FDA Clarifies eCopy Requirements as eSTAR Becomes the New Standard for Device Submissions

The FDA has released updated draft guidance on the eCopy Program, highlighting which requirements still apply while the eSTAR template becomes the default for more and more submission types.

What's Changing?

While eCopy requirements still apply for certain submissions, the eSTAR system is rapidly becoming mandatory—making many traditional eCopy formatting rules obsolete for covered submission types.

Access the full draft guidance below. 

Key Updates for Medical Device Manufacturers

1. eCopy Still Applies – But Only for Submission Types Not Yet Covered by eSTAR

Manufacturers submitting:

• 510(k) (if not using eSTAR),

• De Novo,

• PMA, IDE, EUA, HDE, and Pre-Subs
  must still comply with eCopy rules if eSTAR is not yet required or available for that submission type.

For submission types that must use eSTAR, the eCopy requirements no longer apply.

2. eCopy Requirements Still Apply (Where Relevant)

For submissions where eCopy is still required, the following apply:

• Volume-based folder structure (VOL_001, VOL_002)

• PDF file naming rules: no special characters, searchable text, ≤50MB

• No subfolders inside volumes

• Validation using eCopy Validation Module is mandatory

• Corrections require full resubmission of the eCopy

Non-compliant eCopies = format hold = review delays

3. eSTAR Transition is Well Underway

The FDA continues to expand the mandatory use of eSTAR. Once eSTAR becomes mandatory for all submission types, the traditional eCopy model will be fully phased out.

Keep track of deadlines and announcements to ensure you're using the right format.