UW logo
Human Subjects Division (HSD)

Documents

Document Details

Last Updated 08/02/2016
Version 1.40
Filesize 1.96 MB
Audiences Researcher
Doc Type Form
Use of HSD PDF Forms

HSD Forms are compatible with Adobe Reader, Version 10 and higher, though we recommend use of the most recent version. You may receive messages from Adobe to upgrade.

For Mac users: be sure to open the form in Adobe Reader or Acrobat.

download Adobe Reader

PAPER SUPPLEMENT: Devices

Purpose

This form is a supplement to IRB applications, for activity involving a medical device.

This document is for use with paper-based applications only. Do not use with Zipline. HSD accepts versions from 3/27/2015 on.

Change Notes

  • Related to Ver. 1.30, noted 09/30/2015 @ 07:00pm
    Re-enabled the ability to save form field data
    - sherrye
  • Related to Ver. 1.30, noted 04/15/2015 @ 09:18am
    Updated to reflect new criteria for what is FDA regulated research. Use this version going forward.
    - sherrye
  • Related to Ver. 1.30, noted 04/15/2015 @ 09:17am
    Updated to reflect new criteria for what is FDA regulated research.
    - sherrye
  • Related to Ver. 1.20, noted 12/18/2014 @ 12:11pm
    Removed need for documentation from UW Risk Management
    - sherrye
  • Related to Ver. 1.10, noted 04/25/2014 @ 09:38am
    Removed need for Good Manufacturing Practice documentation. Use this version going forward.
    - sherrye
  • Related to Ver. 1.00, noted 11/01/2013 @ 02:11pm
    Document newly added.
    - sherrye