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Diane Publishing Books
FDA Regulation of Medical Devices
Judith A. Johnson (au)
Congress has debated how best to ensure that consumers have access, as quickly as possible, to new and improved medical devices and, at the same time, prevent devices that are not safe and effective from entering or remaining on the market. Medical devices regulation is complex, in part, because of the wide variety of items that are categorized as medical devices; examples range from a simple tongue depressor to a life-sustaining heart valve. The regulation of medical devices can affect their cost, quality, and availability in the health care system. In order to be legally marketed in the U.S., many medical devices must be reviewed by the Food and Drug Admin. (FDA). FDAäó»s Center for Devices and Radiological Health (CDRH) is primarily responsible for medical device review. Contents of this report: Introduction; The Medical Device Review Process: Premarket Requirements; The Medical Device Review Process: Post-Market Requirements; Appendixes. Tables. This is a print on demand report.
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