Nuke the eCopy Confusion and Chaos!

Nuke the eCopy Confusion and Chaos!

March 11th, 2013 // 4:17 pm @

March 14, 2013

CDRH has been requiring eCopy for every submission since Jan. 1. We have been hearing about MANY eCopy holds because of many compliance issues with the new eCopy format. We have heard about issues including:

  •  File size
  • PDF file format
  • Folder structure
  • Folder naming conventions
  • File naming conventions

Also, people are just plain confused (get unconfused here!) because eCopy is so radically different from the mandatory paper copy that is still required.

Also, FDA makes available free software for compiling an eCopy – eSubmitter.  While there are good points to using this software, there are also issues with the software that people should be aware of before getting started on eCopy.

It is possible to prepare a compliant eCopy without this software but people should be aware of the challenges.  Since PDF file format is the bulk of the content submitted in eCopy, PDF formatting competence is a critical requirement and most people in device regulatory affairs just do not have these skills.

Finally, all support for eSubmitter is through email and when you run into issues it can take several days and several iterations of Q&A to get most questions answered – some of which are still outstanding concerning contradictory requirements in the CDRH final guidance for eCopy.

If all this sounds a bit confusing, well, it is, we are sad to say. However! We do have a NEW webinar from our resident e-submission expert, Antoinette Azevedo, so take heart! 🙂


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