Interventional cardiology live case presentations: regulatory considerations.
Farb
Andrew
A
Office of Device Evaluation, Center for Devices and Radiological Health, U.S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, USA. andrew.farb@fda.hhs.gov
Brown
Sheila A
SA
Wolf
Deborah A
DA
Zuckerman
Bram
B
D002309:Cardiology / Q000331:legislation & jurisprudence* / Q000592:standards*; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards*; D006801:Humans; D019114:Remote Consultation / Q000331:legislation & jurisprudence / Q000592:standards*; D035703:Therapies, Investigational / Q000592:standards; D014481:United States