Buckman Case Testimony At Odds With FDA Pedicle Screw Enforcement
This article was originally published in The Gray Sheet
Executive Summary
A ruling by the U.S. Supreme Court in the pedicle screw case, Buckman Co. v. Plaintiffs' Legal Committee, could influence FDA's enforcement of 21 CFR 801.4 for manufacturers that are aware of off-label use with their products.
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