Post

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.

Posted
By ReguVirta
3 min read

What You Need to Know? 👇

What is the difference between an eCopy and an eSubmission for medical device submissions?

An eCopy is a static electronic version on CD/DVD/flash drive with human-readable documents, while an eSubmission contains structured data for computer processing plus human-readable documents. eCopies are simpler representations, whereas eSubmissions provide richer, dynamic information about the submission.

Which medical device submission types require an eCopy under FDA regulations?

Required submissions include 510(k)s, De Novos, PMAs, IDEs, HDEs, Q-submissions, certain INDs/BLAs for CBER-regulated devices, and all subsequent amendments, supplements, and reports. Exemptions exist for compassionate use IDEs, emergency use reports, adverse event reports, and EUAs.

What happens if my eCopy fails FDA’s technical standards during processing?

Your submission will be placed on eCopy hold and you’ll receive a notification explaining the failure reasons. You must submit a replacement eCopy meeting technical standards plus a signed cover letter within 180 days, or FDA may consider your submission withdrawn.

What are the key technical requirements for PDF files in an eCopy submission?

PDFs must use Adobe Acrobat version 11 or below, be 50MB or smaller, follow the “xxx_Descriptive Name” naming convention with consecutive numbering, contain no password protection, and avoid intentionally embedded attachments that could be missed during review.

How should I organize my eCopy structure for optimal FDA review efficiency?

Use non-volume structure for small submissions with PDFs at root level, or volume-based structure for large/complex submissions using “VOL_xxx_Descriptive Name” folders. Include meaningful descriptive names, bookmarks, and hyperlinks to facilitate reviewer navigation through your submission content.

What non-PDF files can be included in an eCopy and how should they be formatted?

Non-PDF files must be zipped and placed in “STATISTICAL DATA” folders (for data files, metadata) or “MISC FILES” folders (for videos, images, Word versions of labeling). These folders must be at root level with precise spelling, helping streamline review processes.

What You Need to Do 👇

  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 ID: 32d26af111ca2f374cc11098e887dc81
FDA guidance, Final
Medical Devices Premarket Biologics Investigational Device Exemption (IDE) Administrative / Procedural User Fees
This post is licensed under CC BY 4.0 by the author.