The Government Accountability Office has recommended that FDA collect reliable information to report data on pediatric medical devices by consistently using its existing electronic flags in its tracking system or otherwise developing internal controls.

A recently issued report by the Government Accountability Office (GAO) on pediatric device development, has found that FDA does not actually maintain or track its data regarding device approvals in such a way as to allow it to provide the requirement information regarding pediatric device approvals to Congress. 

Although FDA established an “electronic flag” for its reviewers to use to identify the devices labeled for pediatric indications, “these electronic flags are not consistently applied, and the agency does not provide formal training or guidance to its device reviewers regarding proper implementation of the pediatric flags,” the GAO report described. Therefore, information from FDA’s tracking system is not sufficiently reliable to identify PMA and HDE devices labeled for use in pediatric patients, the report concluded, adding that it is difficult to evaluate whether the provisions from FDA Amendments Act of 2007 (FDAAA) have increased the number of pediatric devices when FDA does not provide reliable approval data. 

Recognizing that the development of pediatric devices lags years behind the development of devices for adults, FDAAA provided incentives to develop devices for children, particularly devices that receive FDA’s humanitarian device exemption (HDE), a process for devices that treat or diagnose rare diseases or conditions.  FDAAA also authorized demonstration grants for non-profit consortia to facilitate pediatric device development and required FDA to annually report the number of approved devices labeled for use in pediatric patients. 

PMA and HDE Devices Approved in Fiscal Years 2008 through 2011 by Indicated Population

Note: Totals do not add to 100 percent because of rounding.

The pediatric device consortia created under FDAAA have assisted 107 pediatric device projects in the first two years of the grant program. Between the fiscal years of 2009 and 2010, FDA awarded approximately $5 million in grants to four pediatric device consortia, with the amount depending on the device’s phase of development. 

FDAAA also required GAO to report on pediatric device development. The GAO report one, describes barriers to developing pediatric devices; two, describes how pediatric device consortia have contributed to the development of pediatric devices; and three, examines FDA data on the number of pediatric devices approved since FDAAA was enacted. 

GAO also spoke with stakeholders to assess the barriers to pediatric device development and whether the incentives under FDAAA helped in overcoming those barriers. The stakeholders indicated that, while helpful, the incentives are insufficient, especially because of the small market for pediatric devices involving orphan diseases, and the outsized costs necessary to study them.   

Overall, while GAO was disappointed with the data maintained by FDA regarding approval of pediatric devices, it believes that the FDAAA provisions “show potential for more pediatric devices in future years.” GAO has recommended that FDA collect reliable information to report data on pediatric medical devices by consistently using its existing pediatric electronic flag in its tracking system or otherwise developing internal controls.