Industry Bafflement by CDRH eCopy Rule Continues; FDA Confused, As Well

Industry Bafflement by CDRH eCopy Rule Continues; FDA Confused, As Well

March 15th, 2013 // 7:11 pm @

March 18, 2013

You probably know by now that CDRH now requires eCopy for most submissions since Jan. 1, 2013. Our electronics submissions expert,  Antoinette Azevedo, has been informing us of some of the chaos that surrounds the new requirement both in the industry and at FDA (see our post on eCopy last week). As shoe reported to us last week, there have been instances of many eCopy holds at CDRH because of so many issues with the new format of FDA eCopy. A hold means a delay, which means loss of revenue, and no one wants that.

This week, Azevedo filled us in on some of the other many problems with eCopy that are causing holds and rejections. For example, she notes, “eCopy is now mandatory, but for some reason it is not well publicized and many stakeholders are unaware of the mandate.”

She also told us that the FDA eCopy guidance does not really address how to assure that your paper submission is the equal of the electronic submission. Further, “eCopy guidance does not address where table of contents should be placed in the submission.”

And, ‘fail to load’ will stop your review process from beginning, and many technical flaws in the submission can create a ‘fail to load’ situation, such as:

  • Folder names
  • File names
  • File size
  • Content of folders
  • Length of file names
  • PDF format requirements

Keep in mind, Azevedo told us, that if your submission is on eCopy hold and it is not resolved in 180 days, the application will be considered withdrawn by FDA.

Many in industry have found the PDF file format requirements a surprise and are really challenging to meet. Also, even for submissions that are exempt from eCopy, ‘fail to load’ will still result in an eCopy hold.

Another confusing aspect, she said, is that “CDRH eCopy guidance has nuanced language about what is required vs what is suggested. It requires close reading and interpretation to translate into SOPs, work instructions, checklists, etc.”

And, eCopy often gives contradictory directions. For instance, external links are not allowed, but external book marks ARE allowed.

As far as eSubmitter goes – the free FDA software to help you with the FDA eCopy submission process – it does help you to avoid some technical flaws, but it will give you incorrect information about content and output format. eSubmitter technical support is provided by email only. This means you can spend several days going back and forth on email correspondence trying to sort out a problem.

Lastly, eSubmitter tech support will sometimes give contradictory answers to the same question.

The bottom line is that eCopy is confusing a lot of people on both sides. We suggest you check out our upcoming April 10 Webinar on how to clear up all the eCopy confusion.


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