Risk-benefit assessment is the foundation for FDA’s decision making process in terms of its medical device regulations. This assessment helps to determine whether the advantages a medical device brings to the public outweighs the risks that it might have associated with it. FDA not only focuses on the benefit, but also pays close attention to the extent of that benefit in determining whether the device should be cleared or not. It takes into account factors such as whether the quality of life is increased, how it is increased and for how long these effects will last. Another factor FDA looks at is the medical necessity of the product. They want to make sure that the product being proposed addresses an unmet need in the market. Also, they want to make sure that there are no other cleared products on the market that can be used in treatment of whatever disease the new proposed product is aiming to treat.