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Under its Abbreviated 510k Program, the U.S. Food and Drug Administration (FDA) outlined guidelines for the Safety and Performance Based Pathway, a fast track for medical devices in well established categories to gain market access. These safety metric guidelines for medical devices such as non-spinal bone screws, magnetic resonance coils, and spinal plating systems will be use by manufacturers creating medical devices similar to ones already on the market.  

Learn more here.  

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