Special 510(k) - Modified Medical Device Description

primavesvera

Involved In Discussions
#1
Hey, guys!

This is my first time preparing a special 510(k) and I went through all related topics and guidelines to find the things that are bothering me and I seem to be stuck on one particular - description of the modified device.

In the first submission (I wasn't working here back then), the company provided a device description containing basically everything, from intended use, requirements, risk analysis, testing, every single thing was there.

Now that I have to do a modification of the description of the device, I thought I would be appropriate to use the same document and only insert and highlight the changes.

Do you think this is FDA acceptable? Or is there some other way that I don't know?

Thanks in advance.

P.S. I am aware of the requirements from 807.78.
 
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shimonv

Trusted Information Resource
#2
Hi yvescroce,
Personally, I am not in favour of perpetuating a mistake.
It also depends on how long has it been since the first submission? if it's been a while then your modified device description may end-up looking quite different than the original version.
You have to be smart about this and don't confuse the reviewer.

Shimon
 

primavesvera

Involved In Discussions
#3
Thanks for the answer.
It has been exactly three years since it was cleared.
I just want to avoid the confusion and I thought somebody here might have an interesting solution for how to deal with the changes.
 

shimonv

Trusted Information Resource
#4
I see, than my advise to you is to not bind yourself to the work of your predecessor. Build an appplication and see if it makes good sense; perhaps someone else can have a look at it. In the worst case you can fall back to the original structure.

Shimon
 

mihzago

Trusted Information Resource
#6
In the main body of the submission I would only include the description of things that changed, and reference the previous submission or include full description in the appendices.
 
#8
How great I found this topic. I have a question related to Device Description as well.

I was wondering if someone can help me and explain how to write Device Description document?

According to Acceptance Checklist for Special 510(k)s I figured out that Device Description should be one document containing all parts which are stated within section B (from 10 to 14).

But, I came across a different opinion - Device Description should be a separate document. So, related to part 10 - I need one document, related to part 11 - another, etc.

I'm now so confused and don't know how to start.
 

shimonv

Trusted Information Resource
#9
Hi Timothea,
The device description should contain all the elements contained in section B (10-14). That is the normal practice.


Shimon
 
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