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 Below are the additional resources from this presentation: HDE Draft Guidance Document: www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm389154.htm HDE Approvals: www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/HDEApprovals/ucm161827.htm HDE Database: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfHDE/hde.cfm Humanitarian Device Exemption (HDE): Questions and Answers - Draft Guidance for HDE Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff: www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm389154.htm Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff - Humanitarian Device Exemption (HDE) Regulation: Questions and Answers: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm110194.htm Guidance for Industry and Food and Drug Administration Staff – Humanitarian Use Device (HUD) Designations: www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM336515.pdf Device Advice – Humanitarian Device Exemption: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/HumanitarianDeviceExemption/default.htm HDE Approvals: www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/HDEApprovals/default.htm HDE Checklist for Filing Decisions: www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/HumanitarianDeviceExemption/UCM056830.pdf 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: www.fda.gov/Training/CDRHLearn 2. Device Advice - Text-Based Education * comprehensive regulatory information on premarket and postmarket topics: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance 1. Division of Industry and Consumer Education (DICE) * If you have a question - Email: DICE@fda.hhs.gov * Phone: 1(800) 638-2041 or (301) 796-7100 (Live Agents 9am - 12:30 pm; 1-4:30 pm EST) * Web Homepage: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ContactUs--DivisionofIndustryandConsumerEducation/default.htm