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.
More on: News Regulatory
Don’t miss the next article from HealthFirst 100.
Join our mailing list to receive the latest posts from our blog directly in your inbox.