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. Examples include balloon catheters, prosthetic heart valves, pacemakers, etc. 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. This is where strict guidelines will come into play, mostly because these devices pose the greatest risk. In other words, ensure medical devices are safe. 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. Guidance Notes GN-05 (Date of Issue: 14 Nov.2005), Section 3. Class III Medical Devices Finally, devices with the highest risk for patients are categorized as Class III devices. Identical compliance route to Class IIa devices with an added requirement of a device type examination by a Notified Body. FDA Class II Medical Devices. Guidance Notes for Listing Class II/III Medical Devices. The FDA CDRH classification is based primarily on risk the medical device poses. Types of Class II medical devices include heart rate monitors, x-ray systems, and infusion pumps. 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. 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. Class II medical devices require a little more regulatory control to ensure safety and effectiveness. They must comply with special controls set by the FDA, such as special labeling requirements, performance standards, and more. We make difficult applications easy, so you can focus on making unique devices. The U.S. Federal Drug Administration (FDA) classifies medical devices into three classes, Class I, Class II, and Class III. 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. Class I medical devices are generally deemed low risk and Class III medical devices … _____ For more information For more information regarding classification of medical devices, please do not hesitate to contact the Medical Device … Examples include ventilators and intensive care monitoring equipment. The FDA categorizes medical devices into Class III, Class II and Class I. FDA Class III Medical Devices The classification for a device depends upon the level of risk that is associated with the device. 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