In the draft guidance, FDA is recommending manufacturers design new X-ray imaging devices with protocols and instructions that address use on pediatric patients.
It also proposes manufacturers who do not adequately demonstrate 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.
FDA is collaborating with the Alliance for Radiation Safety in Pediatric Imaging and manufacturers, through the Medical Imaging and Technology Alliance, to develop pediatric imaging radiation safety training materials.
A workshop to discuss FDA’s draft guidance is scheduled for July 16.
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