The Medical Devices Classification dataset contains device names and their associated product codes. The name and product code identify the generic category of a device for FDA. The Product Code assigned to a device is based upon the medical device product classification designated under 21 CFR Parts 862-892.
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:
1. Class I General Controls: With Exemptions or Without Exemptions.
2. Class II General Controls and Special Controls: With Exemptions or Without Exemptions.
3. Class III General Controls and Premarket Approval