Guidance Breakdown: eCopy Program for Medical Device Submissions

What medical device and medtech teams need to know now that the FDA’s eCopy formatting rules are final.

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Today’s guidance breakdown focuses on something purely operational, but critical to getting FDA reviews started on time: the final eCopy Program for Medical Device Submissions guidance issued December 3.

This isn’t a guidance about scientific content, new regulatory pathways, or review standards. It’s about format. Specifically, how the FDA expects device submissions to be prepared and transmitted under Section 745A(b) of the FD&C Act until they transition fully to eSTAR.

The FDA has required eCopies for certain device submissions for years, but this final version clarifies the rules, modernizes the infrastructure requirements, integrates portal-based submissions, and formalizes the program’s relationship to eSTAR. It also replaces the April 2020 version and removes remaining ambiguity around acceptable file types, folder structures, security settings, and naming conventions.

What hasn’t changed is the consequence of getting it wrong: The FDA will not open or begin reviewing a submission until a valid eCopy is received. A missing underscore, locked PDF, or oversized file won’t just earn a correction request; it will stop the review clock before it ever starts.

If your team handles 510(k)s, De Novos, PMAs, HDEs, IDEs, or related amendments, supplements, or reports, this guidance applies.

Below, we’ve distilled the final rule into the key requirements, operational impacts, and practical takeaways to help your technical writing, regulatory operations, and submissions teams get format right the first time.

What an eCopy is (and isn’t)

The FDA is clear here: an eCopy is not an electronic submission platform or database upload. It is:

“An electronic version of your medical device submission created and submitted on a CD, DVD, flash drive, or via the CDRH Portal or ESG NextGen.”

The eCopy must include:

• All submission content in the specified format.

• A signed company cover letter (wet signature or valid digital signature).

Notably, eCopy requirements do not change the scientific or regulatory content of a submission — only the format.

Which subs require an eCopy

Under Section 745A(b), the following submission types require an eCopy unless they are already required to be submitted via eSTAR:

• 510(k) Premarket Notifications

• De Novo requests

• PMAs (all types and supplements)

• Modular PMAs

• PDPs

• IDE applications (with exceptions)

• HDE applications and supplements

• Emergency Use Authorizations (with exceptions)

• Certain INDs and BLAs for CBER-regulated device-biologics

• Pre-Submissions

All subsequent amendments, supplements, and reports related to these submissions are also required to be submitted as eCopies.

Exemptions and waivers

The FDA grants no blanket waivers because tools exist to produce compliant eCopies at low cost. However, the FDA exempted specific submission types, including:

• IDE expanded access compassionate use requests and emergency reports

• IDE adverse event reports

• All EUAs

For these, the FDA encourages eCopies but does not require them. If an optional eCopy fails, the sponsor may instead respond with a paper copy.

What happens if the eCopy is non-compliant

If an eCopy fails automated validation:

• The FDA places the submission on format hold.

• The review clock does not start!

• The FDA sends an email detailing the errors and the process to correct.

Sponsors have 180 days to correct the eCopy before the submission may be treated as withdrawn.

Required formatting standards

Formatting rules are not recommendations — they’re enforced by the loading software, so pay close attention to them.

Key required features include:

• PDF file naming convention: ###_Descriptive Name.pdf (prefix always three digits, starting at 001). Each volume begins its own numbering sequence.

• No security or password protection. PDFs that require a password to open will automatically fail.

• No embedded attachments. Embedded attachments may be removed upon upload and are not searchable.

• Max file size per PDF: 50MB. Larger documents must be split into separate sequential files (e.g., Part 1, Part 2).

• Volume rules (if used): Subfolders inside a volume are not permitted. The folder must follow this naming format: VOL_###_Descriptive Name

• Only two folder types are allowed for non-PDF content—placed at the root level only and zipped before inclusion: MISC FILES and STATISTICAL DATA

Tools to help sponsors

The FDA provides two optional tools:

• The eSubmitter-eCopies Tool helps format submissions correctly during creation.

• The eCopy Validation Module tests the final eCopy before submission to the FDA. The guidance strongly recommends running the validator before sending, especially for physical media.

Submission pathways

Sponsors may transmit eCopies via:

• CDRH Portal (preferred for CDRH devices)

• ESG NextGen (for CBER submissions)

• CD/DVD/flash drive mailed to Document Control Center

Practical impact for manufacturers

This guidance signals a continued transition toward fully electronic regulatory submissions.

In the meantime:

• eSTAR replaces eCopy only where mandated.

• All other device submissions remain subject to eCopy rules.

The FDA calls this a temporary but required compliance bridge toward universal electronic submissions.

Operationalizing this guidance

Because this is a formatting and submission-readiness rule, the fastest way to operationalize it is through process discipline and standardization.

A few concrete steps device teams should take:

• Update internal submission templates and SOPs to reflect the final format rules. Make sure your current submission SOPs, style guides, and document assembly workflows explicitly incorporate (if these requirements aren’t built into templates and SOPs, formatting mistakes become likely—especially in large or multi-author submissions):

  • File naming rules (###_Descriptive Name.pdf)

  • Maximum PDF size limits (50MB)

  • The no security / no password protection rule

  • Volume folder naming format (VOL_###_Descriptive Name)

  • Prohibition on embedded attachments

  • Where and when MISC FILES or STATISTICAL DATA folders are allowed

• Require the use of the FDA’s eCopy Validation Module before transmission.