When seeking Humanitarian Use Device (HUD) status for a device, an HDE application must be submitted to FDA. HDE applications are similar to PMAs but are exempt from the effectiveness requirements of a PMA. They still must contain enough scientific evidence to show that the benefits to health of the device outweigh the risks posed to users or patients. An approved HDE authorizes marketing of a HUD.
Once an HDE is approved, the holder of the HDE is responsible for ensuring that the HUD is only administered at institutions that have an Institutional Review Board (IRB) in accordance with 21 CFR 56. Use of the HUD must be approved by the institution’s IRB, or by another IRB which has agreed to oversee HUD use.
IRBs are responsible for both initial reviews and continuing reviews. During an initial review, the full board of the IRB approves use of the Humanitarian Use Device as it sees fit, for a period of up to one year. In some high-risk cases, the IRB may also limit the number of patients to receive the HUD and require a summary report before approving further use. Continuing reviews may be conducted under the expedited review procedures in 21 CFR 56, unless the IRB determines that a full board review is necessary.