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U.S. Department of Health and Human Services

Science & Research

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Humanitarian Use Devices and Humanitarian Device Exemption

A Humanitarian Use Device (HUD) is a "medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year."  A Humanitarian Device Exemption (HDE) is an application that is similar to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of the Food, Drug, and Cosmetic Act. FDA approval of an HDE authorizes an applicant to market a HUD subject to certain profit and use restrictions. HUDs cannot be sold for profit, except in narrow circumstances.

Pediatric Humanitarian Device Exemptions

HDEs indicated for pediatric use and approved on or after September 27, 2007, may be sold for profit as long as the number of devices distributed in any calendar year does not exceed the annual distribution number (ADN) assigned by the FDA. The Pediatric Advisory Committee (PAC) will annually review all HUDs intended for use in pediatric patients that are approved on or after September 27, 2007, to ensure that the HDE remains appropriate for the pediatric populations for which it is granted.

Pediatric Humanitarian Device Exemptions Approved On or After September 27, 2007

Devices with an asterisk(*) are assigned an ADN and will go to the PAC.

  • Melody Device*
  • Elana Surgical Kit HUD*
  • NeuRX DPS TM, RAM4 Respiratory Stimulation System – does not have a ADN so the company is prohibited from making a profit from the device

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