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Human Subjects Division (HSD)


Document Details

Last Updated 09/25/2015
Version 1.20
Filesize 1.02 MB
Audiences HSD Staff, IRB Member, Researcher
Doc Type Form
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WORKSHEET: FDA Devices and the IDE Requirement


This worksheet provides information and support for individuals assessing whether an FDA-regulated study needs an IDE from the FDA before conducting the research.

Change Notes

  • Related to Ver. 1.20, noted 09/25/2015 @ 09:51pm
    Clarifications to Category 1 and 2
    - sherrye
  • Related to Ver. 1.10, noted 04/25/2014 @ 09:43am
    Updated Category 1 - Transitional or equivalent device so that the two criteria are mutually exclusive.
    - sherrye
  • Related to Ver. 1.00, noted 11/01/2013 @ 11:44am
    Document newly added.
    - sherrye