Challenges of Biotechnology Regulation in the US

The FDA has come under some fire recently after the public caught wind of a story about the FDA’s lenient 510(k) approval process and its shortcomings. Patients can no longer simply trust the word of their doctor on which medical device to choose. Furthermore, doctors are required to be more vigilant when deciding which medical devices they will allow and push to their patients. A great portion of the FDA’s monetary resources goes to the CDRH, and even then, it isn’t enough. This paper will explore different sections of the FDA’s legislature to understand areas that the FDA can improve in. By looking at all the ways that the FDA clears devices for market, categories them by level of danger to human life, and figuring out ways that devices can either be mislabeled and ergo not tested enough, holes in the prevalent regulatory system can be detected. Once issues within the regulatory system are explained, this paper will move on to suggest amendments to the current system, if need be, and call for further research in this field in order to protect the rights and health of patients. Key Words: Biotechnology, Medical Devices, Regulation, 510(k), Premarket Notification, Humanitarian Device Exemption, Premarket Approval, Essure, Dalkon Shield, Theranos, FDA.