The U.S. Food and Drug Administration (FDA) published a final guidance document entitled “Pediatric Information for X-ray Imaging Device Premarket Notifications,” encouraging manufacturers to consider child safety when designing X-ray imaging devices. In the guidance, which applies to new devices and modifications requiring the submission of a new 510(k), the FDA recommends manufacturers design these devices with protocols and instructions that address use on pediatric patients. It encourages the inclusion of pediatric indications and provides recommendations for labeling and instructions for use for X-ray imaging devices likely to be used on children.
This guidance reflects insights from the FDA’s partnerships with experts across the imaging and pediatric communities. It offers a balanced approach, which includes advice for imaging professionals to ensure pediatric patients receive the imaging exams they need without exposure to unnecessary radiation. The FDA believes new X-ray imaging devices should include clear and easily accessible information for imaging professionals on dose mitigation and management techniques, and instructions for imaging patients of all sizes.
The FDA will host a webinar “CDRH Final Guidance: Pediatric Information for X-ray Imaging Device Premarket Notifications” on January 9, 2017, for manufacturers and others interested in learning more about this guidance. More information about the webinar is available athttp://www.fda.gov/cdrhwebinar
For additional information on the special challenges with imaging children, please visit the FDA’sPediatric X-ray Imaging website. Other helpful sites include the, the American Association of Physicists in Medicine, the American College of Radiology, Image Gently Alliance and the World Health Organization.
If you have any questions, please write to Laurel.Burk@fda.hhs.gov.
Office of in Vitro Diagnostics and Radiologic Health
Center for Devices and Radiological Health
Food and Drug Administration