Guidance Documents (Medical Devices and Radiation-Emitting Products) > Providing Information about Pediatric Uses of Medical Devices - Guidance for Industry and Food and Drug Administration Staff

Guidance Documents (Medical Devices and Radiation-Emitting Products) > Providing Information about Pediatric Uses of Medical Devices - Guidance for Industry and Food and Drug Administration Staff

A new guidance document, "Providing Information about Pediatric Uses of Medical Devices," has recently been posted.  This guidance document describes how to compile and submit the readily available pediatric use information required under Section 515A of the FD&C Act.  For more information, please see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm339162.htm