Initial IRB approval 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. 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 have approved HUDs for a specific number of
patients and have required a summary report before approving the use in additional patients.
Continuing review should follow the requirements found at 21 CFR 56, and may be conducted
using the expedited review procedures (see 21 CFR 56.110) unless the IRB determines that full
board review should be performed. The agency believes that the expedited review procedures
are appropriate for continuing review since the initial review would have been performed by the
full board and use of the HUD within its approved labeling does not constitute research.
