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In Brief: Sofamor Danek

This article was originally published in The Gray Sheet

Executive Summary

Sofamor Danek: Submits an additional 140 pages of comments to FDA on the agency's proposal to downclassify pedicle bone screws to Class II. The May 2 comments, which supplement Sofamor Danek's 161-page submission to FDA on March 4, respond to March 1 comments submitted by a group of plaintiffs' lawyers coordinating nationwide pedicle screw liability litigation. Sofamor Danek's comments defend the validity of data supporting Class II status of the devices and the integrity of the downclassification process. In an effort to expedite its review of nearly 2,000 pedicle screw comments, FDA has established a formal working group represented by a "broad range" of expertise in the agency's Office of Device Evaluation...



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