The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as panels. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The three classes and the requirements which apply to them are:
Device Class and Regulatory Controls
1. Class I General Controls
2. Class II General Controls and Special Controls
3. Class III General Controls and Premarket Approval
Device classification depends on the intended use of the device and also upon indications for use. Most Class I devices are exempt from Premarket Notification 510(k) (with the exception of Reserved Devices); most Class II devices require Premarket Notification 510(k); and most Class III devices require Premarket Approval (PMA).