USFDA Guidance: eCopy Program for Medical Device Submissions

As FDA continues to modernize and digitize its medical device review infrastructure, the updated guidance eCopy Program for Medical Device Submissions plays a central role in transitioning industry toward fully electronic submissions. The December 2025 revision, reflected in the attached document, expands the technical requirements, clarifies the interaction between the eCopy and eSTAR programs, and incorporates contemporary digital standards needed to support efficient, error-free FDA review.

This updated guidance represents more than a procedural adjustment—it is a foundational shift toward streamlined, uniform, and rapid submission processing across both CDRH and CBER-regulated devices.

An eCopy is a complete electronic version of a medical device submission provided on CD, DVD, flash drive, or electronically through the CDRH Portal or CBER’s ESG NextGen system. An eCopy must include all elements of the submission in a format that meets FDA’s strict technical standards, including PDF structure, naming conventions, cover letter requirements, and file organization.

FDA emphasizes that an eCopy is not simply a digitized version of a paper submission—it must comply with structural standards that allow for automated loading into FDA’s internal systems.

Submission Types That Require an eCopy

FDA lists a wide range of submission categories where an eCopy is mandatory. These include:

• 510(k) submissions

• De Novo requests

• PMAs and PMA supplements

• PDP submissions

• IDE applications (with limited exemptions)

• Humanitarian Device Exemptions (HDEs)

• Pre-Submissions

• Emergency Use Authorization (EUA) device submissions

• INDs and BLAs containing device components

Although certain categories are exempt, FDA strongly encourages use of eCopies for all submissions because electronic formats facilitate faster processing and reduce administrative delays.

Key Technical Standards Sponsors Must Follow

The most critical portion of the updated guidance involves the technical specifications sponsors must meet to avoid a format hold. FDA outlines strict rules governing how each file must be named, structured, and formatted.

1. Required Folder Structure and Naming Conventions

The guidance mandates a specific numbering system for PDF files, typically using three-digit prefixes such as “001_”, “002_”, etc., followed by descriptive names. Volume-based submissions must follow consistent naming conventions such as “VOL_001”.

Submissions must not contain unauthorized subfolders, temporary files, or non-PDF documents unless those files are placed inside designated ZIP folders like “MISC FILES” or “STATISTICAL DATA”. These requirements preserve uniformity and support automated ingestion.

2. PDF Format Requirements

The guidance explains that:

• PDFs must be text-searchable unless scanning is unavoidable.

• PDFs cannot include passwords or encryption.

• File sizes must remain within defined limits to allow fast loading.

• Fonts should follow FDA-recommended styles for readability.

Bookmarks and hyperlinks are optional but recommended because they make reviewer navigation smoother.

3. The eCopy Validation Module

FDA encourages sponsors to validate their eCopy using the free FDA eCopy Validation Module before submission. This step helps identify hidden system files, improperly formatted PDFs, unallowed characters, or folder-structure errors that could lead to a format hold letter.

Manufacturers must validate the eCopy after copying it to the final media (e.g., USB drive), because file corruption or hidden metadata may be introduced during the copying process. If a submission fails validation, FDA instructs sponsors to regenerate the entire eCopy package—not just fix individual files—to avoid cascading discrepancies.

How FDA Processes an eCopy

After receiving an eCopy, FDA attempts to load it into its internal review systems. If the eCopy meets all technical criteria, the submission moves into acceptance review. If not, FDA issues a format hold letter notifying the sponsor of all deficiencies.

Sponsors must then resubmit a corrected eCopy accompanied by a revised cover letter. The review clock will not begin until the corrected eCopy passes validation. If the sponsor does not submit a corrected eCopy within the allowed timeframe, the FDA may consider the entire submission withdrawn.

Interaction with eSTAR and the Future of Fully Electronic Submissions

The guidance notes that eSTAR—FDA’s structured electronic submission platform—is the future of medical device submissions. As FDA phases in eSTAR for additional submission types, the eCopy Program will eventually serve as a transitional mechanism until full digital standardization is achieved.

However, until eSTAR coverage becomes universal, the eCopy Program remains the legally binding pathway for many submission types. The guidance clarifies that once eSTAR becomes mandatory for a given submission category, an eCopy will no longer be accepted in its place.

CBER-Specific Instructions

The updated guidance also includes requirements for biologic-device combination products regulated by CBER. These submissions may be transmitted electronically through ESG NextGen or delivered physically to the CBER Document Control Center. Regardless of submission method, the technical standards outlined in the eCopy guidance still apply fully.

The updated guidance, particularly when paired with FDA’s broader digital transformation initiatives, positions industry for a more efficient submission experience over time.

For more information, please see the official guidance:eCopy Program for Medical Device Submissions