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eCopy Guidance is Finally Updated by FDA

This blog summarizes the changes in FDA policy, which was released on April 27, 2020, as a new eCopy guidance for device manufacturers.

eCopy statement screen capture eCopy Guidance is Finally Updated by FDA

The date of the guidance above was updated, but the changes to the guidance do not represent any changes in policy. It is an update of contact information and a note regarding eCopies for EUA requests. In August 2016, I had a frustrating week where I had three (3) different submissions placed on eCopy hold by the FDA, three (3) separate times, for a total of nine (9) eCopy hold in the same week. That resulted in an extra $175 of FedEx charges and wasted six (6) USB flash drives. The biggest problem was the submission delay experienced by each of our clients that week, and it wasn’t very comfortable. This terrible, no good, dreadful week ultimately resulted in our company creating a new productized service–preparing FDA eCopies for clients and competitor consultants. We also became international experts on the FDA eCopy guidance. I figured if my experience was this painful, there must be other people that were experiencing the same problem, or many people would experience this problem as soon as they tried to submit their next filing with the FDA.

For about 18 months, we helped a lot of companies prepare FDA eCopy submissions, but then there was a government shutdown, and the FDA unofficially changed their policy. A printed paper copy of pre-submissions, 510ks, and De Novo classification requests would no longer be required. You only needed to print a paper copy of your cover letter and include an electronic copy on a CD, DVD, or USB flash drive. Despite this change in policy, many clients still requested the printed copy, because the FDA legislation was not yet changed, and there was not updated guidance. We explained to each client that the policy had changed, and only two clients asked us to print the paper copy anyway.

In the fall of 2018, the unofficial policy became official, but there was still no updated FDA eCopy guidance for us to refer clients to. This situation frequency resulted in questions from clients about how they should phrase the “eCopy Statement” in their submission cover letter. The eCopy guidance that was current in 2018 stated that you should include the following phrase in your cover letter: “This submission includes an eCopy and a paper copy. The eCopy is an exact duplicate of the paper copy.” However, the paper copy consisted only of the cover letter, and the rest of the submission was solely being provided in electronic format.

The FDA released a new pilot version of the eSubmitter software to help companies prepare 510(k) submissions and to streamline the FDA review of submissions in 2018. However, even electronic submissions prepared with eSubmitter still have to be sent by courier or mail to the FDA Document Center. In 2019, the FDA mentioned that they would be releasing new guidance documents regarding electronic submissions. Still, we were also told that the FDA has no near-term plans to enable companies to submit pre-submissions, 510ks, or De Novo classification requests to the FDA via an electronic submissions gateway (ESG).

Finally, on December 16, 2019, the FDA released a new eCopy guidance. The eCopy guidance was updated again on April 27, 2020, but the changes are updated to include emails, updated webpages, and a note regarding EUA requests.

What DID NOT change in the new eCopy guidance?

The file name requirements are identical. You can still organize your submission in volume structure or document-only structure. You are still limited to PDF file sizes of 50 MB. The eCopy will still be problematic for the FDA to upload if your submission exceeds 1 GB. You still need to ship your eCopy to the FDA Document Center, unless you are submitting to CBER instead of CDRH. You can and should continue to use the eCopy validation software module provided by the FDA to ensure that your eCopy will properly upload. The guidance barely even changed in length; it’s just a few pages shorter now.

What DID change in the new eCopy guidance?

Only two things changed in the new guidance. First, there is no mention of an eCopy statement anywhere. Second, you are required to submit a cover letter in paper format, but it does not need to be included in the electronic format (that’s only recommended).

The “new” eCopy process is not any easier than the process we have been using since February 2018. However, we did update our cover letter template. If you would like a copy, please register for our FDA eCopy webinar.

Should you create your own eCopies, or should you outsource?

If my job was Director of Regulatory Affairs (or a similar position), I would definitely outsource. Regulatory managers in companies are swamped with trying to remain compliant with every applicable medical device regulation, every change to applicable standards, and one hour of your time is a lot more important to your boss than $150.

Does it take one hour to create an eCopy?

No, we can prepare, validate, and ship your eCopy in less than 15 minutes. This is only possible because we do this almost every single day of the week, and we are located only 4 miles from a FedEx full-service office with a 6:25 pm cut-off for drop-off. On the last business day before the end of the FDA fiscal year, we average four (4) submissions on that day alone. We know exactly what to do, we know how to fix all of the most common errors, we know our validation software module is up-to-date, and we never run out of USB flash drives.

How long could it take you to create an eCopy?

If you haven’t done an eCopy in that past year, it could easily take you all day to create an eCopy. You have to read the new eCopy guidance document. You need to format your submission according to the rules and proof-read 100% of the folder and file names. You need to find a new flash drive. You need to save the submission on your USB flash drive. You need to run the eCopy validation software module. You need to read my blog about how to eliminate hidden system volume information folders created by Microsoft Windows 10. You figure out how to find the Command Prompt on your computer. You need to eliminate the hidden folder. You need to re-validate the electronic copy. You need to eject the USB (don’t accidentally re-insert it for any reason). Then you need to download my template for a cover letter, create your cover letter, and sign the cover letter. Then you need to find a FedEx envelope, find the company’s FedEx account number, complete the shipping label, and package up your FedEx envelope. If you’re lucky, you have regular pick-ups scheduled each day, and you finished just-in-time. For 80% of you, you will need to look-up the nearest FedEx dropbox and drive there like a crazed maniac and try to avoid getting a speeding ticket.

Or you could just outsource your eCopy problems.  

Posted in: 510(k)

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