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

Press Release

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Date and Time: July 8, 2015  from 4:30pm to 6pm

Agenda / List of Handouts

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  • Document 2-2 Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices -Draft Guidance for Industry and Food and Drug Administration Staff- (Document issued on: May 6, 2015)

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