Device Advice from the FDA was sponsored by the Human Research Protection Office, Institute of Clinical and Translational Science, and Orthopedic Surgery to provide participants with practical advice about investigational and investigational use devices. Topics covered included regulatory aspects, billing, and device accountability and researcher experiences.
Submissions from 2011
The importance of device accountability, Colin P. Derdeyn
IRB review of device studies, Jonathan M. Green
Device advice, Lynn Henley
2011 Device Advice from the FDA: Agenda, Human Research Protection Office, Washington University School of Medicine in St. Louis
2011 Device Advice from the FDA: IRB case study questions, Human Research Protection Office, Washington University School of Medicine in St. Louis
2011 Device Advice from the FDA: Video file links, Human Research Protection Office, Washington University School of Medicine in St. Louis
Billing and compliance issues with devices, Yi Zhang and Carlos Brown
