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  • 1.  FDA RRA (Remote Regulatory Assessment)

    Posted 27-Jul-2021 12:48
    Does anyone have experience with this process and what it was like? What were your results? We are Class II 510(k). 

    Thanhks in advance,

    Ed

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


  • 2.  RE: FDA RRA (Remote Regulatory Assessment)

    Posted 27-Jul-2021 13:18
    Hi Ed,

    Here's a recent Forum discussion on that topic:

    https://connect.raps.org/communities/community-home/digestviewer/viewthread?MessageKey=2135d52a-320e-4087-a4a0-cf8731fa01a6&CommunityKey=5af348a7-851e-4594-b467-d4d0983b6d89&tab=digestviewer

    Best regards,
    Kevin

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    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 3.  RE: FDA RRA (Remote Regulatory Assessment)

    Posted 27-Jul-2021 15:05

    Thanks Kevin,

    My CEO posed a question about our RRA document exchange with FDA. Do these documents become subject to potential FOIA requests? These would represent quite a bit of our Design History File potentially.


    Thanks,

    Ed



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

    Original Message


  • 4.  RE: FDA RRA (Remote Regulatory Assessment)

    Posted 27-Jul-2021 16:17
    Edited by Kevin Randall 27-Jul-2021 16:23
    I know of no FOIA exemption regarding FDA inspectional records, whether traditional or RRA.  The general federal records that are within the scope of the FOI Act generally include FDA inspectional records.  Moreover, in its RRA overview documents (see the attachments to my posts in the aforesaid RRA thread), FDA indicated that the agency will use the FOIA process for RRA records.

    However, to guard against that, the common best practice is to leverage the FOIA exemption regarding confidential or privileged trade secrets or commercial or financial information.  To do that, be sure to mark such records accordingly so that in the event of an FOIA request, those records will, in theory, be properly redacted by the agency before release.  That said, I've had clients whose confidential information was compromised via the FOIA process nonetheless.  In any event, the risks of such a breach would seem to be the same for an RRA as it would be for an onsite FDA inspection.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 5.  RE: FDA RRA (Remote Regulatory Assessment)

    Posted 22-Feb-2022 13:42
    FDA Recently stated that RRA will continue to be part of the FDA oversight tools post-Covid. Actual clarity on usage is unclear but if it means how it was used the last 2 years I think that bodes well for lower-risk device manufacturers.

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

    Original Message


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