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FDA issues final guidance on Humanitarian Device Exemption process

  • Posted by: inetika
  • Category: GLOBAL NEWS

The US Food and Drug Administration (FDA) has finalised guidance on the Humanitarian Device Exemption (HDE) process, updating the draft issued in June 2018, and superseding ‘Guidance for HDE holders, Institutional Review Boards (IRBs), Clinical Investigators, and Food and Drug Administration Staff, Humanitarian Device Exemptions (HDE) Regulation: Questions and Answers’. dated 8 July 2010.

The new guidance, titled ‘Humanitarian Device Exemption (HDE) Program: Guidance for Industry and Food and Drug Administration Staff’, addresses commonly asked questions about HDEs and Humanitarian Use Devices (HUDs), including FDA actions on HDE applications, post-approval requirements, and special considerations for devices marketed under the HDE Program. The guidance document reflects changes in the HDE Program resulting from statutory amendments made by the 21st Century Cures Act (Cures Act) and explains the criteria FDA considers to determine if “probable benefit” has been demonstrated as part of the Agency’s decision-making process regarding marketing authorization for a HUD.

FDA may grant an HDE, which is an exemption from the effectiveness requirements of sections 514 and 515 of the FD&C Act, if it finds that the device meets all of the following criteria:

  1. The device will not expose patients to an unreasonable or significant risk of illness or injury, and the probable benefit to health from use of the device outweighs the risk of injury or illness from its use while taking into account the probable risks and benefits of currently available devices or alternative forms of treatment;
  2. The device would not be available to a person with the disease or condition in question without the HDE, and no comparable device, other than another device approved under an HDE or Investigational Device Exemption (IDE), is available to treat or diagnose such disease or condition; and
  3. The device is designed to treat or diagnose a disease or condition that affects not more than 8,000 individuals in the United States on an annual basis.

Copies of the new guidance can be accessed from here.

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