I believe that while FDA certifies devices and products for safety, the Quality of the device needs to just above the minimum requirement. Most competitive companies try to achieve much better quality to get the edge over others. No doubt certain times, regulatory bodies fall short in covering up loopholes while setting standards. When technologies improve and grow in a very short time, it must be well regulated by the regulatory bodies keeping the end users in mind. What I feel is, FDA regulations make the companies spend more money in testing the devices or products for safety and/or quality and hence, feel its an unfair practice or even the reason behind the failure to improve the quality of a product.