General, Special Control and Pre Market Approval in Class III Medical devices:
Quality control and safety control mechanisms that are deemed sufficient for the Class I and Class II medical devices are not enough for the third class. The key difference when it comes to these Class III devices is that along with the general control applied to Class I and the special controls applied to Class II, the Class III medical devices need a pre market approval for them. This is inclusive of a scientific review that is to be comprehensive in nature so as to make it certain the device is safe and effective to use.
Additional measures of safety are to be taken with this class of devices because these are made to support and sustain human life and for the well being of people’s health. They either play a role in saving human beings from impairment and if misused or not used safely can cause injury or illness to human beings.