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  • 1.  FDA Third Party Reviewers

    Posted 22-Oct-2019 14:50
    ​Hello,

    I am looking for third party reviewers for FDA submissions. Does anyone has recommendations for third party reviewers? How quick was the review process and did it go smoothly?

    Thank you!

    ------------------------------
    Akanksha Asbe
    Regulatory Affairs Specialist II
    Clinton MA
    United States
    ------------------------------


  • 2.  RE: FDA Third Party Reviewers

    Posted 22-Oct-2019 19:47
    If you search the forum for "third party," you will find a discussion of this topic last May that may be helpful.

    ------------------------------
    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


  • 3.  RE: FDA Third Party Reviewers

    Posted 23-Oct-2019 02:42
    This is the list of reviewers: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfthirdparty/accredit.cfm.  I personally can not give any recommendations because I am not a proponent of the TPR program; find no benefit dealing with a third party when I can work with the FDA reviewer directly.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: FDA Third Party Reviewers

    Posted 23-Oct-2019 11:22
    Hi Akanksha
    I had a client this year use a third party for their review prior to working with my company.  The review was a train wreck and not because their submission was a mess but because the TPR was extremely nit picky to every letter of every standard and FDA guidance.  Further the TPR had its own "experts" that reviewed biocompatibility and came up with some crazy requirements.  My on bioc experts had never heard FDA ask for what this reviewer asked for (it was a piece of tape and electrode that she said needed an environmental battery of conditioning prior to bioc testing and then needed a crazy test panel).  In my opinion the TPRs have to have everything perfect to submit to FDA for final blessing to protect their designation.  FDA in this case is much more flexible and logical because they have more leeway to accept justifications and formats.  

    I have done at least a half dozen other 510ks this year and the FDA has hit their response clock time every time.  I would advise you to stick with communicating directly with the agency.  Let me know how I can help.

    Thank you
    Michelle

    ------------------------------
    Michelle Lott RAC
    Principal & Founder
    michelle@leanraqa.com
    ------------------------------

    Original Message


  • 5.  RE: FDA Third Party Reviewers

    Posted 23-Oct-2019 16:41
    "In my opinion the TPRs have to have everything perfect to submit to FDA for final blessing to protect their designation.  FDA in this case is much more flexible and logical because they have more leeway to accept justifications and formats."

    Exactly.

    If a company is not comfortable working with FDA, then I would suggest working with an RA consultant who can work with the FDA on your behalf.

    ------------------------------
    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


  • 6.  RE: FDA Third Party Reviewers

    Posted 23-Oct-2019 15:10
    Akanksha,

    FDA publishes quarterly performance metrics for 3rd party review organizations.  I have attached the last couple of reports.  Hope they can help.

    Cheers,
    Melissa

    ------------------------------
    Melissa Walker RAC FRAPS
    President & CTO
    Graematter, Inc.
    St Louis MO
    United States
    ------------------------------

    Attachment(s)

    pdf
    ThirdPartyPerformanceReport FY2019Q3.pdf   1.40 MB 1 version
    pdf
    ThirdPartyPerformanceReportQ4 2019.pdf   1.42 MB 1 version
    Original Message


  • 7.  RE: FDA Third Party Reviewers

    Posted 23-Oct-2019 16:13
    Thank you everyone for all the information - very helpful! ​

    ------------------------------
    Akanksha Asbe
    Regulatory Affairs Specialist II
    Clinton MA
    United States
    ------------------------------

    Original Message


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