The U.S. Food and Drug Administration (FDA) regulates medical devices. This includes the development, marketing, and monitoring of medical devices. Medical devices are classified into three categories.
The intrauterine device (IUD) is a form of birth control that became popular in the 1960s. An IUD is a device that is inserted into a woman’s body. It prevents a fertilized egg from implanting.
The U.S. Food and Drug Administration (FDA) regulates prescription drugs and medical devices. Physicians frequently prescribe approved drugs for uses that have not been approved by the FDA. This practice is referred to as off-label use. The FDA prohibits manufacturers from promoting off-label use. However, manufacturers indirectly promote the off-label use of their products in a variety of ways that could possibly lead to injury or even death.
Strict product liability means holding the manufacturer or seller of defective products responsible if the product injures a consumer who buys or uses the product. The courts impose liability for personal injury and property damage caused by products that are defectively designed or manufactured.
In a clinical study, human volunteers receive investigational drug therapy. The effects of the treatment are compared with a control group of human volunteers who receive either the standard treatment or a placebo (a sugar pill that has no therapeutic benefit). Researchers are able to conclude whether the experimental drug had a better outcome than the standard treatment. The experimental drug might produce a better outcome, but it might not work. It could prove dangerous or even deadly.