What is the Humanitarian Device Exemption


The pathway for the Humanitarian Device Exemption (HDE) was created by the US Congress in 1990. Its purpose was to encourage the development and facilitate the access to devices for treating rare diseases and conditions.

The HDE Provision

  • The US Food and Drug Administration have guided the HDE process by providing a product that could be designated for humanitarian use device (HUD) that should be eligible for approval. This can be done provided that it is intended for the benefit of the patients in treating or diagnosing a condition or disease that should affect individuals not more than 4,000 in the US annually.
  • Although an HDE application can be similar to a premarket approval application, it is intended to afford lower threshold for approval. This is because the approval for the HDE should be based on the reasonable assurance of probable benefit and safety. It recognizes the special considerations for rare diseases, which include the lack of alternative treatment forms. This is in contrast to the PMA approval that focuses on the safety and the effectiveness standards only.
  • The HDE has been designed to provide incentives in the development of therapies targeting rare diseases and conditions. This will recognize that the small size of a targeted population can otherwise create economic disincentives to the development of products. Nevertheless, this is unlike the Orphan Drug Act because the HDE process has stimulated the approval and development of few products from its inception.

Low Application of HDE

The HDE program was first approved in 1997, wherein the volume of submissions remained at a low, and oftentimes dipped into 3 submissions on a yearly basis. However, the recent years have shown that the number of HDEs has increased in 2014 and 2015 which both yield high number of approvals ever. The lower number of approvals though indicates that the use remains limited even with efforts were made to make it more attractive.

HDEs in Pediatrics

Another portion of the population that was aimed to benefit from the HDE was the pediatric patients. Due to the devices being used in pediatrics may often result in small populations, the use of HDE for pediatrics has still been encouraged. Nevertheless, only 11 of the pediatric devices in the history of the HDE program have been approved by the mechanism.

Although Congress has first relaxed the profit limitation of the HDEs that should be intended for pediatric patients, the change may have only limited effect. This has been known as it constitute to about 6 new pediatric devices being approved over the course of 8 years since it first took effect.

Variable Uses of HDEs in Therapeutic Areas

There is a significant variation in the use of HDE process, with only a little use of HDE process for diagnostic products. This could be attributed to the low test volume that should permit HDE designation. Although there are inherent differences with the use of HDE, the threshold for the eligibility of the HUD remained the same for both diagnostic and therapeutic products.