Division of Clinical Research

Office of the Vice President and Innovation

Category results for: Bone Screws

FDA Issues New Final Guidances on Safety and Performance Based Pathway Criteria for Certain Device Types

The U.S. Food and Drug Administration (FDA) issued three final guidance documents providing performance criteria for the following device types in support of the Safety and Performance Based Pathway: Spinal Plating Systems Orthopedic Non-Spinal Metallic Bone Screws and Washers Magnetic Resonance Receive-Only Coils Under the Safety and Performance Based Pathway, medical device manufacturers planning to submit […]

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