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  • 1.  private services 510k FOIA request

    This message was posted by a user wishing to remain anonymous
    Posted 04-Jan-2019 10:25
    This message was posted by a user wishing to remain anonymous

    Hi all, 
    I wonder what is the approximate price and timeline for an official 510k FOIA request in the fda website. I have seen old posts and conflicting information on the timeline (from few weeks to several years) but I guess the process has improved over the last few years and I wonder if any of you has a more recent experience. 

    I also would like to know if you are aware of private services that can provide such a service and whether the amount of redacted info is going to be the same as that provided by the FDA. I have heard of http://www.foiservices.com but I wonder if there are others. I checked in their database and they don't have the 510k I am looking for.
    Any input on this topic would be greatly appreciated.
    Thanks


  • 2.  RE: private services 510k FOIA request

    Posted 05-Jan-2019 07:29
    Hello,

    In my experience with some of the more recent 510(k) requests, this is a little more timely in matter of months instead of many months up to years.  Mostly because much of the information is digital now and kept in databases that are more easily found.  However, it does take some time because when a 510(k) is requested through FOI, the Submitter has the opportunity to redact the information, which can take some months for this to be completed.  If you are looking for 510(k)s that are greater than 10 years old then you are still going to be waiting months and months, but more recent 510(k)s are a bit more speedy.

    I am only aware of FOI Services that is a paid service.  I have heard there are couple out there but not sure who they are.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: private services 510k FOIA request

    Posted 05-Jan-2019 09:44
    We frequently make FOIA requests for 510(k)s.  If it has been requested before, it can be much quicker.  If it has not been requested already, the time can be up to two years.  Since they went digital, it is a much smoother process, but can still take several months to get the response.  

    Have been a customer of FOI Services for many years.  An internet search will give you multiple companies that do FOIA requests, but FOI Services specializes in FDA documents.  Looking at the FOI Request logs, they request more documents through FDA's FOIA office than anyone else.  They know the process and do a good job keeping on top of the request.   Not expensive, either.

    Good luck!

    Cheers,
    Melissa

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    Melissa Walker RAC
    President & CTO
    St Louis MO
    United States
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    Original Message


  • 4.  RE: private services 510k FOIA request

    Posted 07-Jan-2019 05:51
    Have to support what Melissa said; there are many companies that do paid services for FOI requests.  I should have clarified that FOI Services, as Melissa indicated, is the only one that I know specialising in FDA documents like 510(k)s or PMAs.  The other companies can do this as well, but FOI Services doing this for many, many years as a good link with the government FOI.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
    ------------------------------

    Original Message


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