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

Press Release

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Wednesday, July 8, 2015   16:30-18:00

Agenda / List of Handouts

  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

Seat Assignment
Instructions on how to handle the handouts
1. Medical devices and medical material for newborn infants and their issues
2-1. Outline of U.S. FDA Guidance on pediatric uses of medical devices
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 -Draft Guidance for Industry and Food and Drug Administration Staff-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)

Minutes

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki,
Chiyoda-ku, Tokyo 100-0013 Japan

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