The FDA issued a final rule cementing posterior cervical screw systems as a class 2 device and will maintain the premarket notification requirement.
Five things to know:
1. Effective May 1, the FDA classified posterior cervical screw systems as a class 2 device, defining a posterior cervical screw system as a device "used to provide immobilization and stabilization in the cervical spine as an adjacent to spinal fusion surgery." This definition distinguishes the device from thoracolumbosacral pedicle screw systems that are used in other regions of the spine.
2. The FDA developed the final rule based on a recommendation from the Orthopaedic and Rehabilitation Devices Panel and accepted public comment on the proposed rule. The agency expects its final rule to assure device safety and effectiveness.
3. Manufacturers of posterior cervical screw systems are now required to develop devices with special controls, including:
• A design with consistent geometry and material composition for intended device use
• Demonstrated mechanical function and durability in nonclinical performance testing
• Biocompatible device components
• Demonstrated cleanliness and sterility in validation testing, or the ability to clean and sterilize the device
• Clear technological features description, intended use indications, device-specific warnings and contraindications on the device label
4. The FDA estimated the final rule could impact 32 device manufacturers that develop 38 products.
5. Companies that manufacture posterior cervical screw systems will likely see a one-time cost of $78.69 to read and understand the rule as well as a $13,189 one-time cost per project for labeling. The agency estimated the total cost of the rule at $503,700.