The FDA CDRH classification is based primarily on risk the medical device poses. A Class III Medical device are very complicated and intricate in design. Guidance Notes for Listing Class II/III Medical Devices. Class I medical devices are generally deemed low risk and Class III medical devices … Identical compliance route to Class IIa devices with an added requirement of a device type examination by a Notified Body. The U.S. Federal Drug Administration (FDA) classifies medical devices into three classes, Class I, Class II, and Class III. FDA Class III Medical Devices They must comply with special controls set by the FDA, such as special labeling requirements, performance standards, and more. There are no regulatory quality system requirements for Class 1 medical devices. These devices either support human life and are of substantial importance in preventing impairment of human health, or they present a potential, unreasonable risk of illness or injury. There are four device classifications--Class I, II, III and IV--using a set of 16 rules found in Schedule 1, Part 1 of the Canadian Medical Devices Regulations (CMDR) SOR/98-282. Class III follows the same guidelines as I and II, but also has to have pre-market approval by the FDA, a scientific review before marketing. The FDA categorizes medical devices into Class III, Class II and Class I. The classification for a device depends upon the level of risk that is associated with the device. Class II medical devices require a little more regulatory control to ensure safety and effectiveness. Class III Medical Devices Finally, devices with the highest risk for patients are categorized as Class III devices. Types of Class II medical devices include heart rate monitors, x-ray systems, and infusion pumps. If your medical device is a Class II device, your company will most likely need to perform a FDA 510(k) submission in order to satisfy FDA Medical Device Registration requirements for clearance to market. Class I, II, and III Medical Devices. This is where strict guidelines will come into play, mostly because these devices pose the greatest risk. FDA Class II Medical Devices. Medical devices are classified according to Health Canada's risk-based system. Guidance Notes GN-05 (Date of Issue: 14 Nov.2005), Section 3. Examples include ventilators and intensive care monitoring equipment. Class III Devices – Class III devices are strictly high risk devices. In the U.S., medical devices are either Class I, Class II, or Class III. Class III In other words, ensure medical devices are safe. The Medical Device regulations require Class II, III and IV medical devices to be manufactured (Class II) or designed and manufactured (Class III and IV) under CAN/CSA ISO 13485:2003. 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