First 510(k) submission - Class II software as medical device

#1
Hello,

We are a start-up company and I'm working in our first 510(k) submission (Class II software as medical device) and I'm sorry for my stupid question but I'm preparing the submission putting all the documents together and I don't know how to put report information into the 510(k). I created a 510(k) structure and I'm coping there all the device information, but as the verification and validation are signed documents I'm not sure if I have to annex the info later (but I will have problems with the page numbering) or if I can just make a copy and paste without the signatures. Could you help me?
 
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monoj mon

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#2
Hello,

We are a start-up company and I'm working in our first 510(k) submission (Class II software as medical device) and I'm sorry for my stupid question but I'm preparing the submission putting all the documents together and I don't know how to put report information into the 510(k). I created a 510(k) structure and I'm coping there all the device information, but as the verification and validation are signed documents I'm not sure if I have to annex the info later (but I will have problems with the page numbering) or if I can just make a copy and paste without the signatures. Could you help me?
Hi Tiffany, I guess you are also preparing the summaries (such as Performance Testing-Bench). So, while preparing the summaries you can refer your test report as "Attachment" and include it along with the summary. I have quickly drafted a sample document for you to give you an idea. By doing this you don't need to worry about the pagination for the report. And, I will suggest to provide the signed reports.
 

Attachments

#3
Hello,

We are a start-up company and I'm working in our first 510(k) submission (Class II software as medical device) and I'm sorry for my stupid question but I'm preparing the submission putting all the documents together and I don't know how to put report information into the 510(k). I created a 510(k) structure and I'm coping there all the device information, but as the verification and validation are signed documents I'm not sure if I have to annex the info later (but I will have problems with the page numbering) or if I can just make a copy and paste without the signatures. Could you help me?
Tiffany88,
If you need support on submission, feel free to contact us. We can help you out.
 

Watchcat

Trusted Information Resource
#4
And, I will suggest to provide the signed reports.
I am curious as to exactly what you mean by "signed" report. Reports with an original "wet" ink signature? A photocopy or scanned copy of those documents? Documents that have been electronically signed? Or copies of the reports that were signed, but not necessarily copies with the signatures on them?

I ask because I'm curious as to how all of this is evolving. I'm not aware of any requirement on FDA's part, and I expect this is more a matter of convention, probably not one uniformly followed in all submissions?
 

monoj mon

Involved In Discussions
#5
copies of the reports that were signed, but not necessarily copies with the signatures on them?
I meant this one.
I expect this is more a matter of convention, probably not one uniformly followed in all submissions?
I just posted my view as a matter of convention to annex the original reports along with the summary format that I provided above since the original poster has asked how to handle the signed reports, whether or not to provide it with the signature.
but as the verification and validation are signed documents I'm not sure if I have to annex the info later (but I will have problems with the page numbering) or if I can just make a copy and paste without the signatures. Could you help me?
 
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