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Consultant for 510k Compilation and Submission wanted - Page 2


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  Post Number #9  
Old 1st November 2016, 01:35 PM
shopaholic717

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

Thanks for the replies. I have a better idea of where to start and what to expect.

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  Post Number #10  
Old 1st November 2016, 01:53 PM
Julie O

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

I would go so far as to say that it is impossible for a single individual to have sufficient experience and expertise to cover all device types and medical specialties. Although...that may depend on what you consider sufficient.

I'm well aware from repeated personal experience that different people mean different things when they talk about "compiling" a submission. Often the term carries with it an underlying current of hope and denial.

Whatever the reasons for an RTA, they are probably not irrelevant to the company that gets its 510(k) rejected. The rate was 58% through the first 9 months of implementation. It has predictably dropped as both industry and FDA have adapted. As of Q2 2015, it stood at 37%, or a little over 1 in 3 510(k)s rejected 18 months after implementation. Do you have a more recent figure on rejection rates?
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  Post Number #11  
Old 2nd November 2016, 01:49 AM
Ronen E

 
 
Total Posts: 3,033
Re: Consultant for 510k Compilation and Submission wanted

I'm still waiting to see a company that looks for someone to "compile" their 510(k) and actually have everything ready for compilation. In 100% of the cases I ran into the "compilation" involved authoring or driving substantial parts of the submission; I'm in the business of 510(k) submission "compilation" () since 2005.
  Post Number #12  
Old 2nd November 2016, 09:52 AM
Julie O

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

Like I said...hope and denial.

At this point, I'm reasonably happy if, after all that "compiling," I think there is a decent chance FDA will concur with the claim of substantial equivalence.
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