Some questions about voluntary consensus standards in traditional 510(k) submission

Ashley Fu

Starting to get Involved
#1
In the traditional 510(k) submission of a software, there are some items about voluntary consensus standards in the RTA checklist. According to the guidance, if you have utilized FDA-recognized consensus standards, you must submit a DOC and list the standards in the DOC. And if we don't utilized FDA-recognized consensus standards, does that mean we needn't to prepare a DOC or DOC is needed, but the part of standard can be omitted.

At the beginning, we thought the voluntary consensus standards were the FDA guidance relevant. Now I am aware of it refers to some EU standards such as ISO or IEC standards. all the content of the submission are prepared according to the FDA guidance except a risk management, which is prepared according to the ISO 14971.
So now there two difficulties:
How can we deal the problem about the voluntary consensus standards ?
And if we submit a DOC containing a consensus standards of ISO 14971, whether FDA will request supplement documentation to support this DOC?

if there are some misunderstanding of the guidance above, I would appreciate you point it out!
 
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monoj mon

Involved In Discussions
#2
If you haven't used any FDA recognized consensus standard, then you simply prepare the DOC and state clearly that no FDA recognized consensus standard has been used. In that case, you don't need to fill out the FDA Form 3654.

At the beginning, we thought the voluntary consensus standards were the FDA guidance relevant
No, the FDA Recognized Consensus standard does not mean "The FDA Guidances". It means the recognized standards from any "Standard Organization" and each recognized standard gets a "Recognition No." The purpose of the FDA Recognized consensus standard is to direct you to the relevant procedure for your device, which includes but not limited to, bench testing, animal testing, biocompatibility testing, risk management, etc. If you have followed (I guess at least some of these general-purpose standards you have followed) any such recognized standards then prepare a summary (I usually prepare it in a tabular format) of it by following this, along with filling up the FDA Form 3654. However, in form 3654 you will need to state if there is any FDA guidance associated with the standard.

And if we submit a DOC containing a consensus standards of ISO 14971, whether FDA will request supplement documentation to support this DOC?
If you are filling up the FDA From 3654, that means you are declaring to conform to recognized standard(s) and you may expect to provide evidence to the FDA. For example, if you have followed the ISO 14971 standard, then you may provide the Risk Management File to the FDA.
 
Last edited:

Ashley Fu

Starting to get Involved
#4
Ok, fist of all, I need to certify the recognized standard(s) relevant. then prepare a summary or a test report relevant, along with filling up the FDA form 3654.
I can't get the form 3654 in the official website, would you please provide network links ?
I don't understand the table of required elements you use. how to fill in it? Do I just need to confirm if every item is included in the summary or a test report?
 

monoj mon

Involved In Discussions
#6
I can't get the form 3654 in the official website, would you please provide network links ?
It is already answered above, the form is no longer needed. I forgot about that.

I don't understand the table of required elements you use. how to fill in it? Do I just need to confirm if every item is included in the summary or a test report?
It is not mandatory, I just said that I provide a very simple table with the Standard No., Standard title, FDA Recognition No., Year of Publication etc. You can take help of that link that I shared about "Required Elements for a DOC" and prepare a suitable table for your submission. Also this guidance may help you to great extent. There are few templates in the PDF file that I shared before. You can use the templates for your DOC and the table will be an add on to it.
 

Ashley Fu

Starting to get Involved
#7
Thanks for offering so much information for me.
There is no doubt that these PDFs are very useful, and I will learn more about them.
 
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