On June 7, the U.S. Food & Drug Administration (FDA) announced that it is updating the humanitarian device exemption (HDE) regulations. The changes are meant to bring the regulations into compliance with the 21st Century Cures Act (the Act), a bill designed to expand patient access to drugs and devices and signed into law by President Obama late last year.
Under the HDE regulations, an entity looking to develop a medical device for a narrow patient population under specific criteria does not need to demonstrate the device’s effectiveness, as is usually required. Instead, those seeking approval must demonstrate, among other things, that the humanitarian use device (HUD) “will not expose patients to an unreasonable or significant risk of illness or injury, and that the probable benefit to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment.”
- Most significantly, the Act increased the cap on the patient population threshold for HUDs from “fewer than 4000” to “not more than 8000” people in the U.S.,” which the regulations have been updated to reflect.
- Under the existing regulations, companies cannot sell HUDs for profit, and HUD use is generally limited to institutions with IRB oversight. However, in compliance with the Act, the FDA has now amended the regulations to remove the requirement that IRB oversight be “local.”
- There will not be a notice and comment period, as the changes line up the regulations with the implementing statute.