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CDRH
The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration (FDA) responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. The CDRH also oversees the radiation safety performance of non-medical devices which emit certain types of electromagnetic radiation, such as cellular phones and microwave ovens. The current head of the CDRH is Jeffrey Shuren, who took over in January 2010. Regulatory classes CDRH splits medical devices into three classes with different regulatory requirements: Class 1 devices include everyday items such as toothbrushes which are unlikely to cause serious consequences if they fail. Manufacturers are required to follow what are called "general controls" which closely match ISO 9000 requirements. In addition to the general controls, Class 2 devices require a premarket notification. This process, commonly known as th ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
FDA Bldg 62 - Exterior (5161375340)
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs, but involves such things as regulating lasers, cellular phones, and condoms, as well as control of disease in contexts varying from ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food And Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, Prescription drug, prescription and Over-the-counter drug, over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, Animal feed, animal foods & feed and Veterinary medicine, veterinary products. The FDA's primary focus is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), but the agency also enforces other laws, notably Section 361 of the Public Health Service Act, as well as associated regulations. Much of this regulatory-enforcement work is not d ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Jeffrey Shuren
Jeffrey Shuren is the Director of the Center for Devices and Radiological Health (CDRH) at the United States Food and Drug Administration (FDA) as of September 2009. According to Shuren, Our center experts and programs help get safe and effective technology to patients and health care professionals on a daily basis. Rapid technological advances enable us to approve such innovations as a diagnostic test for the H1N1 influenza virus, an expandable prosthetic rib for children with abnormal growth conditions, and a test that can help detect ovarian cancer. Accessed 19-Jan-2012. Shuren was responsible for the development of Medicare national coverage determinations for [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Food, Drug And Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations. The introduction of this act was influenced by the death of more than 100 patients due to elixir sulfanilamide, a sulfanilamide medication where the toxic solvent diethylene glycol was use ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Bureau Of State Services
The Bureau of State Services (BSS) was one of three principal operating agencies of the United States Public Health Service (PHS) from 1943 until 1966. The bureau contained the PHS divisions that administered cooperative services to U.S. states through technical and financial assistance, and included significant programs in community health, environmental health, and workforce development. The Bureau was broken up at the beginning of the Public Health Service reorganizations of 1966–1973. The community health and workforce development divisions were eventually merged respectively into two divisions of the Health Resources and Services Administration, with the exception of the division that became the Centers for Disease Control and Prevention (CDC). Most of the Bureau's environmental health divisions became the core of the Environmental Protection Agency when it was created in 1971, with the remaining two divisions becoming the National Institute for Occupational Safety a ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Cleveland Clinic
Cleveland Clinic is a nonprofit American academic medical center based in Cleveland, Ohio. Owned and operated by the Cleveland Clinic Foundation, an Ohio nonprofit corporation established in 1921, it runs a 170-acre (69 ha) campus in Cleveland, as well as 11 affiliated hospitals, 19 family health centers in Northeast Ohio, and hospitals in Florida and Nevada. International operations include the Cleveland Clinic Abu Dhabi hospital in the United Arab Emirates and Cleveland Clinic Canada, which has two executive health and sports medicine clinics in Toronto."Facts & Figures" Cleveland Clinic. Another hospital campus in the United Kingdom, Cleveland Clinic London, opened to outpatients in 2021 and is scheduled to fully open in 2022. Tomislav Mihaljevic is the president and CEO. Cleveland Cl ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Arthur H
