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  • 1.  Redacted 510(k)s

    This message was posted by a user wishing to remain anonymous
    Posted 18-Nov-2019 10:08
    This message was posted by a user wishing to remain anonymous

    Morning. 

    The FDA database has a check option for redacted 510(k)s but the search function only brings up devices from a few years back, the most recent being 2017 I think it was. Would there be anywhere that displays more recent 510(k)s?

    I am compiling a 510(k) so trying to view as many examples as I can and some recent examples would be good.

    Thanks.


  • 2.  RE: Redacted 510(k)s

    Posted 19-Nov-2019 03:15
    It takes approximately one to two years to receive a requested redacted 510(k) through the Freedom of Information Act (FOIA).  
    So it makes sense that there aren't any available for 2018 just yet.

    As an owner of the 510(k) where information is requested, we have the ability to redacted pretty much of the 510(k)s information as we want.
    The competitor that requests the information through the FOIA, also has the option to go back to the FDA and complain the 510(k) has to much redaction. 

     https://www.fda.gov/regulatory-information/freedom-information/how-make-foia-request




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    Colleen Powell
    Director of Regulatory Affairs
    Gloucestershire
    United Kingdom
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    Original Message


  • 3.  RE: Redacted 510(k)s

    Posted 19-Nov-2019 08:34
    You can try the CDRH FOIA Reading Room. https://www.accessdata.fda.gov/scripts/cdrh/devicesatfda/readingroom.cfm

    Unless there has been a request for a redacted 510(k), you probably will not see it posted.  It also takes time to get the redaction done, so that is why there are very few recent 510(k)s posted.  If there is a 510(k) with  a Statement rather than a Summary, you can request the 510(k) from the Applicant.  They are required to send it within 30 days of the request.

    Cheers,
    Melissa

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


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