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Human Subjects Division (HSD)

Regulatory Updates

FDA: Presentation - IRB: Compassionate and Emergency Use

Oct 14, 2010 at 8:30am

The FDA has released a presentation on Compassionate and Emergency Use. Learning objectives of this presentation include:

  • Understand when an emergency need to use an unapproved device may occur
  • Describe the role and responsibilities of the physician who wants to use the device on a patient for emergency or compassionate use
  • Identify the IRB's responsibilities in the compassionate use of an unapproved device
Links to a variety of presentation formats: