Humanitarian Device Exemption (HDE) Program: Overview and Pre-approval Activities

This module will provide an understanding of the HDE program and FDA's review process of an HDE application. Below are the additional resources from this presentation: HDE Draft Guidance Document: HDE Approvals: HDE Database: Humanitarian Device Exemption (HDE): Questions and Answers - Draft Guidance for HDE Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff: Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers: Guidance for Industry and Food and Drug Administration Staff – Humanitarian Use Device (HUD) Designations: Device Advice – Humanitarian Device Exemption: HDE Approvals: HDE Checklist for Filing Decisions: CDRH also provides multiple opportunities for industry education, which are listed on the links below: 1. CDRH Learn - Multi-Media Industry Education * over 80 modules - videos, audio recordings, power point presentations, software-based "how to" modules * accessible on your portable devices: 2. Device Advice - Text-Based Education * comprehensive regulatory information on premarket and postmarket topics: 1. Division of Industry and Consumer Education (DICE) * If you have a question - Email: * Phone: 1(800) 638-2041 or (301) 796-7100 (Live Agents 9am - 12:30 pm; 1-4:30 pm EST) * Web Homepage: