Interventional cardiology live case presentations regulatory considerations

• Published in: Heart rhythm Vol. 7; no. 10; p. e1
• Main Authors: Farb, Andrew, Brown, Sheila A, Wolf, Deborah A, Zuckerman, Bram
• Format: Journal Article
• Language: English
• Published: United States 01.10.2010
• Subjects: Cardiology - legislation & jurisprudence; Cardiology - standards; Clinical Trials as Topic - legislation & jurisprudence; Device Approval - legislation & jurisprudence; Government Regulation; Humans; Informed Consent; Therapies, Investigational; United States; United States Food and Drug Administration; United States
• DOI: 10.1016/j.hrthm.2010.08.024

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.