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  • 1.  Redacted 510(k) Availability

    Posted 28-Oct-2019 10:26
    For those who haven't yet seen this - FDA has added a link to redacted 510(k) summaries to the 510(k) database. You have to click through a bit, but when a 510(k) listing comes up, there will be a link to the redacted 510(k).

    It appears to me that they only have these if they 510(k) has been previously requested and redacted, but it can potentially be a free way to get this information. Hard on FOI Services business model though...

    I also suspect that this is a step towards requiring everyone to redact the 510(k) immediately upon clearance :-)

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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  • 2.  RE: Redacted 510(k) Availability

    Posted 29-Oct-2019 08:03
    Hi Ginger,

    This feature has been there as a check box for awhile (a year or more?) as a checkbox on each 510k's listing, but as you say, it appears only for those previously redacted.

    There used to also be the electronic reading room where you found these. Is that gone, with new website design?

    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------

    Original Message


  • 3.  RE: Redacted 510(k) Availability

    Posted 30-Oct-2019 11:17
    My instinct is that this has more content than the old reading room. I am not sure if that reading room still exists but I admit I haven't gone looking recently either.

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 4.  RE: Redacted 510(k) Availability

    Posted 30-Oct-2019 08:30
    I can see I am going to add confusion to this thread by not being called "Ginger!"

    I thought this was more of a "improving access/structure" in the redesign rather than addiing anything too new - but you tempted me to look again and there does seem to be more redacted files available.

    Thanks for the prompt to look again and not assume there was nothing new!

    Neil

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    Neil Armstrong FRAPS
    CEO MeddiQuest Limited
    Peterborough
    United Kingdom
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    Original Message


  • 5.  RE: Redacted 510(k) Availability

    Posted 30-Oct-2019 09:16
    LOL Neil!

    Yes,  it is a popular name....  When I met someone from Edwards Life Sciences this past March when I was in LA,  they said - oh- your the "Other Ginger".


    You can sign yourself in with that if you'd like.... makes me curious now to go see more there.  I haven't surfed the new FDA website in a while, I have been playing in Asian areas more recently and now trying to keep up with all the new End of Fiscal Year guidances that popped out in Sept..... 

    Have a great week!

    the "other Ginger"

    ------------------------------
    Ginger Cantor, MBA, RAC
    Founder/Principal Consultant
    Centaur Consulting LLC
    River Falls, Wisconsin 54022 USA
    715-307-1850
    centaurconsultingllc@gmail.com
    ------------------------------

    Original Message


  • 6.  RE: Redacted 510(k) Availability

    This message was posted by a user wishing to remain anonymous
    Posted 02-Dec-2019 09:20
    This message was posted by a user wishing to remain anonymous

    Can you show me an example of this? I have looked at the predicates I am interested in and nothing appears. Do you mind providing a product code where I can look at this new feature (just out of curiosity).
    Thanks!
    Original Message


  • 7.  RE: Redacted 510(k) Availability

    Posted 02-Dec-2019 10:43
    I'm wondering why CDRH would want to require everyone to redact the 510(k) immediately upon clearance. Or ever. 

    Might it see this as an alternative to the optional 510(k) summary?  If it really does get involved in the squabble, when applicants that chose the 510(k) statement option are not responsive to later requests, then perhaps it hopes that requiring the redacted 510(k) might alleviate this need?   Or might it be working toward an FOI Services model, where you would pay a fee for the download?

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Mebane, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------

    Original Message


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