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First 510(k) Submission - Don't Forget Tips

Dobby1979

Involved In Discussions
#1
Hi All.

I will be working on our and my first 510(k) submission towards the end of the year and I was wondering if there are any hints and tips that people would recommend? I am guessing there are some housekeeping things, e.g. notifying them that we are using electronic signatures but is there some fundamentals that I must not forget?

Do I need to register online for anything / complete any payment forms early etc?

Thanks in advance.
 

primavesvera

Starting to get Involved
#2
No registration, as far as I know.

However, the payment part is crucial to be done upfront and make sure it goes through, otherwise, it gets held in the Document Control Center (it happened to us last year).

Just double or triple-check that you have all the documents from the checklist (Traditional, Special or Abbreviated) and all the justifications for the documents that you don't submit (maybe it is N/A, but they want to know why).

This is only from the administrative point of view, but it saves you time that you would lose otherwise by being put on Hold for nothing.

Good luck!
 

Dobby1979

Involved In Discussions
#3
Thanks primavesvera.

When you say make the payment upfront, how far up-front do you mean? We are looking to submit towards the end of the year. I don't suppose you have experience with software submissions do you! :)
 

primavesvera

Starting to get Involved
#4
Thanks primavesvera.

When you say make the payment upfront, how far up-front do you mean? We are looking to submit towards the end of the year. I don't suppose you have experience with software submissions do you! :)
As said, last year we had a problem with payment (it was a more administrative issue), but you can't really submit your 510(k) before paying them the fee since you need MDUFA sheet to submit as part of your submission. So, in the final stage of the preparation, do the payment and submit MDUFA sheet together with everything else (don't forget to do an eCopy!).

And yes, we actually did a submission for software this year, however, I don't know if I will be able to provide an adequate answer to your possible future questions. :)
 

mihzago

Quite Involved in Discussions
#5
As primavesvera said, you have to make a payment, and receive Payment Confirmation Number, which you have to include on the cover letter.

Another thing you may want to do, if you are a small company, is to get the Small Business Determination. That way you can significantly reduce the submission fee. Reduced Medical Device User Fees: SBD Program

You mentioned you're submitting a 510(k) for a software. I imagine you used the "Guidance for the Content of Premarket Submission for software contained in Medical Devices". If not, you better use it; it also applies to stand-alone software.

Have you determined the level of concern of the risk for your software? If you for some reason determined this to be "Minor" then I suggest you revisit this assessment. If you're submitting a 510(k), then the agency will most likely kick it back and tell you to change to at least "Moderate".

I've done a number of software 510(k)s and De Novo so let me know if you have other questions.
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Watchcat

Quite Involved in Discussions
#6
Small Business Determination. That way you can significantly reduce the submission fee.
You can also significantly delay your 510(k) if you leave this until late. It takes time...60 days, last time I checked. Plus you can run into administrative snafus here as well, which might further delay things. I don't know of any reason to sit on this, What qualifies you for SBD is unrelated to your device or the content of a premarket submission, nor does it lock you into any particular type of submission, as far as I know.
 
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