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  • 1.  Catch Up 510k - Pros and Cons

    This message was posted by a user wishing to remain anonymous
    Posted 26-Jan-2021 08:38
    This message was posted by a user wishing to remain anonymous

    Hi,

    Hello,

    Have seen some posts on Catch up 510ks in this forum. However can somebody advise on the advantages and disadvantages of choosing this option based on your experience.

    Is it necessary , if you haven't done a 510k in a while , that this is the best option.

    Have read this https://www.nsf.org/newsroom_pdf/md_raps_rf_catch_up_510K.pdf    .

    " During a retrospective review of "letters to file" for a cleared device, a
    510(k) holder may determine one or more "letters to file" were erroneous or overreaching
    in determining the significance of a change(s). In this case, a 510(k) should have been
    submitted prior to implementing the change(s). In such circumstances, a 510(k) holder
    may choose to submit a "catch-up" 510(k) in an effort to mitigate the risk of a Form 483
    or "Warning Letter" resulting from an FDA inspection."

    If the FDA too considers that the recorded changes were significant , how would they review this submission, wouldn't the marketed devices come under scrutiny?


  • 2.  RE: Catch Up 510k - Pros and Cons

    This message was posted by a user wishing to remain anonymous
    Posted 27-Jan-2021 08:32
    This message was posted by a user wishing to remain anonymous

    Ex-FDA here.

    Yes, the marketed devices would come under scrutiny, for the specific changes that are being re-submitted.  This happens frequently...sometimes it's the company who decides they overreached with an LTF -- now and then FDA may find an indication that probably shouldn't have been cleared, or that there has been "indication creep" over years of LTFs.

    In all cases, the marketed device comes under scrutiny, and the manufacturer provides additional data.  If the additional data aren't enough to support, say, a labeling claim that is already on the market, the manufacturer is requested to modify the claim.  I don't know what happens if they don't comply--never ran into that situation.
    Original Message


  • 3.  RE: Catch Up 510k - Pros and Cons

    Posted 27-Jan-2021 10:19

     

     

    Hi original Anon poster,

     

    I agree with the anonymous ex-FDA responder, and would add an additional word of advice.  I've been involved in quite a number of catch-up 510(k)s, and can say from experience that in scrutinizing the marketed product there may be questions raised about whether it can remain on the market while the catch-up submission is being reviewed--especially if a catch-up submission has been requested by FDA.

     

    To manage that particular risk, it's wise to include in your submission some sort of risk assessment that indicates the marketed product does not pose undue risk to patients. One way to do this is to include relevant information from the product's risk management file.  An important component would be the commercial record of the device (i.e., sales and complaint data), supplemented with a discussion of the associated level of risk and its acceptability.

     

    If you are undertaking a catch-up 510(k) on your own volition, commercial record information just confuses reviewers.  As such, it may be better not to include it in the submission, but have it ready to go in case questions arise during the review.  Another option could be to consider a preliminary interaction at the division level before submitting.

     

    Hope that's helpful!  Feel free to contact me directly, if you would like to discuss further.

     

    Best regards,

     

    Ted

     

    --

    Theodore (Ted) Heise, PHD, RAC

    Vice President Regulatory and Clinical Services

     

    MED Institute Inc.

    1330 Win Hentschel Blvd.

    West Lafayette, IN  47906-4149 USA

    765.463.1633 ext. 4444

    http://medinstitute.com

    theise@medinstitute.com

     

     

     




    Original Message


  • 4.  RE: Catch Up 510k - Pros and Cons

    Posted 27-Jan-2021 16:38
    Edited by Rashmi Pillay 27-Jan-2021 16:44
    Hi TEd , ex FDA 


    Is a conventional submission ,then a better approach , or is this not applicable anymore as the changes are already implemented ? 

    ------------------------------
    Rashmi
    ------------------------------

    Original Message


  • 5.  RE: Catch Up 510k - Pros and Cons

    Posted 27-Jan-2021 17:16

     

     

    Hi Rashmi,

     

    I don't see why not.  Just recognize that discussion with the reviewer has the potential to become challenging.

     

    Best regards,

     

    Ted

     

    --

    Theodore (Ted) Heise, PHD, RAC

    Vice President Regulatory and Clinical Services

     

    MED Institute Inc.

    1330 Win Hentschel Blvd.

    West Lafayette, IN  47906-4149 USA

    765.463.1633 ext. 4444

    http://medinstitute.com

    theise@medinstitute.com

     

     

     

     

     




    Original Message


  • 6.  RE: Catch Up 510k - Pros and Cons

    This message was posted by a user wishing to remain anonymous
    Posted 27-Jan-2021 17:37
    This message was posted by a user wishing to remain anonymous

    Interesting question and response from Ex-FDA.

    It is the classic proactive versus reactive question facing RA professionals and their organizations for years.  There will be scrutiny on the product eventually.  An audit / inspection that delves into individual and cumulative changes to a marketed product may raise the issue - typically accompanied by feedback that 'it's never wrong to file (or report or remove)'.

    What is right and what decision the organization takes are not always in agreement.
    Original Message


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