In September of 2019 revisions of the Guidance for Industry and Food and Drug Administration (FDA) Staff: Humanitarian Use Device (HUD) Designations and the Guidance for Industry and FDA Staff: Humanitarian Device Exemption (HDE) Program were released. These guidelines were designed to assist the applicants in preparing their submissions of a HUD and HDE, in addition to the FDA reviewers in their evaluation and analysis. While new revisions of the guidelines were released, applicants should still be encouraged to follow the FDA regulations 21 CFR 814, Subpart H – Humanitarian Use Devices when submitting for HUD and/or HDE approval.