Introduction
Medical devices are classified by the FDA and grouped into 16 medical categories referred to as panels.
A medical device is assigned to a class based on the level of control to assure product
safety and effectiveness. The classes and their requirements are:
- Class I General Controls
- With Exemptions
- Without Exemption
- Class II General Controls and Special Controls
- With Exemptions
- Without Exemption
- Class III General Controls and Premarket Approval