Food and Drug Administration

Hematology and Pathology Devices Panel
of the
Medical Devices Advisory Committee

July18, 2008

SLIDES

FDA Presentations:

FDA Introduction (pdf)
Presented by:
Josephine Bautista, M.S., MT(ASCP), Associate Division Director, Division of Immunology and Hematology, Office of In Vitro Diagnostic Device Evaluation and Safety

CLIA Waiver (pdf)
Presented by:
            Carol Benson, M.A., Associate Division Director, Division of Chemistry
and Toxicology, Office of In Vitro Diagnostic Device Evaluation and Safety

CLIA Waiver, Demonstrating Accuracy (pdf)
Presented by:
Marina Kondratovich, Ph.D., Mathematical Statistician, Division of
Biostatistics, Office of Surveillance and Biometrics

Laboratory and Clinical Issues in CLIA Waiver for CBC/ADCC Devices (pdf)
Presented by:
            · Robert L. Becker, Jr., M.D., Ph.D., Chief Medical Officer, Office of In Vitro
Diagnostic Device Evaluation and Safety

CLIA Statistical Issues for CBC/ADCC Devices (pdf)
Presented by:
            · Estelle Russek-Cohen, Ph.D., Team Leader, Division of Biostatistics, Office of
Surveillance and Biostatistics

FDA Summary (pdf)
Presented by:
Josephine Bautista, M.S., MT(ASCP), Associate Division Director, Division of Immunology and Hematology, Office of In Vitro Diagnostic Device Evaluation and Safety

FDA Questions for the Panel (pdf)
Presented by:
Josephine Bautista, M.S., MT(ASCP), Associate Division Director, Division of Immunology and Hematology, Office of In Vitro Diagnostic Device Evaluation and Safety

Centers for Medicare and Medicaid Systems (CMS) Presentation:
           
2CBC Waiver Panel CMS Issues and Concerns
Presented by: (pdf)
Judy Yost, M.A., MT(ASCP), Director, Division of Laboratory Services,
Centers for Medicare and Medicaid Systems

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