provides adequate safeguards regarding the use of devices in pediatric populations.” The IOM was to examine specifically: (1) the U.S. Food and Drug Administration’s (FDA) monitoring and use of adverse reaction reports, registries, clinical studies, and other postmarket surveillance activities; (2) the adequacy of FDA’s monitoring of commitments for further clinical studies made by manufacturers at the time of approval of specific devices; (3) the adequacy of postmarket surveillance studies to evaluate how children’s active lifestyles may affect failure rates and longevity for implanted devices; and (4) the length of postmarket surveillance studies of implanted devices, including whether studies continue long enough to evaluate the impact of children’s growth and development given the expected length of time that a child will have an implant. The committee was not asked to evaluate FDA’s premarket review of medical devices or to assess barriers to the development of medical devices to meet children’s special needs.

Postmarket surveillance of medical devices used with children is a little-investigated topic. This is partly because the market for most medical products is concentrated among adults, especially older adults. Moreover, discussions of medical product regulation and patient safety focus more on pharmaceuticals than on medical devices and more on the assessment of products prior to marketing than on the subsequent surveillance of product performance.