Safe Medical Device Amendments Of 1990
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Safe Medical Device Amendments Of 1990
Safe Medical Device Amendments of 1990 or Safe Medical Devices Act sanctioned progressive reporting and tracking rules for medical devices classified by the Medical Device Regulation Act. The Act mandates reporting requirements by medical device manufacturers regarding adverse safety events and product effectiveness of devices classified as substantially equivalent to Class III medical devices. The United States Statute established the Health and Human Services Office of International Relations and a U.S. Food and Drug Administration office for regulatory activities concerning healthcare products which are considered a combinational biological, device, or drug product. The Act of Congress transferred the electronic product radiation control provisions established by the Radiation Control for Health and Safety Act. Congressman Henry A. Waxman and Senator Edward M. Kennedy were the chairperson sponsors of the safe medical device amendments. The H.R. 3095 legislation was passed by t ...
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Federal 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 us ...
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Henry A
Henry may refer to: People *Henry (given name) *Henry (surname) * Henry Lau, Canadian singer and musician who performs under the mononym Henry Royalty * Portuguese royalty ** King-Cardinal Henry, King of Portugal ** Henry, Count of Portugal, Henry of Burgundy, Count of Portugal (father of Portugal's first king) ** Prince Henry the Navigator, Infante of Portugal ** Infante Henrique, Duke of Coimbra (born 1949), the sixth in line to Portuguese throne * King of Germany **Henry the Fowler (876–936), first king of Germany * King of Scots (in name, at least) ** Henry Stuart, Lord Darnley (1545/6–1567), consort of Mary, queen of Scots ** Henry Benedict Stuart, the 'Cardinal Duke of York', brother of Bonnie Prince Charlie, who was hailed by Jacobites as Henry IX * Four kings of Castile: **Henry I of Castile **Henry II of Castile **Henry III of Castile **Henry IV of Castile * Five kings of France, spelt ''Henri'' in Modern French since the Renaissance to italianize the name and to ...
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1990 In Law
Year 199 ( CXCIX) was a common year starting on Monday (link will display the full calendar) of the Julian calendar. At the time, it was sometimes known as year 952 ''Ab urbe condita''. The denomination 199 for this year has been used since the early medieval period, when the Anno Domini calendar era became the prevalent method in Europe for naming years. Events By place Roman Empire * Mesopotamia is partitioned into two Roman provinces divided by the Euphrates, Mesopotamia and Osroene. * Emperor Septimius Severus lays siege to the city-state Hatra in Central-Mesopotamia, but fails to capture the city despite breaching the walls. * Two new legions, I Parthica and III Parthica, are formed as a permanent garrison. China * Battle of Yijing: Chinese warlord Yuan Shao defeats Gongsun Zan. Korea * Geodeung succeeds Suro of Geumgwan Gaya, as king of the Korean kingdom of Gaya (traditional date). By topic Religion * Pope Zephyrinus succeeds Pope Victor I, as th ...
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Health Care Quality
Health care quality is a level of value provided by any health care resource, as determined by some measurement. As with quality in other fields, it is an assessment of whether something is good enough and whether it is suitable for its purpose. The goal of health care is to provide medical resources of high quality to all who need them; that is, to ensure good quality of life, cure illnesses when possible, to extend life expectancy, and so on. Researchers use a variety of quality measures to attempt to determine health care quality, including counts of a therapy's reduction or lessening of diseases identified by medical diagnosis, a decrease in the number of risk factors which people have following preventive care, or a survey of health indicators in a population who are accessing certain kinds of care. Definition Health care quality is the degree to which health care services for individuals and populations increase the likelihood of desired health outcomes. Quality of care p ...
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United States Federal Health Legislation
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 ...
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101st United States Congress
The 101st United States Congress was a meeting of the legislative branch of the United States federal government, composed of the United States Senate and the United States House of Representatives. It met in Washington, DC from January 3, 1989, to January 3, 1991, during the final weeks of the administration of U.S. President Ronald Reagan and the first two years of the administration of U.S. President George H. W. Bush. The apportionment of seats in this House of Representatives was based on the Twentieth Census of the United States in 1980. Both chambers maintained a Democratic majority. Major events * January 20, 1989: George H. W. Bush became President of the United States * February 23, 1989: Senate Armed Services Committee rejected, President Bush's nomination of John Tower for Secretary of Defense * March 24, 1989: Exxon Valdez oil spill * December 20, 1989: Operation Just Cause launched to overthrow Panamanian leader Manuel Noriega Major legislation Enacted * A ...
