Updated guidance from the US Food and Drug Administration clarifies aspects of the agency’s program for accepting electronic copies of medical device submissions based on data and experience gathered from running the program.

The new guidance covers the standards that eCopy submissions must meet in order to be accepted by FDA reviewers, and also explains how the agency intends to carry out and implement additional components of its eCopy program.

Attachment 1 of the guidance clarifies technical standards included in eCopy software coding; failure to meet any of these standards will result in a submission not passing the FDA’s eCopy loading process.

• Cover letter requirements: Cover letters should include an ink or digital signature and a statement that reads either “The eCopy is an exact duplicate of the paper copy” or “The eCopy is an exact duplicate of the paper copy except for the following differences.” Applicants should take care not to confuse the eCopy company cover letter with the Form FDA 3514 premarket review cover sheet.
• Volume or non-volume structure requirements: The size of an eCopy submission determines its structure. Small (“non-volume”) eCopy submissions should include one or more PDF files at their root level, while larger (“volume”) eCopy submissions should be structured into folders into which PDF files are clearly organized to allow efficient agency review. Volume eCopy naming and numbering conventions must also be followed.
• PDF file requirements: Both non-volume and volume applications should follow specific PDF file naming conventions, and include no embedded attachments, attributes or passwords. Any single PDF file size should not exceed 50MB.
• Adding non-PDF files: If an applicant needs to attach non-PDF files to an electronic submission, such files should be included via ZIP format in a folder labeled “Statistical Data” or “Misc Files.”