How are Medical Devices Classified?
Device Classification determines, among other things, the type of premarketing submission/application required for FDA clearance to market. • Class I Class I devices are subject to the least regulatory control. They present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Bandage scissors are a Class I device. • Class II Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances. Therefore additional (special) controls (tests and validation) are required to demonstrate safety and effectiveness. Patient Monitors fall under this category. • Class III Class III is the most stringent regulatory category for devices. Class III devices are those for which insufficient information exists to assure safety and effectiveness solely through general and special controls. Class III devices are usually those that support or sust
