July 25, 2012
On Monday, July 16, the Food and Drug Administration (FDA) hosted a public workshop to gather feedback on draft guidance for Pediatric X-ray Imaging Device Premarket Notifications. This guidance and workshop are part of FDA’s larger Dose Reduction Initiative. FDA is currently focusing its efforts through the Center for Devices and Radiological Health (CDRH) on equipment safety; CDRH does not have regulatory authority over radiopharmaceuticals. Many currently marketed X-ray imaging devices have general indications for use that cover a broad range of clinical applications and populations; therefore, FDA encourages manufacturers to provide technical assistance to health care professionals on how to appropriately and safely use these older devices on pediatric patients.
For more information and to view the draft guidance: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm300850.htm