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

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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• Document 2-2 Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices -Draft Guidance for Industry and Food and Drug Administration Staff- (Document issued on: May 6, 2015)