Describe the Medicinal Device Amendment to the Federal Food, Drug, and Cosmetic Act.
In 1976, the United States Congress enacted the Medicinal Device Amendment to the Federal Food, Drug, and Cosmetic Act. This amendment gives the federal Food and Drug Administration (FDA) authority to regulate medicinal devices such as heart pacemakers, kidney dialysis machines, defibrillators, surgical equipment, and other diagnostic, therapeutic, and health devices. The mislabeling of such devices is prohibited. The FDA is empowered to remove "quack" devices from the market.