The pediatric device provisions of the FDA Amendments Act of 2007 were the result of concerns that few medical devices for children were clearing the FDA approval process because of known and unknown barriers.
The GAO reported that the devices continue to face obstacles to reaching the market, including difficulties in recruiting pediatric participants for clinical trials and limited economic incentives for manufacturers to develop pediatric medical devices because of the smaller market for pediatric devices.
But the obstacles to the pediatric devices reaching patients also included the FDA approval process, the GAO found. Specifically, device developers complained that the amount of time required to move through the regulatory process remains unpredictable, which has become a common criticism of the FDA by industry advocates since President Barack Obama took office.
However, the GAO report noted a possible thaw in FDA's device review process in the case of pediatric medical devices, as indicated by recent outreach the agency has conducted (PDF) to educate the public on the ways to use scientific research data to support pediatric effectiveness claims for medical devices.