EXTI - only public co. developing liver device Message Board

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Microcap & Penny Stocks : EXTI - only public co. developing liver device

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To: Danny Kim who wrote (202)	2/28/1998 5:02:00 AM
From: CENTrader	of 1063

Overview -- FDA Modernization Act of 1997 (This page last updated: February 19, 1998) ------------------------------------------------------------------------ Foreword Page Contents ------------------------------------------------------------------------ The Center for Devices and Radiological Health (CDRH) develops and implements national programs to protect the public health in the fields of medical devices and radiological health. These programs are intended to assure the safety, effectiveness, and proper labeling of medical devices; to promote quality in mammographic services; and to control unnecessary human exposure to potentially hazardous radiation, and to ensure the safe, efficacious use of such radiation. The basic framework governing the regulation of medical devices is established in the Medical Device Amendments to the Federal Food, Drug, and Cosmetic (FFD&C) Act. The Medical Device Amendments were enacted on May 28, 1976. The FFD&C Act was again amended with respect to the regulation of medical devices by the Safe Medical Devices Act of 1990 and the Medical Device Amendments of 1992. New provisions governing the export of FDA regulated products, including medical devices, were established in the FDA Export Reform and Enhancement Act of 1996. The FFD&C Act was most recently amended by the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). Signed into law on November 21, 1997, the Modernization Act contained provisions related to all products under FDA's jurisdiction. This document summarizes each device-related section of the FDAMA in "plain English." It is not intended to be interpretive or to set forth Agency policy for implementation. More here.... fda.gov

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