What is it about?
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.
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Why is it important?
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.
Perspectives
Myxomatous mitral valve disease is the most common cause of severe mitral regurgitation, in the United States and Europe. This brief report will outline the regulatory history of the device, and the outcomes of two patients who underwent safety and efficacy testing of a new annuloplasty prototype ring medical device [1], for myxomatous mitral valve disease prior to the manufacturer’s marketing launch on the US market.
Acquire Publications
Read the Original
This page is a summary of: A Tale of Two Rings: The Need for Informed Consent, Journal of Case Reports and Medical History, November 2023, Acquire Publications LLC,
DOI: 10.54289/jcrmh2300137.
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