Choppy Road Ahead for Confusing eCopy Initiative

Choppy Road Ahead for Confusing eCopy Initiative

March 19th, 2013 // 4:10 am @

Avoid Problems with CDRH eCopy

March 19, 2013

On Jan. 1, 2013, the new FDA guidance titled ‘eCopy Program for Medical Device Submissions: Guidance for Industry and Food and Drug Administration Staff” went into effect. This guidance provides us with instructions on how to do medical device submissions to the agency with eCopy. If you tried to put a submission to FDA with just paper after this date, you discovered that this was not just any old FDA guidance document. The response to a paper-only submission was what is called an ‘eCopy hold notification.’ That is, the submission is considered not even received by FDA.

The guidance is unusual in that it is both guidance and law. Some sections of the document are not subject to restrictions that FDA usually has in its good guidance practice regs, including the mandate that guidances do not establish legally enforceable requirements.

The guidance states that an eCopy is a precise duplicate of the paper submission that is submitted on a CD, DVD or flash driver. As the submitter, you still are required to send a full paper copy as well as a signed cover letter.

Note: The guidance suggests that you use the new eSubmitter format as the template for your submission. But, the eSubmitter link on the agency site isn’t an active gateway for those making CDRH eCopy submissions. The link is active though for CBER submissions.

The guidance also gives directions for which types of submissions require an eCopy, and which do not require it. there is a reference table on page 6 of the guidance that tells you which types of submissions require eCopy. Compassionate use IDE submissions and emergency use authorizations of medical products are exempt from eCopy, although FDA encourages them.

All other submissions, including 510ks, PMAs, IDEs, HDEs and most others must use eCopy.

This guidance appears to have surprised many sponsors. Law sections did not appear to go through the same review process with a public comment period before they were made into law. It also appears that even some FDA staff have been having trouble with the eCopy process. Since implementation of eCopy, there have been reports of wrong dates on submission receipt notices, and FDA, and submission numbers have been forgotten by FDA.

According to one person’s eCopy experience, there still is a long way to go in ironing out the kinks in the eCopy system:

“My experience with submitting an eCopy was not good. I submitted two similar 510(k)s for the same client about a week apart. This was last fall and I sent in one hard copy and one eCopy.

About a week after I got delivery confirmation of the second submission, the lead reviewer called me and said that entire sections were missing from my submission, pages were out of order, and she had not received the eCopies. Evidently someone at the DCC decided that I had sent in only one hard copy of submission #1 and followed up with the second paper copy a week later and thrown everything together. I suggested that she load the submission from the CDs I had sent. She replied she never saw the CDs with the eCopy and would I please just send zippped files to her email.

Just to make things REAL interesting, I had received the electronic ackowledgment letter in rtf format with no comments other than the submission had been received. When I received the hard copy, the rtf file was different. It said that the eCopy had failed the validation. The files that had caused the eCopy to fail the validation were:
K85.pdf, Kxxxxxx.pdf and Kyyyyyy.pdf, where Kxxxxxx was the K-number assigned to the submission and Kyyyyyy is some other submission I had nothing to do with. I have no idea where the K85.pdf came from. I did not put any of those files on the CD.

Needless to say I do not have a lot of confidence in the procedure but it looks like we do not have a choice.”

We do have a Webinar coming up April 10 that will help you to understand the complexities of eCopy….read more here.


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