Device Guidances Under Safety/Performance Pathway

Federal Register notice: FDA has made available several device-specific draft guidance documents for the agency’s device Safety and Performance Based Pathway. They are: Spinal Plating Systems — Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff; Cutaneous Electrode for Recording Purposes — Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff; Conventional Foley Catheters — Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff; and Orthopedic Non-Spinal Metallic Bone Screws and Washers — Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff. To view the notice, click here.