Spinal systems 510(k) guidance
This article was originally published in The Gray Sheet
Executive Summary
Primary endpoints for clinical trials of spinal systems, including pedicle screw systems and intervertebral body fusion cages, should include fusion or non fusion status, low back or overall pain, and function, a final guidance issued Jan. 24 states. Industry representatives had argued before the Orthopedic and Rehabilitation Devices Panel last year that pain relief was too subjective to be a primary endpoint. The final guidance adds "historical-based study," involving literature or retrospective data, to study design options previously listed in August 1998 draft guidance. "So long as the study design choice effectively addresses the safety and effectiveness of the spinal system and the inherent biases...FDA is committed to...considering the 'least burdensome' means of protocol development," the guidance states
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