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Today, the U.S. Food and Drug Administration issued a final guidance, Humanitarian Device Exemption (HDE) Program, to provide updated information about the HDE application process and other considerations specific to the HDE Program.
An HDE application is the premarket submission for a Humanitarian Use Device (or HUD), which is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects, or is manifested in, not more than 8,000 individuals in the United States per year. A device approved under an HDE application is exempt from the requirement to demonstrate a reasonable assurance of effectiveness. To be eligible for an HDE, the FDA must determine, among other things, that the device would not be available to a person with the disease or condition in question without the HDE approval and that there is no comparable device, other than another device approved under an HDE or Investigational Device Exemption (IDE), available to treat or diagnose the disease or condition.
As required by the 21st Century Cures Act, the final guidance explains the principal criteria that the FDA considers when determining if probable benefit(s) to health have been demonstrated for a HUD that is being reviewed through the HDE Program. The final guidance also discusses FDA’s assessment of the probable benefits and risks for a device as part of its HDE application review. When performing this probable benefit-risk assessment, the FDA considers relevant factors in the context of the intended use of device, including the target patient population and the size of the population. The FDA’s probable benefit-risk assessment also considers currently available alternative treatments or diagnostics. The final guidance includes a filing checklist to clarify the information needed for the FDA to consider the application sufficiently complete to allow substantive review, as well as tools to assist application review staff in consistent decision-making.
The guidance issued today finalizes the draft guidance on the HDE Program that was issued on June 12, 2018. This final guidance supersedes Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and Food and Drug Administration Staff, Humanitarian Device Exemptions (HDE) Regulation: Questions and Answers, issued July 8, 2010.
Humanitarian Device Exemption