FDA Amends Humanitarian Device Exemption Regulations
The US Food and Drug Administration (FDA) on Tuesday announced that it is amending its regulations governing humanitarian device exemptions (HDE) to reflect changes brought on by the 21st Century Cures Act.
These exemptions provide a pathway for device makers looking to develop medical devices for small patient populations by exempting them from demonstrating a device's effectiveness.
Instead, a company must demonstrate that the humanitarian use device (HUD) "will not expose patients to an unreasonable or significant risk of illness or injury." Additionally, FDA restricts manufacturers from selling HUDs at a profit in most cases and limits their use to facilities with IRB oversight.
The changes are made in a final rule set to be published in the Federal Register on Wednesday, and are being issued without a notice and comment period as the changes in the final rule are in line with changes to the statute they implement.
Under the Cures Act, Congress increased the patient population threshold for HUDs from "fewer than 4,000" to "not more than 8,000." As such, FDA says it is amending its regulations to reflect that change.
FDA also is amending the requirements for institutional review board (IRB) oversight for humanitarian use devices to remove the requirement that the IRB overseeing their use be local, as stipulated by Cures.
This change reflects a shift in in the clinical landscape toward using a single or central IRB for multi-site studies.