FDA BRIEF: Week of April 18, 2016



 External Pacemaker Pulse Generator Devices

Reclassified from Class III to Class II

Based on:

  • Review of the MAUDE safety database and recall data
  • Review of current scientific literature
  • 2013  Circulatory System Devices Panel  deliberations
  • Special controls, in conjunction with general controls, will provide reasonable assurance of the safety and effectiveness




Electrical stimulation devices intended to treat self-injurious or aggressive behavior

Proposal to BAN 

Based on:

  • Review of clinical and scientific data, input from experts, treated individuals and their parents, disability rights groups, 2014 FDA advisory panel
  • Unreasonable and substantial risk to public health
  • Risk cannot be corrected or eliminated through labeling
  • Alternative approaches available – Positive behavioral support, medications

FDA will work with health care providers to facilitate safe transition to alternate care




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