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Updated: May 7, 2025

Aortic Ring Assay
Published on: November 24, 2009
A Tale of Two Rings: The Need for Informed Consent
1Most Sacred Heart of Jesus Cardiovascular and Valvular Institute, Chicago IL.
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.
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