The US Food and Drug Administration (FDA) has proposed a rule change with regard to posterior cervical screw systems.
The FDA wishes to classify these systems as class II, which reflects ‘special controls’. Premarket notification will still be required to provide a reasonable assurance of safety and effectiveness of the device.
According to the FDA website, ‘special controls’ reflect regulatory requirements. “FDA classifies into class II devices for which general controls alone 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,” the website explains.