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Safe Medical Devices for Children
Recommendation 5.2: FDA’s system for monitoring and reporting postmarket study commitments should include information about the disposition of study findings, for example, a change in the labeling of a device. It should also provide for the responsible and understandable reporting of the source, methods, and findings of monitored postmarket studies.
Beyond study monitoring, another step the agency should consider to increase accountability for postmarket surveillance is to provide its advisory committees with periodic follow-up information on the products they have reviewed. Such information should cover the status, methods, and findings of required postmarket studies and also include adverse event reports, safety alerts, recalls, or other actions associated with previously reviewed products. When a manufacturer is released from responsibility for information collection, the rationale should be described. This information may help advisory committees judge whether their conclusions about approval were prudent and whether their follow-up questions were reasonable.
The next chapter discusses what the committee was able to discover—given the absence of a database of study commitments—about postmarket studies relating to children’s growth and development or active lifestyles. The chapter also examines some of the methodological, ethical, and practical challenges in conducting pediatric device studies.