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:
Copies of the new guidance can be accessed from here.