Summary of FDA Legislation The Food and Drug Administration is the first federal agency designed to protect consumers from harm. The Food and Drug Administration (FDA) was established in 1906 with the passage of the 1906 Pure Food and Drug Act and is considered the oldest consumer protection agency in the federal government (FDA, 2015). The Food and Drug Act was also developed in 1906, which, authorized the FDA to pursue action against drug companies if a drug caused harm to consumers. The Safe Medical Device Act was established in 1990 to ensure that hospitals report any form of medical device related injury or illness of patients or staff would be reported to the manufacturer of the device. In addition, if the medical device caused death …show more content…
They provided a voice for the American people providing an accurate picture of living conditions in communities. Upton Sinclair was as famous writer that wrote a novel called The Jungle that provided an accurate description of the living conditions of immigrants in Chicago and the industrial industry. The novel caused a heightened concern for safety from consumers and public officials and also targeted concerns of sanitary issues and packaging violation in the meatpacking industry. Upton Sinclair was considered a muckraker journalist that was responsible for inspiring public outrage which, cause numerous political movements in the early 1900’s. Sinclair’s novel, the Jungle exposed the inhumane living conditions and treatment of immigrants while also exposing the unsanitary conditions of the meat packaging industry. The publication fueled the enactment of the Pure Food and Drug Act of …show more content…
115). The Federal Food, Drug, and Cosmetic Act of 1938 covered the initial laws aimed to protect consumers from medical devices. Unfortunately, the law only covered the sale of medical devices that were believed to be unsafe or misleading claims of effectiveness (Shi & Singh, 2013, p.117). In 1970, there were over 200,000 women that claimed injury linked to use of the Dalkon Shield, which was believed to be an effective means of contraceptive (Kolata, 1987). As a result of the Dalkon Shield Disaster, the government passed an amendment that required premarket reviews of medical devices to ensure the safety of