Final answer:
The Medical Device Amendment of 1976 established regulations for medical devices, with oversight by the FDA's CDRH. The FDA also monitors the quality of pharmaceuticals, food, and dietary supplements with varying degrees of regulation. Strict safety protocols protect consumers, but can delay the availability of new therapies.
Step-by-step explanation:
The Medical Device Amendment of 1976 provided regulations for medical devices. This amendment to the Federal Food, Drug, and Cosmetic Act introduced significant regulatory mechanisms for ensuring the safety and effectiveness of medical devices placed on the market. Under these regulations, the Center for Devices and Radiological Health (CDRH), a branch of the FDA, oversees the premarket approval, manufacturing, performance, and safety of medical devices. Medical devices range from simple items like toothbrushes to advanced technologies such as implantable brain pacemakers.
Food and Drug Administration (FDA) regulates not just medical devices but also other products, including pharmaceuticals, food safety, and dietary supplements. While dietary supplements are regulated by the FDA, they are treated more like food than drugs, meaning they don't have to meet the stringent approval standards that pharmaceuticals do. However, dietary supplements must still comply with Good Manufacturing Standards set by the FDA.
Regarding pharmaceuticals, the FDA's strict regulatory processes are in place to ensure that only safe and effective medicines reach consumers. In this system, protected individuals ("winners") are those who are not exposed to potentially harmful drugs. However, stringent regulations can sometimes result in delays in getting new drugs to the market, which can adversely affect patients who need them ("losers").