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Redacted 510(k)s - Example wanted

Al Rosen

Staff member
Super Moderator
#11
Yup, unicorns abound.
Sorry, scratch that.

Al,

I'm here to share and help (and the record would prove that), but there's only a fine line between "generous" sharing and rude abuse of good will. If I (or anyone) have put in a lot of time and work into preparing something (not to mention years of learning things the hard way), I don't necessarily want to give it away as a freebie but I might be open to negotiating a fair compensation for my efforts, should anyone be interested. The fact that someone didn't plan or budget properly and "doesn't have money" is not particularly moving as far as I'm concerned. Sorry if that's too harsh on anyone.

To me the key word is "fair".
Ronen, my comment was not directed to you. It was directed to thinqbetter. Sorry if I wasn't clear.
 

Ronen E

Problem Solver
Staff member
Super Moderator
#12
Ronen, my comment was not directed to you. It was directed to thinqbetter. Sorry if I wasn't clear.
On the contrary, it was perfectly clear and no apology is required. My rant was directed at the seemingly growing frequency at which people ask for "big" work products here - totally inappropriately IMO - and the disturbing sentiment that anyone expecting a fair return on their (sometimes career-long) efforts is just greedy or ungenerous. Sorry for abusing your post for making my point - I couldn't help it... :)

People, I have the utmost respect to the DIY approach, but its Y actually stands for "yourself". You get stuck sometimes, that's fine - there are a lot of good people here to spot-help. But asking people to hand out their hard-earned work products for nothing, just because it's too easy to ask online anonymously, is plain rude IMO. Yes, Elsmar's moto is "People Helping People" but that implies reciprocity. You give some, you get some, preferably in that order I think.
 
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Al Rosen

Staff member
Super Moderator
#13
I think you have misunderstood me saying ‘generous’ as meaning I am asking for someone to sell me this! I was meaning in a light hearted way that someone might be willing to share a redacted a file that they had.
I have my 20 (well 21actually) but I don’t know if I have included enough detail or not formatted in a correct way. We are a small company and don’t have the money to involve consultants, yet we want to try and ensure the submission goes as smoothly as possible. I just thought someone might have a redacted submission that gave enough detail to be useful as the ones on the FDA website do not really help in my opinion.
I understood what you were requesting and I don't think anyone would be able to even sell you a "lightly" redacted 510k. There is too much proprietary information within one. If you've already submitted 20 or 21, you should be more confident, Take your shot and submit your 510k. The reviewer will give you feedback. The only cost will be some time.
 

Dobby1979

Involved In Discussions
#14
Yup, unicorns abound.
Sorry, scratch that.

Al,

I'm here to share and help (and the record would prove that), but there's only a fine line between "generous" sharing and rude abuse of good will. If I (or anyone) have put in a lot of time and work into preparing something (not to mention years of learning things the hard way), I don't necessarily want to give it away as a freebie but I might be open to negotiating a fair compensation for my efforts, should anyone be interested. The fact that someone didn't plan or budget properly and "doesn't have money" is not particularly moving as far as I'm concerned. Sorry if that's too harsh on anyone.

To me the key word is "fair".
If my posting caused you offence then I apologise Ronen. I understand the hard work that people would have put in to their submissions and I did not expect someone to just say 'here, take the whole submission', just something more than you can see on the FDA website, and more recent to that point!
 
#15
in a generous mood
It's not a matter of generosity. It's a matter of proprietary and confidential information and of non-disclosure agreements.

a slightly redacted file
You might contact FOI Services and tell them you want to purchase a 510(k), doesn't matter how old it is or what type of device, just cheap and lightly redacted. They may be able and willing to find one for you.

We are a small company and don’t have the money to involve consultants
The hard reality is that the money available to develop a product is not determined by the size of the company that wants to develop it, but by the perceived market value of the product. When management keeps saying "we can't afford it" what they are really telling you is "our product isn't worth it."
 
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