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FDA Center For Devices And Radiological Health
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 the ... [...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] |
Steven Nissen
Steven E. Nissen (born 1948) is an American cardiologist, researcher and patient advocate. He was chairman of cardiovascular medicine at the Cleveland Clinic, in Cleveland, Ohio.Steven Nissen MD, physician profil Cleveland Clinic, retrieved 2/2010 Joining Cleveland Clinic in 1992, Nissen served as Vice-Chairman of the Department of Cardiology (1993–2002), Section Head of Clinical Cardiology (1992–2000), and Director of the Coronary Intensive Care Unit (1992–1997). Most recently, he served as Medical Director of the Cleveland Clinic Cardiovascular Coordinating Center (C5), an organization that directs multi-center clinical trials. Nissen still attends in the Cardiac Critical Care Unit periodically throughout the year. Education Nissen graduated high school from the Webb School of California and pursued his undergraduate degree at the University of Michigan. He then went on to receive his medical degree from the University of Michigan School of Medicine in Ann Arbor. He comp ... [...More Info...] [...Related Items...] OR: [Wikipedia] [Google] [Baidu] |
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