This final rule classifies posterior cervical screw systems as class II devices with special controls. Although posterior cervical screw systems are currently unclassified, manufacturers currently must submit a 510(k) premarket notification to market these devices. We conclude that class II special controls in addition to general controls will reasonably ensure the safety and effectiveness of these medical devices. The one-time costs include the relabeling of affected devices to comply with the labeling requirements of the final rule, and the time needed to read and understand the final rule. We estimate the total one-time costs equal $503,700. Annualized over 10 years, the costs equal $62,777 at a 7 percent discount rate and $52,853 at a 3 percent discount rate. We did not quantify benefits for this rule.

Regulatory Impact Analysis

Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems (Final Rule) (PDF - 127KB)

Federal Register: 84 FR 22088, April 1, 2019

Docket: FDA-2015-N-3785