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A HUD is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States, per year.
When the clinical use of the HUD with a Humanitarian Device Exemption (HDE) is within the Food and Drug Administration (FDA) approved labeling, the use is not research nor a clinical investigation. An Investigational Device Exemption (IDE) does not apply.
FDA regulations require that the HUD be used at a facility overseen by an IRB. Further, IRB Committee review and approval of the HUD is required, prior to use.
The HUD may be used off label via Emergency Use or through a Compassionate Use Device Request (IDE applies). For the latter, prospective IRB Committee review and approval is required.
The IRB will review the protocol, using criteria at 21 CFR 56.111 and 45 CFR 46.111. The IRB will not specifically address subparts at HHS or the FDA.
While consent is not required, a HUD consent template is available, and routinely used at UCI.
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