FDA has published a draft guidance document entitled "Pediatric Information for X-ray Imaging Device Premarket Notifications" which encourages manufacturers to consider the safety of children in the design of new X-ray imaging devices. In the draft guidance, FDA is recommending that manufacturers design new X-ray imaging devices with protocols and instructions that address use on pediatric patients.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 include a label that cautions against use in pediatric populations.
The guidance is part of FDA’s larger Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging, launched in February 2010. In addition to the draft guidance document, FDA has launched a Pediatric X-ray Imaging website that provides information on the benefits and risks of imaging using ionizing radiation, recommendations for parents and health care providers to help reduce exposure to unnecessary radiation exposure, and information for manufacturers of X-ray imaging devices. Additionally, FDA is collaborating with the Alliance for Radiation Safety in Pediatric Imaging (ARSPI) and manufacturers, through the Medical Imaging and Technology Alliance (MITA), on developing pediatric imaging radiation safety training materials.