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125. Humanitarian Use Devices

FDA regulations at 21 CFR 814, Subpart H describe requirements by which manufacturers may ship medical devices, designated as humanitarian-use devices (HUD), when the intended use is to benefit patients in the treatment and diagnosis of diseases or conditions that affect or are manifested in fewer than 4,000 individuals in the US per year. Use of HUDs requires

  • prior FDA humanitarian device exemption (HDE) Approval Order,
  • prior IRB approval, and
  • informed consent from the patient receiving the HUD.

An HDE is a premarket approval application submitted to FDA in which an individual or sponsor seeks a HDE from the effectiveness requirements of sections 514 and 515 of Chapter V of the Food, Drug, and Cosmetics Act. HDE approval is conferred when the FDA determines

  • the HUD will not expose patients to an unreasonable or significant risk of illness or injury;
  • the probable health benefit from use of the device outweighs the risk of injury/illness from its use, with consideration for the risks and benefits of currently available devices or alternative forms of treatment;
  • the device would not be available to a person with the disease or illness in question without the HDE approval; and
  • there is no comparable device, other than another device approved under an HDE or Investigational Device Exemption (IDE), available to treat or diagnose the disease or condition.

NOTE: This policy addresses only those FDA regulations that are relevant to investigators and IRB review of HUDs. It is not a comprehensive review of regulations for HUD. Individuals interested in processes for designating HUDs and submission and review of Humanitarian Device Exemption (HDE) applications are advised to review the complete §814, Subpart H. Additional information about HUDs may be found in the FDA draft guidance: Humanitarian Device Exemption (HDE): Questions and Answers - Draft Guidance for HDE Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff - issued March 18, 2014. Non-HUD uses of these devices requires a Premarket Approval Application (PMA) (see §814 Subparts A, B, C, D, and E for information about PMAs).

Submission Requirements for Clinical Use of HUD

Physicians must complete the following steps for IRB review and approval of each new project involving a HUD:

  • Create a New Project in IRBNet
  • Add Part I, Cover Sheet
  • Add Humanitarian Use Device Application (available from the researcher library in IRBNet)
  • Add FDA HDE Approval Order
  • Add documentation of approval from the physician's institution/business for use of the HUD
  • Add product labeling
  • Add the patient information packet that will accompany the HUD
  • Add device manufacturer's requirements/recommendations for practitioner training and qualifications for implementation of the device, and documentation from practitioner that she/he meets same
  • Add sample consent form for use of the HUD
  • Add study materials: assessment instruments, surveys, questionnaires, data collection logs, procedural protocols
  • Share IRBNet access for all study personnel and the Responsible Official
  • Provide her/his electronic signature through IRBNet
  • Submit the project for Full Committee Review

Although not an FDA requirement, the University IRB requires physicians to obtain patient consent specific to use of the HUD. Before use of an HUD, patients must be informed of the following

  • risks and potential benefits of the HUD,
  • procedures associated with the use of the device, and
  • a statement that the device is a humanitarian use device for which effectiveness for the labeled indication has not been demonstrated.

Requirements for IRB Approval for Clinical Use of HUD

Use of HUD in accordance with the terms of the approved HDE and device labeling is not considered to be research as defined by the FDA; this use is considered clinical use of an approved device. Clinical uses of HUDs are initially reviewed and approved by the convened IRB.

When reviewing an application for use of an HUD, the University IRB will ensure IRB members or consultants have the appropriate experience and expertise for a complete and adequate review of the use of the HUD at the University/Affiliate site. In the absence of this expertise, the IRB may enter into an agreement with a similarly constituted IRB for oversight of the use of the HUD.

The IRB will not approve uses that exceed the scope of the FDA-approved indications (as evidenced in the HDE Approval Order or other documentation from FDA).

The University IRB may limit the scope of the FDA-approved indications or impose additional restrictions.

Following IRB approval of an HUD, the University IRB does not require review of each individual use providing the use is consistent with the FDA-approved indications and any additional IRB restrictions.

Continuing review must be completed at least annually for clinical uses of HUD. At the initial or a subsequent continuing review, the convened IRB may determine that continuing reviews may be completed via expedited review procedures as long as no unanticipated problems occur during the review period.

IRB determinations for initial and continuing reviews of HUD use are made available to the submitting physician as published Board Documents in IRBNet.

Physician Reporting Requirements for Clinical Use of HUD

Within five days of learning about FDA actions (e.g., FDA-approved amendments to the HDE; changes to the FDA-approved indications; or amended product labeling, clinical or patient brochure physicians must report the action/changes to the IRB.

Physicians must inform the IRB and FDA as soon as possible but no more than 10 days after receiving information that reasonably suggests a device with an approved HDE under her or his use (or a similar device marketed by the manufacturer or importer) may have caused or contributed to a death or serious injury or has malfunctioned; or would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

At continuing review (at least annually), physicians must report the number of HUD uses that fall within the FDA-approved indications and IRB limitations (if applicable).

Emergency Use of an HUD

If a physician determines that IRB approval cannot be obtained in an emergency situation in time to prevent serious harm or death to a patient, an HUD may be used without prior IRB approval providing that within five days of the emergency use, the physician provides written notification to the IRB Chair with the following information:

  • the identification of the patient involved;
  • the date of the HUD use; and
  • the reason for the HUD use.

Investigational Use of HUD

In addition to the clinical use described above, an HDE holder may collect safety and effectiveness data for the HDE-approved indications. FDA considers such uses to constitute clinical investigations.

  • If the HUD is being used as approved in the HDE and device labeling, and the HUD is not a significant risk device, the investigation is not subject to requirement for an IDE because the HUD is a legally marketed device (under the HDE).
  • If the uses of the HUD are outside of the HDE-approved indications or approved labeling, or the HUD is a significant risk device, an IDE is required.

NOTE: University/Affiliate investigators conducting investigational uses of non-significant risk HUDs must comply with the requirements for investigational devices (at §812); IRB review (at §56.111); informed consent (at §50.20); documentation of consent (unless the IRB waives the requirement for participants to sign a written consent form in accordance with regulations at §56.109, item (c)); and reporting unanticipated adverse device effects (at §812.150, item (a)(1).

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