Table 4.

The three groups in which devices can be classified into under Food and Drug Administration (FDA) rules [144].

Class	Description
I	Devices are subject to a comprehensive set of regulatory authorities called general controls that are applicable to all classes of devices.
II	Devices for which general controls, by themselves, are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance.
III	Devices for which general controls, by themselves, are insufficient and for which there is insufficient information to establish special controls to provide reasonable assurance of the safety and effectiveness of the device. Class III devices typically require premarket approval.