Jan 10, 2012

A recent report by the US Government Accountability Office (GAO) finds that the Food and Drug Administration has not consistently taken steps to identify and track medical devices designated for pediatric use.

The FDA Amendments Act of 2007 (FDAAA), implemented in part to spur development of more medical devices to treat pediatric populations, requires the FDA to identify all devices labeled for use in pediatric patients, and provide annual reports to Congress on the numbers of such devices approved. Although the agency has the capability to identify pediatric devices in its existing internal tracking system, the GAO report contends that the capability has not been consistently used to do so. As such, the FDA’s data on pediatric devices is not reliable or timely, according to the GAO.

GAO reviewers identified 18 devices brought to market either via the FDA’s Humanitarian Device Exemption (HDE) or premarket approval (PMA) process since the FDAAA went into effect; but reviewers also found that indications for use statements for 72% of all devices approved via HDE or PMA had no patient-age-specific information, meaning that additional pediatric devices could be on the US market.

The GAO recommends more consistent use of existing electronic flagging capabilities by FDA personnel in order to better account for the amount of pediatric medical devices marketed in the US.


  • Stewart Eisenhart