This is a good question where it brings up the issue where the definition for significant risk is relative. There may be varying perspectives in the proper definition of the term and this can cause an argument on the possible drawbacks of the device. However, despite the relativity in reality, the true perspective definition that controls the flow of things is the FDA’s. They are the decisive force on what qualifies to be a significant risk for a user. In my opinion, significant risk refers to physically disabling drawbacks and condition-worsening effects posed by a device. The product must be evaluated with these “risks” in order to see whether or not placing the product in the market where customers can use it would be practical. The regulation must check whether or not the drawbacks of the device are acceptable. Also, during the clinical trial phase, when these problems are diagnosed, solutions must be presented in order to improve the device.