Depending upon the class of the device FDA regulations do vary. The rules also vary accordingly depending upon the risk of the device. Device prototype is the most important part where a basic structure is shown and the properties and importance of the device is estimated.Refining the prototype provides researchers with important information about the product’s potential use for people. The prototype process attempts to reduce risk of harm in people. When the device is under FDA review it has certain things to be taken under concern such as Humanitarian Device Exemption, Premarket Notification and Premarket Approval Application. In addition to all approval process and application of the device into the market, maintenance of the manufacturing and design is the most important thing. FDA officials conduct routine inspections of medical device manufacturing facilities across the United States. Manufacturers may be informed of inspections in advance, or the inspections may be unannounced. Inspections may be routine or caused by a particular problem. The purpose of these inspections is to make sure developers are following good manufacturing practices. FDA can shut down a manufacturing facility if standards are not met.