FDA Recommends Imaging Devices Be Designed with Pediatric Patients in Mind

May 16, 2012 | Strategic Insights for Health System


The U.S. Food and Drug Administration (FDA) has issued a May 10, 2012, draft guidance document that recommends that manufacturers design new x-ray and other imaging devices with protocols and instructions to address use on pediatric patients. Part of FDA’s initiative to reduce unnecessary radiation exposure from medical imaging that was launched in February 2010, the draft guidance would require manufacturers to include at least four children's settings on all new imaging devices: newborn, 1-year-old, 5-year-old, and 12-year-old. The guidance also proposes that manufacturers who do not adequately demonstrate that their new x-ray imaging devices are safe and effective for pediatric patients should include a label on their device that cautions against use in pediatric populations.

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