Summary: This policy applies to the emergency use of test articles and the emergency use of Humanitarian Use Devices (HUDs).
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Attachments and Other References
- Emergency, Expanded Access for an Investigational Medical Product (One Patient)
- Emergency/One-Time Use Consent Template (Word Doc)
- Emergency Use of an Investigational Drug or Biologic - Information Sheet
- Guidance on IDE Policies and Procedures: Expanded Access to Unapproved Devices
- Using HUDs in Emergency Situations