Humanitarian Use Device Guidance

Definitions

Humanitarian Use Device (HUD)

A HUD is a device that is intended to benefit patients in the treatment and diagnosis of diseases or conditions that affect or is manifested in less than 4,000 individuals in the United States per year. The U.S. Office of Orphan Products Development (OOPD) determines if a device meets specific requirements, including scientific rationale and population prevalence, for designation as an HUD.

Humanitarian Device Exemption (HDE)

A Humanitarian Device Exemption (HDE) is an application that is similar to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of sections 514 and 515 of the Food, Drug, and Cosmetic Act (the Act). FDA approval of an HDE authorizes an applicant to market a Humanitarian Use Device (HUD), subject to certain profit and use restrictions set forth in section 520(m) of the Act. Specifically, as described below, HUDs cannot be sold for profit, except in narrow circumstances, and they can only be used in a facility after an IRB has approved their use in that facility, except in certain emergencies.

Additional guidance for HUDs can be found in FDA Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and Food and Drug Administration Staff, Humanitarian Device Exemption (HDE) Regulation: Questions and Answers.

IRB Review and Guidance

Initial Review

Initial IRB approval is required and should be performed at a convened IRB meeting. The IRB does not need to review and approve individual uses of an HUD, but rather the IRB may approve use of the device as it sees fit. That is, the IRB may approve use of the HUD without any further restrictions, under a protocol, or on a case-by-case basis.

  • HDE Approval: IRBs are responsible for ensuring that HDE approval has been granted before approving the device for use at their institution.
  • Consent Document Review: UT Southwestern IRB requires submission of informed consent for review using the HUD consent form template found in IRB Forms.
  • HIPAA/ HIPAA Waiver Review: Because the use of an HUD is for diagnosis or treatment purposes only, the HIPAA regulations for research are not applicable. Therefore, a HIPAA Research Authorization and/or Waiver of Authorization are not required.

Continuing Review

IRBs may approve the use of the device for a period of time, not to exceed one year. 21 CFR 56.109(f). In some higher-risk cases, IRBs may approve HUDs for a specific number of patients and require a summary report before approving the use in additional patients. Continuing review should follow the requirements found at 21 CFR 56. The UT Southwestern IRB requires all continuing reviews for HUDs to go through the full-board review.

  • Correspondence from HDE holder: A summary of all correspondence received from the holder of the HDE since the last IRB review must be submitted at the time of continuing review.
  • FDA actions: The current FDA-approved product labeling for the HUD; summary of any known FDA action(s) taken regarding the HUD since the last IRB review must be provided at the time of continuing review.

Modifications

IRB approval is required prior to initiation of any changes/modifications of the HUD and/or of the proposed clinical use(s) of the HUD. The responsible physician requesting a modification must submit through the eIRB system. 

Prompt Reporting Requirements

Whenever the responsible physician receives or otherwise becomes aware of information, from any source, which reasonably suggests the HUD has or may have caused or contributed to the death or serious injury of a patient, the physician must report such findings to the FDA and the IRB (using the eIRB Reportable Event function) as soon as possible, but no later than 2 working days after learning of the adverse event or problem. 

The responsible physician must report to the IRB any FDA action(s) taken regarding the HUD for which s/he has become aware. This report will be submitted (using the eIRB Reportable Events function) to the IRB within two days of receiving knowledge of such FDA action. Depending on the nature of the FDA action taken, an IRB Chair may elect to initiate an immediate IRB action to suspend IRB approval for use of the device. 

For more information, please refer to UT Southwestern Humanitarian Device Use Guidance found on the IRB Forms page. 

References and Additional Guidance

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