- 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- Cutaneous Electrodes for Recording Purposes – Performance Criteria for Safety and Performance Based Pathway – Draft Guidance for Industry and Food and Drug Administration Staff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Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway – Draft Guidance for Industry and Food and Drug Administration Staff
- Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway – Draft Guidance for Industry and Food and Drug Administration Staff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
Posted at Marcelo's Medicaldevice.expert website...
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