The U.S. Food and Drug Administration has issued a “draft guidance document” detailing the agency’s position on information that should be provided in premarket notifications for X-ray imaging devices that could be used on children.
On May 9, 2012, the FDA issued a Federal Register notice—Pediatric Information for X-ray Imaging Device Premarket Notifications—that says the guidance is to “minimize uncertainty” during the premarket review process of X-ray imaging devices for pediatric use.
Currently, most X-ray imaging devices are marketed with a general indication for use statement, the FDA says. However, “many general use X-ray imaging devices have neither addressed the unique issues associated with pediatric use, nor contain labeling specific for use on pediatric patients, even though many (if not all) of these devices are used, or could be used, to image pediatric patients,” the notice says.
Therefore, the draft guidance is to “encourage the inclusion of pediatric indications for use for X-ray imaging device premarket notifications and to provide recommendations on information to support such indications,” the notice says. “This draft guidance applies only to complete X-ray imaging devices that could be used on pediatric patients.”
A guidance document providing premarket notifications for X-ray imaging devices used on children is necessary because children are more radiosensitive than adults, and that increases the cancer risk per unit dose of ionizing radiation for younger patients, the FDA says.
In addition, younger patients have a longer expected lifetime for the effects of radiation exposure to manifest as cancer, and the use of equipment and exposure settings designed for adults can result in excessive radiation exposure for younger patients
The FDA says the draft guidance is not final nor is it in effect at this time, and the agency is accepting comments on the document. The deadline for comments is Sept. 7, 2012.