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eCopy Hidden System Files Created by Windows 10 Updates

This article explains how to debug problems created by Windows 10 updates, which automatically create eCopy hidden system files.

ecopy replacement for 510k submission 1024x422 eCopy Hidden System Files Created by Windows 10 Updates

If you are looking for a quick solution to remove a hidden system file from your eCopy flash drive, that you created using Windows 10, please follow the following steps:

  1. Enter the Command Prompt, a desktop app, by typing “CMD” into the Cortana search field.
  2. Then type the letter of the drive where your flash drive is located, followed by a colon (e.g., “D:”).
  3. Then type the following red text exactly (there is a single space before each forward slash): rmdir “system volume information”/s /q
  4. Then rerun the eCopy Validation Module to verify the system volume folder has been removed.
  5. Then eject the flash drive using the flash drive symbol in your taskbar to prevent any corruption of the flash drive.
  6. Now you can safely remove the flash drive and ship it to the FDA.
  7. Do NOT re-insert the flash drive into any computer before shipping–even at an office supply store.

We can also prepare your FDA eCopy for you and ship it to the FDA for a flat fee of $150. Details are found on our FDA eCopy webinar page.

The above picture is a USB flash drive with a replacement eCopy for a recent 510k submission I worked on. A couple of weeks ago, one of these little USB flash drives and the Microsoft Corporation conspired to create one of the most creative riddles I have ever solved in my entire life.

How do you delete a file you can see?

Not just any old hidden file, but a hidden system file called: “IndexerVolumeGuid.”

eCopy Hidden System Files

IndexerVolumeGuid is a special system file that was on my brand new USB flash drive in the System Volume Information Folder. This file keeps an index of the files in the System Volume Information Folder. Your computer can use that index to recover accidentally deleted information. Usually, this is a useful and desirable feature, but I purchased my brand new USB flash drive to send an eCopy 510k submission to the FDA Document Center. Unfortunately, the FDA Document Center cannot accept system files. The problem was that I couldn’t see the files, because they are hidden.

How can you delete a file you can’t see?

I had a software problem, and the process used to fix software problems is called debugging.

Debugging Windows Software Updates

There is a specific position that you should be in when you are trying to debug a software problem. First, you need to be sitting down and hunched over your computer. Second, you need to rest your forehead in your hand, sigh heavily and maybe even moan softly from time to time. I prefer to curse the genius programmers at Microsoft and repeat my mantra of “I can’t believe this. It’s ridiculous.” You know you are concentrating properly if the vein in your forehead is throbbing so much that other people can see it throbbing through your hand.

The most valuable tool for debugging software problems with Windows is Windows Help. It’s an online manual that has the answers to every conceivable question you can ask about Windows. The only time it’s failed to be helpful is when I’m trying to connect to the internet. The “online” nature of Windows Help limits its usefulness in solving problems with internet connections for some reason.

Finding eCopy Hidden System Files

I typed into Windows Help, “show hidden system files.” After 10 minutes of reading, I learned that the default setting for Windows Explorer is to hide system files, and bad things can happen if you unhide those files. I also learned that you could change the default setting by entering the Windows Control Panel, and then clicking on “Appearance and Personalization.” Finally, you click on “File Explorer Options,” click on “View” and then scroll through about 50 possible configuration options until you see the setting for “Hide Protected Operating System Files.” Then you deselect this option–despite the recommendation to keep these files hidden.

Finding the Control Panel

Next, I typed into Windows Help, “How to find Windows Control Panel.” Of course, there are about 20 different ways to reach the Windows Control Panel, but you only need one. Then I followed the instructions from Windows Help, and finally, I could see the hidden system folder, but I couldn’t delete it.

Next, I tried formatting the USB drive. That worked until I pulled the USB drive out and inserted it again. Windows has a cool new feature that automatically creates a hidden system folder on your USB drive–even if you don’t want one.

Disable Removable Drive Indexing

Windows Help again to the rescue. I learned that I needed to disable the removable drive indexing feature to do that I needed to use Group Policy Editor, which I didn’t have. Windows Help told me that I could use the Windows Registry Editor or “Regedit” program instead if I was unfortunate enough to be using something other than Windows XP. Next, Windows Help instructed me to open a folder called Windows Search. Windows Search was a folder found 7-levels deep in the registry of the computer, but it seemed to be missing from my computer. Again, Windows Help instructed me on how to create a Windows Search Folder and add a file called “DisableRemovableDriveIndexing.” Then I only needed to change the settings from a “0” to a “1” and reboot my computer.

Finally, 2 hours later, my USB drive no longer had eCopy hidden system files, and my computer would no longer create one automatically–until the next Windows update, which occurred a week later. Since I originally posted this article, there have been several Windows 10 updates, and each one has caused problems similar to the eCopy hidden system files. If you prepare your own FDA eCopy submission, please subscribe to my free FDA eCopy webinar updates to keep up with the latest Windows 10 “features” and how the changes will affect your eCopy preparations.

Other Resources

In August 2017, I recorded two relate webinars:

  1. 510k Lessons Learned
  2. FDA eCopy webinar

If you are interested in specific guidance related to eCopy hidden system files, or eCopy submission in general, you can also review the following FDA guidance documents:

  • eCopy Guidance – FDA Guidance document revised 12/3/2015; eCopy Program for Medical Device Submissions
  • eCopies Validation Module (a voluntary tool that verifies the format of an eCopy you have already developed on your local drive)

Posted in: 510(k)

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