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Category: FDA

26Jul
Thoracolumbosacral Pedicle Screw System Performance Data from the FDA
By Brian Buckin FDA

Thoracolumbosacral Pedicle Screw System Performance Data from the FDA

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…

16Oct
Biocompatibility Pulse Check: How FDA’s New Requirements Affect Our Industry
By adminin FDA, Medical, Product Development

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…

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