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 […]
New from CDRH
The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on October 24, 2019. To view listings for other dates, see CDRH New – News and Updates. Federal Register: Orthopedic Devices; Classification of Orthopedic Surgical Instrumentation Designed for Osteochondral Implants with Press-Fit Fixation Federal Register: Physical Medicine Therapeutic Devices; Classification of the Internal Therapeutic […]