Law302 Foodand Drug Administration Essay

2948 words - 12 pages

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Administrative Law - Food and Drug AdministrationAdministrative Law - Food and Drug AdministrationThis course has touched on many legal aspects that are pertinent to business managers in today's business world. One chapter addressed during the course of this class has stood out more than any other to me. In chapter 6, administrative law and the importance of administrative agencies was addressed. According to Bagley (2013 p.145) "Administrative law concerns the powers and procedures of administrative agencies, such as the Internal Revenue Service (IRS), which collects taxes, and the Securities and Exchange Commission (SEC), which regulates the securities markets." One administrative agency, in particular, effects my professional life on an everyday basis. The Food and Drug Administration (FDA) is a federal agency attached to the Department of Health and Human Services and regulates all medical devices manufactured and sold within the United States. For the last eighteen years, I have worked for a company which designs, develops and manufactures medical devices. Each day I make decisions and take actions which have are based on existing FDA regulations. Failure to meet FDA regulations could result in fines and criminal prosecution for both me and my company. More importantly, failure to meet FDA regulations when manufacturing devices could result in an end users injury or death. Although I have used the FDA code of Federal Regulations, I have never learned how they came into existence, are changed, and the penalties for not adhering to them. That being said, I wanted to research the history of the Food and Drug Administration, how rules and regulations are enacted and changed, how the regulations apply to my job, and the ramifications of not adhering to the Code of Federal Regulations. A history of the FDA, how federal regulations are enacted and/or changed, how the code of federal regulations applied to my job, and consequences of failing to adhere to FDA regulations are summarized below.The origin of medical device regulation in the United States can be traced back to 1906 with the passage of the Food and Drug Act. With the passage of the Food and Drug Act, the U.S. government was given the power to interrupt manufacture and sales of foods, drugs, and devices which were deemed unsafe or had misleading claims of effectiveness (Sall 2013). In 1927, the U.S. Food and Drug Administration (FDA) was formed in order to administer the concepts of the Food and Drug Act. In 1938, through the passage of the Federal Food, Drug, and Cosmetic Act the FDA was given the authority to seize any products or devices deemed unsafe or mislabeled. As more and more drugs and medical devices were introduced into the market, the decision was made for premarket review of medical devices, rather than just enforcement of seizure of problematic devices. In order to address this issue, congress passed the Drug Amendments of 1962...

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