FDA standards are there to be followed and every manufacturer has to follow the standards. The product should be tested for enough amount of times in suitable working conditions to be sure enough of its working, sustainability, the FDA standards of testing should be taken into consideration for the device testing. There are cases where the devices were recalled for defects in its design one such example is Johnson & Johnson’s DePuy Knee replacement device which was approved under 510(k) in 2010 as there were similar devices in the market at those time hence there was no clinical trial of the device. Soon after there were many reports stating loosening Attune system and a lawsuit was filed as the product had design issues.