Does My FDA eCopy Submission Meet FDA Requirements?

Does My FDA eCopy Submission Meet FDA Requirements?

April 10th, 2013 // 3:27 am @

April 9, 2013

fdaecopy

We continue to see a lot of mass confusion and questions about FDA’s new eCopy initiative. We hope that our Webinar on FDA eCopy April 10 and May 2 will help registrants to better understand eCopy’s complex requirements.

One of the most common questions we hear about eCopy is: How do we know before we submit to FDA whether our eCopy will meet their standards of acceptance?

According to FDA, they strongly recommend you to use the free eSubmitter-eCopies tool that is on FDA’s site: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm317334.htm. One of the major pluses of using this FDA tool is that it will create your eCopy in real time, and is fully consistent with all standards.

Using the eSubmitter-eCopies tool is designed to prevent long delays in the review of all submissions. This way, you should not have to untangle various technical issues on your end to make your eCopy FDA compliant. Note that it is not required to use this free FDA tool, and you can skip that step. But we do not recommend it.

If you have technical questions about producing your eCopy, FDA says you should email cdrhesub@cdrh.fda.gov before you submit your eCopy.

If you are having another party processing your eCopy, note that the eCopy still has to meet all standards for eCopy for it to be processed. It does not matter if the eCopy was made by you or a third party. The applicant does not have to include their own personal cover letter as a section of the submission, but FDA standards do mandate that the third party does have a signed cover letter with a proper eCopy statement.

If you have a third party submitting your 510k, there will be two CDs that make up the eCopy. The first CD has the applicant submission and should be clearly labeled. The second CD will have the accredited person’s review records and should be clearly marked. The accredited person must make sure that the CDs meet all standards for an eCopy.

FDA eCopy Webinar – April 10 and May 2

We are holding a very informative FDA eCopy Webinar on both April 10 and May 2 that should help you to answer your questions on how to submit an FDA-compliant eCopy.


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