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General Accounting Office
The U.S. Government Accountability Office (GAO) is a legislative branch government agency that provides auditing, evaluative, and investigative services for the United States Congress. It is the supreme audit institution of the federal government of the United States. It identifies its core "mission values" as: accountability, integrity, and reliability. It is also known as the "congressional watchdog". Powers of GAO The work of the GAO is done at the request of congressional committees or subcommittees or is mandated by public laws or committee reports. It also undertakes research under the authority of the Comptroller General. It supports congressional oversight by: * auditing agency operations to determine whether federal funds are being spent efficiently and effectively; * investigating allegations of illegal and improper activities; * reporting on how well government programs and policies are meeting their objectives; * performing policy analyses and outlining options for ...
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List Of Presidents Of The United States
The president of the United States is the head of state and head of government of the United States, indirectly elected to a four-year Term of office, term via the United States Electoral College, Electoral College. The officeholder leads the Executive (government), executive branch of the Federal government of the United States, federal government and is the commander-in-chief of the United States Armed Forces. Since the office was established in 1789, 45 men have served in 46 presidencies. The first president, George Washington, won a unanimous vote of the Electoral College; one, Grover Cleveland, served two non-consecutive terms and is therefore counted as the 22nd and 24th president of the United States, giving rise to the discrepancy between the number of presidencies and the number of persons who have served as president. The incumbent president is Joe Biden. There are five living former presidents: Jimmy Carter, Bill Clinton, George W. Bush, Barack Obama, and Donald Trum ...
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Legislation
Legislation is the process or result of enrolled bill, enrolling, enactment of a bill, enacting, or promulgation, promulgating laws by a legislature, parliament, or analogous Government, governing body. Before an item of legislation becomes law it may be known as a bill (proposed law), bill, and may be broadly referred to as "legislation" while it remains under consideration to distinguish it from other business. Legislation can have many purposes: to regulate, to authorize, to outlaw, to provide (funds), to sanction, to grant, to declare, or to restrict. It may be contrasted with a non-legislative act by an Executive (government), executive or administrative body under the authority of a legislative act. Overview Legislation is usually proposed by a member of the legislature (e.g. a member of Congress or Parliament), or by the executive, whereupon it is debated by members of the legislature and is often amended before passage (legislature), passage. Most large legislatures enact ...
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Edward M
Edward is an English given name. It is derived from the Anglo-Saxon name ''Ēadweard'', composed of the elements '' ēad'' "wealth, fortune; prosperous" and '' weard'' "guardian, protector”. History The name Edward was very popular in Anglo-Saxon England, but the rule of the Norman and Plantagenet dynasties had effectively ended its use amongst the upper classes. The popularity of the name was revived when Henry III named his firstborn son, the future Edward I, as part of his efforts to promote a cult around Edward the Confessor, for whom Henry had a deep admiration. Variant forms The name has been adopted in the Iberian peninsula since the 15th century, due to Edward, King of Portugal, whose mother was English. The Spanish/Portuguese forms of the name are Eduardo and Duarte. Other variant forms include French Édouard, Italian Edoardo and Odoardo, German, Dutch, Czech and Romanian Eduard and Scandinavian Edvard. Short forms include Ed, Eddy, Eddie, Ted, Teddy and Ned ...
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Radiation Control For Health And Safety Act Of 1968
Radiation Control for Health and Safety Act of 1968 was an amendment to the Public Health Service Act mandating performance standards for electronic products suspectible of electromagnetic radiation or radiation emissions. The United States statute established provisions involving research and development programs for the studies of electromagnetic shielding, ionizing radiation, non-ionizing radiation, and exposure assessment to humans. The Act of Congress was recodified to Title 21 from Title 42 with the passage of the Safe Medical Device Amendments of 1990. The electronic product radiation control provisions are authorized for administrative law purposes by the Federal Food, Drug, and Cosmetic Act. The H.R. 10790 legislation was passed by the 90th United States Congressional session and enacted into law by the 36th President of the United States Lyndon B. Johnson on October 18, 1968. Declaration of Radiation Control Safety Act U.S. Congressional Statement of Purpose :Congres ...
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Medical Device Regulation Act
The Medical Device Regulation Act or Medical Device Amendments of 1976 was introduced by the 94th Congress of the United States. Congressman Paul G. Rogers and Senator Edward M. Kennedy were the chairperson sponsors of the medical device amendments. The Title 21 amendments were signed into law on May 28, 1976, by the 38th President of the United States Gerald R. Ford. The U.S. legislation enacted in 1976 amended the Food, Drug, and Cosmetic Act of 1938 signed by the 32nd President of the United States Franklin D. Roosevelt. History During the 1960s, the Secretary of Health, Education, and Welfare The United States secretary of health and human services is the head of the United States Department of Health and Human Services, and serves as the principal advisor to the president of the United States on all health matters. The secretary is ... (HEW) commissioned the Cooper Committee to study the adverse effects of medical devices for human use. In 1970, the study committee rec ...
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