The ABCs of IDEs: The FDA’s Role in Investigational Device Studies
Presenter
Andrew Farb, MD, US Food and Drug Administration, Columbia, MD
Andrew Farb, MD, US Food and Drug Administration, Columbia, MD
Learning Objectives:
- Define Investigational Device Exemptions (IDEs)
- Describe when an IDE is needed to conduct device clinical research
- Discuss Category A vs. Category B devices for FDA and CMS
Keywords: Cath Lab Administration, Cath Lab Leadership Boot Camp and Training and Professional Development