GAO Reports on Approval of Pediatric Medical Devices

By Jennifer D. Newberger –

The Government Accountability Office (“GAO”) recently issued a report on pediatric device development.  The report “(1) describes barriers to developing pediatric devices, (2) describes how pediatric device consortia have contributed to the development of pediatric devices, and (3) examines FDA data on the number of pediatric devices approved since FDAAA was enacted.” 

The GAO was required to issue a report of this type pursuant to the FDA Amendments Act of 2007 (“FDAAA”).  FDAAA had a suite of incentives to develop devices for children, particularly devices that receive a humanitarian device exemption (“HDE”).  FDAAA also authorized “demonstration grants” for nonprofit consortia to facilitate pediatric device development, and required FDA to provide annual reports to Congress on the number of approved pediatric devices.  Finally, FDAAA also required GAO to issue a report on pediatric device development.

Perhaps the most interesting finding is that FDA does not actually maintain or track its data regarding device approvals in such a way as to allow it to provide the required 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, “FDA officials reported that these electronic flags are not consistently applied, and that the agency does not provide formal training or guidance to its device reviewers regarding proper implementation of the pediatric flags.  Therefore, information from FDA’s tracking system is not sufficiently reliable to identify PMA and HDE devices labeled for use in pediatric patients.”  It is certainly difficult to evaluate whether FDAAA’s provisions have increased the number of pediatric devices when FDA does not provide reliable approval data. 

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.   

With regard to the pediatric consortia, GAO found that the pediatric device consortia created under FDAAA assisted 107 pediatric device projects in the first two years of the grant program.  FDA awarded approximately $5 million in grants to four pediatric device consortia in fiscal years 2009 and 2010.  The support provided by the consortia varied depending on the device’s phase of development. 

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.”