Recalls of several commonly used implantable medical devices after US Food and Drug Administration (FDA) approval have led to increasing scrutiny of the tools and techniques employed for assuring post-marketing medical device safety. [1-4] The most established surveillance methods rely on a mix of mandatory and voluntary adverse event reporting systems, such as the MedSun system, Med-Watch and the "Adverse Event Reporting System". However, these systems are limited by their inability to assess accurate event rates due to event under-reporting and a lack of information regarding the total number of devices implanted. [5-7] Other more recent mechanisms for monitoring the safety of devices, including mandated post-approval clinical registries, have been implemented to address the need to detect long term adverse events and device performance in high risk patient populations and to address gaps in knowledge regarding treatment efficacy and safety beyond the populations studied in randomized clinical trials. [7] Although such registries may be mandated as a condition of approval, the lack of industry incentives and FDA enforcement capacity have resulted in a low execution rates for much of the last decade. [7]
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