Medical Equipment Classification Guide
The Food and Drug Administration (FDA) has established classifications for about 1,700 different generic kinds of Medical Equipments and Devices and grouped them into 16 medical specialities mentioned as panels. Each of those generic sorts of Medical Equipment and Device is assigned to at least one of three regulatory classes supported the extent of control necessary to assure the security and effectiveness of the device. The three classes and therefore the requirements which apply to them are. 1.) Class 1 General Controls Medical Equipments and Devices With Exemptions Medical Equipments and Devices Without Exemptions. 2.) Class 2 General Controls and Special Controls Medical Equipments and Devices With Exemptions Medical Equipments and Devices Without Exemptions. 3.) Class 3 General Controls and Premarket Approval The class to which your device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to plug. If your devi...