What is one difference between a Drug Approval and a Humanitarian Device Exemption (HDE)?

The distinction highlighted in the correct answer emphasizes that a Humanitarian Device Exemption (HDE) is specifically tailored for medical devices intended to treat or diagnose rare diseases or conditions, commonly referred to as "orphan" indications. In contrast, traditional drug approvals are aimed at a wider range of diseases that affect larger groups of people. This targeted approach for HDEs allows for certain regulatory flexibility to address medical needs for conditions that may not have significant market incentives, as the patient populations are small and thus the commercial viability for conventional devices might be low.

This understanding is pivotal in regulatory affairs, as it speaks to the purpose and intention behind approval pathways: while standard drug approvals focus on broader public health needs, HDEs provide a framework to encourage innovation in areas that may otherwise remain underserved.