Activity Description
In response to a provision in the Medical Device User Fee and Modernization Act of 2002, an IOM committee examined the system under the Federal Food, Drug, and Cosmetic Act for postmarket surveillance of medical devices to assess whether the system provides adequate safeguards for the use of devices in children.
The study assessed the Food and Drug Administration's (FDA) monitoring and use of adverse reaction reports, registries, clinical studies, and other postmarket surveillance activities to identify unsafe or ineffective products. It also considered the adequacy of the Food and Drug Administration's monitoring of commitments for further clinical studies made by manufacturers at the time of approval of specific medical devices.
Two questions focused on implantable devices, asking whether postmarket surveillance studies are adequate to assess evaluate how children's active lifestyles may affect implant failure rates and longevity and whether studies continue long enough to evaluate the impact of children's growth and development.
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