Making changes to IDE device

#1
Hi all,
I have been off the US market regulatory for a while and I am trying to get back to it while keeping us out of trouble.
We have an IDE under evaluation right now but Engineering has made some minor changes to the device (minor software bugs correction mostly). I am wondering if this falls under a 5 day notice or not. I find the regulations unclear on that front.
When do you submit?
When do you document in QMS?
Which regulation /guideline do yo follow for this type of changes?
Thanks!
 
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#3
Yes I am but but I find section (III) (A) lacks clarity:
Modifications that constitute a significant change in design or basic principle of operation (not my case), or that were not made in response to information gathered during the course of the investigation (my case - bug fixes), however, may not be made without prior approval of an IDE supplement.
and then it refers to a post-marketing guidance... according to which I would simply have to document

I find it difficult to understand what the Agency wants in that case: a supplement (I would understand for a significant change) or a note to file (I am leaning toward that)
 
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Watchcat

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#4
I am attaching the language in regulation without all the irrelevant language, such as that which applies to emergency use, clinical protocols, etc. I often find this makes things easier to follow and understand.

It seems clear to me that your choices are 1) prior approval or 2) 5-day notice. There is no third option, note to file.

the 5-day notice should include the same information you would have on hand to support the notion that a post-market change that did not require a new 510(k). Since you didn't get prior approval or put in a 5-day notice for any of the changes, you are now screwed. No worries, happens to the best of us.

Here's what I would do now, promptly, but not in a crazed rush. The horses are out of the barn already.

1) Take immediate steps to assure that no more changes are made to the device during the investigation without your prior approval.
By this I don't mean send out an email to engineering. Either revise the appropriate SOP or write a new one and walk it through the approval process. This action is your single best protection from unpleasant consequences.
(Try not to panic anyone. Tell them they probably should have been reported. You can handle that, but you do not plan to handle any more.)

2) Send FDA a notice of all the changes that have been made so far, including the "credible" evidence to support the notion that the changes "do not constitute a significant change in design or basic principles of operation" and "were made in response to information gathered during the course of an investigation."
If the engineers say they fixed a bug, the credible information for the latter requirement is the name(s) of the investigator(s) who reported the bug and the date on which they reported it. If your engineers identified the bug on their own, you are screwed again, because then you were supposed to get prior approval. Oops. Again, it happens.

If you determine that you should have gotten prior approval, but didn't, request it now. This time, more in a rush, but still not crazed. Horse is still out of the barn already. A very important piece of information to included is the date on which the investigator(s) first used (or had access to) the "fixed" device.

If anyone in your company balks at this approach, point out to them that you are going to have to report *all* changes in your annual report. However FDA reacts on hearing about it now, you can be confident it will not react any better if it doesn't hear about it until then. (Depending on the timing, you should also check to see if any of the changes might have been included in a previous annual report. If so, you are off the hook for those....meaning you. The company...those changes are now in FDA's hands. Maybe they comes back to bite some day, maybe not. Regardless, FDA was told, it didn't say anything, and, although silence is not actually assent, in this situation, it will do. No point in telling it about the same change twice.)

I can offer you a good bit more advice, but it's pointless if my interpretation is wrong. This is entirely possible, since I haven't dealt with this myself. So I'm going to stop here.

On Monday, you still need to address 1) above...that advice stands, regardless. Start gathering your credible evidence, which you will need, regardless. Then see if anyone here has a different interpretation than I do, or experience that suggest you should do otherwise.
 

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#5
Thank you Watchcat - since the IDE is not approved yet (still under review) I believe the horses are still in the barn ;-)
Changes have been reviewed and approved by Regulatory so no worries there either, I have been compiling them and trying to understand the process prior to getting the approval
I have compiled the changes made to the investigational device since we sent the IDE in and will prepare a 5 day notice to be sent once the IDE is approved
I had found the same references you shared but did not find them clear - I appreciate your help
 

Watchcat

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#6
the IDE is not approved yet
Oh! Good. I missed that. Since you were asking about a 5-day notice I was thinking it was already approved.

Changes have been reviewed and approved by Regulatory
I would stop approving changes to the device that is being used in the trial. You are essentially mucking around with the identity of your test article in the middle of testing...some data collected on one version, some on another, jeopardizing scientific validity. Everyone can argue that the changes are minor, don't affect safety and effectiveness, etc, etc. but....if that's true, then what's the big rush? Run the trial "clean," with no changes to the investigational device.
 
#7
Oh! Good. I missed that. Since you were asking about a 5-day notice I was thinking it was already approved.



I would stop approving changes to the device that is being used in the trial. You are essentially mucking around with the identity of your test article in the middle of testing...some data collected on one version, some on another, jeopardizing scientific validity. Everyone can argue that the changes are minor, don't affect safety and effectiveness, etc, etc. but....if that's true, then what's the big rush? Run the trial "clean," with no changes to the investigational device.
Actually - since the IDE is only submitted at this point I am not affecting integrity of the data - I have not collected any yet. I plan on continuing to add minor changes up to a the approval, send a 5 day notice and get everything on the books to have the best version of the product available for the trial. Does it make sense?
 

Watchcat

Trusted Information Resource
#8
Yes, I would not approve change to the device that is being used in the trial. While it is still under review...I think it encourages bad habits on the part of your engineers, but otherwise does no substantive harm. I would also warn them that the design will be frozen once the trial starts.

Since engineers love to tweak, they will die a thousand deaths of frustration unless you also tell them that they can still make changes, but they will not be implemented during the trial. They should have the documentation ready for when you submit the...510(k), De novo, PMA. And then you get to explain why all those changes don't affect safety and effectiveness, LOL.

Or you can stubbornly sit on all changes through clearance or whatever and then take up the matter of whether a new submission or amendment is needed to incorporate them into the device. The latter approach is often favored by startups that need to get something through FDA to appease investors, whether it is the something they actually want to market or not.
 
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