Regulatory Focus™ > News Articles > FDA Finalizes Guidance on Minimizing X-Ray Radiation for Children

FDA Finalizes Guidance on Minimizing X-Ray Radiation for Children

Posted 29 November 2017 | By Michael Mezher 

FDA Finalizes Guidance on Minimizing X-Ray Radiation for Children

The US Food and Drug Administration (FDA) on Monday finalized guidance aimed at reducing the amount of radiation children are exposed to from x-ray imaging devices.

While x-ray imaging can increase the risk of cancer for both adult and pediatric patients, FDA says that radiation is a greater concern for pediatric patients as they are more sensitive to radiation and have a longer expected lifetime during which cancer could develop. FDA also says that x-ray imaging devices that lack exposure settings for pediatric patients can lead to children being exposed to more radiation than is medically necessary.

FDA says the guidance is meant to increase clarity around the review process for x-ray imaging devices, encourage manufacturers to include pediatric indications for use in their premarket notifications and to provide recommendations for labeling.

The guidance applies to both x-ray imaging devices intended for pediatric populations and general use, FDA says.

Aside from limiting x-ray imaging to only situations that are medically necessary, FDA says that radiation exposure can be reduced by using techniques to optimize the dose of radiation to the lowest amount that still yields an adequate image.

While FDA says that imaging professionals can safely limit the dose of radiation from x-ray equipment that lacks specific features or instructions for pediatric use, imaging professionals have told the agency that doing so can be challenging without additional information from the manufacturer.

"Manufacturers seeking marketing clearance for a new x-ray imaging device that could be used in pediatric populations should address pediatric use in their risk assessment and provide mitigations where appropriate, regardless of whether the device has a specific pediatric indication," FDA writes.

The guidance goes on to discuss considerations for pediatric populations, conducting risk assessments and specific features that can be added to x-ray imaging devices to make them safer for children, such as automatic exposure control and pediatric pre-sets.

FDA


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