6.3 Humanitarian Use Device (HUD)

Last Revised: 5/26/2021

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for the use of a medical device that has a Humanitarian Use Device (HUD) designation.


2.0 Policy

It is the policy of the Organization that all uses of an HUD will be reviewed and approved in accordance with FDA regulations at 21 CFR 50, 56 and 814 Subpart H, as well as HHS regulations at 45 CFR 46.


3.0 Definitions


4.0 IRB Review Procedures


DOCUMENT HISTORY:

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

 Revised: 2/12/2018 - revision not documented

 Revised: 5/26/2021 - Clarified requirement for IDE and for SR/NSR determination when conducting a clinical investigation with an HUD; clarified materials to be reviewed by the IRB; clarified that use of HUD off-label is allowable without additional review; described specific additional information to be included in the CF if HUD is used outside its approved indication; stylistic and organization changes.


Revision #7
Created 24 October 2019 21:41:38 by Autumn M Eberly
Updated 17 April 2025 16:07:47 by Robert A Lewis