• prevalence among children of a condition treated with a medical device;

  • presence of significant developmental questions;

  • uncertainty about the short-term or long-term safety and effectiveness of a device to diagnose or treat a condition;

  • known or potential burden (mortality, morbidity, impaired functioning, diminished quality of life) on children and their families;

  • variability in clinical practice;

  • potential of a study to affect clinical practice or regulatory actions; and

  • potential relevance of research findings to other medical conditions or devices.

The recommendations presented above clearly require that many, in addition to FDA, share responsibility for the development of better information about the safety and effectiveness of medical devices used with children. This theme of shared responsibility is reiterated and expanded in the next chapter.



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