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Electronic Submission Format Requirements for Orphan Drug and Humanitarian Use Device Designation Requests (DRAFT)

This guidance applies to electronic submissions of orphan-drug and humanitarian use device (HUD) designation requests to the Office of Orphan Products Development (OPD), including related submissions such as amendments, correspondence, and annual reports.

This is a draft guidance. Not for implementation.

  1. Determine preferred submission method (ESG or physical media)
  2. If using ESG:
    • Complete preparatory activities
    • Register and obtain digital certificate
    • Follow format requirements
  3. If using physical media:
    • Prepare properly labeled CD-ROMs
    • Include paper cover letter
    • Follow protective packaging requirements
  4. For all submissions:
    • Use text-based format where possible
    • Include proper bookmarks and hyperlinks
    • Follow table of contents structure per regulations
    • Ensure virus-free status
    • Include all required documentation
    • Maintain electronic format for subsequent submissions
  5. Keep contact information for technical support:
    • ESG preparation: esgprep@fda.gov
    • Orphan drug format questions: desigesub@fda.hhs.gov
    • HUD format questions: hudesub@fda.hhs.gov

Key Considerations

Software

  • Documents should be submitted in text-based format when possible
  • PDF format should be used for references and publications
  • Documents should enable clear viewing, easy navigation, and ability to print page by page
  • Documents should allow copying of text, images and data into other common software formats

Cybersecurity

  • Submissions must be virus-free with documentation of virus checking software used
  • For FDA Gateway submissions, digital certificates are required for electronic signatures
  • Secure messaging standards must be followed

Labelling

  • Physical media must be properly labeled with:
    • Type of designation request
    • Request number
    • Company name
    • Drug/Device name
    • Submission type and date
    • Number of media units
    • Contact information

Other considerations

  • 21 CFR Part 11: Electronic Records; Electronic Signatures
  • 21 CFR Part 316: Orphan Drugs
  • 21 CFR Part 814: Premarket Approval of Medical Devices

Original guidance

  • Electronic Submission Format Requirements for Orphan Drug and Humanitarian Use Device Designation Requests
  • HTML / PDF
  • Issue date: 2006-02-01
  • Last changed date: 2021-05-13
  • Status: DRAFT
  • Official FDA topics: Medical Devices, Administrative / Procedural, Drugs, Biologics
  • ReguVirta summary file ID: 5e82dfef77d17f5796bf7e03defba18c
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