Interventional cardiology live case presentations: regulatory considerations.
Live case presentations are increasingly common at interventional cardiology conferences. Taking advantage of significant advances in communication technology, broadcasts of procedures can be viewed as an extension of traditional medical education targeted to large groups of practitioners. However, there are important ethical, commercial, and patient safety issues associated with live cases that deserve attention. Use of investigational devices in live case demonstrations is subject to review and approval by FDA's Center for Devices and Radiological Health (CDRH), and the outcomes of patients participating in live cases are considered in the overall clinical study results. This article discusses CDRH's regulatory view of live case presentations with a focus on patient safety, clinical trial integrity, and concerns regarding improper medical device promotion.
Farb
Andrew
A
Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland 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*; D004501:Education, Medical / Q000941:ethics / Q000331:legislation & jurisprudence* / Q000592:standards; D006801:Humans; D019114:Remote Consultation / Q000331:legislation & jurisprudence* / Q000592:standards*; D035703:Therapies, Investigational / Q000592:standards; D014481:United States