What is the role of Humanitarian Use Devices under HDE?

Humanitarian Use Devices (HUDs) are specifically designed for the treatment or diagnosis of conditions affecting individuals in a small patient population, typically those with rare diseases or conditions. The Humanitarian Device Exemption (HDE) allows for the approval of these devices, enabling access to potentially beneficial technologies for patients who may otherwise have no treatment options due to the limited prevalence of their conditions. Under this framework, the intent is to address unmet medical needs for populations that are considered too small for traditional clinical studies necessary for standard device approval.

The other choices focus on broader applications or misinterpret the intent of HUDs. Devices approved for large population use would not qualify under HDE, as the purpose of HUDs is to cater specifically to rare conditions. Similarly, devices for treating common conditions or those that can be marketed without clinical trials do not align with the HDE's primary focus on rarity and specific patient needs. Therefore, option C highlights the core purpose of Humanitarian Use Devices within the regulatory framework, emphasizing their role in improving health outcomes for patients with rare diseases or conditions.