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 risk of developing cancer from excessive radiation exposure is slight but “it is real and compels us to be proactive about reducing patients’ exposure as much as possible, without jeopardizing the diagnostic quality of the exam,” Vasum Peiris, CDRH’s chief medical officer for pediatrics and special populations, said in an FDA Voice blog post.
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.
The guidance applies to existing x-ray imaging devices as well as new ones, though it is meant to be used with device-specific guidances and the general policies for 510(k) submissions. If user-requested modifications are made on existing devices to optimize imaging parameters and pediatric-specific protocols, new 510(k) submissions will not be required, the agency said.
“These recommendations, while significant and capable of making an important difference in the amount of radiation pediatric patients receive, also strike the right balance between safety and burden to manufacturers,” Peiris said.
Read the Pediatric Information for X-ray Imaging Device Premarket Notifications guidance here: www.fdanews.com/11-30-17-Pediatricinfoxray.pdf.