The FDA has very strict guidelines that have to be followed in order to have a device reach the market. These protocols are just standard for FDA. The device may also need to be classified in terms of a Class I, II, III device. The FDA wants to make sure that the device does not malfunction and it is used appropriately and with essentially no harm to others. 44% of voluntary recalls could have been prevented by adequate design controls, which is why the FDA stepped in to make specific requirements for certain products. The FDA will consider the human interaction and the potential of the device to cause any harm that can potentially be fatal to the individual. It also has to approve of the premarket approval application and continue to inspect the device to make sure no changes are made and they are performing to the utmost ability.