FDA Finalizes Guidance to Limit Radiation Exposure With X-Ray Imaging Devices

December 1, 2017

The FDA released final recommendations for manufacturers of x-ray imaging devices aimed at clarifying the premarket review process and encouraging pediatric indications.

The recommendations, drafted in 2012, outline how the devices can be designed, tested, and labeled with the goal of helping medical professionals make more informed decisions on radiation doses during x-ray imaging exams to limit unnecessary exposure.

Exposure to ionizing radiations is particularly concerning with younger patients as they are more radiosensitive than adults, the likelihood of the effects manifesting as cancer is greater, and exposure settings intended for adult use can result in children being overexposed, the FDA said.

The FDA recommended that manufacturers, as part of their device design, perform a risk assessment that considers specific risks and mitigations arising from the use of their device in pediatric populations to minimize the risk of excessive radiation exposure.

In terms of labeling, it is recommended that the pediatric summary includes this caution statement: “Use special care when imaging patients outside the typical adult size range.” The devices should also be designed to be easy-to-use with clear instructions on optimizing doses.

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