The 4th Subcommittee on Evaluation of Medical Devices in Pediatric Use

Agenda

1. Current status of medical devices for pediatric use
2. U.S. FDA’s Guidance on evaluation of medical devices for pediatric use
3. Others

List of Handouts

• Document 1　Medical devices and medical material for newborn infants and their issues
• Document 2-1　Outline of U.S. FDA Guidance on pediatric uses of medical devices
• Document 2-2　Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices -Draft Guidance for Industry and Food and Drug Administration Staff- (Document issued on: May 6, 2015)