FDA eCopy program

With the term eCopy, the FDA refers to the electronic copy/version of paper-based submissions, e.g., as part of a 510(k) submission.

In December 2020, the FDA published a revised version of the guidance document eCopy Program for Medical Device Submissions.

Is the eCopy program mandatory?

The short answer to this question is “partially”.

The FDA requires eCopies for the following submissions, among others, by Section 745A/(b) of the Food, Drug and Cosmetic Act (FD&C) and its amendment by Section 1136 of the FDASIA:

• Premarket Submission 510(k), also “third party” ones. FromOctober 2023 on, these will only be accepted in eSTAR format.
• De Novo. From October 2025, these will also only be accepted in eSTAR format.
• Premarket Approval Application (PMA)
• Investigational Device Exemption (IDE)
• Product Development Protocol (PDP)
• Humanitarian Device Exemption (HDE)
• Special approvals / Emergency Use Authorization (EUA)
• Q-Submissions

What are the provisions for the eCopy format?

In its guidance document eCopy Program for Medical Device Submissions, the FDA describes the requirements, including:

• The file size of the entire package should not exceed 1GB.
• The size of a single PDF file must not exceed 50 MB.
• PDF files must not have any embedded annexes or be password protected.
• If there are subfolders, their names must begin with VOL_001_, etc.
• The file names must begin with the prefix 001_, 002_, etc.
• Only PDFs should be submitted. If other file formats are necessary (e.g., Excel, SAS, XML), these should be stored in special folders.
• A standard font such as Times New Roman, Helvetica, or Arial should be used, ideally in 12-point font size and black on white.
• PDF files should be searchable, i.e., generated directly by a program such as Word, and not contain scans that have not been converted into readable text using OCR.

The entire package can now be submitted electronically to the FDA via the CDRH portal – at least for medical devices regulted by the Center for Device and Radiological Health (CDRH) jurisdiction. Alternatively, the eCopy can be submitted using a physical storage medium (e.g., DVD or USB drive).

Tooling

The FDA provides tools:

• for creating packages (eSubmitter-eCopies Tool): This tool creates the required prefixes for file names and directories for you. You decide whether you need it.
• for validating eCopy packages (eCopies Validation Module).
• for communicating with the agency via the Electronic Submissions Gateway.

eCopy Guidance Document: What’s New?

The changes to the guidance document eCopy Program for Medical Device Submissions are modest and contain fewer new requirements, but rather clarifications and explanations:

• The FDA recommends bookmarks and hyperlinks within the documents to make navigation easier.
• The FDA explains how to create such bookmarks and hyperlinks.
• The FDA clarifies the requirements for sizes and fonts.
• The FDA recommends its tools.

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Change history:

• 2024-11-18: Revision with regard to the eSTAR format