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Human Subjects Division (HSD)


Document Details

Last Updated 09/26/2014
Version 2.00
Filesize 2.14 MB
Audiences HSD Staff, IRB Member
Doc Type Form
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WORKSHEET: Device Risk Determination


This worksheet is used as guidance to facilitate the IRB's determination about the risk level of an investigational device. The IRB follows the procedures described in the SOP FDA-Regulated Research.

Change Notes

  • Related to Ver. 2.00, noted 09/26/2014 @ 11:26am
    This checklist has been converted to an optional worksheet.
    - sherrye
  • Related to Ver. 1.00, noted 11/01/2013 @ 11:54am
    Document newly added.
    - sherrye