Although FDA approval is very useful to protect public health thru controlling medical devices and pharmaceutical drugs and ensure safety and effectiveness. Some of the most important points to be followed by the design process team in order to ensure production efficiency is to meet the pre-set development goals in a well-studied time frame (the device launch date). Another point is to meet the medical device market aims and learn about other competitors. It is also important to meet all the FDA main demands before submitting the product for regulation such as meeting the Premarket Approval (PMA) application needs or a Premarket Notification 510(k) requirements and labeling.