In a recent article presented in the Journal of Biomechanics, “Mechanical performance of thoracolumbosacral pedicle screw systems: An analysis of data submitted to the Food and Drug Administration,” members of…
Category: FDA
Biocompatibility Pulse Check: How FDA’s New Requirements Affect Our Industry
We all knew it was coming—new regulations regarding biologics. The U.S. Food and Drug Administration (FDA) issued guidance in 2016 for ISO 10993-1, partially in response to a number of…