Humanitarian device exemption

Investigational Device Exemption (IDE), Humanitarian Device Exemption (HDE), or Premarket Approval (PMA) numbers for device trials... 

Two devices are commercially available. Thera-Sphere (glass microsphere MDS Nordion, Kana-ta, Canada) was approved in 1999 by the Food and Drug Administration (FDA) under a Humanitarian Device Exemption (HDE) for the treatment of unresectable hepatocellular carcinoma (HCC) in patients who can have appropriately positioned hepatic arterial catheters with or without portal vein thrombosis [1]. SIR-Spheres (resin microsphere Sirtex Medical, Lane Cove, Australia) were granted full pre-marketing approval in 2002 by the FDA for the treatment of colorectal metastases in conjunction with intra-hepatic FUDR [2]. Both devices have European approval for liver neoplasia and approvals in various Asian countries. 

On the pulmonary side, the Medtronic Melody transcatheter has been successfully implanted in over 1000 patients to date to address right ventricular outflow tract (RVOT)/pulmonary trunk dysfunction. This device has been FDA approved under the Humanitarian Device Exemption (HDE) program, paving the way for implantation in patients in the United States as well. 

F. Premarket Notification, Investigational Device exemptions including Humanitarian Exemptions, Premarket Approval, Product Development Protocols, Classification, Device Tracking, Petitions for Reclassification, postmarket surveillance under Sections 510(k), 513, 515, 519, 520(g) and (m), and 522, and the advisory committees necessary to support these activities. 

Humanitarian use devices are those intended to treat a disease or condition that affects fewer than 4000 people in the United States. The FDA is authorized to exempt a sponsor from the obligation to demonstrate the effectiveness of such a device to obtain marketing approval however, the sponsor is precluded from selling the product for more than the cost to develop and produce it. 

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