The U.S. Food and Drug Administration (FDA) published a final guidance on November 28 regarding pediatric x-rays, recommending dose reductions in new x-ray devices.
The guidance, Pediatric Information for X-ray Imaging Device Premarket Notifications, recommends manufacturers include dose reduction features in their equipment designs and pediatric resources when they develop and manufacture x-ray equipment. The FDA also suggests industry ensure the tools are straightforward to implement with clear, understandable instructions on how to optimize dose.
Specifically, the guidance targets the premarket review process of 510(k)s for x-ray imaging devices to encourage the inclusion of pediatric indications for use for x-ray imaging device premarket notifications and provide recommendations regarding labeling.
