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TMJ implant oversight

This article was originally published in The Gray Sheet

Executive Summary

Government Accountability Office finds imperfect post-approval reporting by the three firms with approved implants for temporomandibular joint (TMJ) replacement. TMJ Concepts did not submit five of seven required annual reports between 2000 and 2006; and insufficient information was included in six annual reports from TMJ Implants and one report from Walter Lorenz. While FDA sent deficiency letters to the latter two firms, it was not until GAO's investigation, between October 2006 and August 2007, that FDA asked for the missing reports from TMJ Concepts. The 1GAO study was requested by Sens. Edward Kennedy, D-Mass., Tom Harkin, D-Iowa, and Herb Kohl, D-Wis., and released Oct. 17. It examined FDA's oversight, including premarket concerns and monitoring of sponsor compliance with conditions of approval, for the four TMJ implant devices approved since 1998. All the implants required three-year postmarket studies
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