Spine-Tech spinal implant IDE rejection Aug. 1 reaffirms two-year data rule, company says.
This article was originally published in The Gray Sheet
Executive SummarySPINE-TECH IDE REJECTION AUG. 1 REAFFIRMS TWO-YEAR FOLLOW-UP REQUIREMENT for spinal implant studies, the company maintains in an Aug. 20 citizen's petition to FDA. The spinal implant maker says that its investigational device exemption application for a "new spinal device" was denied by FDA on Aug. 1 because "the protocol did not require two-year follow-up data on all patients in the trial" (emphasis Spine-Tech's). Spine-Tech urges FDA to reject a premarket approval application for Sofamor Danek's Novus LC threaded interbody fusion system due to alleged lack of follow-up data.
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