SPINAL IMPLANT FOLLOW-UP REQUIREMENTS MAY RECEIVE FURTHER PUBLIC DISCUSSION, AGENCY SAYS; TWO-YEAR DATA STANDARD UPHELD BY ADVISORY PANEL
This article was originally published in The Gray Sheet
Executive Summary
FDA may conduct further meetings to discuss the feasibility of spinal implant data follow-up lengths of less than two years, Celia Witten, Director of the Division of General and Restorative Devices in FDA's Office of Device Evaluation, reported at a Dec. 11 meeting of FDA's Orthopedic and Rehabilitation Devices Panel in Bethesda, Maryland.