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Consultant for 510k Compilation and Submission wanted


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510(k), consultants and consulting
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  Post Number #1  
Old 24th October 2016, 11:19 AM
shopaholic717

 
 
Total Posts: 3
Read This! Consultant for 510k Compilation and Submission wanted

I am wondering if anyone can recommend a consultant to do the final compilation of our 510k submission? First time through and I see many consultants and would like to talk to a few. I am not sure how to filter the field.

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  Post Number #2  
Old 24th October 2016, 11:47 AM
Marc's Avatar
Marc

 
 
Total Posts: 25,427
Re: Consultant for 510k compilation/submission

It would probably help if you let people know where you are located since you did not put your location in your Profile here.
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  Post Number #3  
Old 24th October 2016, 01:13 PM
shopaholic717

 
 
Total Posts: 3
Re: Consultant for 510k Compilation and Submission wanted

Sorry. I am located in Rochester NY.
Thank you
  Post Number #4  
Old 24th October 2016, 01:37 PM
Susanne T Smith

 
 
Total Posts: 1
Re: Consultant for 510k Compilation and Submission wanted

Quote:
In Reply to Parent Post by shopaholic717 View Post

I am wondering if anyone can recommend a consultant to do the final compilation of our 510k submission? First time through and I see many consultants and would like to talk to a few. I am not sure how to filter the field.
HI You are looking for a consultant to compile and complete a 510K submission. I have been working in the medical device field since 1984.

You can write me at [email removed]. and I will forward you my CV and if interested then we can chat. I am currently writing Clinical Evaluation Reports, reviewing client's 510K currently. Please not in your response "Seeking 510K Consultant" in case your EM goes into Spam Mail.......Thank you! Susanne Smith

Last edited by howste; 25th October 2016 at 02:04 PM. Reason: Removed email address
  Post Number #5  
Old 24th October 2016, 05:22 PM
mihzago

 
 
Total Posts: 120
Re: Consultant for 510k Compilation and Submission wanted

what type of a product and FDA branch?
  Post Number #6  
Old 1st November 2016, 11:59 AM
Julie O

 
 
Total Posts: 221
Re: Consultant for 510k Compilation and Submission wanted

I'm not sure how to filter the field either, and I've been in this biz since the 80s.

I think what mihzago is saying that type of product and reviewing branch are two filters you can apply. Type of product is a very narrow filter, so the chances of finding someone in your lifetime who has compiled a 510(k) for that specific product, and who is also working as a consultant, may be zero. Finding someone who has done so successfully since FDA instituted its new "Refuse to Accept" policy for 510(k)s, which resulted in something like 60% pf 510(k)s being rejected FOR REVIEW (not declared NSE) in the first year...? Heh.

I think FDA reviewing branch is a more realistic filter, unless you just like looking for needles in haystacks. I would also look for someone who has successfully filed under the new RTA policy, although that may be a pretty narrow filter too, not only because of the high rejection rates, but because it's new enough that some people may not yet have had their shot at getting rejected.

Other than that, what do you mean by "compile"? If that's really all you want, hire a sharp temporary admin, hand them the appropriate guidance(s) to follow, and let 'em have at it. That is a reasonable (and inexpensive) approach if you aren't a VC-backed start-up that needs to get some people rich quick. If you take this approach, there is a high probability that FDA will kick it back to you the first time, but they will tell you why, so then you can fix it and resubmit. The RTA review doesn't take that long, but I would build a delay of a month into your timeline to account for this probability.

Alternatively, if you want to spend a good chunk of money, I can refer you to someone that I can virtually guarantee will submit a 510(k) that FDA will accept the first time....unless of course they tell you that the information you've provided for the "compilation" isn't adequate for filing, but you insist on submitting it anyway.
  Post Number #7  
Old 1st November 2016, 12:21 PM
Julie O

 
 
Total Posts: 221
Re: Consultant for 510k Compilation and Submission wanted

Oh...if you go with the temp, then yes, location will be important. Otherwise, unless your comfort level requires that the work be done underneath your nose, probably not important. Most regulatory work is done virtually these days.

I can virtually guarantee that the person I would recommend for a virtual guarantee of a successful filing is not going to be available to do the work in your offices, in part because they are professional consultants, not temporary contract laborers, and in part because they wouldn't see the point of struggling to do the work separated from the processes and tools that they have developed to expedite the compilation process and assure quality of the submission. What they bring to the table isn't just "compilation" services, but the ability to tell you whether what you have available to compile is adequate to support filing and also a finding of substantial equivalence, in addition to their processes and tools.

On the other hand, if you are confident you have all the information needed and are satisfied with your own processes and tools for regulatory compillations, no point in spending the money. That is, unless it's going to get ugly if someone has to tell investors that FDA refused to file your 510(k). This is more commonly the reason companies are willing to pay the big bucks for "compilation" by a professional consultant, rather than an interest in the actual quality of the submission.
  Post Number #8  
Old 1st November 2016, 12:35 PM
mihzago

 
 
Total Posts: 120
Re: Consultant for 510k Compilation and Submission wanted

the questions about the type (not a specific device) is to find out a general category of the device, e.g. is a software, electronic or electromechanical device, implantable, disposable, etc.
The question about the branch is to narrow down the medical specialty of the device.

The reason for these questions is that I do not know a single consultant or anyone that has a sufficient experience and expertise to cover all device types and medical specialties, though I'm sure there are plenty of consulting firms that do cover all areas, but even then I would probably choose an individual or firm that specializes in certain area.

My assumption is that someone is looking for a consultant to prepare a submission including recommendations and a thorough review, not just collating pages into a binder.

Using RTA experience is totally irrelevant, in my opinion, as it is for the most part an administrative process. The 60% reject rate was only during the first 6 months and mostly due to really silly and inconsequential issues, or cases where the reviewer was overstepping the bounds of the RTA checklist. Supposedly the FDA has fixed that.
Thanks to mihzago for your informative Post and/or Attachment!
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