Humanitarian device exemption (HDE)
What is a Humanitarian Device Exemption (HDE)?
An HDE is an application submitted to the Food and Drug Administration (FDA) to obtain approval for a Humanitarian Use Device (HUD). A HUD is a device that intends to benefit patients by diagnosing or treating a disease or condition that manifests or affects fewer than 8,000 individuals in the U.S. each year.
There are two steps to receiving an HDE:
- The company files an HUD designation request, which the FDA’s Office of Orphan Products Development (OOPD) must confirm meets the standards of a HUD.
- The sponsor then submits an HDE application, which has a 30-day filing period and a 75-day review clock.
The HDE is like the premarket approval application (PMA) but is exempt from the effectiveness requirements—it does not have to include clinical investigation results to verify the effectiveness of the device. However, the HDE application must still contain enough information for the FDA to determine that the device does not pose a significant or unreasonable risk of injury or illness.
What are the provisions for obtaining an HDE?
Devices that are approved for an HDE must be designed to treat or diagnose a disease or condition affecting less than 8,000 individuals in the U.S. per year, not expose patients to significant or unreasonable risk, have benefits for use that outweigh the risks, and be a device that is not otherwise available and has no comparable devices.
HUDs are critical for improving health outcomes in very specific patient populations, and the HDE encourages companies to produce these devices by making the approval process easier.