129. Humanitarian Use Devices
FDA allows manufacturers to ship medical devices that are intended 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. These devices are sometimes called humanitarian-use devices (HUD).IRB approval is required for a HUD because of the special circumstances that govern approval and use of a HUD device. Because a randomized clinical trial was not performed on the product, FDA made a determination of the relative safety of the device and the probable benefit to patients from the available data. However, FDA expects that final decision as to that probable benefit vs. the risks, for an institution, rests with the IRB. Also, the patients who typically qualify for receipt of an HUD device have few options and the FDA wants to make certain that patients are treated appropriately given the compromised medical condition that qualify them for use of the device. By requiring IRB approval, FDA is allowing the review board to make the final decision as to whether or not the device should be used by their physicians and to have a prospective dialogue with the physicians regarding its use.
- Device manufacturers must obtain a Humanitarian Device Exemption (HDE) from the FDA in order to market such devices.
- IRB may request University and affiliate investigators include the HDE and device labeling with the IRB application packet to use an HUD for treatment, diagnosis or research.
- The HUD application must be submitted prior to the use of the device except in an emergency, as addressed below.
- A physician or healthcare provider must be listed as the responsible clinician on the HUD application submitted to the IRB.
- All other clinicians or healthcare providers who have the appropriate privileges and credentials and intend to administer the HUD for its approved indications must be listed on the application.
- Patients must be told about the use of an HUD via a patient consent document or information sheet; or the manufacturer's brochure.
NOTE: by law, informed consent specific to use of the HUD device is not required. However, IRBs may require that patient consent, specific to use of the device, is obtained. In these cases, physicians must abide by the rules set forth for their institution by the reviewing IRB.
- Patients must be informed of the following:
o risks and potential benefits of the HUD,
o procedures associated with the use of the device, and
o statement that the device is a humanitarian use device for which effectiveness for the labeled indication has not been demonstrated.
- The IRB may not approve uses that exceed the scope of the FDA-approved indications. However, the University IRB may limit the scope of the FDA-approved indications or impose additional restrictions.
The Biomedical IRB does not require review of each individual use of an HUD as long as the device is used for the FDA-approved indications and with regard for any additional IRB restrictions.
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 must initially be reviewed and approved by the convened Biomedical IRB. At that time, 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. Continuing review must be completed at least annually for clinical uses of HUD.
Investigational Use of HUD
In addition to its clinical use, an HDE holder may collect safety and effectiveness data for the HDE-approved indications. While this use constitutes a clinical investigation, FDA considers the investigation exempt from the requirement to obtain an IDE as long as the device is being used as approved in the HDE and device labeling, and the HUD is not an SR device.
Such investigational uses of NSR HUDs require IRB approval and informed consent. Clinical investigations involving NSR HUDs will initially and continually be reviewed at convened IRB meetings.
Physician Reporting Requirements for HUD Use
At continuing review, physicians must report the number of HUD uses that fall within the FDA-approved indications and IRB limitations (if applicable).
Physicians must report changes to the HDE, FDA actions, or changes to the FDA-approved indications (promptly or within five days of learning about the actions or changes).
- Examples from FDA include HDE amendments or supplemental approval letters.
- Examples from the HUD manufacturer include amended product labeling, or clinical brochure or patient brochure.
As soon as possible but no more than 10 days, physicians must inform the IRB and FDA 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.
Emergency Use of an HUD
If a physician in an emergency situation determines that IRB approval cannot be obtained in time to prevent serious harm or death to a patient, an HUD may be used without prior IRB approval. Within five days of the emergency use of an HUD, the physician must provide the IRB with the following:
- a description of the patient's condition;
- the circumstances necessitating use of the device;
- a discussion of why alternative therapies or diagnostics are unsatisfactory; and
- information to address the patient protection measures.
All FDA actions and any changes to the FDA-approved indication for the use of the HUD must be reported to the IRB by the clinician or healthcare provider who requested use of the HUD as soon as possible, but no later than 5 working days after receiving knowledge of such actions or changes.
· Related correspondence from the HUD manufacturer (e.g., amended product labeling, clinical brochure, and patient brochure) or FDA (e.g., HDE amendment or supplement approval letters) must be submitted to the IRB.
· The initial review of the HUD application will occur at the next convened IRB meeting.
· The IRB will have among its members (or consultants) the appropriate experience and expertise to perform a complete and adequate review of the use of the HUD at that institution.
· The physician will receive correspondence from the IRB regarding determination similar to any other Board action.