By Stewart Eisenhart, Emergo Group
The U.S. Food & Drug Administration is planning new premarket notification requirements for manufacturers of X-ray imaging systems used on pediatric patients.
New agency guidance argues that the general indications for use most X-ray devices currently provide on the U.S. market do not address particular concerns regarding higher sensitivity of pediatric patients to effects of radiation emitted by these devices. If enacted into law, the new guidance could impact not only 510(k) submission requirements, but also device design issues and labeling for manufacturers whose products fall under the new proposal.
According to the guidance, manufacturers seeking 510(k) clearance for new X-ray imaging devices must either provide additional data to support safety and effectiveness in pediatric populations, or provide warning labels for their products if they intend only to target adult populations following FDA clearance.
Information that new rules would require manufacturers to include in their 510(k) premarket notification applications include clear definitions of indications for use for pediatric patients; device descriptions explaining device design features for pediatric patients; and risk assessment data that includes risks specific to pediatric populations.
Pediatric-appropriate protocols, laboratory image quality and dose assessments, and clinical image quality assessments pertaining to pediatric populations should also be included.
The FDA is accepting public comment on the guidance over the next 120 days.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.