RESEARCH Post-marketing surveillanc r

Full list of author information is available at the end of the articleBackground The US Food and Drug Administration (FDA) defines a medical device as an instrument used to diagnose, treat or prevent a disease or abnormal physical condition without any chemical action in the body [1]. The med-ical device industry has grown in the past ten years. Between 2004 and 2009, the sales of medical devices in-creased by 56%, while pharmaceutical sales increased by 38 % during the same period [2]. Excluding diagnostics, the medical device industry is a USD 200 billion busi-ness worldwide, with projected sales of USD 95 billion in 2010 in the US alone [2]. Unlike drug therapies, the approval processes for med-ical devices typically do not require clinical effectiveness and safety data derived from a randomized clinical trial (RCT) [3], even for FDA class III medical devices, whic