Determining how restricted a certain medical device or drug should be in order to effectively protect consumers is certainly a difficult and somewhat abstract task. Assessing the risks and possible side effects requires a tremendous amount of effort and even then, there is almost never a 100% certainty that those observations are accurate. Therefore, when we acknowledge the restrictions and guidelines the FDA imposes on companies for these products, it is important to understand that it is better safe than sorry. It would obviously be counter-intuitive to produce a product that resulted in harming consumers that intend to improve the quality of their lives so to ensure the prevention of that is more helpful than not. Of course without such strict requirements, we may have an increase in the development of innovative medical technology, but it will come at a cost to great to justify. In addition, it is important to note that the medical device industry is, well, and industry. It consists of multiple competitive companies, all working to provide the best products as quickly as possible. This, as a result, often leads to a disregard for quality and safety which would otherwise be a severe issue without the enforcement the FDA imposes.