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Humanitarian Use Device (HUD) Designation Requests: Content and Format

This guidance document assists applicants in preparing and submitting Humanitarian Use Device (HUD) designation requests to FDA's Office of Orphan Products Development (OOPD). A HUD designation is required before submitting a Humanitarian Device Exemption (HDE) marketing application. The guidance explains how to demonstrate that a device is designed to treat or diagnose a disease/condition affecting not more than 8,000 individuals in the US per year.

  1. Determine if device is therapeutic or diagnostic to properly estimate affected population
  2. Prepare comprehensive device description including:
    • Detailed specifications and dimensions
    • Visual representations
    • Mechanistic and operative aspects
  3. Compile robust scientific rationale with:
    • All relevant nonclinical and clinical data
    • Proof-of-principle data
    • Both positive and negative results
  4. Document population estimates through:
    • Literature citations
    • Medical journals/textbooks
    • Government statistics
    • Expert consultations (minimum 3 independent experts if needed)
  5. For orphan subsets:
    • Justify based on device properties/limitations
    • Provide scientific/medical rationale for restricted use
  6. Submit complete request with:
    • Cover letter
    • Table of contents
    • All required sections
    • Supporting documentation
    • Bibliography and references
  7. Include electronic copy (eCopy) as one of two required submission copies

Key Considerations

Non-clinical testing

  • Nonclinical information on device verification and validation against design specifications is reviewed in HDE application, not HUD request

Labelling

  • OOPD designates a device for a rare disease/condition, not for specific indications or labeling
  • HUD designation may be broader than eventual HDE approved indications

Other considerations


Original guidance

  • Humanitarian Use Device (HUD) Designation Requests: Content and Format
  • HTML / PDF
  • Issue date: 2019-09-05
  • Last changed date: 2021-05-13
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, Good Clinical Practice (GCP), Biologics
  • ReguVirta summary file ID: b1fbfa36666fd75d3a41aa5b88f6f5ee
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