A Tale of Two Rings: The Need for Informed Consent

Abstract

Over the past 85 years, the mission of the FDA’s Center for Device and Radiologic Health has been to provide safe medical devices for the US consumer, and to adapt the regulatory standards to meet the needs of the rapidly evolving medical device industry. This brief report is the historical account of two investigational devices dating back to 2006, the devices never receiving FDA approval for use in patients during a clinical trial, and the patients never received informed consent.