CurrentBlue Cross Blue Shield - IowaPolicy N/A

Humanitarian Use Devices (HUD)

Policy governs coverage determination for FDA-designated Humanitarian Use Devices (HUDs)/Humanitarian Device Exemptions (HDEs), specifying when HUDs are considered medically necessary versus investigational and outlining IRB requirements and documentation for coverage.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyHumanitarian Use Devices (HUD)

Policy CodePolicy N/A

Change TypeAnnual Review / Renewal

Effective Date

Next Review Date2026-07

Key ActionProviders must supply documentation of institutional review board (IRB) approval demonstrating the HUD will be used in accordance with the FDA-labeled HDE indication(s).

POLICY UPDATE CHANGES

Policy renewed and reviewed July 2025 (Annual Review).

<4,000/yrHUD Prevalence Threshold

1IRB required for coverage

Coverage Summary & Scope

Policy governs coverage determination for FDA-designated Humanitarian Use Devices (HUDs)/Humanitarian Device Exemptions (HDEs), specifying when HUDs are considered medically necessary versus investigational and outlining IRB requirements and documentation for coverage.

Background: A HUD is a device intended for diseases or conditions affecting fewer than 4,000 individuals per year in the United States and is evaluated by the FDA through the HDE pathway, which permits marketing based on safety and probable benefit rather than the higher premarket approval standard.

When HUDs Are Medically Necessary or Investigational

Investigational / Not Covered

HUDs requested for uses outside the FDA-labeled HDE indication(s) are considered investigational and not covered when ALL of the following apply:

ALL of the following

Criterion 1: Requested use is off-label (outside FDA-labeled Humanitarian Device Exemption (HDE) indication[s]);
Criterion 2: Safety and/or effectiveness for the requested off-label use cannot be established by review of the available published peer reviewed literature;
Criterion 3: Therefore, the HUD for the off-label use is considered investigational and not covered.

Required Documentation & Facility Responsibilities

Documentation Required

IRB Approval Documentation Required

Providers must provide documentation of institutional review board (IRB) approval showing the HUD will be used in accordance with the FDA-labeled Humanitarian Device Exemption (HDE) indication(s).

Documentation Required

Facility IRB Requirement

Coverage is limited to facilities that have an institutional review board (IRB) to oversee clinical application of HUDs; ensure IRB approval is obtained prior to use of the device.

Background and Key Definitions

A Humanitarian Use Device (HUD) is a medical device intended to benefit individuals by treatment or diagnosis of a disease or condition that affects fewer than 4,000 individuals in the United States per year. The FDA evaluates HUDs via the Humanitarian Device Exemption (HDE) pathway, which allows marketing approval based on evidence of safety and probable benefit rather than the higher standard of reasonable assurance of effectiveness. Under FDA requirements, HUD use is restricted to the FDA-labeled HDE indication(s) and generally requires institutional review board (IRB) approval to ensure the device will be used in accordance with those labeled indications.

Term	Definition
Humanitarian Use Device (HUD)	A medical device intended to benefit individuals by treatment or diagnosis of a disease or condition that affects fewer than 4,000 individuals in the United States per year.
Humanitarian Device Exemption (HDE)	An FDA approval pathway for HUDs allowing marketing for FDA-labeled indications based on evidence of safety and probable benefit rather than the higher standard required for premarket approval (reasonable assurance of effectiveness).
IRB	Institutional Review Board responsible for oversight and approval of HUD application to ensure use is consistent with FDA-labeled indication(s).