Guidance Would Mandate Pediatric Safety Tests, Labeling for X-Rays

Makers of X-ray imaging devices would need to take special steps to ensure their products perform safely and effectively when used on children, under an FDA draft guidance. The draft, “Pediatric Information for X-Ray Imaging Device Premarket Notifications,” is part of a larger initiative to reduce unnecessary radiation exposure from medical imaging. The FDA has scheduled a July 16 public meeting to discuss the issue. The guidance and meeting follow a March 2010 meeting during which radiological experts pointed out that many devices in the field lack labeling information that would help them to be used in pediatric patients.
Devices & Diagnostics Letter