett and Rosenstein 1989). These recommendations provide guidance applicable to accidents at nuclear power plants and many other types of accidents where a significant radiation dose2 could be received as a result of consumption of contaminated food. These recommendations rescind and replace the 1982 FDA recommendations."
United States. Food and Drug Administration; Center for Devices and Radiological Health (U.S.). Office of Health and Industry Programs
1998-08-13
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Accidental Radioactive Contamination of Human Food and Animal Feeds: Recommendations for State or Local Agencies
Recommendations on accidental radioactive contamination of human food and animal feeds were issued in 1982 by the Food and Drug Administration (FDA). Since then, there has been enough significant advancement related to emergency planning to warrant updating the recommendations. This document incorporates new scientific information, radiation protection philosophy and experience gained since 1982 to provide updated recommendations and guidance.
United States. Food and Drug Administration
1998-08-13
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Cost Analysis of regulatory Options to Reduce the Risk of an Outbreak of Transmissible Spongiform Encephalopathies (TSEs) in the United States
This analysis summarizes the regulatory impacts of the FDA final rule and provides further documentation on several topics relating to the costs and benefits of FDA regulation of the TSE hazard, as requested by FDA.
United States. Food and Drug Administration
1997-04-30
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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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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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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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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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Strategic Priorities 2011-2015: Responding to the Public Health Challenges of the 21st Century
This plan presents the Food and Drug Administration's (FDA) priorities from 2011 through 2015. "FDA's primary responsibility is to protect the American people from unsafe or mislabeled food, drugs, and other medical products and to make sure consumers have access to accurate, science-based information about the products they need and rely on every day. The agency also guides and oversees the development and availability of effective new medical products and new food products that harness the latest advances in science and technology to improve the health and well-being of American consumers. [...] The purpose of this document is to outline FDA's strategic intentions and plans for the next five years (2011 - 2015). This document is intended to communicate the Commissioner's key priorities, including cross-cutting strategic priorities, program-specific strategic goals, and long-term objectives. These goals and objectives provide the vehicle for focusing agency efforts to achieve FDA's public health mission and to fulfill our role in supporting the larger mission and strategic goals of [the Department of Health and Human Services]." In supporting the aforementioned mission, the FDA's long-term objective is to "increase the nation's preparedness to address threats as a result of bioterrorism, pandemic and emerging infectious diseases."
United States. Food and Drug Administration
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Consumer's Guide to Food Safety: Severe Storms and Hurricanes
This page from the Food Safety Inspection Service provides information on food safety during an emergency resulting from severe storms or hurricanes. "Did you know that a flood, fire, national disaster, or the loss of power from high winds, snow, or ice could jeopardize the safety of your food? Knowing how to determine if food is safe and how to keep food safe will help minimize the potential loss of food and reduce the risk of foodborne illness. This Consumer's Guide will help you make the right decisions for keeping your family safe during an emergency."
United States. Food and Drug Administration
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U.S. Food and Drug Administration: Foods [website]
This is the Food and Drug Administration [FDA] Foods website. It provides links to news, safety programs, programs, and areas of special interests as it relates to food safety.
United States. Food and Drug Administration
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Home Preparation Procedure for Emergency Administration of Potassium Iodide Tablets to Infants and Small Children
"In the event of accidental release of radioactive iodine into the atmosphere, potassium iodide (KI) is recommended for use as an aid to other emergency measures, such as evacuation and food control measures. When used correctly, potassium iodide can prevent or reduce the amount of radioactive iodine taken up by the thyroid gland. The government stockpiles potassium iodide for emergency uses, such as in the event of an unexpected release of radioactive iodide. Potassium iodide (KI) is stockpiled as tablets because tablets are easier to store; however, infants and small children cannot swallow tablets. In an emergency such as an unexpected release of radioactive iodine, the potassium iodide tablets may need to be given to infants and children by their parents or caregivers. Since potassium iodide dissolved in water may be too salty to drink, the Food and Drug Administration (FDA) is providing parents or caregivers with instructions on how to mix the potassium iodide tablets with a food or a drink to disguise the taste so infants and small children will take the medicine in an emergency."
United States. Food and Drug Administration
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Strategic Partnership Program Agroterrorism (SPPA) Initiative: Final Summary Report September 2005 - September 2008
"To assist in protecting the nation's food supply, the Federal Bureau of Investigation (FBI), Department of Homeland Security (DHS), U.S. Department of Agriculture (USDA), and the Food and Drug Administration (FDA) developed a joint assessment program, the Strategic Partnership Program Agroterrorism (SPPA) Initiative. The purpose of this initiative was to conduct a series of assessments of the food and agricultural sector in collaboration with private industry and State volunteers. These assessments supported the requirements for a coordinated food and agriculture infrastructure protection program as stated in the National Infrastructure Protection Plan (NIPP), Sector Specific Plans (SSP), National Preparedness Guidelines (released in 2007), and Homeland Security Presidential Directive 9 (HSPD-9), Defense of US Agriculture and Food. SPPA assessments were conducted on a voluntary basis between one or more industry representatives for a particular product or commodity, their trade association(s), and Federal and State Government agricultural, public health and law enforcement officials. Together, they conducted a vulnerability assessment of that industry's production process using the CARVER + Shock tool. The acronym 'CARVER' stands for the factors assessed: Criticality, Accessibility, Recuperability, Vulnerability, Effect, Recognizability, and Shock. As a result of each assessment, participants identified individual nodes, or process points that are of highest concern, protective measures and mitigation steps that may reduce the vulnerability of these nodes, and research gaps/needs. Discussions of mitigation steps and good security practices were general in nature, focusing on physical security improvements for food processing facilities and biosecurity practices and disease surveillance for livestock and plants."
