2016 Meeting Materials of the Microbiology Devices Panel

November 9-10, 2016: Meeting Materials FDA Generated

• Waiver: Randall T. Hayden, M.D.
• Acknowledgment: Randall T. Hayden, M.D.
• Waiver: Michael G. Ison, M.D., M.S.
• Acknowledgment: Michael G. Ison, M.D., M.S.
• Waiver: Joanna M. Schaenman, M.D., Ph.D.
• Acknowledgment: Joanna M. Schaenman, M.D., Ph.D.
• Agenda: Nov. 9, 2016
• Roster: Nov. 9, 2016
• Panel Questions: Nov. 9, 2016
• FDA Executive Summary: Nov. 9, 2016
• Presentation - Device Reclassification: Nov. 9, 2016
• Presentation - Discussion and Recommendations for the Classification of Quantitative Viral Load Assays for Transplant-associated Opportunistic Viral Infections: Nov. 9, 2016
• Presentation - Background of CMV Regulatory Path and Intended Use: Nov. 9, 2016
• Presentation - FDA Perspective on CMV Viral Load Assay Reclassification: Nov. 9, 2016
• Presentation - EBV and BK Viruses: Nov., 9, 2016
• Agenda: Nov. 10, 2016
• Roster: Nov. 10, 2016
• FDA Executive Summary: Nov. 10, 2016
• FDA Executive Summary - Errata: Nov. 10, 2016
• Presentation - Clinical Considerations for Procalcitonin-Guided Evaluation and Management of Lower Respiratory Tract Infections and Sepsis: Nov. 10, 2016
• Presentation - Procalcitonin for the Evaluation and Antibiotic Management of Suspected Lower Respiratory Tract Infections and Sepsis: Nov. 10, 2016
• Presentation - Statistical Considerations for Procalcitonin-Guided Evaluation and Management of Lower Respiratory Tract Infections and Sepsis: Nov. 10, 2016
• 24 Hour Summary: Nov. 9, 2016
• 24 Hour Summary: Nov. 10, 2016
• Transcript: Nov. 9, 2016
• Transcript: Nov. 10, 2016

November 9-10, 2016: Meeting Materials Non-FDA Generated

• BioMerieux VIDAS BRAHMS PCT Briefing Document: Nov. 10, 2016
• BioMerieux VIDAS BRAHMS PCT Briefing Document - ERRATA : Nov. 10, 2016
• Presentation - Clinical Applications of CMV Viral Load Assays in Transplantation: Nov. 9, 2016
• Presentation - Clinical Applications of EBV
• Presentation - Technical Issues with CMV Viral Load Testing and Standards: Nov. 9, 2016
• Presentation - Measurement of EBV and BK Viral load in the Lab: Nov. 9, 2016
• Presentation - Challenges in Studying Rapid Diagnostic Tests in Outpatient Respiratory Tract Infections: Nov. 10, 2016
• Presentation - BioMerieux VIDAS BRAHMS for Procalcitonin (PCT) Guided Antibiotic Therapy: Nov. 10, 2016

August 16, 2016: Meeting Materials FDA Generated

• Agenda: August 16, 2016
• FDA Executive Summary: August 16, 2016
• Roster: August 16, 2016
• FDA Presentation (Alberto Gutierrez, Ph.D.): August 16, 2016
• FDA Presentation (Gina Conenello, Ph.D.): August 16, 2016
• 24 Hour Summary: August 16, 2016
• Transcript: August 16, 2016

August 16, 2016: Meeting Materials Non-FDA Generated

• Presentation: Gail Bolan, M.D.
• Presentation: Stephen Lindstrom, PhD