Medical Devices: Sophisticated Legislation after Long Struggle

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Abstract
The Federal Food and Drug Administration (FDA) has finally achieved enactment of comprehensive legislation that will strictly regulate the growing medical-devices industry. The battle has taken over 10 years. Each year the FDA tried again to expand its jurisdiction from drugs, cosmetics and food to medical equipment and devices, everything from tongue depressors to heart-lung machines, and the industry lined up the opposition. Leading physicians in medical practice and clinical research were in the front lines of the witnesses objecting to the bills, year after year. The primary concern of the medical witnesses was that federal regulation would substantially delay . . .

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