Food and Drug Administration

Gastroenterolog and Renal Devices Panel

June 8, 2005


Critical Path Initiative, Sousan Altaie, PhD, FDA (PPT) (PDF)

Condition of Approval Studies: Recent Changes in CDRH, Susan Gardner, PhD, FDA (PPT) (HTM)

Final Combined Presentations (PPT) (HTM)

Nocturnal Home Hemodialysis, Carolyn Neuland, PhD, FDA (PPT) (HTM)

Overview of Conventional Hemodialysis Delivery Devices, Joshua Nipper, ME, FDA (PPT) (HTM)

Human Factors (HF) and Nocturnal Home Hemodialysis (NHD), Michael Mendelson, DDS, MS, FDA (PPT) (HTM)

Nocturnal Home Hemodialysis, Claudia Ruiz-Zacharek, MD, FDA (PPT) (HTM)

Final Panel Discussion Points (PPT) (HTM)

Draft Panel Discussion Points (PPT) (HTM)