The FDA has issued an updated version of its eCopy Program guidance, providing clarifications to an established electronic submission framework in place for more than a decade. The revisions primarily refine expectations, align terminology, and integrate the program more closely with eSTAR and current electronic submission pathways. For medical device sponsors, the document functions as an incremental yet important step in maintaining consistency in electronic submission formats.
FDA’s 2025 update to the eCopy Program for Medical Device Submissions represents a routine but meaningful refinement to a longstanding electronic document infrastructure. Originally introduced to support the Agency’s transition away from paper-based workflows, the eCopy framework serves as an interim electronic format until full implementation of eSTAR for all designated submission types. The updated guidance clarifies technical expectations, incorporates current tools such as the CDRH Portal and ESG NextGen, and harmonizes the eCopy process with the statutory requirements of the FD&C Act section 745A(b).
Under this framework, eCopies remain required for a broad range of submission types—including 510(k)s, De Novos, PMAs and associated supplements, IDEs, HDEs, certain INDs and BLAs handled by CBER, and all Pre-Submissions—unless the submission is already mandated to use eSTAR. The guidance reiterates that FDA will not initiate review until a valid eCopy is received and confirmed to meet technical specifications. Submissions that fail automated loading checks are placed on format hold, with the review clock suspended until deficiencies are corrected.
The document provides extensive detail on the technical standards governing eCopy preparation. These include mandatory file-naming conventions using three-digit numeric prefixes, restrictions on special characters, limitations on individual PDF file size (≤50MB), and requirements for searchable text whenever practicable. The guidance also emphasizes proper structuring of volume-based versus non-volume-based eCopies, appropriate use of the “MISC FILES” and “STATISTICAL DATA” folders for non-PDF materials, and the avoidance of embedded attachments within PDFs. The Agency continues to strongly recommend creating PDFs directly from native files rather than by scanning, due to concerns regarding image quality, OCR performance, and file size.
The 2025 revision also aligns the eCopy program with contemporary submission pathways. FDA notes a preference for electronic transmission through the CDRH Portal or ESG NextGen, although physical media remain acceptable. The updated document ensures that the eCopy framework interfaces appropriately with eSTAR as that program expands and gradually replaces eCopies for additional submission types. Overall, the modifications are incremental and procedural, reflecting the FDA’s ongoing effort to maintain consistency across electronic submission mechanisms.
The updated eCopy guidance does not introduce new conceptual requirements but reinforces the technical conventions that sponsors must follow to avoid format-hold delays. As the FDA continues its gradual migration toward fully electronic and structured submissions, adherence to the established eCopy standards remains operationally important. Sponsors should view this guidance as a technical update within an existing regulatory continuum rather than a substantive policy shift.
