In the draft guidance, the FDA recommends that manufacturers design new X-ray imaging devices with protocols and instructions that address use on pediatric patients. It also proposes manufacturers that 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.
The FDA scheduled a workshop for July 16 to discuss the draft guidance. To view the draft guidance in full, click here.
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