United States. Food and Drug Administration
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U.S. Food and Drug Administration: Emergency Preparedness and Response
This U.S. Food and Drug Administration webpage provides information and resources on emergency preparedness and response. Topics on the webpage include: "Crisis Management"; "Counterterrorism and Emerging Threats"; "Medical Countermeasures"; "National Incidents Management System Implementation"; "Emergency Preparedness"; and "Emergency Response".
United States. Food and Drug Administration
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U.S. Food and Drug Administration: For Health Professionals
This U.S. Food and Drug Administration webpage provides information and resources for health professionals. Topics on the webpage include: "Articles of Interest"; "Biologics"; "Cosmetics"; "Drugs"; "Food Safety and Nutrition"; "Medical Devices"; and "Radiological Health".
United States. Food and Drug Administration
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United States Food and Drug Administration Food Defense [website]
This website presented by the United States Food and Drug Administration (FDA) offers tools and resource pertaining to food defense. "FDA works with other government agencies and private sector organizations to help reduce the risk of tampering or other malicious, criminal, or terrorist actions on the food and cosmetic supply."
United States. Food and Drug Administration
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Food Defense Plan Builder
This webpage from United States Food and Drug Administration (FDA) offers the Food Defense Plan Builder which "is a user-friendly software program designed to assist owners and operators of food facilities with developing personalized food defense plans for their facilities. This user-friendly tool harnesses existing FDA tools, guidance, and resources for food defense into one single application. The Food Defense Plan Builder guides the user through the following sections: [1] Company Information [2] Broad Mitigation Strategies [3] Vulnerability Assessment [4] Focused Mitigation Strategies [5] Emergency Contacts [6] Action Plan [7] Supporting Documents".
United States. Food and Drug Administration
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Home Use Devices: How To Prepare For and Handle Power Outages for Medical Devices that Require Electricity
"As a home medical device user, it is important that your device works during a power outage and that you have a plan in place to ensure you know what to do. This completed booklet will help you have an established plan to obtain and organize your medical device information, take necessary actions so that you can continue to use your device, have the necessary supplies for the operation of your device, and know where to go or what to do during a power outage. If you use more than one medical device, you should complete a booklet for each device and ask your healthcare professional to help you. Remember to update this booklet as your treatment, doctors, caregivers, or personal contacts change."
United States. Food and Drug Administration
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Food Defense Mitigation Strategies Database
"This database is one of several tools developed by the FDA [Food and Drug Administration] for the food industry to help protect our nation's food supply from intentional acts of contamination or tampering. Specifically, this resource is designed for companies that produce, process, store, package, distribute, or transport food or food ingredients. It provides a range of preventive measures that companies may choose to better protect their facility, personnel, and operations. These safety measures are specific to individual categories that impact every step of the food production and distribution process."
United States. Food and Drug Administration
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Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health
"Medical devices play a crucial role in the treatment and diagnosis of illness and disease. They range from common medical supplies (bandages, hospital gowns) to complex instruments that help save and sustain life (heart valves, artificial pancreas). They include tools that aid in the detection of disease (MRIs [magnetic resonance imaging], in vitro diagnostics) and digital technology that is driving a revolution in health care (medical apps, surgical planning tools, closed loop drug delivery devices). [...] Although medical devices provide great benefits to patients, they also present risks. FDA's public health responsibilities span the life cycle of medical devices and, at every stage, FDA must make well-supported regulatory decisions, taking into account the totality of the evidence, to determine whether the benefits outweigh the risks."
United States. Food and Drug Administration
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Latest COVID-19 Information from the FDA [website]
From the Website: "'Along with other federal, state, and local agencies and public health officials across the country, the FDA continues critical work to protect public health during the COVID-19 [coronavirus disease 2019] pandemic.'" This website contains various COVID-19 resources from the FDA.
United States. Food and Drug Administration
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Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Cleveland Clinic 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 Cleveland Clinic 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
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Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [Wren Laboratories COVID-19 PCR 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 Wren Laboratories COVID-19 PCR [polymerase chain reaction] 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
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Fact Sheet for Healthcare Providers: LifeHope 2019-nCoV Real-Time RT-PCR Diagnostic 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 LifeHope 2019-nCoV [novel coronavirus] Real-Time RT-PCR [reverse transcription polymerase chain reaction] Diagnostic 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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Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [MD Anderson High-Throughput 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 MD Anderson High-throughput 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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Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [PCL SARS-CoV-2 Real-Time 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 PCL SARS-CoV-2 Real-Time RT-PCR [Patients Choice Laboratories severe acute respiratory syndrome coronavirus 2 real time 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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Fact Sheet for Healthcare Providers: Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Tests [MiraDx SARS-CoV-2 RT-PCR]
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 MiraDx SARS-CoV-2 RT-PCR [severe acute respiratory syndrome coronavirus 2 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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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
