The 2nd 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 1-1　Current status of approval of pediatric cardiovascular medical devices and medical material in Japan(The material is provided by Dr. Hitoshi Kato, a member of the Subcommittee)
• Document 1-2　Current status of approval of pediatric cardiovascular medical devices and medial material in Japan(The material is provided by Dr. Hitoshi Kato, a member of the Subcommittee)(Modified version of the material of #1-1 for publishing purposes)

• Document 2　Introducing U.S. FDA's thoughts on medical devices in pediatric use - Outline of the Guidance
• Ref.1　Premarket Assessment of Pediatric Medical Devices Guidance for Industry and Food and Drug Administration Staff (Document Issued on: March 24, 2014)
• Ref.2　Providing Information about Pediatric Uses of Medical Devices Guidance for Industry and Food and Drug Administration Staff (Document Issued on: May 1, 2014)