date:May 11, 2012
In the draft guidance, FDA is recommending that manufacturers design new X-ray imaging devices with protocols and instructions that address use on pediatric patients.
It also proposes that manufacturers who do not adequately demonstrate that their new X-ray imaging devices are safe and effective in pediatric patients should include a label on their device that cautions against use in pediatric populations.
To help health care providers more safely use their current equipment on pediatric pat