Arthur Higelin (born 27 March 1966), better known under his stage name Arthur H (), is a French pianist, songwriter and singer. He is best known in France for his live performances—four of his albums were recorded live. Life and career He is the son of the French singer Jacques Higelin and Nicole Courtois, and half brother of singers Izïa Higelin and stage and film actor, theatre director and music video director Kên Higelin. After traveling in the West Indies, he studied music in Boston before returning to Paris and developing his eclectic but highly personal musical style, drawing on such influences as Thelonious Monk, Serge Gainsbourg, the Sex Pistols, jazz, blues, Middle Eastern music and the tango. He first performed in 1988 in clubs in Paris, as leader of a trio with bassist Brad Scott and drummer Paul Jothy. His first album, ''Arthur H'' (1990), combined rhythmic experimentation and '' bal-musette'' elements with a vocal style which has been compared to Tom Waits ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Medical Devices
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase. Discovery of what would be considered a medical device by modern standards dates as far back as c. 7000 BC in Baluchistan where Neolithic dentists used flint-tipped drills and bowstrings. Study of archeology and Roman medical literature also indicate that many types of medical devices were in widespread use during the time of ancient Rome. In the United States it wasn't until the Federal Food, Drug, and Cosmetic Act (FD&C ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biologic Medical Product
A biopharmaceutical, also known as a biological medical product, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semisynthesized from biological sources. Different from totally synthesized pharmaceuticals, they include vaccines, whole blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living medicines used in cell therapy. Biologics can be composed of sugars, proteins, nucleic acids, or complex combinations of these substances, or may be living cells or tissues. They (or their precursors or components) are isolated from living sources—human, animal, plant, fungal, or microbial. They can be used in both human and animal medicine. Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. Some regulatory agencies use the terms ''biologi ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
Biotechnology Revolution
Biotechnology is the application of scientific and engineering principles to the processing of materials by biological agents to provide goods and services. From its inception, biotechnology has maintained a close relationship with society. Although now most often associated with the development of drugs, historically biotechnology has been principally associated with food, addressing such issues as malnutrition and famine. The history of biotechnology begins with zymotechnology, which commenced with a focus on brewing techniques for beer. By World War I, however, zymotechnology would expand to tackle larger industrial issues, and the potential of industrial fermentation gave rise to biotechnology. However, both the single-cell protein and gasohol projects failed to progress due to varying issues including public resistance, a changing economic scene, and shifts in political power. Yet the formation of a new field, genetic engineering, would soon bring biotechnology to the forefro ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States Environmental Protection Agency
The Environmental Protection Agency (EPA) is an independent executive agency of the United States federal government tasked with environmental protection matters. President Richard Nixon proposed the establishment of EPA on July 9, 1970; it began operation on December 2, 1970, after Nixon signed an executive order. The order establishing the EPA was ratified by committee hearings in the House and Senate. The agency is led by its administrator, who is appointed by the president and approved by the Senate. The current administrator is Michael S. Regan. The EPA is not a Cabinet department, but the administrator is normally given cabinet rank. The EPA has its headquarters in Washington, D.C., regional offices for each of the agency's ten regions and 27 laboratories. The agency conducts environmental assessment, research, and education. It has the responsibility of maintaining and enforcing national standards under a variety of environmental laws, in consultation with sta ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
United States Public Health Service Reorganizations Of 1966–1973
United may refer to: Places * United, Pennsylvania, an unincorporated community * United, West Virginia, an unincorporated community Arts and entertainment Films * ''United'' (2003 film), a Norwegian film * ''United'' (2011 film), a BBC Two film Literature * ''United!'' (novel), a 1973 children's novel by Michael Hardcastle Music * United (band), Japanese thrash metal band formed in 1981 Albums * ''United'' (Commodores album), 1986 * ''United'' (Dream Evil album), 2006 * ''United'' (Marvin Gaye and Tammi Terrell album), 1967 * ''United'' (Marian Gold album), 1996 * ''United'' (Phoenix album), 2000 * ''United'' (Woody Shaw album), 1981 Songs * "United" (Judas Priest song), 1980 * "United" (Prince Ital Joe and Marky Mark song), 1994 * "United" (Robbie Williams song), 2000 * "United", a song by Danish duo Nik & Jay featuring Lisa Rowe Television * ''United'' (TV series), a 1990 BBC Two documentary series * ''United!'', a soap opera that aired on BBC One from 1965-19 ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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