LAW302 - Foodand Drug Administration

Essay by bradjoe67College, UndergraduateA, November 2014

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Administrative Law - Food and Drug Administration

Administrative Law - Food and Drug Administration

This 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...