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
- HTML: http://www.fda.gov/Training/CDRHLearn/ucm180876.htm
- Video format with captioning: http://fda.yorkmedia.com/fda/Viewer/?peid=d61c521d-ee6d-4ac2-8eae-61c2700f5237
- PDF printer-friendly format: http://www.fda.gov/downloads/Training/CDRHLearn/UCM180888.pdf
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