CDRH New September 20, 2019

The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on September 19, 2019. To view listings for other dates, see CDRH New - News and Updates.

Collaborative Communities: Addressing Healthcare Challenges Together Webinar: Collaborative Communities - October 29, 2019 FDA in Brief: FDA announces participation in first two ‘Collaborative Communities’ working to develop solutions to medical device innovation challenges Framework for the Safety and Performance Based Pathway Webinar - Safety and Performance Based Pathway Performance Criteria - November 7, 2019 Safety and Performance Based Pathway - Guidance for Industry and Food and Drug Administration Cutaneous Electrodes for Recording Purposes - Performance Criteria for Safety and Performance Based Pathway - Draft Guidance for Industry and Food and Drug Administration Staff Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway - Draft Guidance for Industry and Food and Drug Administration Staff Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway - Draft Guidance for Industry and Food and Drug Administration Staff Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices (Medical Product Safety Network) Federal Register: Safety and Performance Based Pathway Device-Specific Guidance; Draft Guidances for Industry and Food and Drug Administration Staff