Regulatory Open Forum

 View Only

  • 1.  FDA FOI request

    This message was posted by a user wishing to remain anonymous
    Posted 09-Aug-2021 10:20
    This message was posted by a user wishing to remain anonymous

    Hi,

    During the FOI request , does the FDA share the information of the requestor to the requestee?


  • 2.  RE: FDA FOI request

    Posted 09-Aug-2021 11:34
    We had a FOIA request of our 510(k) and we were notified of the request

    ------------------------------
    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
    ------------------------------

    Original Message


  • 3.  RE: FDA FOI request

    This message was posted by a user wishing to remain anonymous
    Posted 10-Aug-2021 11:43
    This message was posted by a user wishing to remain anonymous

    Hello,

    We knew who requested our 510(K). If you are planning one and dont want them to know who asked, why not ask a consultant to do it for you?
    Original Message


  • 4.  RE: FDA FOI request

    Posted 10-Aug-2021 10:16
    Generally no. You may get notified that there has been a request (for instance if you need to redact something) but even that is typically only for the first request.

    Keep in mind, that people can also get FOIA info from 3rd parties like FOI Services, and once they have a copy they can provide it to many clients and FDA would have no way to even know.

    I suppose you might be able to make an FOI request for the identity of people requesting certain FOI information, but that seems like a lot of work for very little benefit.

    Ginger

    ------------------------------
    Ginger Glaser RAC
    Chief Technology Officer
    MN
    ------------------------------

    Original Message


Related Content