6.2 Research Involving Investigational and Marketed Devices

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for research involving investigational and marketed devices.


2.0 Policy


3.0 Definitions


4.0 Requirements


5.0 IRB Procedures


6.0 Exemptions from IDE Requirements


DOCUMENT HISTORY:

 Written: 1/12/2016 - original author not recorded

 Revised: 3/2/2018 - revision not documented

 Revised: 5/6/2022 (Approved: 5/6/2022) - revision not documented

 Revised: 9/29/2022 - corrected typographic errors in section 4.2  {Approved: Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Revised 1/23/2024 – clarified IRB procedures (section 5.1); added definition of custome device, and included such devices as exempt from IDE requirements (sections 3.1.4 and 6.1.4). {Approved Rusty McCulloh (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}


Revision #8
Created 24 October 2019 21:41:19 by Autumn M Eberly
Updated 24 March 2025 15:12:17 by Robert A Lewis