Assuring public safety after widespread adoption of medical devices is critically important, and has been identified as a priority by the Food and Drug Administration (FDA).1 Growing public concern regarding postmarket safety of medical devices stems in part from an increasing recognition that medical device failure, although infrequent, may lead to injury. Regulatory agencies, such as FDA, are faced with the competing pressures of ensuring patient safety while simultaneously improving the efficiency of medical device approval. Unfortunately, premarket medical device approval studies are frequently limited by small sample size, restricted patient and provider populations, and inadequate duration of follow-up.2 3 Therefore, strengthening approaches of postmarket safety evaluation are increasingly important.

The FDA strategy for postmarket safety evaluation has relied extensively on reporting of adverse events by physicians, patients and device manufacturers through the Medical Device Reporting system. It has become increasingly apparent that, despite a vested interested in …