Finalization of pedicle bone screw downclassification sought by AANS in comments to FDA.
This article was originally published in The Gray Sheet
FINALIZATION OF PEDICLE BONE SCREW DOWNCLASSIFICATION URGED BY NEUROSURGEONS in a May 6 citizens petition to FDA. The American Academy of Neurosurgeons wants FDA to finalize the rule in order to validate the data used to support downclassification and bolster the group's position in ongoing product liability litigation. In addition, AANS maintains that FDA's "delay in finalizing the downclassification of pedicle fixation devices is causing confusion in both the medical profession and the general public, and is having a chilling effect on the educational programs of the AANS and the other medical societies."
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