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Electronic Copy (eCopy) Program for Medical Device Submissions: Technical Standards and Requirements

This guidance explains the eCopy Program for medical device submissions, implementing section 745A(b) of the FD&C Act. It provides standards for submitting electronic copies (eCopies) of medical device submissions to FDA, aiming to improve review efficiency by making electronic versions immediately available.

  1. Determine if your submission type requires an eCopy
  2. Plan submission structure (volume-based or non-volume-based)
  3. Prepare signed cover letter following requirements
  4. Convert documents to compliant PDF format (Adobe v11 or below, <50MB)
  5. Follow required naming conventions for files and folders
  6. Organize non-PDF files in appropriate folders (STATISTICAL DATA or MISC FILES)
  7. Validate eCopy using FDA’s eCopy Validation Module before submission
  8. Submit eCopy on CD, DVD, or flash drive with paper copy of signed cover letter
  9. Consider using FDA’s free eSubmitter-eCopies tool to ensure compliance
  10. Plan for potential eCopy hold response within 180 days if issues are found

Key Considerations

Software

  • Only Adobe Acrobat PDF version 11 or below is accepted
  • No embedded attachments or attributes in PDFs
  • No PDFs requiring passwords to open
  • PDF file size limited to 50MB or below
  • Statistical data and other non-PDF files must be submitted in zip format under specific folders

Cybersecurity

  • No security settings requiring passwords to open PDFs
  • No embedded attachments that could compromise security

Labelling

  • Labeling documents should be provided in both PDF and Microsoft Word formats (Word version in MISC FILES folder)

Other considerations

  • eCopy must include a signed cover letter (wet or digital signature)
  • Specific naming conventions required for volumes and files
  • Maximum recommended total submission size of 1GB
  • Specific folder structure requirements for volume-based and non-volume-based submissions
  • Statistical data must be submitted in “STATISTICAL DATA” folder
  • Miscellaneous files must be submitted in “MISC FILES” folder

Original guidance

  • Electronic Copy (eCopy) Program for Medical Device Submissions: Technical Standards and Requirements
  • HTML / PDF
  • Issue date: 2020-04-27
  • Last changed date: 2023-08-10
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, Biologics, Investigational Device Exemption (IDE), Administrative / Procedural, User Fees
  • ReguVirta summary file ID: 32d26af111ca2f374cc11098e887dc81
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