What are the two steps involved in securing FDA marketing approval for a HUD?

The process for securing FDA marketing approval for a Humanitarian Use Device (HUD) involves two specific steps: obtaining a HUD designation and then submitting a Humanitarian Device Exemption (HDE) application.

First, obtaining the HUD designation is crucial because it identifies the device as intended to benefit patients with rare diseases or conditions affecting fewer than 8,000 individuals in the United States per year. This designation is necessary to recognize the device's intended use and makes it eligible for the special regulatory pathway available for HUDs.

Secondly, after receiving the HUD designation, the next step is to submit the HDE application to the FDA. This submission provides data demonstrating that the device meets certain safety and effectiveness criteria, albeit the standards for traditional medical devices are adjusted given the rare patient populations involved. The HDE submission process offers a pathway for devices that address unmet medical needs, allowing access to innovative treatments while still adhering to necessary safety regulations.

Through these steps, the FDA facilitates the introduction of devices that provide significant benefits to patients with rare conditions, balancing innovation with safety oversight.