What is the primary purpose of a Humanitarian Device Exemption (HDE)?

The primary purpose of a Humanitarian Device Exemption (HDE) is to provide a pathway for devices intended to benefit patients with rare medical conditions or diseases. The HDE is designed to facilitate access to medical devices that may not have extensive evidence of efficacy due to the limited patient population affected by the condition they aim to treat. Unlike typical device approvals, which require substantial evidence of efficacy, HDEs allow for an alternative approach that focuses on safety and a reasonable assurance of effectiveness, albeit with less data.

This pathway enables manufacturers to introduce devices to the market faster for conditions that may not attract a large enough patient population to conduct traditional clinical trials, thereby addressing an unmet medical need. Those conditions, often referred to as "orphan diseases," typically do not provide a financial incentive for companies to invest in the necessary clinical research for full market approval.

Other options, while they touch upon related concepts, do not accurately convey the HDE's primary aim: demonstrating efficacy or simplifying the clinical trial process does not align with the core purpose of addressing the specific context of rare conditions within the regulatory framework.